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COLISTIMETHATE SODIUM
Overview
What is COLISTIMETHATE SODIUM?
Colistimethate for Injection, USP is a sterile parenteral antibiotic product which, when reconstituted (see), is suitable for intramuscular or intravenous administration.
Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity). The sodium content is approximately 0.158 mg (0.0069 mEq) Sodium per milligram of Colistin. Colistimethate for Injection, USP contains colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake. The color of the reconstituted solution is clear, pale yellow.
Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The molecular formula is CHNNaOS and the structural formula is represented below:
Dbu is 2,4-diaminobutanoic acid; R is 5-methylheptyl in colistin A & 5-methylhexyl in colistin B.
What does COLISTIMETHATE SODIUM look like?
What are the available doses of COLISTIMETHATE SODIUM?
Sorry No records found.
What should I talk to my health care provider before I take COLISTIMETHATE SODIUM?
Sorry No records found
How should I use COLISTIMETHATE SODIUM?
Colistimethate for Injection, USP is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of . This antibiotic is not indicated for infections due to or . Colistimethate for Injection, USP has proven clinically effective in treatment of infections due to the following gram-negative organisms:
Colistimethate for Injection, USP may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Colistimethate for Injection, USP and other antibacterial drugs, Colistimethate for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
ID37
Important:
What interacts with COLISTIMETHATE SODIUM?
The use of Colistimethate for Injection, USP is contraindicated for patients with a history of sensitivity to the drug or any of its components.
What are the warnings of COLISTIMETHATE SODIUM?
The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
Maximum daily dose calculated from colistin base activity should not exceed 5 mg/kg/day with normal renal function.
Transient neurological disturbances may occur. These include circumoral paresthesia or numbness, tingling or formication of the extremities, generalized pruritus, vertigo, dizziness, and slurring of speech. For these reasons, patients should be warned not to drive vehicles or use hazardous machinery while on therapy. Reduction of dosage may alleviate symptoms. Therapy need not be discontinued, but such patients should be observed with particular care.
Nephrotoxicity can occur and is probably a dose-dependent effect of colistimethate sodium. These manifestations of nephrotoxicity are reversible following discontinuation of the antibiotic.
Overdosage can result in renal insufficiency, muscle weakness, and apnea (see section). See subsection for use concomitantly with other antibiotics and curariform drugs.
Respiratory arrest has been reported following intramuscular administration of colistimethate sodium. Impaired renal function increases the possibility of apnea and neuromuscular blockade following administration of colistimethate sodium. Therefore, it is important to follow recommended dosing guidelines. See section for use in renal impairment.
What are the precautions of COLISTIMETHATE SODIUM?
General
Since Colistimethate for Injection, USP is eliminated mainly by renal excretion, it should be used with caution when the possibility of impaired renal function exists. The decline in renal function with advanced age should be considered.
When actual renal impairment is present, Colistimethate for Injection, USP may be used, but the greatest caution should be exercised and the dosage should be reduced in proportion to the extent of the impairment. Administration of amounts of Colistimethate for Injection, USP in excess of renal excretory capacity will lead to high serum levels and can result in further impairment of renal function, initiating a cycle which, if not recognized, can lead to acute renal insufficiency, renal shutdown, and further concentration of the antibiotic to toxic levels in the body. At this point, interference of nerve transmission at neuromuscular junctions may occur and result in muscle weakness and apnea (see section).
Signs indicating the development of impaired renal function include: diminishing urine output, rising BUN and serum creatinine and decreased creatinine clearance. Therapy with Colistimethate for Injection, USP should be discontinued immediately if signs of impaired renal function occur. However, if it is necessary to reinstate the drug, dosing should be adjusted accordingly after drug plasma levels have fallen (seesection).
Prescribing Colistimethate for Injection, USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Drug Interactions
Certain other antibiotics (aminoglycosides and polymyxin) have also been reported to interfere with the nerve transmission at the neuromuscular junction. Based on this reported activity, they should not be given concomitantly with Colistimethate for Injection, USP except with the greatest caution.
Curariform muscle relaxants (e.g., tubocurarine) and other drugs, including ether, succinylcholine, gallamine, decamethonium and sodium citrate, potentiate the neuromuscular blocking effect and should be used with extreme caution in patients being treated with Colistimethate for Injection, USP.
Sodium cephalothin may enhance the nephrotoxicity of Colistimethate for Injection, USP. The concomitant use of sodium cephalothin and Colistimethate for Injection, USP should be avoided.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal carcinogenicity studies and genetic toxicology studies have not been performed with colistimethate sodium. There were no adverse effects on fertility or reproduction in rats at doses of 9.3 mg/kg/day (0.30 times the maximum daily human dose when based on mg/m).
Pregnancy
Nursing Mothers
It is not known whether colistimethate sodium is excreted in human breast milk. However, colistin sulphate is excreted in human breast milk. Therefore, caution should be exercised when colistimethate sodium is administered to nursing women.
Geriatric Use
Clinical studies of colistimethate sodium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Pediatric Use
In clinical studies, colistimethate sodium was administered to the pediatric population (neonates, infants, children and adolescents). Although adverse reactions appear to be similar in the adult and pediatric populations, subjective symptoms of toxicity may not be reported by pediatric patients. Close clinical monitoring of pediatric patients is recommended.
Information for Patients
Patients should be counseled that antibacterial drugs including Colistimethate for Injection, USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Colistimethate for Injection, USP is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Colistimethate for Injection, USP or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
What are the side effects of COLISTIMETHATE SODIUM?
