Generic Name: Colistimethate Sodium
Class: Polymyxins
VA Class: AM900
CAS Number: 8068-28-8
Special Alerts:
[Posted 06/30/2011] A National Alert for Serious Medication Errors has been issued by the American Society of Health-System Pharmacists (ASHP) and the Institute for Safe Medication Practices (ISMP), warning that potentially fatal errors may occur with dosing for the antibiotic colistimethate for injection. The use of this drug has been increasing due to its value as a last resort treatment for multi-drug resistant organisms.
Colistimethate is a prodrug, a pre-cursor of a drug that converts to an active drug in the human body as it is metabolized. However, in the U.S., the strength of all FDA-approved colistimethate for injection products is labeled in terms of the base drug, colistin, not the prodrug. The label expresses the strength as 150 mg of colistin base per vial.
Dosing information also is expressed in terms of the colistin base. However, on the Internet and in some journal references, dosing information is based on the prodrug, colistimethate. This has resulted in situations where the prodrug dose is ordered but confused as a colistin dose, which results in doses approximately 2.5 times higher than intended.
In a recent case, a physician mistakenly ordered a dose of colistimethate as the prodrug, but the amount was dispensed as the colistin base. The patient developed complications including acute renal failure and later died.
The alert provides recommendations to prevent misdosing of colistimethate, which include developing dose limits, restricting prescribing to infectious disease specialists, and monitoring the patients’ renal function. Physicians, pharmacists, and nurses are expected to use these recommendations to take immediate action to prevent serious medication errors at their facility.
Alerts are issued by ASHP and ISMP when a significant risk for serious or fatal errors is detected through ISMP’s National Medication Error Reporting Program (MERP). Alerts are distributed to healthcare practitioners and organizations through ISMP, ASHP, and the National Council on Medication Error Reporting and Prevention.
Introduction
Antibacterial; sulfamethyl derivative (methane sulfonate) of colistin that is hydrolyzed to colistin in vitro (in aqueous solutions) and in vivo.134 Colistin (polymyxin E) is a polymyxin antibiotic structurally and pharmacologically related to polymyxin B.134
Uses for Coly-Mycin M
Gram-negative Aerobic Bacterial Infections
Treatment of acute or chronic infections caused by certain susceptible gram-negative bacteria (e.g., Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa).100
Used only when the causative agent is susceptible and other more effective and less toxic anti-infectives are contraindicated or ineffective.a
May be useful alone or in conjunction with other anti-infectives for treatment of infections caused by multiple-drug resistant gram-negative bacteria, such as respiratory tract infections in cystic fibrosis patients caused by multiple-drug resistant Ps. aeruginosa.106 119 121 122 135
Not indicated for infections caused by Proteus or Neisseria.100
Respiratory Tract Infections
Administered by oral inhalation via nebulization† in adult and pediatric cystic fibrosis patients for early treatment of Ps. aeruginosa respiratory tract infections and for suppressive therapy in those colonized with Ps. aeruginosa.109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126
Safety and efficacy not established and the drug is not labeled by FDA for administration via nebulization†.109 110 Adverse respiratory effects (e.g., bronchoconstriction) have occurred with this route119 130 131 and there has been at least one fatality in a patient who self-administered a nebulizer treatment using a premixed solution of the drug.109 110 (See Respiratory Effects under Cautions.)
Coly-Mycin M Dosage and Administration
Administration
Administer by IM injection, IV injection, or continuous IV infusion.100 Also has been administered by oral inhalation via nebulization†.109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126
Solutions for IM injection, IV injection, or continuous IV infusion should be freshly prepared and used within 24 hours.100
Extemporaneously prepared solutions for nebulization† should be used promptly after being prepared.109 A fatality has been reported in a cystic fibrosis patient who self-administered a nebulizer treatment using a premixed solution of the drug.109 110 (See Respiratory Effects under Cautions.)
