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Drug overview for TOUJEO SOLOSTAR (insulin glargine,human recombinant analog):
Generic name: INSULIN GLARGINE,HUMAN RECOMBINANT ANALOG (IN-su-lin GLAR-jeen)
Drug class: Intermediate-, Long-acting, and Combination Insulins
Therapeutic class: Endocrine
Insulin glargine, insulin glargine-aglr, and insulin glargine-yfgn are biosynthetic (rDNA origin), long-acting human insulin analogs. Insulin glargine (Lantus(R) ) and insulin glargine (Basaglar(R) ) are structurally and pharmacologically similar drugs that contain a related drug substance. Basaglar(R) was licensed by FDA through an abbreviated approval pathway (505(b)(2)) that relied in part on FDA's finding of safety and effectiveness for Lantus(R).
Comparative studies found no substantial differences between the pharmacokinetics, immunogenicity, or toxicity of Lantus(R) and Basaglar(R). Although Basaglar(R) is highly similar to Lantus(R) in terms of composition, strength, presentation, structure, and physicochemical and biological properties, it was not approved as a biosimilar or an interchangeable biologic product. At the time of the approval, insulin was classified by FDA as a chemical, not a biologic product, and there was no biologic reference product for insulin glargine; thus, biosimilarity to insulin glargine could not be established.
Instead, Basaglar(R) was referred to as a ''follow-on'' insulin glargine preparation; FDA determined that there was no need to use a different nonproprietary name (insulin glargine) for Basaglar(R) at that time. Subsequently, the classification of insulin was changed to a biologic product, and Basaglar(R) was included as a "rollover" drug product under this definition; however, Basaglar(R) is still not considered a biosimilar or interchangeable with Lantus(R). Insulin glargine-aglr (Rezvoglar(R)) and insulin glargine-yfgn (Semglee(R)) are biosimilar to insulin glargine (Lantus(R)).
FDA defines a biosimilar as a biological product that is highly similar to an FDA-licensed reference biological with the exception of minor differences in clinically inactive components and for which there are no clinically meaningful differences in safety, purity, or potency. The claim of biosimilarity is based on a totality-of-evidence approach, which includes consideration of data from analytical, animal, and clinical studies (e.g., human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity assessment, additional comparative clinical studies). Therefore, biosimilarity may be established even when there are formulation or minor structural differences as long as these differences are not clinically meaningful.
Biosimilars are approved through an abbreviated licensure pathway that establishes biosimilarity between the proposed biological and the reference biological but does not independently establish safety and effectiveness of the proposed biological. In order to be considered an interchangeable biosimilar, a biological product must meet additional requirements beyond demonstrating biosimilarity to its reference product; these requirements include demonstrating that the biological product can be expected to produce the same clinical results as the reference product in any given patient and, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is no greater than the risk of using the reference product without such alteration or switch. Biosimilar products that are interchangeable can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.
Both insulin glargine-aglr (Rezvoglar(R)) and insulin glargine-yfgn (Semglee(R)) are designated as interchangeable with insulin glargine (Lantus(R)). In this monograph, unless otherwise stated, the term "insulin glargine products" refers to insulin glargine (the reference drug) and its biosimilars (insulin glargine-aglr and insulin glargine-yfgn).
Insulin glargine is commercially available as Lantus(R) (100 units/mL), Basaglar(R) (100 units/mL), and a concentrated preparation (Toujeo(R); 300 units/mL). Two insulin glargine biosimilars are currently available. Biosimilarity of these products has been demonstrated for the indications described in Table 1.
Biosimilarity to originator insulin glargine is additionally supported by comparative clinical studies in patients with type 1 and type 2 diabetes mellitus. Table 1. Insulin Glargine Biosimilar Products and FDA-licensed Indications FDA Labeled Indication Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Insulin glargine-aglr X X Insulin glargine-yfgn X X
Generic name: INSULIN GLARGINE,HUMAN RECOMBINANT ANALOG (IN-su-lin GLAR-jeen)
Drug class: Intermediate-, Long-acting, and Combination Insulins
Therapeutic class: Endocrine
Insulin glargine, insulin glargine-aglr, and insulin glargine-yfgn are biosynthetic (rDNA origin), long-acting human insulin analogs. Insulin glargine (Lantus(R) ) and insulin glargine (Basaglar(R) ) are structurally and pharmacologically similar drugs that contain a related drug substance. Basaglar(R) was licensed by FDA through an abbreviated approval pathway (505(b)(2)) that relied in part on FDA's finding of safety and effectiveness for Lantus(R).
Comparative studies found no substantial differences between the pharmacokinetics, immunogenicity, or toxicity of Lantus(R) and Basaglar(R). Although Basaglar(R) is highly similar to Lantus(R) in terms of composition, strength, presentation, structure, and physicochemical and biological properties, it was not approved as a biosimilar or an interchangeable biologic product. At the time of the approval, insulin was classified by FDA as a chemical, not a biologic product, and there was no biologic reference product for insulin glargine; thus, biosimilarity to insulin glargine could not be established.
Instead, Basaglar(R) was referred to as a ''follow-on'' insulin glargine preparation; FDA determined that there was no need to use a different nonproprietary name (insulin glargine) for Basaglar(R) at that time. Subsequently, the classification of insulin was changed to a biologic product, and Basaglar(R) was included as a "rollover" drug product under this definition; however, Basaglar(R) is still not considered a biosimilar or interchangeable with Lantus(R). Insulin glargine-aglr (Rezvoglar(R)) and insulin glargine-yfgn (Semglee(R)) are biosimilar to insulin glargine (Lantus(R)).
FDA defines a biosimilar as a biological product that is highly similar to an FDA-licensed reference biological with the exception of minor differences in clinically inactive components and for which there are no clinically meaningful differences in safety, purity, or potency. The claim of biosimilarity is based on a totality-of-evidence approach, which includes consideration of data from analytical, animal, and clinical studies (e.g., human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity assessment, additional comparative clinical studies). Therefore, biosimilarity may be established even when there are formulation or minor structural differences as long as these differences are not clinically meaningful.
Biosimilars are approved through an abbreviated licensure pathway that establishes biosimilarity between the proposed biological and the reference biological but does not independently establish safety and effectiveness of the proposed biological. In order to be considered an interchangeable biosimilar, a biological product must meet additional requirements beyond demonstrating biosimilarity to its reference product; these requirements include demonstrating that the biological product can be expected to produce the same clinical results as the reference product in any given patient and, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is no greater than the risk of using the reference product without such alteration or switch. Biosimilar products that are interchangeable can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.
Both insulin glargine-aglr (Rezvoglar(R)) and insulin glargine-yfgn (Semglee(R)) are designated as interchangeable with insulin glargine (Lantus(R)). In this monograph, unless otherwise stated, the term "insulin glargine products" refers to insulin glargine (the reference drug) and its biosimilars (insulin glargine-aglr and insulin glargine-yfgn).
Insulin glargine is commercially available as Lantus(R) (100 units/mL), Basaglar(R) (100 units/mL), and a concentrated preparation (Toujeo(R); 300 units/mL). Two insulin glargine biosimilars are currently available. Biosimilarity of these products has been demonstrated for the indications described in Table 1.
Biosimilarity to originator insulin glargine is additionally supported by comparative clinical studies in patients with type 1 and type 2 diabetes mellitus. Table 1. Insulin Glargine Biosimilar Products and FDA-licensed Indications FDA Labeled Indication Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Insulin glargine-aglr X X Insulin glargine-yfgn X X
DRUG IMAGES
TOUJEO SOLOSTAR 300 UNIT/ML
The following indications for TOUJEO SOLOSTAR (insulin glargine,human recombinant analog) have been approved by the FDA:
Indications:
Type 1 diabetes mellitus
Type 2 diabetes mellitus
Professional Synonyms:
Adult onset diabetes mellitus
Adult onset diabetes
Adult onset DM
Diabetes mellitus type 1
Diabetes mellitus type 2
Diabetes mellitus type II
Immune mediated diabetes mellitus
Insulin dependent diabetes mellitus
Insulin-dependent diabetes mellitus
Insulin-dependent DM
Juvenile diabetes
Juvenile onset DM
Juvenile-onset diabetes mellitus
Juvenile-onset diabetes
Ketosis-prone diabetes mellitus
Ketosis-prone diabetes
Ketosis-prone DM
Ketosis-resistant diabetes mellitus
Ketosis-resistant DM
Maturity onset diabetes mellitus
Maturity onset diabetes
Non-insulin dependent diabetes mellitus
Non-insulin-dependent diabetes mellitus
Type I diabetes mellitus
Type II diabetes mellitus
Indications:
Type 1 diabetes mellitus
Type 2 diabetes mellitus
Professional Synonyms:
Adult onset diabetes mellitus
Adult onset diabetes
Adult onset DM
Diabetes mellitus type 1
Diabetes mellitus type 2
Diabetes mellitus type II
Immune mediated diabetes mellitus
Insulin dependent diabetes mellitus
Insulin-dependent diabetes mellitus
Insulin-dependent DM
Juvenile diabetes
Juvenile onset DM
Juvenile-onset diabetes mellitus
Juvenile-onset diabetes
Ketosis-prone diabetes mellitus
Ketosis-prone diabetes
Ketosis-prone DM
Ketosis-resistant diabetes mellitus
Ketosis-resistant DM
Maturity onset diabetes mellitus
Maturity onset diabetes
Non-insulin dependent diabetes mellitus
Non-insulin-dependent diabetes mellitus
Type I diabetes mellitus
Type II diabetes mellitus
The following dosing information is available for TOUJEO SOLOSTAR (insulin glargine,human recombinant analog):
The dosage of insulin glargine products is expressed in units. Each unit of insulin glargine is approximately equal to 0.036 mg of the drug.
