Cystografin-Dilute

Drug overview for CYSTOGRAFIN-DILUTE (diatrizoate meglumine):

Generic name: DIATRIZOATE MEGLUMINE
Drug class:
Therapeutic class: Diagnostic Agents

No enhanced Introduction information available for this drug.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for CYSTOGRAFIN-DILUTE (diatrizoate meglumine) have been approved by the FDA:

Indications:
Diagnostic imaging

Professional Synonyms:
Diagnostic imaging exam
Diagnostic imaging procedure
Diagnostic radiography
Diagnostic radiology

The following drug interaction information is available for CYSTOGRAFIN-DILUTE (diatrizoate meglumine):

Contraindicated
Severe
Moderate

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
Metformin/Iodinated Contrast Materials SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Use of iodinated contrast materials may result in acute changes in renal function, resulting in a decrease in metformin clearance.(1-3) CLINICAL EFFECTS: Use of iodinated contrast materials may increase levels of metformin, which may result in lactic acidosis.(1-3) PREDISPOSING FACTORS: Pre-existing renal dysfunction may contribute to decreased clearance of metformin. Other factors which may increase the risk for lactic acidosis include age greater than 65 years, dehydration, metabolic acidosis, sepsis, a history of hepatic impairment, alcoholism, or heart failure.(1-4) PATIENT MANAGEMENT: Evaluate renal function prior to contrast procedure. According to manufacturer recommendations, discontinue metformin at the time of, or prior to, the contrast imaging procedure in patients with a history of liver disease, alcoholism, heart failure, or if contrast is to be administered intra-arterially. When contrast is to be administered by other routes, discontinue metformin at the time of, or prior to, the procedure for patients with an estimated glomerular filtration rate (eGFR) of 30 to 60 mL/min/1.73 m2. Re-evaluate eGFR 48 hours after the imaging procedure and restart metformin if renal function is stable. Discontinuation of metformin is not required if eGFR is > 60 mL/min/1.73 m2.(4) According to American College of Radiology guidelines, discontinue metformin at the time of, or prior to, the contrast imaging procedure in patients with acute kidney injury or chronic kidney disease (Stage IV or V or eGFR < 30 mL/min/1.73 m2), or who are undergoing arterial catheter studies that might result in emboli (atheromatous or other) to the renal arteries. Re-evaluate eGFR 48 hours after the imaging procedure and restart metformin if renal function is normal. Discontinuation of metformin is not required in patients with no evidence of acute kidney injury and with eGFR >= 30 mL/min/m2.(5) DISCUSSION: An FDA review of the medical literature showed that metformin may be safely used in patients with mild or moderate renal impairment, resulting in modifications of prescribing recommendations and method for evaluation of renal function.(4) A clinical review of 33 patients on metformin who had received contrast media showed elevations in serum creatinine of the four patients with baseline elevations. The 29 patients with normal baseline renal function showed no elevations after administration of contrast media. The authors recommend that a baseline serum creatinine is obtained for all patients and that metformin should only be discontinued in patients with baseline elevations.(6) A retrospective study of ninety-seven patients currently taking metformin underwent a radiologic procedure with contrast media. Of these patients, 4 developed contrast material associated nephropathy and eight patients had an increased risk of lactic acidosis, with a baseline serum creatinine <1.5mg/dl.(7) A prospective clinical trial with 50 diabetic patients on metformin with baseline serum creatinine <1.47mg/dl showed no statistical difference in renal function before and 48 hours after administration of contrast media. The authors recommend a baseline serum creatinine for all patients and suggest that temporary discontinuation of metformin may not be necessary when baseline renal function is <1.47mg/dl.(8) A systematic review of the literature reveals that 17 of 18 case reports of metformin-induced lactic acidosis involved patients with renal dysfunction prior to administration of contrast media. The authors recommend a baseline serum creatinine in all patients and if renal dysfunction is present, metformin should be discontinued for 48 hours before and after administration of contrast media. The authors recommend follow-up creatinine measurement in patients with prior renal impairment or known comorbidities affecting lactate levels.(9)	ACTOPLUS MET, ALOGLIPTIN-METFORMIN, DAPAGLIFLOZIN-METFORMIN ER, GLIPIZIDE-METFORMIN, GLYBURIDE-METFORMIN HCL, INVOKAMET, INVOKAMET XR, JANUMET, JANUMET XR, JENTADUETO, JENTADUETO XR, KAZANO, METFORMIN ER GASTRIC, METFORMIN ER OSMOTIC, METFORMIN HCL, METFORMIN HCL ER, PIOGLITAZONE-METFORMIN, RIOMET, SAXAGLIPTIN-METFORMIN ER, SEGLUROMET, SITAGLIPTIN-METFORMIN, SYNJARDY, SYNJARDY XR, TRIJARDY XR, XIGDUO XR, ZITUVIMET, ZITUVIMET XR

Drug Interaction

Drug Names

Metformin/Iodinated Contrast Materials

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Use of iodinated contrast materials may result in acute changes in renal function, resulting in a decrease in metformin clearance.(1-3)

CLINICAL EFFECTS: Use of iodinated contrast materials may increase levels of metformin, which may result in lactic acidosis.(1-3)

PREDISPOSING FACTORS: Pre-existing renal dysfunction may contribute to decreased clearance of metformin. Other factors which may increase the risk for lactic acidosis include age greater than 65 years, dehydration, metabolic acidosis, sepsis, a history of hepatic impairment, alcoholism, or heart failure.(1-4)