IM Administration
Reconstitution
Reconstitute colistimethate sterile powder by adding 2 mL of sterile water for injection to a vial labeled as containing 150 mg of colistin; swirl gently to avoid frothing.100 The resultant solution contains 75 mg of colistin per mL.100
Inject the appropriate dose of reconstituted solution IM.100
IV Injection
Reconstitution
Reconstitute colistimethate sterile powder by adding 2 mL of sterile water for injection to a vial labeled as containing 150 mg of colistin; swirl gently to avoid frothing.100 Resultant solution contains 75 mg of colistin per mL.100
Rate of Administration
Inject the appropriate dose of reconstituted solution directly into a vein over 3–5 minutes.100
IV Infusion
For solution and drug compatibility information, see Compatibility under Stability.
Reconstitution and Dilution
Reconstitute colistimethate sterile powder by adding 2 mL of sterile water for injection to a vial labeled as containing 150 mg of colistin; swirl gently to avoid frothing.100 Resultant solution contains 75 mg of colistin per mL.100
Add one-half of the total daily dose to a compatible IV solution.100 (See Compatibility under Stability.)
Rate of Administration
Inject one-half of the total daily dose directly into a vein over 3–5 minutes (as reconstituted solution), then administer the dilution containing the remaining one-half of the total daily dose by slow IV infusion over 22–23 hours beginning 1–2 hours after the injection.100
The infusion rate should be 5–6 mg/hour in patients with normal renal function.a Reduce rate depending on the degree of renal impairment.100
Oral Inhalation†
For oral inhalation via nebulization†, an isotonic solution has been prepared by diluting the appropriate dose in 2–4 mL of preservative-free 0.9% sodium chloride injection, sterile water, or a mixture of 0.9% sodium chloride injection and sterile water.110 111 112 114 115 121 126 131
Extemporaneously prepared solutions for nebulization† should be used promptly after being prepared.109 A fatality has been reported in a cystic fibrosis patient who self-administered a nebulizer treatment using a premixed solution of the drug.109 110 (See Respiratory Effects under Cautions.)
Bronchoconstriction has occurred almost immediately after initiation of nebulization†;119 premedication with bronchodilators can be used to reduce the potential for bronchoconstriction.119 120 122 130 131 (See Respiratory Effects under Cautions.)
Dosage
Available as colistimethate sodium.100
Dosage of colistimethate sodium commercially available in the US is expressed in terms of colistin base.100
Dosage of colistimethate sodium preparations commercially available in some other countries (e.g., United Kingdom, Greece) is expressed in terms of colistimethate sodium or in terms of international units.111 112 113 114 115 116 117 118 121 129 The fact that dosages reported in published clinical studies or case reports may vary depending on the preparation used should be considered.120 129
To avoid confusion, it has been suggested that dosage of colistimethate should preferably be expressed in terms of international units.129 135 When expressed in terms of international units, each mg of colistin base has a potency of 30,000 international units129 134 and each mg of colistimethate sodium has a potency of 12,500 international units.129
Dosage is identical for either IV or IM administration.100
Pediatric Patients
General Dosage for Infants and Children
IM or IV Injection
2.5–5 mg/kg of colistin daily given in 2–4 divided doses, depending on the severity of the infection.100
Continuous IV Infusion
2.5–5 mg/kg of colistin daily, depending on the severity of the infection.100 Give the first half of the dose by direct IV injection and the second half of the dose by slow IV infusion over 22–23 hours beginning 1–2 hours after the injection.100
Pseudomonas aeruginosa Infections in Cystic Fibrosis Patients
Oral Inhalation†
33.33–66.66 mg of colistin 2 or 3 times daily.111 112 113 114 115 117 128 This corresponds to 1–2 million international units 2 or 3 times daily.111 112 113 114 115 116 117 121 128
Adults
General Adult Dosage
IM or IV Injection
2.5–5 mg/kg of colistin daily given in 2–4 divided doses, depending on the severity of the infection.100
Continuous IV Infusion
2.5–5 mg/kg of colistin daily, depending on the severity of the infection.100 Give the first half of the dose by direct IV injection and the second half of the dose by slow IV infusion over 22–23 hours beginning 1–2 hours after the injection.100
Pseudomonas aeruginosa Infections in Cystic Fibrosis Patients†
Oral Inhalation†
33.33–66.66 mg of colistin 2 or 3 times daily.111 112 113 114 115 117 128 This corresponds to 1–2 million international units 2 or 3 times daily.111 112 113 114 115 116 117 121 128
Prescribing Limits
Pediatric Patients
IM or IV
Maximum of 5 mg/kg of colistin daily in those with normal renal function.100
Adults
IM or IV
Maximum of 5 mg/kg of colistin daily in those with normal renal function.100
Special Populations
Hepatic Impairment
No specific dosage recommendations at this time.100
Renal Impairment
Adjust IM or IV dosage in patients with renal impairment.100 Decrease IM or IV dose and frequency in proportion to the degree of renal impairment.100 (See Table.)