The dosage of the fixed combination of insulin glargine and lixisenatide (insulin glargine/lixisenatide) has been expressed in terms of the insulin glargine component; however, each mL of insulin glargine/lixisenatide contains 100 units of insulin glargine and 33 mcg of lixisenatide.
Individualize dosage based on the patient's metabolic needs, blood glucose determinations, and glycemic control goals to obtain optimum therapeutic effect.
The dosage of the fixed combination of insulin glargine and lixisenatide (insulin glargine/lixisenatide) has been expressed in terms of the insulin glargine component; however, each mL of insulin glargine/lixisenatide contains 100 units of insulin glargine and 33 mcg of lixisenatide.
Individualize dosage based on the patient's metabolic needs, blood glucose determinations, and glycemic control goals to obtain optimum therapeutic effect.
Insulin glargine products are administered by subcutaneous injection once daily into the abdomen, thigh, or upper arm at the same time each day using a conventional insulin syringe or the appropriate injection pen (e.g., SoloStar(R), KwikPen(R)). The fixed combination preparation of insulin glargine and lixisenatide (insulin glargine/lixisenatide) is administered by subcutaneous injection once daily using a prefilled injection pen. Insulin glargine/lixisenatide should be administered within 1 hour before the first meal of the day.
If a dose of insulin glargine/lixisenatide is missed, the patient should resume the once-daily regimen with the next scheduled dose. Insulin glargine products or insulin glargine/lixisenatide should not be administered IV, IM, or via an infusion pump. A planned rotation of sites within an area should be followed to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
Clinical studies have not indicated important differences in absorption of insulin glargine products from the various injection areas (e.g., abdomen, thigh, upper arm). It is not necessary to shake the vials of insulin glargine products prior to measuring the dosage. Insulin glargine products or insulin glargine/lixisenatide should not be mixed with other insulins, other drugs, or diluted with other solutions.
Insulin glargine products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit. The drug should be administered only if the solution is clear, colorless, and without particulates. Unopened injection pens and vials containing insulin glargine products 100 units/mL should be stored at 2-8degreesC and protected from direct heat and light until the expiration date; the drug should not be frozen.
Alternatively, unopened injection pens and vials containing insulin glargine products 100 units/mL may be stored at room temperature (below 30degreesC) and away from direct heat and light for up to 28 days. Opened (in-use) vials containing insulin glargine products 100 units/mL should be stored at 2-8degreesC for up to 28 days. Alternatively, such in-use vials may be stored at room temperature away from direct heat and light for up to 28 days.
In-use injection pens of insulin glargine products 100 units/mL (e.g., Kwikpen(R), SoloStar(R)) should be stored at room temperature away from heat and direct light for up to 28 days; in-use injection pens should not be refrigerated. Unopened injection pens of insulin glargine 300 units/mL (Toujeo(R)) should be stored at 2-8degreesC and protected from direct heat and light until the expiration date; the drug should not be frozen. In-use injection pens of insulin glargine 300 units/mL should be stored at room temperature away from heat and direct light for up to 56 days; such in-use injection pens should not be refrigerated.
Injection pens containing insulin glargine/lixisenatide should be stored at 2-8degreesC in the original carton and protected from light before first use; after first use, the injection pens should be stored at room temperature below 25degreesC. The injection pens should not be frozen; they should not be used if freezing has occurred. Injection pens of insulin glargine/lixisenatide should be discarded 28 days after first use, even if some drug remains in the pen. The accompanying labeling should be consulted for additional details about the administration of insulin glargine products or insulin glargine/lixisenatide.
If a dose of insulin glargine/lixisenatide is missed, the patient should resume the once-daily regimen with the next scheduled dose. Insulin glargine products or insulin glargine/lixisenatide should not be administered IV, IM, or via an infusion pump. A planned rotation of sites within an area should be followed to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
Clinical studies have not indicated important differences in absorption of insulin glargine products from the various injection areas (e.g., abdomen, thigh, upper arm). It is not necessary to shake the vials of insulin glargine products prior to measuring the dosage. Insulin glargine products or insulin glargine/lixisenatide should not be mixed with other insulins, other drugs, or diluted with other solutions.
Insulin glargine products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit. The drug should be administered only if the solution is clear, colorless, and without particulates. Unopened injection pens and vials containing insulin glargine products 100 units/mL should be stored at 2-8degreesC and protected from direct heat and light until the expiration date; the drug should not be frozen.
Alternatively, unopened injection pens and vials containing insulin glargine products 100 units/mL may be stored at room temperature (below 30degreesC) and away from direct heat and light for up to 28 days. Opened (in-use) vials containing insulin glargine products 100 units/mL should be stored at 2-8degreesC for up to 28 days. Alternatively, such in-use vials may be stored at room temperature away from direct heat and light for up to 28 days.
In-use injection pens of insulin glargine products 100 units/mL (e.g., Kwikpen(R), SoloStar(R)) should be stored at room temperature away from heat and direct light for up to 28 days; in-use injection pens should not be refrigerated. Unopened injection pens of insulin glargine 300 units/mL (Toujeo(R)) should be stored at 2-8degreesC and protected from direct heat and light until the expiration date; the drug should not be frozen. In-use injection pens of insulin glargine 300 units/mL should be stored at room temperature away from heat and direct light for up to 56 days; such in-use injection pens should not be refrigerated.
Injection pens containing insulin glargine/lixisenatide should be stored at 2-8degreesC in the original carton and protected from light before first use; after first use, the injection pens should be stored at room temperature below 25degreesC. The injection pens should not be frozen; they should not be used if freezing has occurred. Injection pens of insulin glargine/lixisenatide should be discarded 28 days after first use, even if some drug remains in the pen. The accompanying labeling should be consulted for additional details about the administration of insulin glargine products or insulin glargine/lixisenatide.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for TOUJEO SOLOSTAR (insulin glargine,human recombinant analog):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Antidiabetic Agents/Gatifloxacin SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The exact mechanism is unknown. CLINICAL EFFECTS: Concurrent use of gatifloxacin may result in hypoglycemia and/or hyperglycemia.(1-4) Hypoglycemia is more common during the first three days of concurrent therapy. Hyperglycemia is more common after the first three days of concurrent therapy.(2) PREDISPOSING FACTORS: Elderly patients, especially those with decreased renal function may be predisposed to this interaction.(2) PATIENT MANAGEMENT: Patients receiving concurrent gatifloxacin should be closely monitored for hypoglycemia during the first three days of concurrent therapy and for hyperglycemia after the first three days of concurrent therapy. Patients should be instructed to discontinue gatifloxacin if hypoglycemia or hyperglycemia occur.(2) DISCUSSION: Hypoglycemia has been reported with gatifloxacin and glyburide(1,5,6) or glimepiride.(7) In a study in patients with type 2 diabetes mellitus, concurrent gatifloxacin (400 mg daily for 10 days) had no effect on the pharmacokinetics of glyburide (steady state daily regimen); however, pharmacodynamic interactions have been reported.(2) Health Canada has received 19 reports of hypoglycemia in patients taking gatifloxacin. Seventeen of these involved concurrent hypoglycemic agents. Health Canada has received 2 reports of hyperglycemia in patients taking gatifloxacin and hypoglycemic agents. Health Canada has received 2 reports of patients experiencing hypoglycemia and hyperglycemia during concurrent gatifloxacin and hypoglycemic agents.(3) In a study, 13 reports of dysglycemia were reported in patients taking gatifloxacin. Ten of these patients had diabetes mellitus and were on concurrent hypoglycemic agents. Of these ten patients, nine patients experienced hypoglycemia, while one patient experienced hyperglycemia.(8) |
GATIFLOXACIN SESQUIHYDRATE |
There are 12 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Antidiabetics/Epinephrine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Gluconeogenesis, glycogenolysis, and lipolysis are increased by epinephrine. Also, insulin secretion and glucose uptake by peripheral tissues are decreased by epinephrine. CLINICAL EFFECTS: Increased blood glucose resulting in decreased effectiveness of the antidiabetic agent. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Caution when starting or stopping epinephrine in diabetic patients. Adjust the antidiabetic dose as needed based on blood glucose levels. DISCUSSION: This interaction is likely to occur based upon well documented properties of the interacting drugs. However, there is individual variability in its occurrence. |
ADRENALIN, ARTICADENT DENTAL, ARTICAINE-EPINEPHRINE, ARTICAINE-EPINEPHRINE BIT, BUFFERED LIDOCAINE-EPINEPHRINE, BUPIVACAINE HCL-EPINEPHRINE, BUPIVACAINE-DEXAMETH-EPINEPHRN, CITANEST FORTE DENTAL, EPINEPHRINE, EPINEPHRINE BITARTRATE, EPINEPHRINE HCL-0.9% NACL, EPINEPHRINE HCL-D5W, EPINEPHRINE-0.9% NACL, EPINEPHRINE-D5W, LIDOCAINE HCL-EPINEPHRINE, LIDOCAINE HCL-EPINEPHRINE-NACL, LIDOCAINE-EPINEPHRINE, LIGNOSPAN STANDARD, MARCAINE-EPINEPHRINE, ORABLOC, R.E.C.K.(ROPIV-EPI-CLON-KETOR), RACEPINEPHRINE HCL, SENSORCAINE-EPINEPHRINE, SENSORCAINE-MPF EPINEPHRINE, SEPTOCAINE, VIVACAINE, XYLOCAINE DENTAL-EPINEPHRINE, XYLOCAINE WITH EPINEPHRINE, XYLOCAINE-MPF WITH EPINEPHRINE |
