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Drug overview for COLY-MYCIN M PARENTERAL (colistin (as colistimethate sodium)):
Generic name: COLISTIN (AS COLISTIMETHATE SODIUM) (koe-LIS-ti-METH-ate)
Drug class: Polymyxins
Therapeutic class: Anti-Infective Agents
Colistimethate sodium is a prodrug of colistin. Colistin (also known as polymyxin E) is a polymyxin antibiotic structurally and pharmacologically related to polymyxin B.
No enhanced Uses information available for this drug.
Generic name: COLISTIN (AS COLISTIMETHATE SODIUM) (koe-LIS-ti-METH-ate)
Drug class: Polymyxins
Therapeutic class: Anti-Infective Agents
Colistimethate sodium is a prodrug of colistin. Colistin (also known as polymyxin E) is a polymyxin antibiotic structurally and pharmacologically related to polymyxin B.
No enhanced Uses information available for this drug.
DRUG IMAGES
COLY-MYCIN M 150 MG VIAL
The following indications for COLY-MYCIN M PARENTERAL (colistin (as colistimethate sodium)) have been approved by the FDA:
Indications:
E. coli infection
Enterobacter infection
Klebsiella infection
Pseudomonas aeruginosa infection
Professional Synonyms:
Aerobacter infection
E. coli infectious disease
Enterobacter infectious disease
Escherichia coli infection
Infection due to Escherichia coli
Infection due to Pseudomonas aeruginosa
Pseudomonas aeruginosa infectious disease
Pseudomonas pyocyanea infection
Pseudomonas pyocyaneus infection
Indications:
E. coli infection
Enterobacter infection
Klebsiella infection
Pseudomonas aeruginosa infection
Professional Synonyms:
Aerobacter infection
E. coli infectious disease
Enterobacter infectious disease
Escherichia coli infection
Infection due to Escherichia coli
Infection due to Pseudomonas aeruginosa
Pseudomonas aeruginosa infectious disease
Pseudomonas pyocyanea infection
Pseudomonas pyocyaneus infection
The following dosing information is available for COLY-MYCIN M PARENTERAL (colistin (as colistimethate sodium)):
The Institute for Safe Medication Practices (ISMP) alerted healthcare professionals about the risk of serious and potentially fatal medication errors related to dosage of colistimethate sodium.
Colistimethate sodium is a prodrug of colistin and is inactive until hydrolyzed in vivo to colistin. In the US, vials and carton packaging of colistimethate sulfate are labeled as colistimethate for injection; however, strength and dosage of the drug are expressed in terms of colistin base activity (colistin). This dosage convention must be considered when prescribing, preparing, and dispensing colistimethate sodium.
Healthcare professionals should be aware that, in the US, colistimethate sodium must only be prescribed in terms of colistin. If the drug is prescribed as colistimethate or colistimethate sodium, the prescriber should be contacted to verify the dosage in terms of colistin. At least 1 fatality related to acute renal failure and other complications occurred when colistimethate sodium was prescribed in terms of the prodrug (instead of colistin), resulting in administration of a dosage approximately 2.5
times greater than it should have been.
Healthcare professionals also should be aware that strength and dosage of colistimethate sodium preparations commercially available in some other countries may be expressed in terms of colistimethate sodium, in terms of colistin, or as international units. (See Dosage and Administration: Dosage.)
Any medication errors involving colistimethate sodium should be reported to the ISMP National Medication Error Reporting Program and the FDA MedWatch program.
Dosage of colistimethate sodium commercially available in the US is expressed in terms of colistin.
Dosage of colistimethate sodium preparations commercially available in some other countries (e.g., United Kingdom, Greece) may be expressed in terms of colistimethate sodium, in terms of colistin, or as international units. The fact that dosages reported in published clinical studies or case reports may vary depending on the country of origin and the preparation used should be considered.
Although not the dosage convention in the US, it has been suggested that dosage of colistimethate sodium should preferably be expressed in terms of international units to avoid confusion. When expressed in terms of international units, each mg of colistin base has a potency of 30,000 international units and each mg of colistimethate sodium has a potency of 12,500 international units.
The usual IM or IV dosage of colistimethate sodium for adults and children with normal renal function is 2.5-5 mg/kg of colistin daily given in 2-4 divided doses, depending on the severity of the infection.