PATIENT MANAGEMENT: Evaluate renal function prior to contrast procedure. According to manufacturer recommendations, discontinue metformin at the time of, or prior to, the contrast imaging procedure in patients with a history of liver disease, alcoholism, heart failure, or if contrast is to be administered intra-arterially. When contrast is to be administered by other routes, discontinue metformin at the time of, or prior to, the procedure for patients with an estimated glomerular filtration rate (eGFR) of 30 to 60 mL/min/1.73

m2. Re-evaluate eGFR 48 hours after the imaging procedure and restart metformin if renal function is stable. Discontinuation of metformin is not required if eGFR is > 60 mL/min/1.73

m2.(4) According to American College of Radiology guidelines, discontinue metformin at the time of, or prior to, the contrast imaging procedure in patients with acute kidney injury or chronic kidney disease (Stage IV or V or eGFR < 30 mL/min/1.73 m2), or who are undergoing arterial catheter studies that might result in emboli (atheromatous or other) to the renal arteries. Re-evaluate eGFR 48 hours after the imaging procedure and restart metformin if renal function is normal. Discontinuation of metformin is not required in patients with no evidence of acute kidney injury and with eGFR >= 30 mL/min/m2.(5)

DISCUSSION: An FDA review of the medical literature showed that metformin may be safely used in patients with mild or moderate renal impairment, resulting in modifications of prescribing recommendations and method for evaluation of renal function.(4) A clinical review of 33 patients on metformin who had received contrast media showed elevations in serum creatinine of the four patients with baseline elevations. The 29 patients with normal baseline renal function showed no elevations after administration of contrast media.

The authors recommend that a baseline serum creatinine is obtained for all patients and that metformin should only be discontinued in patients with baseline elevations.(6) A retrospective study of ninety-seven patients currently taking metformin underwent a radiologic procedure with contrast media. Of these patients, 4 developed contrast material associated nephropathy and eight patients had an increased risk of lactic acidosis, with a baseline serum creatinine <1.5mg/dl.(7)

A prospective clinical trial with 50 diabetic patients on metformin with baseline serum creatinine <1.47mg/dl showed no statistical difference in renal function before and 48 hours after administration of contrast media. The authors recommend a baseline serum creatinine for all patients and suggest that temporary discontinuation of metformin may not be necessary when baseline renal function is <1.47mg/dl.(8)

A systematic review of the literature reveals that 17 of 18 case reports of metformin-induced lactic acidosis involved patients with renal dysfunction prior to administration of contrast media. The authors recommend a baseline serum creatinine in all patients and if renal dysfunction is present, metformin should be discontinued for 48 hours before and after administration of contrast media. The authors recommend follow-up creatinine measurement in patients with prior renal impairment or known comorbidities affecting lactate levels.(9)

ACTOPLUS MET, ALOGLIPTIN-METFORMIN, DAPAGLIFLOZIN-METFORMIN ER, GLIPIZIDE-METFORMIN, GLYBURIDE-METFORMIN HCL, INVOKAMET, INVOKAMET XR, JANUMET, JANUMET XR, JENTADUETO, JENTADUETO XR, KAZANO, METFORMIN ER GASTRIC, METFORMIN ER OSMOTIC, METFORMIN HCL, METFORMIN HCL ER, PIOGLITAZONE-METFORMIN, RIOMET, SAXAGLIPTIN-METFORMIN ER, SEGLUROMET, SITAGLIPTIN-METFORMIN, SYNJARDY, SYNJARDY XR, TRIJARDY XR, XIGDUO XR, ZITUVIMET, ZITUVIMET XR

There are 0 moderate interactions.

Moderate List
Asthma
Hypothyroidism

The following adverse reaction information is available for CYSTOGRAFIN-DILUTE (diatrizoate meglumine):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 23 severe adverse reactions.

More Frequent	Less Frequent
None.	Hypertension

Rare/Very Rare
Acute generalized exanthematous pustulosis Acute myocardial infarction Anaphylaxis Anuria Bradycardia Bronchospastic pulmonary disease Cardiac arrhythmia Cerebrovascular accident Dehydration Dermal necrosis DRESS syndrome Hematuria Hypotension Hypothyroidism Oliguria Pulmonary edema Renal failure Stevens-johnson syndrome Thromboembolic disorder Tonic clonic seizure Toxic epidermal necrolysis Transient blindness

Rare/Very Rare

Acute generalized exanthematous pustulosis
Acute myocardial infarction
Anaphylaxis
Anuria
Bradycardia
Bronchospastic pulmonary disease
Cardiac arrhythmia
Cerebrovascular accident
Dehydration
Dermal necrosis
DRESS syndrome
Hematuria
Hypotension
Hypothyroidism
Oliguria
Pulmonary edema
Renal failure
Stevens-johnson syndrome
Thromboembolic disorder
Tonic clonic seizure
Toxic epidermal necrolysis
Transient blindness

There are 13 less severe adverse reactions.

More Frequent	Less Frequent
Cough Dysgeusia Injection site sequelae Vasodilation of blood vessels	Chills Dizziness Headache disorder Hyperhidrosis Nausea Paresthesia Polydipsia Rhinitis Vomiting

Rare/Very Rare
None.

The following precautions are available for CYSTOGRAFIN-DILUTE (diatrizoate meglumine):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

No enhanced Pregnancy information available for this drug.

No enhanced Lactation information available for this drug.

No enhanced Geriatric Use information available for this drug.