| Selected Antidiabetics/MAOIs SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The exact mechanism by which MAO inhibitors affect carbohydrate metabolism and subsequent enhancement of the hypoglycemic action of insulin is not clear. The adrenergic response to hypoglycemia may be blocked by insulin release caused by MAOI's. In vitro studies have shown that MAO inhibitors are capable of both potentiating and inhibiting insulin release, depending on their concentrations. Stimulation of glucose-mediated insulin secretion is believed to be related to the MAO inhibitory effects of the drugs. CLINICAL EFFECTS: The hypoglycemic response to both insulin and glucose lowering agents including alpha glucosidase inhibitors, meglitinides, and sulfonylurea may be increased. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Concurrent MAO inhibitor therapy for depression in a diabetic patient will often require reduction in dosage of the hypoglycemic agent because of enhanced hypoglycemic effects. Since the extent of the reaction is highly unpredictable, any diabetic patients receiving MAO inhibitors should be monitored for possible excessive hypoglycemia. DISCUSSION: This interaction is likely to occur. The interaction between MAOIs and insulin is well documented. Additional documentation is necessary to confirm the potential interaction of MAOI's with other glucose lowering agents including alpha glucosidase inhibitors, meglitinides, and sulfonylureas but is expected to occur based on pharmacologic similarity. It may take several weeks for the full hypoglycemic effect of the MAOI to occur. Conversely, it may take several weeks for the effect to dissipate after stopping the MAOI. Furazolidone is known to be a monoamine oxidase inhibitor. Methylene blue, when administered intravenously, has been shown to reach sufficient concentrations to be a potent inhibitor of MAO-A. Metaxalone is a weak inhibitor of MAO. |
AZILECT, EMSAM, FURAZOLIDONE, LINEZOLID, LINEZOLID-0.9% NACL, LINEZOLID-D5W, MARPLAN, MATULANE, METAXALONE, METHYLENE BLUE, NARDIL, PARNATE, PHENELZINE SULFATE, PROCARBAZINE HCL, PROVAYBLUE, RASAGILINE MESYLATE, SELEGILINE HCL, TRANYLCYPROMINE SULFATE, ZELAPAR, ZYVOX |
| Thiazides/Antidiabetics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Thiazides antagonize hypoglycemic effects of antidiabetics due to intrinsic hyperglycemic activity. CLINICAL EFFECTS: Impaired glucose tolerance and diminished hypoglycemic effects of antidiabetics may occur. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Caution when starting or stopping thiazides in diabetic patients. Adjust the antidiabetic dose as needed based on blood glucose levels. DISCUSSION: This interaction is likely to occur based upon well documented properties of the interacting drugs. However, there is individual variability in its occurrence. A cross-sectional study of 425 outpatients found 46 patients with 86 suspected drug interactions resulting in uncontrolled glycemia. Recorded drug interactions included hydrochlorothiazide-gliclazide (22.1%), hydrochlorothiazide-insulins (2.3%), and chlorothiazide-gliclazide (1.2%). Using the drug interaction probability scale (DIPS), these drug interactions were categorized as possible.(2) |
ACCURETIC, AMILORIDE-HYDROCHLOROTHIAZIDE, AMLODIPINE-VALSARTAN-HCTZ, ATACAND HCT, ATENOLOL-CHLORTHALIDONE, AVALIDE, BENAZEPRIL-HYDROCHLOROTHIAZIDE, BENICAR HCT, BISOPROLOL-HYDROCHLOROTHIAZIDE, CANDESARTAN-HYDROCHLOROTHIAZID, CAPTOPRIL-HYDROCHLOROTHIAZIDE, CHLOROTHIAZIDE, CHLOROTHIAZIDE SODIUM, CHLORTHALIDONE, DIOVAN HCT, DIURIL, EDARBYCLOR, ENALAPRIL-HYDROCHLOROTHIAZIDE, EXFORGE HCT, FOSINOPRIL-HYDROCHLOROTHIAZIDE, HEMICLOR, HYDROCHLOROTHIAZIDE, HYZAAR, INDAPAMIDE, INZIRQO, IRBESARTAN-HYDROCHLOROTHIAZIDE, LISINOPRIL-HYDROCHLOROTHIAZIDE, LOSARTAN-HYDROCHLOROTHIAZIDE, LOTENSIN HCT, METHYLDOPA-HYDROCHLOROTHIAZIDE, METOLAZONE, METOPROLOL-HYDROCHLOROTHIAZIDE, MICARDIS HCT, OLMESARTAN-AMLODIPINE-HCTZ, OLMESARTAN-HYDROCHLOROTHIAZIDE, PROPRANOLOL-HYDROCHLOROTHIAZID, QUINAPRIL-HYDROCHLOROTHIAZIDE, SPIRONOLACTONE-HCTZ, TELMISARTAN-HYDROCHLOROTHIAZID, TENORETIC 100, TENORETIC 50, THALITONE, TRIAMTERENE-HYDROCHLOROTHIAZID, TRIBENZOR, TRICHLORMETHIAZIDE, VALSARTAN-HYDROCHLOROTHIAZIDE, VASERETIC, ZESTORETIC |
| Insulin/Fenfluramine;Dexfenfluramine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Fenfluramine increases glucose uptake at the receptor site (ie, skeletal muscle). CLINICAL EFFECTS: The hypoglycemic effect of insulin is increased. PREDISPOSING FACTORS: Diabetes. PATIENT MANAGEMENT: In diabetic patients receiving insulin, monitor blood glucose levels and observe the patient for signs of hypoglycemia when initiating therapy with fenfluramine and for symptoms of hyperglycemia when fenfluramine is discontinued. DISCUSSION: When administered before meals or to fasting patients, fenfluramine has been found to have hypoglycemic action. Numerous reports have demonstrated fenfluramine to potentiate the hypoglycemic effect of insulin in diabetic patients. |
FINTEPLA |
| Pioglitazone/Insulin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The exact mechanism is unknown, but may be the result of additive fluid retention.(1,2) CLINICAL EFFECTS: The concurrent use of pioglitazone with insulin may increase the risk of edema and heart failure.(1,2) PREDISPOSING FACTORS: Specific risk factors for heart failure could not be determined. Patients with ongoing edema are more likely to have edema-associated adverse effects with combination therapy.(1) PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for cardiovascular adverse events. If signs and symptoms of congestive heart failure develop, patients should be treated according to current standards of care. Consideration should be given to lowering the dosage of or discontinuing pioglitazone.(1,2) DISCUSSION: In a clinical trial, two of 191 (1.1%) of patients receiving pioglitazone (15 mg) and insulin and two of 188 (1.1%) of patients receiving pioglitazone (30 mg) and insulin developed congestive heart failure. None of the patients receiving insulin alone developed congestive heart failure.(1) |
ACTOPLUS MET, ACTOS, ALOGLIPTIN-PIOGLITAZONE, DUETACT, OSENI, PIOGLITAZONE HCL, PIOGLITAZONE-GLIMEPIRIDE, PIOGLITAZONE-METFORMIN |
| Bupropion/Hypoglycemics; Insulin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Bupropion can lower the seizure threshold and when given concurrently with other medications that also lower the threshold there is an increased risk of seizure.(1,2) CLINICAL EFFECTS: Concurrent use of bupropion and hypoglycemics or insulin may increase the risk of seizure.(1,2) PREDISPOSING FACTORS: The risk of seizures may be increased in patients with a history of head trauma or prior seizure; CNS tumor; severe hepatic cirrhosis; excessive use of alcohol or sedatives; addiction to opiates, cocaine, or stimulants; use of over-the-counter stimulants an anorectics; a total daily dose of bupropion greater than 450 mg or single doses greater than 150 mg; rapid escalation of bupropion dosage; or with concomitant medications known to lower seizure threshold (antidepressants, antipsychotics, systemic steroids, theophylline).(1,2) PATIENT MANAGEMENT: The use of bupropion in patients treated with oral hypoglycemic agents or insulin should be undertaken only with extreme caution and with low initial bupropion dosing and small gradual dosage increases.(1,2) Single doses should not exceed 150 mg.(1,2) The maximum daily dose of bupropion should not exceed 300 mg for smoking cessation(2) or 450 mg for depression.(1) DISCUSSION: Because of the risk of seizure from concurrent bupropion and other agents that lower seizure threshold, the manufacturer of bupropion states that the concurrent use of bupropion and oral hypoglycemic agents or insulin should be undertaken only with extreme caution and with low initial bupropion dosing and small gradual dosage increases.(1,2) |
APLENZIN, AUVELITY, BUPROPION HCL, BUPROPION HCL SR, BUPROPION XL, CONTRAVE, FORFIVO XL, WELLBUTRIN SR, WELLBUTRIN XL |
| Selected Antidiabetic Agents/Selected Quinolones SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The exact mechanism is unknown. CLINICAL EFFECTS: Concurrent use of quinolones and antidiabetic agents may result in severe hypoglycemia.(1-7) Hypoglycemia can lead to coma. PREDISPOSING FACTORS: Elderly patients, especially those with decreased renal function may be predisposed to this interaction.(5) PATIENT MANAGEMENT: Patients maintained on antidiabetic agents who require concurrent therapy with a quinolone should be closely monitored for hypoglycemia.(1-4) Patients should be instructed to discontinue quinolone use and contact their doctor if hypoglycemia occurs.(2,4) Signs of hypoglycemia may include confusion, dizziness, feeling shaky, unusual hunger, headaches, irritability, pounding heart or very fast pulse, pale skin, sweating, trembling, weakness, or unusual anxiety. DISCUSSION: Hypoglycemia has been reported with concurrent ciprofloxacin and glyburide,(1,8,9) levofloxacin and glyburide,(2,10,11) norfloxacin and glyburide,(3) levofloxacin and glipizide (12) as well as levofloxacin and metformin-glibenclamide.(14) There has been one report of fatal hypoglycemia with concurrent levofloxacin and glyburide(9) and one of the above reports of hypoglycemia with concurrent levofloxacin and glyburide resulted in hypoxic brain injury.(11) A review of postmarketing adverse event data for the fluoroquinolones and hypoglycemic coma identified 56 reports in FAERS search from October 1987- April 2017 and 11 additional cases in the medical literature. Most patients had risk factors for hypoglycemia. 41 patients were taking one or more hypoglycemic drugs. 13 deaths occurred (some of these patients had renal insufficiency). 9 patients did not fully recover and had resultant disability.(13) |
AVELOX IV, BAXDELA, CIPRO, CIPROFLOXACIN, CIPROFLOXACIN HCL, CIPROFLOXACIN-D5W, LEVOFLOXACIN, LEVOFLOXACIN HEMIHYDRATE, LEVOFLOXACIN-D5W, MOXIFLOXACIN, MOXIFLOXACIN HCL, OFLOXACIN |