Scr (mg/100mL) | IM or IV Dose (mg) | Frequency (times/day) | Total daily dose (mg) | Approximate daily dose (mg/kg/day) |
|---|---|---|---|---|
0.7–1.2 | 100–150 | 2–4 | 300 | 5 |
1.3–1.5 | 75–115 | 2 | 150–230 | 2.5–3.8 |
1.6–2.5 | 66–150 | 1–2 | 133–150 | 2.5 |
2.6–4 | 100–150 | every 36 hours | 100 | 1.5 |
Geriatric Patients
Select IM or IV dosage with caution, usually initiating therapy at the low end of the dosage range.100 Consider the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly.100
Obese Patients
Base dosage on ideal body weight.100
Cautions for Coly-Mycin M
Contraindications
Hypersensitivity to colistimethate or any ingredient in the formulation.100
Warnings/Precautions
Warnings
Nephrotoxicity
Nephrotoxicity (decreased urine output, increased BUN and Scr, proteinuria, hematuria, casts in the urine) reported with usual dosage.a Acute tubular necrosis has been reported and was not necessarily preceded by progressive renal impairment.a
Nephrotoxicity generally reversible when the drug is discontinued.a Additional increases in Scr frequently occur for 1–2 weeks following discontinuance of the drug.a
Monitor renal function.a Nephrotoxicity probably is dose-dependent,100 but adverse renal effects may occur regardless of dosage.a
Use with caution in patients in whom the possibility of renal impairment exists (e.g., geriatric patients).100
Discontinue drug immediately if diminishing urine output, increasing BUN or Scr, or decreased Clcr occur.100 If colistimethate must be reinstated, dosage should be adjusted after plasma concentrations of the drug have declined.100 (See Renal Impairment under Dosage and Administration.)
Neurotoxicity
Transient neurologic effects reported, including circumoral or peripheral paresthesia or numbness, tingling, or formication of the extremities or tongue, generalized pruritus, dizziness, vertigo, giddiness, ataxia, blurred vision, and slurred speech.100 a
If neurologic effects occur, they generally appear within the first 4 days of therapy and disappear upon discontinuing the drug.a
More severe neurotoxic effects (e.g., mental confusion, coma, psychosis, seizures) also reported, especially when high dosage was used or renal function was impaired.a
The drug does not necessarily have to be discontinued if neurologic effects occur, but monitor patient closely; some of these effects may be alleviated by reducing dosage.100 a
Patients should not drive vehicles or use hazardous machinery while receiving colistimethate.100
Neuromuscular Blockade
Neuromuscular blockade (which may result in respiratory arrest) can occur, especially when used in patients who have neuromuscular disease such as myasthenia gravis or are receiving neuromuscular blocking agents, general anesthetics, or other drugs with neuromuscular blocking potential.a (See Specific Drugs under Interactions.)