The maximum IM or IV dosage of colistimethate sodium recommended by the manufacturer for patients with normal renal function is 5 mg/kg of colistin daily.
The manufacturer recommends that dosage for obese patients should be based on an estimate of ideal body weight.
For early treatment of Pseudomonas aeruginosa respiratory tract infections in adult and pediatric cystic fibrosis patients or for suppressive therapy in adult or pediatric cystic fibrosis patients colonized with Ps. aeruginosa, colistimethate sodium has been given by oral inhalation via nebulization+ in a dosage of 33.33-66.66
mg of colistin 2 or 3 times daily. This corresponds to a dosage of 1-2 million international units 2 or 3 times daily.
In patients with renal impairment, dosage of colistimethate sodium should be decreased in proportion to the degree of renal impairment.
Dosage for Adults with Renal Impairment
Creatinine Clearance (mL/minute) IM or IV Dosage (of Colistin) 80 or greater 2.5-5 mg/kg daily given in 2-4 divided doses 50-79 2.5-3.8
mg/kg daily given in 2 divided doses 30-49 2.5 mg/kg daily given as a single dose or in 2 divided doses 10-29 1.5 mg/kg given once every 36 hours
Colistimethate sodium is a prodrug of colistin and is inactive until hydrolyzed in vivo to colistin. In the US, vials and carton packaging of colistimethate sulfate are labeled as colistimethate for injection; however, strength and dosage of the drug are expressed in terms of colistin base activity (colistin). This dosage convention must be considered when prescribing, preparing, and dispensing colistimethate sodium.
Healthcare professionals should be aware that, in the US, colistimethate sodium must only be prescribed in terms of colistin. If the drug is prescribed as colistimethate or colistimethate sodium, the prescriber should be contacted to verify the dosage in terms of colistin. At least 1 fatality related to acute renal failure and other complications occurred when colistimethate sodium was prescribed in terms of the prodrug (instead of colistin), resulting in administration of a dosage approximately 2.5
times greater than it should have been.
Healthcare professionals also should be aware that strength and dosage of colistimethate sodium preparations commercially available in some other countries may be expressed in terms of colistimethate sodium, in terms of colistin, or as international units. (See Dosage and Administration: Dosage.)
Any medication errors involving colistimethate sodium should be reported to the ISMP National Medication Error Reporting Program and the FDA MedWatch program.
Dosage of colistimethate sodium commercially available in the US is expressed in terms of colistin.
Dosage of colistimethate sodium preparations commercially available in some other countries (e.g., United Kingdom, Greece) may be expressed in terms of colistimethate sodium, in terms of colistin, or as international units. The fact that dosages reported in published clinical studies or case reports may vary depending on the country of origin and the preparation used should be considered.
Although not the dosage convention in the US, it has been suggested that dosage of colistimethate sodium should preferably be expressed in terms of international units to avoid confusion. When expressed in terms of international units, each mg of colistin base has a potency of 30,000 international units and each mg of colistimethate sodium has a potency of 12,500 international units.
The usual IM or IV dosage of colistimethate sodium for adults and children with normal renal function is 2.5-5 mg/kg of colistin daily given in 2-4 divided doses, depending on the severity of the infection.
The maximum IM or IV dosage of colistimethate sodium recommended by the manufacturer for patients with normal renal function is 5 mg/kg of colistin daily.
The manufacturer recommends that dosage for obese patients should be based on an estimate of ideal body weight.
For early treatment of Pseudomonas aeruginosa respiratory tract infections in adult and pediatric cystic fibrosis patients or for suppressive therapy in adult or pediatric cystic fibrosis patients colonized with Ps. aeruginosa, colistimethate sodium has been given by oral inhalation via nebulization+ in a dosage of 33.33-66.66
mg of colistin 2 or 3 times daily. This corresponds to a dosage of 1-2 million international units 2 or 3 times daily.
In patients with renal impairment, dosage of colistimethate sodium should be decreased in proportion to the degree of renal impairment.