| Antidiabetics/Selected Ophthalmic Non-Cardioselective Beta-Blockers SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Not fully established. Probably blockade of a variety of beta-adrenergic responses to hypoglycemia.(1,2) CLINICAL EFFECTS: Diminished response to sulfonylureas and insulin may occur. Frequency and severity of hypoglycemic episodes may be increased, while warning symptoms of low blood sugar may be masked.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Try to avoid beta-blocker therapy, particularly in diabetics prone to hypoglycemic attacks. One of the cardioselective agents may decrease risk of hypertensive attacks and allow more rapid glucose recovery from hypoglycemia. Patients should be counseled not to rely on tachycardia to diagnose hypoglycemia, since it is masked by beta-blocker therapy. Diaphoresis is unaffected by beta-blockade and can be used by the diabetic to recognize hypoglycemia. DISCUSSION: A double blind, randomized, 12 month study of 39 patients tested the metabolic effects of pindolol (5mg BID) compared to control group on insulin sensitivity. The patient's insulin sensitivity index decreased 17% when on pindolol treatment compared to placebo (p<0.01). Insulin mediated glucose uptake was significantly lower (p<0.05) with propranolol treatment than with placebo.(3) A study of 26 patients with chronic heart failure showed that carvedilol (average daily dose 27.5mg/d) caused a significant decrease in fasting insulin levels (17.09 to 10.77 microU/ml, p <0.05) compared to pre-treatment levels. This trial also showed that patients on carvedilol had significantly (p=0.015) lower fasting insulin levels (10.77 microU/ml) compared to the fasting insulin levels (20.72 microU/ml) of patients on bisoprolol treatment (5.9mg/d).(4) There have been case reports of hypoglycemia following the addition of ophthalmic timolol to a diabetic regimen.(5-7) Studies have shown that ophthalmic beta-blockers, especially the aqueous solution, have significant systemic absorption and do not undergo first-pass metabolism.(8,9) |
BETIMOL, BIMATOPROST-DORZOLAMID-TIMOLOL, BRIMONIDINE TARTRATE-TIMOLOL, CARTEOLOL HCL, COMBIGAN, COSOPT, COSOPT PF, DORZOLAMIDE-TIMOLOL, ISTALOL, LEVOBUNOLOL HCL, TIMOLOL, TIMOLOL MALEATE, TIMOLOL-BIMATOPROST, TIMOLOL-BRIMONI-DORZOL-BIMATOP, TIMOLOL-BRIMONIDIN-DORZOLAMIDE, TIMOLOL-DORZOLAMIDE-BIMATOPRST, TIMOPTIC OCUDOSE |
| Insulin/Selected Systemic Non-Cardioselective Beta-Blockers SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Not fully established. Probably blockade of a variety of beta-adrenergic responses to hypoglycemia. CLINICAL EFFECTS: Diminished response to insulin may occur. Frequency and severity of hypoglycemic episodes may be increased, while warning symptoms of low blood sugar may be masked. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Try to avoid beta-blocker therapy, particularly in diabetics prone to hypoglycemic attacks. One of the cardioselective agents may decrease risk of hypertensive attacks and allow more rapid glucose recovery from hypoglycemia. Patients should be counseled not to rely on tachycardia to diagnose hypoglycemia, since it is masked by beta-blocker therapy. Diaphoresis is unaffected by beta-blockade and can be used by the diabetic to recognize hypoglycemia. DISCUSSION: A class effect of diminished glucose-lowering effects is expected with concurrent use of beta-blockers and insulin. It is prudent to monitor serum glucose closely in patients receiving beta-blocker therapy because symptoms of hypoglycemia may be masked. A double blind, randomized, 12 month study of 39 patients tested the metabolic effects of pindolol (5 mg BID) compared to control group on insulin sensitivity. The patient's insulin sensitivity index decreased 17% when on pindolol treatment compared to placebo (p<0.01). Insulin mediated glucose uptake was significantly lower (p<0.05) with propranolol treatment than with placebo. (1) A study of 26 patients with chronic heart failure showed that carvedilol (average daily dose 27.5 mg/d) caused a significant decrease in fasting insulin levels (17.09 to 10.77 microU/ml, p <0.05) compared to pre-treatment levels. This trial also showed that patients on carvedilol had significantly (p=0.015) lower fasting insulin levels (10.77 microU/ml) compared to the fasting insulin levels (20.72 microU/ml) of patients on bisoprolol treatment (5.9mg/d).(2) |
BETAPACE, BETAPACE AF, HEMANGEOL, INDERAL LA, INDERAL XL, INNOPRAN XL, NADOLOL, PINDOLOL, PROPRANOLOL HCL, PROPRANOLOL HCL ER, PROPRANOLOL-HYDROCHLOROTHIAZID, SOTALOL, SOTALOL AF, SOTALOL HCL, SOTYLIZE, TIMOLOL MALEATE |
| Insulin/Carvedilol; Labetalol SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Not fully established. Probably blockade of a variety of beta-adrenergic responses to hypoglycemia. CLINICAL EFFECTS: Diminished response to insulin may occur. Frequency and severity of hypoglycemic episodes may be increased, while warning symptoms of low blood sugar may be masked. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Try to avoid beta-blocker therapy, particularly in diabetics prone to hypoglycemic attacks. One of the cardioselective agents may decrease risk of hypertensive attacks and allow more rapid glucose recovery from hypoglycemia. Patients should be counseled not to rely on tachycardia to diagnose hypoglycemia, since it is masked by beta-blocker therapy. Diaphoresis is unaffected by beta-blockade and can be used by the diabetic to recognize hypoglycemia. DISCUSSION: A class effect of diminished glucose-lowering effects is expected with concurrent use of beta-blockers and insulin. It is prudent to monitor serum glucose closely in patients receiving beta-blocker therapy because symptoms of hypoglycemia may be masked. A double blind, randomized, 12 month study of 39 patients tested the metabolic effects of pindolol (5 mg BID) compared to control group on insulin sensitivity. The patient's insulin sensitivity index decreased 17% when on pindolol treatment compared to placebo (p<0.01). Insulin mediated glucose uptake was significantly lower (p<0.05) with propranolol treatment than with placebo. (1) A study of 26 patients with chronic heart failure showed that carvedilol (average daily dose 27.5 mg/d) caused a significant decrease in fasting insulin levels (17.09 to 10.77 microU/ml, p <0.05) compared to pre-treatment levels. This trial also showed that patients on carvedilol had significantly (p=0.015) lower fasting insulin levels (10.77 microU/ml) compared to the fasting insulin levels (20.72 microU/ml) of patients on bisoprolol treatment (5.9mg/d).(2) |
CARVEDILOL, CARVEDILOL ER, COREG, COREG CR, LABETALOL HCL, LABETALOL HCL-WATER |
| Selected Antidiabetic Agents/Chloroquine; Hydroxychloroquine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The exact mechanism is unknown. Chloroquine and hydroxychloroquine may increase insulin sensitivity by inhibiting insulin metabolism and inflammation and increasing cellular uptake of glucose and glycogen synthesis.(1,2) These effects may result in additive hypoglycemia with anti-diabetic agents. CLINICAL EFFECTS: Concurrent use of chloroquine or hydroxychloroquine and antidiabetic agents may result in severe hypoglycemia.(3) Hypoglycemia can lead to coma. PREDISPOSING FACTORS: Elderly patients, especially those with decreased renal function may be predisposed to this interaction. PATIENT MANAGEMENT: Patients maintained on antidiabetic agents who require concurrent therapy with chloroquine or hydroxychloroquine should be closely monitored for hypoglycemia. A decrease in the dose of insulin or other anti-diabetic medications may be required. Patients should be advised of the risk and symptoms of hypoglycemia and to contact their doctor if hypoglycemia occurs.(3) Signs of hypoglycemia may include confusion, dizziness, feeling shaky, unusual hunger, headaches, irritability, pounding heart or very fast pulse, pale skin, sweating, trembling, weakness, or unusual anxiety. DISCUSSION: Hydroxychloroquine has been shown to cause severe hypoglycemia including loss of consciousness that could be life threatening.(3) Concomitant hypoglycemic agents may increase the risk and/or severity of this effect. A 77 year old man who was stable on twice daily insulin suffered two episodes of hypoglycemic coma 2 weeks after starting prednisone 5 mg daily and hydroxychloroquine 400 mg daily for rheumatoid arthritis. His insulin dosage required a decrease of 37%.(4) Many studies have investigated the glucose-lowering effect of hydroxychloroquine. In a clinical trial of type II diabetics on maximal doses of sulfonylureas, addition of hydroxychloroquine lowered hemoglobin A1C (HbA1C) up to 1% more than placebo.(5) Another clinical trial of type II diabetics on metformin and glimepiride or gliclazide found that hydroxychloroquine 400 mg daily reduced fasting blood glucose (FBG), post-prandial glucose (PPG), and HbA1C to a similar degree as pioglitazone 15 mg daily at 24 weeks.(6) In a prospective observational study, 250 uncontrolled type II diabetics on metformin, glimepiride, pioglitazone, sitagliptin, and a SGLT-2 inhibitor received hydroxychloroquine 400 mg daily for 48 weeks. HbA1C decreased from 8.83% to 6.44%, FBG decreased by 40.78%, and PPG decreased by 58.95%. The doses of metformin were reduced by 50%, glimepiride and sitagliptin by 75%, and SGLT-2 inhibitors were discontinued in most patients.(7) |
CHLOROQUINE PHOSPHATE, HYDROXYCHLOROQUINE SULFATE, PLAQUENIL, SOVUNA |
| Selected Antidiabetics/Safinamide SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The exact mechanism by which MAO inhibitors such as safinamide affect carbohydrate metabolism and subsequent enhancement of the hypoglycemic action of insulin is not clear. The adrenergic response to hypoglycemia may be blocked by insulin release caused by MAOI's. In vitro studies have shown that MAO inhibitors are capable of both potentiating and inhibiting insulin release, depending on their concentrations. Stimulation of glucose-mediated insulin secretion is believed to be related to the MAO inhibitory effects of the drugs. CLINICAL EFFECTS: The hypoglycemic response to both insulin and glucose lowering agents including alpha glucosidase inhibitors, meglitinides, and sulfonylurea may be increased. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Concurrent MAO inhibitor therapy for depression in a diabetic patient will often require reduction in dosage of the hypoglycemic agent because of enhanced hypoglycemic effects. Since the extent of the reaction is highly unpredictable, any diabetic patients receiving MAO inhibitors should be monitored for possible excessive hypoglycemia. DISCUSSION: This interaction is likely to occur. The interaction between MAOIs and insulin is well documented. Additional documentation is necessary to confirm the potential interaction of MAOI's with other glucose lowering agents including alpha glucosidase inhibitors, meglitinides, and sulfonylureas but is expected to occur based on pharmacologic similarity. It may take several weeks for the full hypoglycemic effect of the MAOI to occur. Conversely, it may take several weeks for the effect to dissipate after stopping the MAOI. |
XADAGO |
The following contraindication information is available for TOUJEO SOLOSTAR (insulin glargine,human recombinant analog):
Drug contraindication overview.