Apnea and neuromuscular blockade reported most frequently when dosage was not reduced in proportion to the degree of renal impairment.a
If apnea occurs, respiration should be assisted, and calcium chloride injections and oxygen administered if appropriate.a
Neuromuscular blockade induced by colistimethate is noncompetitive and is not reversed by neostigmine.a
Respiratory Effects
Administration by oral inhalation via nebulization† has caused bronchoconstriction in adult and pediatric cystic fibrosis patients.119 130 131 Bronchoconstriction has occurred almost immediately after initiation of nebulization and can last for >30 minutes.119
Premedication with bronchodilators may reduce the potential for bronchoconstriction.119 120 122 130 131
Pre- and posttreatment pulmonary function tests recommended to identify patients who may be predisposed to bronchoconstriction.119 Bronchodilator premedication recommended in young children who are unable to perform pulmonary function tests.131
Respiratory distress progressing over several days to acute respiratory failure, multi-organ system failure, and death was reported in a patient who received colistimethate by oral inhalation via nebulization†.109 110 This patient self-administered the nebulizer treatment using a colistimethate solution prepared by a pharmacy and dispensed in premixed unit dose ready-to-use vials.109 110 This fatality may have been related to the fact that a premixed solution of colistimethate was used in the nebulizer.109 110
Extemporaneously prepared solutions of colistimethate should be used promptly.109 After colistimethate is mixed with water and buffer, it undergoes spontaneous hydrolysis to colistin.110 A component of colistin (polymyxin E1) has been shown to cause pulmonary inflammatory reactions in animals and may contribute to such local toxicity in humans.109 110 119
Respiratory arrest reported following IM administration.100
Clostridium difficile-associated Diarrhea and Colitis
Treatment with anti-infectives may permit overgrowth of Clostridium difficile.100 101 102 103 104 105 C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including colistimethate, and may range in severity from mild diarrhea to fatal colitis.100 101 102 103 104 105
Consider CDAD if diarrhea develops during or after therapy and manage accordingly.100 101 102 103 104 105 Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.100
If CDAD is suspected or confirmed, discontinuance of the anti-infective may be necessary.100 101 102 103 104 105 Some mild cases may respond to discontinuance alone.100 101 102 103 104 105 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.100 101 102 103 104 105
General Precautions
Superinfection
Prolonged use may result in overgrowth of nonsusceptible organisms (e.g., Proteus).a If suprainfection or superinfection occurs during therapy, appropriate anti-infective therapy should be instituted.a
Selection and Use of Anti-Infectives
To reduce development of drug-resistant bacteria and maintain effectiveness of colistimethate and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.100
When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.100 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.100
Specific Populations
Pregnancy
Category C.100
Lactation
Not known whether colistimethate is distributed into milk;100 colistin is distributed into milk.100 Use with caution.100
Pediatric Use
Used in neonates, infants, children, and adolescents.100 Adverse effect profile in pediatric patients appears to be similar to that in adults; however, monitor closely since subjective symptoms of toxicity may not be reported by pediatric patients.100
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.100 Other clinical experience has not revealed age-related differences in response.100
Select dosage with caution, usually starting at the low end of the dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.100
Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function.100 Consider monitoring renal function because of age-related decreases in renal function.100 (See Renal Impairment under Dosage and Administration.)
Renal Impairment
Use with caution in patients in whom the possibility of renal impairment exists (e.g., geriatric patients).100
If used in patients with renal impairment, reduce dosage and frequency of administration in proportion to the degree of impairment.100 (See Renal Impairment under Dosage and Administration.)
Dosage that exceeds renal excretory capacity will lead to high serum concentrations of the drug, which can result in further impairment of renal function and possibly acute renal insufficiency, renal shutdown, and neuromuscular blockade.100