Dosage for Adults with Renal Impairment
Creatinine Clearance (mL/minute) IM or IV Dosage (of Colistin) 80 or greater 2.5-5 mg/kg daily given in 2-4 divided doses 50-79 2.5-3.8
mg/kg daily given in 2 divided doses 30-49 2.5 mg/kg daily given as a single dose or in 2 divided doses 10-29 1.5 mg/kg given once every 36 hours
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| COLY-MYCIN M 150 MG VIAL | Maintenance | Adults inject 2 milliliters (150 mg) by intravenous route every 12 hours |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| COLISTIMETHATE 150 MG VIAL | Maintenance | Adults inject 2 milliliters (150 mg) by intravenous route every 12 hours |
The following drug interaction information is available for COLY-MYCIN M PARENTERAL (colistin (as colistimethate sodium)):
There are 2 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Live Typhoid Vaccine/Antimicrobials SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1) CLINICAL EFFECTS: Vaccination may be ineffective. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3) DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3) |
VIVOTIF |
| Selected Nephrotoxic Agents/Bacitracin SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Bacitracin may cause renal failure due to glomerular and tubular necrosis. Concurrent administration of other nephrotoxic agents may result in additive renal toxicity.(1-3) CLINICAL EFFECTS: Concurrent use of bacitracin with other potentially nephrotoxic agents may result in renal toxicity.(1-3) PREDISPOSING FACTORS: Dehydration and high-dose bacitracin may predispose to adverse renal effects.(1) PATIENT MANAGEMENT: Health Canada states that bacitracin is contraindicated in patients with renal impairment, including those taking other nephrotoxic drugs.(1) The Canadian and US manufacturers of bacitracin state that concomitant use of bacitracin with other potentially nephrotoxic agents should be avoided.(2,3) DISCUSSION: Renal impairment is a major toxicity of bacitracin. Cases of nephrotoxicity have been reported when bacitracin was used off-label.(1-3) |
BACITRACIN, BACITRACIN MICRONIZED, BACITRACIN ZINC |
There are 3 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 |
|---|---|
| Colistimethate/Selected Nephrotoxic Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Colistimethate can cause nephrotoxicity.(1,2) Concurrent administration of other nephrotoxic agents may result in an increased risk of nephrotoxicity.(1) It is suspected that cephalothin interferes with the excretion of colistimethate resulting in enhanced nephrotoxicity.(2,3) CLINICAL EFFECTS: Concurrent use of colistimethate with other nephrotoxic agents may result in additive nephrotoxic effects. PREDISPOSING FACTORS: Factors predisposing to nephrotoxicity include higher cumulative doses of colistimethate, longer treatment duration, hypovolemia, and critical illness. PATIENT MANAGEMENT: Concurrent use of potentially nephrotoxic agents with colistimethate should be avoided.(1,2) If concurrent use is necessary, it should be undertaken with great caution.(1) DISCUSSION: In a case control study of 42 patients on intravenous colistimethate sodium, NSAIDs were identified as an independent risk factor for nephrotoxicity (OR 40.105, p=0.044).(4) In 4 case reports, patients developed elevated serum creatinine and blood urea nitrogen following concurrent colistimethate and cephalothin (3 patients) or when colistimethate followed cephalothin therapy (1 patient).(3) A literature review found that individual nephrotoxic agents, including aminoglycosides, vancomycin, amphotericin, IV contrast, diuretics, ACE inhibitors, ARBs, NSAIDs, and calcineurin inhibitors, were not consistently associated with additive nephrotoxicity when used with colistimethate. However, when multiple agents (at least 2 additional potential nephrotoxins) were used concurrently, there was a significant correlation to colistimethate nephrotoxicity.(5) |