*Known hypersensitivity to insulin glargine or any ingredient in the preparation. *During episodes of hypoglycemia.
*Known hypersensitivity to insulin glargine or any ingredient in the preparation. *During episodes of hypoglycemia.
There are 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Hypoglycemic disorder |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Disease of liver |
| Hypokalemia |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for TOUJEO SOLOSTAR (insulin glargine,human recombinant analog):
Adverse reaction overview.
Common adverse effects associated with insulin glargine products during clinical trials include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain. Adverse effects occurring in at least 5% patients receiving insulin glargine/lixisenatide in clinical trials include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.
Common adverse effects associated with insulin glargine products during clinical trials include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain. Adverse effects occurring in at least 5% patients receiving insulin glargine/lixisenatide in clinical trials include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.
There are 11 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Hypersensitivity drug reaction Hypertension |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Bronchospastic pulmonary disease Dyspnea Hypoglycemic disorder Hypokalemia Hypotension Localized cutaneous amyloidosis Tongue swelling |
There are 22 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Pharyngitis |
Back pain Bronchitis Cataracts Cough Depression Edema Injection site sequelae Lipodystrophy Peripheral edema Rhinitis Sinusitis Skin rash Urinary tract infection Weight gain |
| Rare/Very Rare |
|---|
|
Diarrhea Headache disorder Lip swelling Pruritus of skin Subcutaneous nodules Upper respiratory infection Urticaria |
The following precautions are available for TOUJEO SOLOSTAR (insulin glargine,human recombinant analog):
Safety and efficacy of the 100-unit/mL preparations of insulin glargine products (Lantus(R), Semglee(R), Rezvoglar(R) ) have been established in pediatric patients. Use for this indication is supported by evidence from an adequate and well-controlled study in 174 pediatric patients 6--15 years of age with type 1 diabetes mellitus, and from adequate and well-controlled studies in adults with diabetes mellitus. In the pediatric clinical study, pediatric patients with type 1 diabetes mellitus had a higher incidence of severe symptomatic hypoglycemia compared to adults in studies with type 1 diabetes mellitus.
Safety and efficacy of the 100-unit/mL preparation of insulin glargine (Basaglar(R)) have been established in pediatric patients 6--15 years of age with type 1 diabetes mellitus based on an adequate and well-controlled trial of another insulin glargine product in pediatric patients 6--15 years of age with type 1 diabetes mellitus and additional data in adult patients with type 1 diabetes mellitus. In the pediatric clinical trials, pediatric patients (aged 6--15 years) with type 1 diabetes mellitus had a higher incidence of severe symptomatic hypoglycemia compared to adults in trials with type 1 diabetes mellitus. Safety and efficacy have not been established in children younger than 6 years of age with type 1 diabetes mellitus or in pediatric patients with type 2 diabetes mellitus.
Safety and efficacy of the 300-unit/mL preparation of insulin glargine (Toujeo(R)) have been established in pediatric patients 6 years of age and older with diabetes mellitus. Use for this indication is supported by evidence from an adequate and well-controlled study in 463 pediatric patients 6--17 years of age with type 1 diabetes mellitus and from studies in adults with diabetes mellitus. Safety and efficacy of the 300-unit/mL preparation of insulin glargine (Toujeo(R)) have not been established in children younger than 6 years of age. Safety and efficacy of insulin glargine/lixisenatide have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Safety and efficacy of the 100-unit/mL preparation of insulin glargine (Basaglar(R)) have been established in pediatric patients 6--15 years of age with type 1 diabetes mellitus based on an adequate and well-controlled trial of another insulin glargine product in pediatric patients 6--15 years of age with type 1 diabetes mellitus and additional data in adult patients with type 1 diabetes mellitus. In the pediatric clinical trials, pediatric patients (aged 6--15 years) with type 1 diabetes mellitus had a higher incidence of severe symptomatic hypoglycemia compared to adults in trials with type 1 diabetes mellitus. Safety and efficacy have not been established in children younger than 6 years of age with type 1 diabetes mellitus or in pediatric patients with type 2 diabetes mellitus.
Safety and efficacy of the 300-unit/mL preparation of insulin glargine (Toujeo(R)) have been established in pediatric patients 6 years of age and older with diabetes mellitus. Use for this indication is supported by evidence from an adequate and well-controlled study in 463 pediatric patients 6--17 years of age with type 1 diabetes mellitus and from studies in adults with diabetes mellitus. Safety and efficacy of the 300-unit/mL preparation of insulin glargine (Toujeo(R)) have not been established in children younger than 6 years of age. Safety and efficacy of insulin glargine/lixisenatide have not been established in pediatric patients.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Published studies with use of insulin glargine products during pregnancy have not reported a clear association with adverse developmental outcomes including major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups. In animal reproduction studies, rats and rabbits were exposed to insulin glargine during organogenesis at 50 and 10 times the human subcutaneous dosage of 0.2
units/kg per day, respectively. Overall, the effects of insulin glargine products did not generally differ from those observed with regular human insulin. However, dilation of the cerebral ventricles was observed in some rabbit fetuses.
There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy, including increased maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications, and increased fetal risk of major birth defects, stillbirth, and macrosomia-related morbidity. There may be risks to the fetus from exposure to lixisenatide during pregnancy based on animal reproduction studies. Insulin glargine/lixisenatide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
units/kg per day, respectively. Overall, the effects of insulin glargine products did not generally differ from those observed with regular human insulin. However, dilation of the cerebral ventricles was observed in some rabbit fetuses.
There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy, including increased maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications, and increased fetal risk of major birth defects, stillbirth, and macrosomia-related morbidity. There may be risks to the fetus from exposure to lixisenatide during pregnancy based on animal reproduction studies. Insulin glargine/lixisenatide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
There are either no or limited data on the presence of insulin glargine products in human milk, the effects on the breast-fed infant, or the effects on milk production. Endogenous insulin is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for insulin glargine products, and any potential adverse effects on the breast-fed child from insulin glargine products or from the underlying maternal condition.
Of the total number of subjects enrolled in clinical studies of patients with type 1 and type 2 diabetes mellitus who were treated with the 100-unit/mL preparation of insulin glargine (Lantus(R)), 316 patients (15%) were >=65 years of age and 42 patients (2%) were >=75 years of age. Of the total number of subjects enrolled in clinical studies of patients with type 2 diabetes who were treated with the 100-unit/mL preparation of insulin glargine (Basaglar(R)) or another insulin glargine product, each in combination with oral agents in a controlled clinical trial environment, 28.3% of patients were >=65 years of age and 4.5%
were >=75 years of age. In controlled clinical studies with the 300-unit/mL preparation of insulin glargine (Toujeo(R)), 30 patients (9.8%) with type 1 diabetes mellitus and 327 patients (26.3%) with type 2 diabetes mellitus were >=65 years of age; among them, 2% with type 1 diabetes mellitus and 3% with type 2 diabetes mellitus were >=75 years of age. In controlled clinical studies with insulin glargine/lixisenatide, 210 patients (25.2%) were >=65 years of age and 33 patients (4%) were >=75 years of age.
No overall differences in safety or effectiveness were observed between patients >=65 years of age and younger adult patients; greater sensitivity of some older individuals cannot be ruled out. Initial dosage, dose increments, and maintenance dosage of insulin glargine or insulin glargine/lixisenatide should be conservative to avoid hypoglycemia.
were >=75 years of age. In controlled clinical studies with the 300-unit/mL preparation of insulin glargine (Toujeo(R)), 30 patients (9.8%) with type 1 diabetes mellitus and 327 patients (26.3%) with type 2 diabetes mellitus were >=65 years of age; among them, 2% with type 1 diabetes mellitus and 3% with type 2 diabetes mellitus were >=75 years of age. In controlled clinical studies with insulin glargine/lixisenatide, 210 patients (25.2%) were >=65 years of age and 33 patients (4%) were >=75 years of age.