Discontinue drug immediately if diminishing urine output, increasing concentrations of BUN or Scr, or decreased Clcr occur.100
Common Adverse Effects
Renal effects, nervous system effects.100
Interactions for Coly-Mycin M
Neurotoxic or Nephrotoxic Drugs
Concomitant or sequential use with other drugs that have neurotoxic and/or nephrotoxic effects may result in additive toxicity and should be avoided, if possible.100 a
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Aminoglycosides | Possible increased risk of nephrotoxic and/or neurotoxic effects;100 a possible potentiation of neuromuscular blockade100 | Use caution;100 avoid concurrent or sequential use, if possiblea |
Amphotericin B | Possible increased risk of nephrotoxic and/or neurotoxic effectsa | Avoid concurrent or sequential use, if possiblea |
Capreomycin | Possible increased risk of nephrotoxic and/or neurotoxic effectsa | Avoid concurrent or sequential use, if possiblea |
Neuromuscular blocking agents and general anesthetics (succinylcholine, tubocurarine, ether, decamethonium) | Possible potentiation of neuromuscular blockade100 a | Use extreme caution100 |
Polymyxin B sulfate | Possible increased risk of nephrotoxic and/or neurotoxic effects;100 a possible potentiation of neuromuscular blockade100 | Use caution;100 avoid concurrent or sequential use, if possible100 a |
Vancomycin | Possible increased risk of nephrotoxic and/or neurotoxic effectsa | Avoid concurrent or sequential use, if possiblea |
Coly-Mycin M Pharmacokinetics
Absorption
Bioavailability
Not absorbed orally;a must be given parenterally.a
Following IM administration, peak serum concentrations attained within 2 hours.a
Special Populations
Following IV administration of colistimethate sodium in a dosage of 5–7 mg/kg of colistin daily given in 3 equally divided doses (maximum 70–100 mg every 8 hours) in cystic fibrosis patients 14–53 years of age, mean peak serum concentrations after first dose and at steady state are 21.4 mcg/mL and 23 mcg/mL, respectively;133 mean 8-hour trough concentrations after first dose and at steady state are 2.8 mcg/mL and 4.5 mcg/mL, respectively.133
Following oral inhalation via nebulization† of colistimethate sodium in a dosage of 66.66 mg of colistin (2 million international units) in cystic fibrosis patients 12–48 years of age, peak serum concentrations of 0.17 mcg/mL are attained in 1.5 hours.132
Distribution
Extent
Widely distributed into body tissues following IV or IM administration.a Negligible concentrations attained in synovial, pleural, or pericardial fluids.a
Minimal concentrations attained in CSF following IV or IM administration in patients with normal or inflamed meninges.a
Crosses placenta.100
Not known whether colistimethate is distributed into milk; colistin is distributed into milk.100
Plasma Protein Binding
>50% bound.a
Special Populations
Following IV administration in cystic fibrosis patients 14–53 years of age, steady state volume of distribution is 0.09 L/kg.133
Following oral inhalation via nebulization† in cystic fibrosis patients 12–48 years of age, sputum concentrations peaked in 1 hour and remained >4 mcg/mL for up to 12 hours in most patients.132
Elimination
Metabolism
Hydrolyzed in vivo to colistin and possibly other metabolites with fewer substituted amino groups.a Rate and extent of hydrolysis as well as the specific metabolites and their antibacterial activities have not been determined to date.a
Elimination Route
Excreted mainly by the kidneys via glomerular filtration.a Antimicrobial activity in urine generally higher than in serum.a
May be removed by hemodialysis and, to a lesser extent, by peritoneal dialysis.134
Half-life
1.5–8 hours in adults with normal renal function.a
Special Populations
Children: Serum concentrations decline more rapidly than in adults.a
Impaired renal function: Serum concentrations are higher and the half-life prolonged.a Half-life ranges from 10–20 hours in patients with Clcr <20 mL/minute.a In a few anuric patients, half-life of antimicrobial activity ranged from 2–3 days.a
Cystic fibrosis patients 14–53 years of age receiving IV colistimethate: Half-life is 3.4 hours after the first dose and 3.5 hours at steady state.133
Cystic fibrosis patients 12–48 years of age receiving colistimethate by oral inhalation via nebulization†: Half-life is 4.1–4.5 hours.132
Stability
Storage
Parenteral
Powder for Injection
20–25°C.100
Following reconstitution, store at 2–8°C or 20–25°C and use within 7 days.100
Reconstituted solutions further diluted with a compatible IV solution should be used within 24 hours.100
Extemporaneously prepared solutions for oral inhalation via nebulization† should be used promptly after being mixed.109 (See Respiratory Effects under Cautions.)