ACCUPRIL, ACCURETIC, ADEFOVIR DIPIVOXIL, AFINITOR, AFINITOR DISPERZ, ALTACE, AMLODIPINE BESYLATE-BENAZEPRIL, AMLODIPINE-OLMESARTAN, AMLODIPINE-VALSARTAN, AMLODIPINE-VALSARTAN-HCTZ, ANAPROX DS, ANJESO, ARBLI, ARTHROTEC 50, ARTHROTEC 75, ASTAGRAF XL, ATACAND, ATACAND HCT, AVALIDE, AVAPRO, AZOR, BENAZEPRIL HCL, BENAZEPRIL-HYDROCHLOROTHIAZIDE, BENICAR, BENICAR HCT, BIKTARVY, BISMUTH SUBSALICYLATE, BROMFENAC SODIUM, BUPIVACAINE-KETOROLAC-KETAMINE, CALDOLOR, CAMBIA, CANDESARTAN CILEXETIL, CANDESARTAN-HYDROCHLOROTHIAZID, CAPTOPRIL, CAPTOPRIL-HYDROCHLOROTHIAZIDE, CELEBREX, CELECOXIB, CHOLINE MAGNESIUM TRISALICYLAT, CIMDUO, CISPLATIN, COMBOGESIC, COMBOGESIC IV, COMPLERA, CONSENSI, COXANTO, COZAAR, CYCLOSPORINE, CYCLOSPORINE MODIFIED, DAYPRO, DELSTRIGO, DESCOVY, DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM ER, DICLOFENAC SODIUM MICRONIZED, DICLOFENAC SODIUM-MISOPROSTOL, DIFLUNISAL, DIOVAN, DIOVAN HCT, DISALCID, DOLOBID, EC-NAPROSYN, EC-NAPROXEN, EDARBI, EDARBYCLOR, EFAVIRENZ-EMTRIC-TENOFOV DISOP, EFAVIRENZ-LAMIVU-TENOFOV DISOP, ELYXYB, EMTRICITABINE-TENOFOVIR DISOP, ENALAPRIL MALEATE, ENALAPRIL-HYDROCHLOROTHIAZIDE, ENALAPRILAT, ENTRESTO, ENTRESTO SPRINKLE, ENVARSUS XR, EPANED, EPROSARTAN MESYLATE, ETODOLAC, ETODOLAC ER, EVEROLIMUS, EXFORGE, EXFORGE HCT, FELDENE, FENOPROFEN CALCIUM, FENOPRON, FLURBIPROFEN, FOSINOPRIL SODIUM, FOSINOPRIL-HYDROCHLOROTHIAZIDE, FYARRO, GENGRAF, GENVOYA, HEPSERA, HYDROCODONE-IBUPROFEN, HYZAAR, IBU, IBUPAK, IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN-FAMOTIDINE, INDOCIN, INDOMETHACIN, INDOMETHACIN ER, INFLAMMACIN, INFLATHERM(DICLOFENAC-MENTHOL), IRBESARTAN, IRBESARTAN-HYDROCHLOROTHIAZIDE, KEMOPLAT, KETOPROFEN, KETOPROFEN MICRONIZED, KETOROLAC TROMETHAMINE, KIPROFEN, LISINOPRIL, LISINOPRIL-HYDROCHLOROTHIAZIDE, LODINE, LOFENA, LOSARTAN POTASSIUM, LOSARTAN-HYDROCHLOROTHIAZIDE, LOTENSIN, LOTENSIN HCT, LOTREL, LUPKYNIS, MB CAPS, MECLOFENAMATE SODIUM, MEFENAMIC ACID, MELOXICAM, METHOTREXATE, METHOTREXATE SODIUM, MICARDIS, MICARDIS HCT, MOEXIPRIL HCL, NABUMETONE, NABUMETONE MICRONIZED, NALFON, NAPRELAN, NAPROSYN, NAPROTIN, NAPROXEN, NAPROXEN SODIUM, NAPROXEN SODIUM CR, NAPROXEN SODIUM ER, NAPROXEN-ESOMEPRAZOLE MAG, NEOPROFEN, NEORAL, ODEFSEY, OLMESARTAN MEDOXOMIL, OLMESARTAN-AMLODIPINE-HCTZ, OLMESARTAN-HYDROCHLOROTHIAZIDE, OXAPROZIN, PERINDOPRIL ERBUMINE, PHENYL SALICYLATE, PHENYLBUTAZONE, PIROXICAM, PRESTALIA, PROGRAF, QBRELIS, QUINAPRIL HCL, QUINAPRIL-HYDROCHLOROTHIAZIDE, R.E.C.K.(ROPIV-EPI-CLON-KETOR), RAMIPRIL, RELAFEN DS, ROPIVACAINE-CLONIDINE-KETOROLC, ROPIVACAINE-KETOROLAC-KETAMINE, SALSALATE, SANDIMMUNE, SIROLIMUS, SODIUM SALICYLATE, SPRIX, STRIBILD, SULINDAC, SUMATRIPTAN SUCC-NAPROXEN SOD, SYMBRAVO, SYMFI, SYMFI LO, SYMTUZA, TACROLIMUS, TACROLIMUS XL, TELMISARTAN, TELMISARTAN-AMLODIPINE, TELMISARTAN-HYDROCHLOROTHIAZID, TEMSIROLIMUS, TENOFOVIR DISOPROXIL FUMARATE, TOLECTIN 600, TOLMETIN SODIUM, TORISEL, TORONOVA II SUIK, TORONOVA SUIK, TORPENZ, TOXICOLOGY SALIVA COLLECTION, TRANDOLAPRIL, TRANDOLAPRIL-VERAPAMIL ER, TRESNI, TREXIMET, TRIBENZOR, TRUVADA, URIMAR-T, URNEVA, VALSARTAN, VALSARTAN-HYDROCHLOROTHIAZIDE, VASERETIC, VASOTEC, VEMLIDY, VIMOVO, VIREAD, VIVLODEX, ZESTORETIC, ZESTRIL, ZIPSOR, ZORTRESS, ZORVOLEX, ZYNRELEF |
| Fecal Microbiota Spores/Antibiotics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1) CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1) DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores. |
VOWST |
| Selected Nephrotoxic Agents/Polymyxin B SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Polymyxin B can cause nephrotoxicity with a slight degree of tubular damage. Concurrent administration of other nephrotoxic agents may result in an increased risk of nephrotoxicity.(1) CLINICAL EFFECTS: Concurrent use of polymyxin B with other nephrotoxic agents may result in additive nephrotoxic effects. Polymyxin B nephrotoxicity is characterized by albuminuria, cellular casts, azotemia, diminished urine output, elevated BUN and rising blood levels usually after about 4 days of therapy.