No overall differences in safety or effectiveness were observed between patients >=65 years of age and younger adult patients; greater sensitivity of some older individuals cannot be ruled out. Initial dosage, dose increments, and maintenance dosage of insulin glargine or insulin glargine/lixisenatide should be conservative to avoid hypoglycemia.
The following prioritized warning is available for TOUJEO SOLOSTAR (insulin glargine,human recombinant analog):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for TOUJEO SOLOSTAR (insulin glargine,human recombinant analog)'s list of indications:
| Type 1 diabetes mellitus | |
| E10 | Type 1 diabetes mellitus |
| E10.1 | Type 1 diabetes mellitus with ketoacidosis |
| E10.10 | Type 1 diabetes mellitus with ketoacidosis without coma |
| E10.11 | Type 1 diabetes mellitus with ketoacidosis with coma |
| E10.2 | Type 1 diabetes mellitus with kidney complications |
| E10.21 | Type 1 diabetes mellitus with diabetic nephropathy |
| E10.22 | Type 1 diabetes mellitus with diabetic chronic kidney disease |
| E10.29 | Type 1 diabetes mellitus with other diabetic kidney complication |
| E10.3 | Type 1 diabetes mellitus with ophthalmic complications |
| E10.31 | Type 1 diabetes mellitus with unspecified diabetic retinopathy |
| E10.311 | Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema |
| E10.319 | Type 1 diabetes mellitus with unspecified diabetic retinopathy without macular edema |
| E10.32 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy |
| E10.321 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema |
| E10.3211 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye |
| E10.3212 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye |
| E10.3213 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral |
| E10.3219 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E10.329 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema |
| E10.3291 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye |
| E10.3292 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye |
| E10.3293 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral |
| E10.3299 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E10.33 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy |
| E10.331 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema |
| E10.3311 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye |
| E10.3312 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye |
| E10.3313 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral |
| E10.3319 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E10.339 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema |
| E10.3391 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye |
| E10.3392 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye |
| E10.3393 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral |
| E10.3399 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E10.34 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy |
| E10.341 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema |
| E10.3411 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye |
| E10.3412 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye |
| E10.3413 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral |
| E10.3419 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E10.349 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema |
| E10.3491 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye |
| E10.3492 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye |
| E10.3493 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral |
| E10.3499 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E10.35 | Type 1 diabetes mellitus with proliferative diabetic retinopathy |
| E10.351 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema |
| E10.3511 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye |
| E10.3512 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye |
| E10.3513 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral |
| E10.3519 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye |
| E10.352 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula |
| E10.3521 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye |
| E10.3522 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye |
| E10.3523 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral |
| E10.3529 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye |
| E10.353 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula |
| E10.3531 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye |
| E10.3532 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye |
| E10.3533 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral |
| E10.3539 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye |
| E10.354 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment |
| E10.3541 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye |
| E10.3542 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye |
| E10.3543 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral |
| E10.3549 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye |
| E10.355 | Type 1 diabetes mellitus with stable proliferative diabetic retinopathy |
| E10.3551 | Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, right eye |
| E10.3552 | Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, left eye |
| E10.3553 | Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral |
| E10.3559 | Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eye |
| E10.359 | Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema |
| E10.3591 | Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye |
| E10.3592 | Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye |
| E10.3593 | Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral |
| E10.3599 | Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye |
| E10.36 | Type 1 diabetes mellitus with diabetic cataract |
| E10.37 | Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment |
| E10.37x1 | Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye |
| E10.37x2 | Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye |
| E10.37x3 | Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral |
| E10.37x9 | Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye |
| E10.39 | Type 1 diabetes mellitus with other diabetic ophthalmic complication |
| E10.4 | Type 1 diabetes mellitus with neurological complications |
| E10.40 | Type 1 diabetes mellitus with diabetic neuropathy, unspecified |
| E10.41 | Type 1 diabetes mellitus with diabetic mononeuropathy |
| E10.42 | Type 1 diabetes mellitus with diabetic polyneuropathy |
| E10.43 | Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy |
| E10.44 | Type 1 diabetes mellitus with diabetic amyotrophy |
| E10.49 | Type 1 diabetes mellitus with other diabetic neurological complication |
| E10.5 | Type 1 diabetes mellitus with circulatory complications |
| E10.51 | Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene |
| E10.52 | Type 1 diabetes mellitus with diabetic peripheral angiopathy with gangrene |
| E10.59 | Type 1 diabetes mellitus with other circulatory complications |
| E10.6 | Type 1 diabetes mellitus with other specified complications |
| E10.61 | Type 1 diabetes mellitus with diabetic arthropathy |
| E10.610 | Type 1 diabetes mellitus with diabetic neuropathic arthropathy |
| E10.618 | Type 1 diabetes mellitus with other diabetic arthropathy |
| E10.62 | Type 1 diabetes mellitus with skin complications |
| E10.620 | Type 1 diabetes mellitus with diabetic dermatitis |
| E10.621 | Type 1 diabetes mellitus with foot ulcer |
| E10.622 | Type 1 diabetes mellitus with other skin ulcer |
| E10.628 | Type 1 diabetes mellitus with other skin complications |
| E10.63 | Type 1 diabetes mellitus with oral complications |
| E10.630 | Type 1 diabetes mellitus with periodontal disease |
| E10.638 | Type 1 diabetes mellitus with other oral complications |
| E10.64 | Type 1 diabetes mellitus with hypoglycemia |
| E10.641 | Type 1 diabetes mellitus with hypoglycemia with coma |
| E10.649 | Type 1 diabetes mellitus with hypoglycemia without coma |
| E10.65 | Type 1 diabetes mellitus with hyperglycemia |
| E10.69 | Type 1 diabetes mellitus with other specified complication |
| E10.8 | Type 1 diabetes mellitus with unspecified complications |
| E10.9 | Type 1 diabetes mellitus without complications |
| E10.A | Type 1 diabetes mellitus, presymptomatic |
| E10.A0 | Type 1 diabetes mellitus, presymptomatic, unspecified |
| E10.A1 | Type 1 diabetes mellitus, presymptomatic, stage 1 |
| E10.A2 | Type 1 diabetes mellitus, presymptomatic, stage 2 |
| Type 2 diabetes mellitus | |
| E08 | Diabetes mellitus due to underlying condition |
| E08.0 | Diabetes mellitus due to underlying condition with hyperosmolarity |
| E08.00 | Diabetes mellitus due to underlying condition with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHc) |
| E08.01 | Diabetes mellitus due to underlying condition with hyperosmolarity with coma |
| E08.1 | Diabetes mellitus due to underlying condition with ketoacidosis |
| E08.10 | Diabetes mellitus due to underlying condition with ketoacidosis without coma |
| E08.11 | Diabetes mellitus due to underlying condition with ketoacidosis with coma |
| E08.2 | Diabetes mellitus due to underlying condition with kidney complications |
| E08.21 | Diabetes mellitus due to underlying condition with diabetic nephropathy |
| E08.22 | Diabetes mellitus due to underlying condition with diabetic chronic kidney disease |
| E08.29 | Diabetes mellitus due to underlying condition with other diabetic kidney complication |
| E08.3 | Diabetes mellitus due to underlying condition with ophthalmic complications |
| E08.31 | Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy |
| E08.311 | Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema |
| E08.319 | Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy without macular edema |
| E08.32 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy |
| E08.321 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema |
| E08.3211 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, right eye |
| E08.3212 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, left eye |
| E08.3213 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, bilateral |
| E08.3219 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E08.329 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema |
| E08.3291 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, right eye |
| E08.3292 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, left eye |
| E08.3293 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, bilateral |
| E08.3299 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E08.33 | Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy |
| E08.331 | Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema |
| E08.3311 | Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, right eye |
| E08.3312 | Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, left eye |
| E08.3313 | Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, bilateral |
| E08.3319 | Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E08.339 | Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema |
| E08.3391 | Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, right eye |
| E08.3392 | Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, left eye |
| E08.3393 | Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, bilateral |
| E08.3399 | Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E08.34 | Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy |
| E08.341 | Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema |
| E08.3411 | Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, right eye |
| E08.3412 | Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, left eye |
| E08.3413 | Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, bilateral |
| E08.3419 | Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E08.349 | Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema |
| E08.3491 | Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, right eye |
| E08.3492 | Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, left eye |
| E08.3493 | Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, bilateral |
| E08.3499 | Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E08.35 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy |
| E08.351 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema |
| E08.3511 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, right eye |
| E08.3512 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, left eye |
| E08.3513 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, bilateral |
| E08.3519 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, unspecified eye |
| E08.352 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula |
| E08.3521 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye |
| E08.3522 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye |
| E08.3523 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral |
| E08.3529 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye |
| E08.353 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula |
| E08.3531 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye |
| E08.3532 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye |
| E08.3533 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral |
| E08.3539 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye |
| E08.354 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment |
| E08.3541 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye |
| E08.3542 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye |
| E08.3543 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral |
| E08.3549 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye |
| E08.355 | Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy |
| E08.3551 | Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, right eye |
| E08.3552 | Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, left eye |
| E08.3553 | Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, bilateral |
| E08.3559 | Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, unspecified eye |
| E08.359 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema |
| E08.3591 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, right eye |
| E08.3592 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, left eye |