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Parenteral
Solution Compatibility
Compatible100 |
|---|
Dextrose 5% in 0.225%, 0.45%, or 0.9% sodium chloride |
Dextrose 5% in water |
Invert sugar 10% |
Ringer’s injection, lactated |
Sodium chloride 0.9% |
Drug Compatibility
Compatible |
Amikacin sulfate |
Ascorbic acid injection |
Chloramphenicol sodium succinate |
Cimetidine HCl |
Diphenhydramine HCl |
Heparin sodium |
Penicillin G potassium |
Penicillin G sodium |
Phenobarbital sodium |
Polymyxin B sulfate |
Ranitidine HCl |
Vitamin B complex with C |
Incompatible |
Erythromycin lactobionate |
Hydrocortisone sodium succinate |
Kanamycin sulfate |
Actions and Spectrum
Inactive until hydrolyzed to colistin;a hydrolysis occurs in vitro in aqueous solutions and in vivo.a
Usually bactericidal.a
Acts like a cationic detergent and binds to and damages bacterial cytoplasmic membrane of susceptible bacteria causing alteration of the osmotic barrier and leakage of essential intracellular metabolites and nucleosides.a
In vitro spectrum of activity includes certain gram-negative bacteria.100 a Inactive against gram-positive bacteria, fungi, and viruses.a
Gram-negative bacteria: Active in vitro against Acinetobacter, Citrobacter, Escherichia coli, Enterobacter, Haemophilus influenzae, Klebsiella pneumoniae, Pseudomonas aeruginosa, Salmonella, Shigella, and some strains of Bordetella and Vibrio.100 a Most strains of Proteus, Providencia, Serratia, Neisseria gonorrhoeae, N. meningitidis, and Bacteroides fragilis are resistant to colistin.100 a
Resistance has been induced in vitro in strains originally susceptible.a Resistance may be reversible when drug is withdrawn.a Resistance developed rarely during therapy.a
Resistant Ps. aeruginosa reported rarely, including in some patients receiving long-term treatment with colistimethate administered by oral inhalation via nebulization†.122 134
Resistant Acinetobacter baumannii,136 Enterobacter cloacae,138 and Klebsiella pneumoniae reported rarely.137 138
Complete cross-resistance occurs between colistin and polymyxin B;134 cross-resistance with other anti-infectives has not been reported to date.a
Advice to Patients
Advise patients that antibacterials (including colistimethate) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).100
Importance of completing full course of therapy, even if feeling better after a few days.100
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with colistimethate or other antibacterials in the future.100
Importance of informing clinician if there is evidence of neurotoxicity (e.g., paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, speech disorders, apnea) or nephrotoxicity (e.g., decreased urine output).a
Patients should be warned that the drug may impair their ability to perform hazardous activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle).a
Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.100 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.100
Patients should be advised not to use any premixed, ready-to-use liquid preparations of colistimethate for nebulization and to discard any unused vials of premixed, ready-to-use liquid preparations of the drug that they may have in their possession.109 110
Importance of informing clinician of existing or contemplated therapy, including prescription and OTC drugs, and any concomitant illnesses.a
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a
Importance of advising patients of other important precautionary information.a (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection | 150 mg (of colistin)* | Colistimethate Sodium for Injection | Paddock, X-Gen |
Coly-Mycin M Parenteral | Monarch |
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 25, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
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103. Fekety R for the American College of Gastroenterology Practice Parameters Committee. Guidelines for the diagnosis and management of Clostridium difficile-associated diarrhea and colitis. Am J Gastroenterol. 1997; 92:739-50. (IDIS 386628) [IDIS 386628] [PubMed 9149180]
104. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile-associated disease. Am J Health-Syst Pharm. 1998; 55:1407-11. [IDIS 407213] [PubMed 9659970]
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109. Food and Drug Administration. Public health advisory on colistimethate (marketed as Coly-Mycin M and generic products). Rockville, MD; 2007 June 28. From FDA website.
110. Food and Drug Administration. Information for healthcare professionals on colistimethate (marketed as Coly-Mycin M and generic products). Rockville, MD; June 28 2007. From FDA website.
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113. Valerius NH, Koch C, Hoiby N. Prevention of chronic Pseudomonas aeruginosa colonisation in cystic fibrosis by early treatment. Lancet . 1991; 338:725–6.
114. Hoiby N, Frederiksen B, Pressler T. Eradication of early Pseudomonas aeruginosa infection. J Cystic Fibro. 2005; 4:49-54.
115. Frederiksen B, Koch C, Hoiby N. Antibiotic treatment of initial colonization with Pseudomonas aeruginosa postpones chronic infection and prevents deterioration of pulmonary function in cystic fibrosis. Pediatr Pulmonol. 1997; 23:330–5.
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