(1,2) PREDISPOSING FACTORS: Factors predisposing to nephrotoxicity include higher cumulative doses and longer duration of therapy of polymyxin B and exposure to multiple nephrotoxins.(2) PATIENT MANAGEMENT: Concurrent or sequential use of potentially nephrotoxic agents with polymyxin B should be avoided. If concurrent use is necessary, it should be undertaken with great caution. Check renal function at baseline and monitor renal function and polymyxin B blood levels frequently during therapy.(1) DISCUSSION: Polymyxin B is associated with high rates of nephrotoxicity. Concurrent use with other nephrotoxins may increase the risk of nephrotoxicity. |
POLYMYXIN B SULFATE |
There are 1 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 |
|---|---|
| Neuromuscular Blocking Agents/Polypeptide Antibiotics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Synergistic pharmacologic activity. Polymyxin B affects neuromuscular transmission by blocking acetylcholine receptors. Its action is thus post-synaptic and the neuromuscular block has no antagonists. Polymyxin B causes neostigmine resistance to d-tubocurarine blockade and calcium resistance to the blockade evoked by aminoglycoside antibiotics (1,2,3,4). A pre-synaptic mechanism may also be involved with decreased release of acetylcholine. CLINICAL EFFECTS: May see an increase in the neuromuscular blocking effects, including profound sedation, respiratory depression, coma, and/or death. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If it is necessary to administer these drugs concurrently, do so with extreme caution. Monitor neuromuscular function and adjust the dose of the neuromuscular blocking agent accordingly. If concurrent use is necessary, monitor patients for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. DISCUSSION: Concomitant administration of polypeptide antibiotics and neuromuscular blocking agents has been shown to produce synergism of the effects on skeletal muscles. Concurrent administration of these drugs has been associated with prolonged respiratory depression, respiratory paralysis, and apnea. This interaction has been documented with colistimethate, polymyxin B, bacitracin, and vancomycin. |
ANECTINE, ATRACURIUM BESYLATE, BOTOX, BOTOX COSMETIC, CISATRACURIUM BESYLATE, DAXXIFY, DYSPORT, JEUVEAU, MYOBLOC, NIMBEX, QUELICIN, ROCURONIUM BROMIDE, SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE-NACL, VECURONIUM BROMIDE, VECURONIUM BROMIDE-WATER, XEOMIN |
The following contraindication information is available for COLY-MYCIN M PARENTERAL (colistin (as colistimethate sodium)):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Clostridioides difficile infection |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Myasthenia gravis |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Neuromuscular blockade |
The following adverse reaction information is available for COLY-MYCIN M PARENTERAL (colistin (as colistimethate sodium)):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 13 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Paresthesia |
| Rare/Very Rare |
|---|
|
Acute respiratory distress syndrome Anaphylaxis Apnea Bronchospastic pulmonary disease Clostridioides difficile infection Nephrotoxicity Neuromuscular blockade Pseudo-bartter syndrome Respiration changes Seizure disorder Slurred speech Urticaria |
There are 8 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Cough Vertigo |
Dizziness Fever Gastrointestinal irritation Pruritus of skin Skin rash |
| Rare/Very Rare |
|---|
|
Oliguria |
The following precautions are available for COLY-MYCIN M PARENTERAL (colistin (as colistimethate sodium)):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Safe use of colistimethate sodium during pregnancy has not been established. When colistimethate sodium was given to rabbits during organogenesis in an IM dosage of 4.15 or 9.3
mg/kg (0.25 or 0.55 times, respectively, the maximum daily human dosage based on mg/m2), talipes varus occurred in 2.6 or 2.9% of fetuses, respectively.