| E08.3593 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, bilateral |
| E08.3599 | Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, unspecified eye |
| E08.36 | Diabetes mellitus due to underlying condition with diabetic cataract |
| E08.37 | Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment |
| E08.37x1 | Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, right eye |
| E08.37x2 | Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, left eye |
| E08.37x3 | Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, bilateral |
| E08.37x9 | Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, unspecified eye |
| E08.39 | Diabetes mellitus due to underlying condition with other diabetic ophthalmic complication |
| E08.4 | Diabetes mellitus due to underlying condition with neurological complications |
| E08.40 | Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified |
| E08.41 | Diabetes mellitus due to underlying condition with diabetic mononeuropathy |
| E08.42 | Diabetes mellitus due to underlying condition with diabetic polyneuropathy |
| E08.43 | Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy |
| E08.44 | Diabetes mellitus due to underlying condition with diabetic amyotrophy |
| E08.49 | Diabetes mellitus due to underlying condition with other diabetic neurological complication |
| E08.5 | Diabetes mellitus due to underlying condition with circulatory complications |
| E08.51 | Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy without gangrene |
| E08.52 | Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy with gangrene |
| E08.59 | Diabetes mellitus due to underlying condition with other circulatory complications |
| E08.6 | Diabetes mellitus due to underlying condition with other specified complications |
| E08.61 | Diabetes mellitus due to underlying condition with diabetic arthropathy |
| E08.610 | Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathy |
| E08.618 | Diabetes mellitus due to underlying condition with other diabetic arthropathy |
| E08.62 | Diabetes mellitus due to underlying condition with skin complications |
| E08.620 | Diabetes mellitus due to underlying condition with diabetic dermatitis |
| E08.621 | Diabetes mellitus due to underlying condition with foot ulcer |
| E08.622 | Diabetes mellitus due to underlying condition with other skin ulcer |
| E08.628 | Diabetes mellitus due to underlying condition with other skin complications |
| E08.63 | Diabetes mellitus due to underlying condition with oral complications |
| E08.630 | Diabetes mellitus due to underlying condition with periodontal disease |
| E08.638 | Diabetes mellitus due to underlying condition with other oral complications |
| E08.64 | Diabetes mellitus due to underlying condition with hypoglycemia |
| E08.641 | Diabetes mellitus due to underlying condition with hypoglycemia with coma |
| E08.649 | Diabetes mellitus due to underlying condition with hypoglycemia without coma |
| E08.65 | Diabetes mellitus due to underlying condition with hyperglycemia |
| E08.69 | Diabetes mellitus due to underlying condition with other specified complication |
| E08.8 | Diabetes mellitus due to underlying condition with unspecified complications |
| E08.9 | Diabetes mellitus due to underlying condition without complications |
| E09 | Drug or chemical induced diabetes mellitus |
| E09.0 | Drug or chemical induced diabetes mellitus with hyperosmolarity |
| E09.00 | Drug or chemical induced diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHc) |
| E09.01 | Drug or chemical induced diabetes mellitus with hyperosmolarity with coma |
| E09.1 | Drug or chemical induced diabetes mellitus with ketoacidosis |
| E09.10 | Drug or chemical induced diabetes mellitus with ketoacidosis without coma |
| E09.11 | Drug or chemical induced diabetes mellitus with ketoacidosis with coma |
| E09.2 | Drug or chemical induced diabetes mellitus with kidney complications |
| E09.21 | Drug or chemical induced diabetes mellitus with diabetic nephropathy |
| E09.22 | Drug or chemical induced diabetes mellitus with diabetic chronic kidney disease |
| E09.29 | Drug or chemical induced diabetes mellitus with other diabetic kidney complication |
| E09.3 | Drug or chemical induced diabetes mellitus with ophthalmic complications |
| E09.31 | Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy |
| E09.311 | Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema |
| E09.319 | Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy without macular edema |
| E09.32 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy |
| E09.321 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema |
| E09.3211 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye |
| E09.3212 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye |
| E09.3213 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral |
| E09.3219 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E09.329 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema |
| E09.3291 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye |
| E09.3292 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye |
| E09.3293 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral |
| E09.3299 | Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E09.33 | Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy |
| E09.331 | Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema |
| E09.3311 | Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye |
| E09.3312 | Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye |
| E09.3313 | Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral |
| E09.3319 | Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E09.339 | Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema |
| E09.3391 | Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye |
| E09.3392 | Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye |
| E09.3393 | Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral |
| E09.3399 | Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E09.34 | Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy |
| E09.341 | Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema |
| E09.3411 | Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye |
| E09.3412 | Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye |
| E09.3413 | Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral |
| E09.3419 | Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E09.349 | Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema |
| E09.3491 | Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye |
| E09.3492 | Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye |
| E09.3493 | Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral |
| E09.3499 | Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E09.35 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy |
| E09.351 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema |
| E09.3511 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye |
| E09.3512 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye |
| E09.3513 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral |
| E09.3519 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye |
| E09.352 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula |
| E09.3521 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye |
| E09.3522 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye |
| E09.3523 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral |
| E09.3529 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye |
| E09.353 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula |
| E09.3531 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye |
| E09.3532 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye |
| E09.3533 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral |
| E09.3539 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye |
| E09.354 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment |
| E09.3541 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye |
| E09.3542 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye |
| E09.3543 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral |
| E09.3549 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye |
| E09.355 | Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy |
| E09.3551 | Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, right eye |
| E09.3552 | Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, left eye |
| E09.3553 | Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, bilateral |
| E09.3559 | Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eye |
| E09.359 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular edema |
| E09.3591 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye |
| E09.3592 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye |
| E09.3593 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral |
| E09.3599 | Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye |
| E09.36 | Drug or chemical induced diabetes mellitus with diabetic cataract |
| E09.37 | Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment |
| E09.37x1 | Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, right eye |
| E09.37x2 | Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, left eye |
| E09.37x3 | Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral |
| E09.37x9 | Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye |
| E09.39 | Drug or chemical induced diabetes mellitus with other diabetic ophthalmic complication |
| E09.4 | Drug or chemical induced diabetes mellitus with neurological complications |
| E09.40 | Drug or chemical induced diabetes mellitus with neurological complications with diabetic neuropathy, unspecified |
| E09.41 | Drug or chemical induced diabetes mellitus with neurological complications with diabetic mononeuropathy |
| E09.42 | Drug or chemical induced diabetes mellitus with neurological complications with diabetic polyneuropathy |
| E09.43 | Drug or chemical induced diabetes mellitus with neurological complications with diabetic autonomic (poly)neuropathy |
| E09.44 | Drug or chemical induced diabetes mellitus with neurological complications with diabetic amyotrophy |
| E09.49 | Drug or chemical induced diabetes mellitus with neurological complications with other diabetic neurological complication |
| E09.5 | Drug or chemical induced diabetes mellitus with circulatory complications |
| E09.51 | Drug or chemical induced diabetes mellitus with diabetic peripheral angiopathy without gangrene |
| E09.52 | Drug or chemical induced diabetes mellitus with diabetic peripheral angiopathy with gangrene |
| E09.59 | Drug or chemical induced diabetes mellitus with other circulatory complications |
| E09.6 | Drug or chemical induced diabetes mellitus with other specified complications |
| E09.61 | Drug or chemical induced diabetes mellitus with diabetic arthropathy |
| E09.610 | Drug or chemical induced diabetes mellitus with diabetic neuropathic arthropathy |
| E09.618 | Drug or chemical induced diabetes mellitus with other diabetic arthropathy |
| E09.62 | Drug or chemical induced diabetes mellitus with skin complications |
| E09.620 | Drug or chemical induced diabetes mellitus with diabetic dermatitis |
| E09.621 | Drug or chemical induced diabetes mellitus with foot ulcer |
| E09.622 | Drug or chemical induced diabetes mellitus with other skin ulcer |
| E09.628 | Drug or chemical induced diabetes mellitus with other skin complications |
| E09.63 | Drug or chemical induced diabetes mellitus with oral complications |
| E09.630 | Drug or chemical induced diabetes mellitus with periodontal disease |
| E09.638 | Drug or chemical induced diabetes mellitus with other oral complications |
| E09.64 | Drug or chemical induced diabetes mellitus with hypoglycemia |
| E09.641 | Drug or chemical induced diabetes mellitus with hypoglycemia with coma |
| E09.649 | Drug or chemical induced diabetes mellitus with hypoglycemia without coma |
| E09.65 | Drug or chemical induced diabetes mellitus with hyperglycemia |
| E09.69 | Drug or chemical induced diabetes mellitus with other specified complication |
| E09.8 | Drug or chemical induced diabetes mellitus with unspecified complications |
| E09.9 | Drug or chemical induced diabetes mellitus without complications |
| E11 | Type 2 diabetes mellitus |
| E11.0 | Type 2 diabetes mellitus with hyperosmolarity |
| E11.00 | Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHc) |
| E11.01 | Type 2 diabetes mellitus with hyperosmolarity with coma |
| E11.1 | Type 2 diabetes mellitus with ketoacidosis |
| E11.10 | Type 2 diabetes mellitus with ketoacidosis without coma |
| E11.11 | Type 2 diabetes mellitus with ketoacidosis with coma |
| E11.2 | Type 2 diabetes mellitus with kidney complications |
| E11.21 | Type 2 diabetes mellitus with diabetic nephropathy |
| E11.22 | Type 2 diabetes mellitus with diabetic chronic kidney disease |
| E11.29 | Type 2 diabetes mellitus with other diabetic kidney complication |
| E11.3 | Type 2 diabetes mellitus with ophthalmic complications |
| E11.31 | Type 2 diabetes mellitus with unspecified diabetic retinopathy |
| E11.311 | Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema |
| E11.319 | Type 2 diabetes mellitus with unspecified diabetic retinopathy without macular edema |
| E11.32 | Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy |
| E11.321 | Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema |
| E11.3211 | Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye |
| E11.3212 | Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye |
| E11.3213 | Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral |
| E11.3219 | Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E11.329 | Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema |
| E11.3291 | Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye |
| E11.3292 | Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye |
| E11.3293 | Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral |
| E11.3299 | Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E11.33 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy |
| E11.331 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema |
| E11.3311 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye |
| E11.3312 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye |
| E11.3313 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral |
| E11.3319 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E11.339 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema |
| E11.3391 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye |
| E11.3392 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye |
| E11.3393 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral |
| E11.3399 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E11.34 | Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy |
| E11.341 | Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema |
| E11.3411 | Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye |
| E11.3412 | Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye |
| E11.3413 | Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral |
| E11.3419 | Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E11.349 | Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema |
| E11.3491 | Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye |
| E11.3492 | Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye |
| E11.3493 | Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral |
| E11.3499 | Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E11.35 | Type 2 diabetes mellitus with proliferative diabetic retinopathy |
| E11.351 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema |
| E11.3511 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye |
| E11.3512 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye |
| E11.3513 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral |
| E11.3519 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye |
| E11.352 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula |
| E11.3521 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye |
| E11.3522 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye |
| E11.3523 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral |
| E11.3529 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye |
| E11.353 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula |
| E11.3531 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye |
| E11.3532 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye |
| E11.3533 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral |
| E11.3539 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye |
| E11.354 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment |
| E11.3541 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye |
| E11.3542 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye |
| E11.3543 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral |
| E11.3549 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye |
| E11.355 | Type 2 diabetes mellitus with stable proliferative diabetic retinopathy |
| E11.3551 | Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, right eye |
| E11.3552 | Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, left eye |
| E11.3553 | Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral |
| E11.3559 | Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eye |
| E11.359 | Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema |
| E11.3591 | Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye |
| E11.3592 | Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye |
| E11.3593 | Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral |
| E11.3599 | Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye |
| E11.36 | Type 2 diabetes mellitus with diabetic cataract |
| E11.37 | Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment |
| E11.37x1 | Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye |
| E11.37x2 | Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye |
| E11.37x3 | Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral |
| E11.37x9 | Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye |
| E11.39 | Type 2 diabetes mellitus with other diabetic ophthalmic complication |
| E11.4 | Type 2 diabetes mellitus with neurological complications |
| E11.40 | Type 2 diabetes mellitus with diabetic neuropathy, unspecified |
| E11.41 | Type 2 diabetes mellitus with diabetic mononeuropathy |
| E11.42 | Type 2 diabetes mellitus with diabetic polyneuropathy |
| E11.43 | Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy |
| E11.44 | Type 2 diabetes mellitus with diabetic amyotrophy |
| E11.49 | Type 2 diabetes mellitus with other diabetic neurological complication |
| E11.5 | Type 2 diabetes mellitus with circulatory complications |
| E11.51 | Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene |
| E11.52 | Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene |
| E11.59 | Type 2 diabetes mellitus with other circulatory complications |
| E11.6 | Type 2 diabetes mellitus with other specified complications |
| E11.61 | Type 2 diabetes mellitus with diabetic arthropathy |
| E11.610 | Type 2 diabetes mellitus with diabetic neuropathic arthropathy |
| E11.618 | Type 2 diabetes mellitus with other diabetic arthropathy |
| E11.62 | Type 2 diabetes mellitus with skin complications |
| E11.620 | Type 2 diabetes mellitus with diabetic dermatitis |
| E11.621 | Type 2 diabetes mellitus with foot ulcer |
| E11.622 | Type 2 diabetes mellitus with other skin ulcer |
| E11.628 | Type 2 diabetes mellitus with other skin complications |
| E11.63 | Type 2 diabetes mellitus with oral complications |
| E11.630 | Type 2 diabetes mellitus with periodontal disease |
| E11.638 | Type 2 diabetes mellitus with other oral complications |
| E11.64 | Type 2 diabetes mellitus with hypoglycemia |
| E11.641 | Type 2 diabetes mellitus with hypoglycemia with coma |
| E11.649 | Type 2 diabetes mellitus with hypoglycemia without coma |
| E11.65 | Type 2 diabetes mellitus with hyperglycemia |
| E11.69 | Type 2 diabetes mellitus with other specified complication |
| E11.8 | Type 2 diabetes mellitus with unspecified complications |
| E11.9 | Type 2 diabetes mellitus without complications |
| E13 | Other specified diabetes mellitus |
| E13.0 | Other specified diabetes mellitus with hyperosmolarity |
| E13.00 | Other specified diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHc) |
| E13.01 | Other specified diabetes mellitus with hyperosmolarity with coma |
| E13.1 | Other specified diabetes mellitus with ketoacidosis |
| E13.10 | Other specified diabetes mellitus with ketoacidosis without coma |
| E13.11 | Other specified diabetes mellitus with ketoacidosis with coma |
| E13.2 | Other specified diabetes mellitus with kidney complications |
| E13.21 | Other specified diabetes mellitus with diabetic nephropathy |
| E13.22 | Other specified diabetes mellitus with diabetic chronic kidney disease |
| E13.29 | Other specified diabetes mellitus with other diabetic kidney complication |
| E13.3 | Other specified diabetes mellitus with ophthalmic complications |
| E13.31 | Other specified diabetes mellitus with unspecified diabetic retinopathy |
| E13.311 | Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema |
| E13.319 | Other specified diabetes mellitus with unspecified diabetic retinopathy without macular edema |
| E13.32 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy |
| E13.321 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema |
| E13.3211 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye |
| E13.3212 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye |
| E13.3213 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral |
| E13.3219 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E13.329 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema |
| E13.3291 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye |
| E13.3292 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye |
| E13.3293 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral |
| E13.3299 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E13.33 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy |
| E13.331 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema |
| E13.3311 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye |
| E13.3312 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye |
| E13.3313 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral |
| E13.3319 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E13.339 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema |
| E13.3391 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye |
| E13.3392 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye |
| E13.3393 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral |
| E13.3399 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E13.34 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy |
| E13.341 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema |
| E13.3411 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye |
| E13.3412 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye |
| E13.3413 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral |
| E13.3419 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E13.349 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema |
| E13.3491 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye |
| E13.3492 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye |
| E13.3493 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral |
| E13.3499 | Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye |
| E13.35 | Other specified diabetes mellitus with proliferative diabetic retinopathy |
| E13.351 | Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema |
| E13.3511 | Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye |
| E13.3512 | Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye |
| E13.3513 | Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral |
| E13.3519 | Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye |
| E13.352 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula |
| E13.3521 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye |
| E13.3522 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye |
| E13.3523 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral |
| E13.3529 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye |
| E13.353 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula |
| E13.3531 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye |
| E13.3532 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye |
| E13.3533 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral |
| E13.3539 | Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye |
| E13.354 | Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment |
| E13.3541 | Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye |
| E13.3542 | Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye |
| E13.3543 | Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral |
| E13.3549 | Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye |
| E13.355 | Other specified diabetes mellitus with stable proliferative diabetic retinopathy |
| E13.3551 | Other specified diabetes mellitus with stable proliferative diabetic retinopathy, right eye |
| E13.3552 | Other specified diabetes mellitus with stable proliferative diabetic retinopathy, left eye |
| E13.3553 | Other specified diabetes mellitus with stable proliferative diabetic retinopathy, bilateral |
| E13.3559 | Other specified diabetes mellitus with stable proliferative diabetic retinopathy, unspecified eye |
| E13.359 | Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema |
| E13.3591 | Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye |
| E13.3592 | Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye |
| E13.3593 | Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral |
| E13.3599 | Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye |
| E13.36 | Other specified diabetes mellitus with diabetic cataract |
| E13.37 | Other specified diabetes mellitus with diabetic macular edema, resolved following treatment |
| E13.37x1 | Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, right eye |
| E13.37x2 | Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, left eye |
| E13.37x3 | Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral |
| E13.37x9 | Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye |
| E13.39 | Other specified diabetes mellitus with other diabetic ophthalmic complication |
| E13.4 | Other specified diabetes mellitus with neurological complications |
| E13.40 | Other specified diabetes mellitus with diabetic neuropathy, unspecified |
| E13.41 | Other specified diabetes mellitus with diabetic mononeuropathy |
| E13.42 | Other specified diabetes mellitus with diabetic polyneuropathy |
| E13.43 | Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy |
| E13.44 | Other specified diabetes mellitus with diabetic amyotrophy |
| E13.49 | Other specified diabetes mellitus with other diabetic neurological complication |
| E13.5 | Other specified diabetes mellitus with circulatory complications |
| E13.51 | Other specified diabetes mellitus with diabetic peripheral angiopathy without gangrene |
| E13.52 | Other specified diabetes mellitus with diabetic peripheral angiopathy with gangrene |
| E13.59 | Other specified diabetes mellitus with other circulatory complications |
| E13.6 | Other specified diabetes mellitus with other specified complications |
| E13.61 | Other specified diabetes mellitus with diabetic arthropathy |
| E13.610 | Other specified diabetes mellitus with diabetic neuropathic arthropathy |
| E13.618 | Other specified diabetes mellitus with other diabetic arthropathy |
| E13.62 | Other specified diabetes mellitus with skin complications |
| E13.620 | Other specified diabetes mellitus with diabetic dermatitis |
| E13.621 | Other specified diabetes mellitus with foot ulcer |
| E13.622 | Other specified diabetes mellitus with other skin ulcer |
| E13.628 | Other specified diabetes mellitus with other skin complications |
| E13.63 | Other specified diabetes mellitus with oral complications |
| E13.630 | Other specified diabetes mellitus with periodontal disease |
| E13.638 | Other specified diabetes mellitus with other oral complications |
| E13.64 | Other specified diabetes mellitus with hypoglycemia |
| E13.641 | Other specified diabetes mellitus with hypoglycemia with coma |
| E13.649 | Other specified diabetes mellitus with hypoglycemia without coma |
| E13.65 | Other specified diabetes mellitus with hyperglycemia |
| E13.69 | Other specified diabetes mellitus with other specified complication |
| E13.8 | Other specified diabetes mellitus with unspecified complications |
| E13.9 | Other specified diabetes mellitus without complications |
Formulary Reference Tool