In addition, increased resorption occurred at the 9.3 mg/kg dosage. The drug was not teratogenic when the same dosages were used in rats (0.13 or 0.3 times the maximum daily human dosage, respectively, based on mg/mm2). There are no adequate and controlled studies to date using colistimethate sodium in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.
mg/kg (0.25 or 0.55 times, respectively, the maximum daily human dosage based on mg/m2), talipes varus occurred in 2.6 or 2.9% of fetuses, respectively.
In addition, increased resorption occurred at the 9.3 mg/kg dosage. The drug was not teratogenic when the same dosages were used in rats (0.13 or 0.3 times the maximum daily human dosage, respectively, based on mg/mm2). There are no adequate and controlled studies to date using colistimethate sodium in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.
It is not known whether colistimethate sodium is distributed into milk, but colistin sulfate has been detected in milk. Therefore, colistimethate sodium should be used with caution in nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for COLY-MYCIN M PARENTERAL (colistin (as colistimethate sodium)):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for COLY-MYCIN M PARENTERAL (colistin (as colistimethate sodium))'s list of indications:
| E. coli infection | |
| A04.0 | Enteropathogenic escherichia coli infection |
| A04.1 | Enterotoxigenic escherichia coli infection |
| A04.2 | Enteroinvasive escherichia coli infection |
| A04.3 | Enterohemorrhagic escherichia coli infection |
| A04.4 | Other intestinal escherichia coli infections |
| A41.51 | Sepsis due to escherichia coli [e. coli] |
| B96.2 | Escherichia coli [e. coli ] as the cause of diseases classified elsewhere |
| B96.20 | Unspecified escherichia coli [e. coli] as the cause of diseases classified elsewhere |
| B96.21 | Shiga toxin-producing escherichia coli [e. coli] [STEc] o157 as the cause of diseases classified elsewhere |
| B96.22 | Other specified shiga toxin-producing escherichia coli [e. coli] [STEc] as the cause of diseases classified elsewhere |
| B96.23 | Unspecified shiga toxin-producing escherichia coli [e. coli] [STEc] as the cause of diseases classified elsewhere |
| B96.29 | Other escherichia coli [e. coli] as the cause of diseases classified elsewhere |
| J15.5 | Pneumonia due to escherichia coli |
| P23.4 | Congenital pneumonia due to escherichia coli |
| P36.4 | Sepsis of newborn due to escherichia coli |
| Enterobacter infection | |
| B96.89 | Other specified bacterial agents as the cause of diseases classified elsewhere |
| Klebsiella infection | |
| B96.1 | Klebsiella pneumoniae [k. pneumoniae] as the cause of diseases classified elsewhere |
| J15.0 | Pneumonia due to klebsiella pneumoniae |
| Pseudomonas aeruginosa infection | |
| A41.52 | Sepsis due to pseudomonas |
| B96.5 | Pseudomonas (aeruginosa) (mallei) (pseudomallei) as the cause of diseases classified elsewhere |
| J15.1 | Pneumonia due to pseudomonas |
| P23.5 | Congenital pneumonia due to pseudomonas |
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