The following adverse reactions have been reported:
Gastrointestinal:
Nervous System:
Integumentary:
Body as a Whole:
Laboratory Deviations:
Respiratory System:
Renal System:
To report SUSPECTED ADVERSE REACTIONS, contact Heritage Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or .
What should I look out for while using COLISTIMETHATE SODIUM?
The use of Colistimethate for Injection, USP is contraindicated for patients with a history of sensitivity to the drug or any of its components.
Maximum daily dose calculated from colistin base activity should not exceed 5 mg/kg/day with normal renal function.
Transient neurological disturbances may occur. These include circumoral paresthesia or numbness, tingling or formication of the extremities, generalized pruritus, vertigo, dizziness, and slurring of speech. For these reasons, patients should be warned not to drive vehicles or use hazardous machinery while on therapy. Reduction of dosage may alleviate symptoms. Therapy need not be discontinued, but such patients should be observed with particular care.
Nephrotoxicity can occur and is probably a dose-dependent effect of colistimethate sodium. These manifestations of nephrotoxicity are reversible following discontinuation of the antibiotic.
Overdosage can result in renal insufficiency, muscle weakness, and apnea (see section). See subsection for use concomitantly with other antibiotics and curariform drugs.
Respiratory arrest has been reported following intramuscular administration of colistimethate sodium. Impaired renal function increases the possibility of apnea and neuromuscular blockade following administration of colistimethate sodium. Therefore, it is important to follow recommended dosing guidelines. See section for use in renal impairment.
Clostridium difficile
C. difficile
C. difficile
C. difficile
C
difficile
C. difficile
What might happen if I take too much COLISTIMETHATE SODIUM?
Overdosage with colistimethate sodium can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may lead to apnea, respiratory arrest and death. Overdosage with the drug can also cause acute renal failure, manifested as decreased urine output and increases in serum concentrations of BUN and creatinine.
As in any case of overdose, colistimethate sodium therapy should be discontinued and general supportive measures should be utilized.
It is unknown whether colistimethate sodium can be removed by hemodialysis or peritoneal dialysis in overdose cases.
How should I store and handle COLISTIMETHATE SODIUM?
Protect polymer bottles of OMNIPAQUE from strong daylight and direct exposure to sunlight. Do not freeze. OMNIPAQUE should be stored at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Injection in all presentations may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).SPECIAL HANDLING AND STORAGE FOR POLYMER BOTTLES ONLY: DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING.Protect polymer bottles of OMNIPAQUE from strong daylight and direct exposure to sunlight. Do not freeze. OMNIPAQUE should be stored at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Injection in all presentations may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).SPECIAL HANDLING AND STORAGE FOR POLYMER BOTTLES ONLY: DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING.Protect polymer bottles of OMNIPAQUE from strong daylight and direct exposure to sunlight. Do not freeze. OMNIPAQUE should be stored at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Injection in all presentations may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).SPECIAL HANDLING AND STORAGE FOR POLYMER BOTTLES ONLY: DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING.Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake and is available as one vial per carton (NDC 23155-193-31).Store unreconstituted product at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.Rx only.Manufactured by:Emcure Pharmaceuticals Ltd.,Hinjawadi, Pune, India.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901.DRUG (3784)Rev. 04/17Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake and is available as one vial per carton (NDC 23155-193-31).Store unreconstituted product at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.Rx only.Manufactured by:Emcure Pharmaceuticals Ltd.,Hinjawadi, Pune, India.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901.DRUG (3784)Rev. 04/17Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake and is available as one vial per carton (NDC 23155-193-31).Store unreconstituted product at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.Rx only.Manufactured by:Emcure Pharmaceuticals Ltd.,Hinjawadi, Pune, India.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901.DRUG (3784)Rev. 04/17Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake and is available as one vial per carton (NDC 23155-193-31).Store unreconstituted product at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.Rx only.Manufactured by:Emcure Pharmaceuticals Ltd.,Hinjawadi, Pune, India.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901.DRUG (3784)Rev. 04/17Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake and is available as one vial per carton (NDC 23155-193-31).Store unreconstituted product at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.Rx only.Manufactured by:Emcure Pharmaceuticals Ltd.,Hinjawadi, Pune, India.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901.DRUG (3784)Rev. 04/17Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake and is available as one vial per carton (NDC 23155-193-31).Store unreconstituted product at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.Rx only.Manufactured by:Emcure Pharmaceuticals Ltd.,Hinjawadi, Pune, India.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901.DRUG (3784)Rev. 04/17Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake and is available as one vial per carton (NDC 23155-193-31).Store unreconstituted product at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.Rx only.Manufactured by:Emcure Pharmaceuticals Ltd.,Hinjawadi, Pune, India.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901.DRUG (3784)Rev. 04/17Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake and is available as one vial per carton (NDC 23155-193-31).Store unreconstituted product at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.Rx only.Manufactured by:Emcure Pharmaceuticals Ltd.,Hinjawadi, Pune, India.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901.DRUG (3784)Rev. 04/17Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake and is available as one vial per carton (NDC 23155-193-31).Store unreconstituted product at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.Rx only.Manufactured by:Emcure Pharmaceuticals Ltd.,Hinjawadi, Pune, India.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901.DRUG (3784)Rev. 04/17Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake and is available as one vial per carton (NDC 23155-193-31).Store unreconstituted product at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.Rx only.Manufactured by:Emcure Pharmaceuticals Ltd.,Hinjawadi, Pune, India.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901.DRUG (3784)Rev. 04/17Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake and is available as one vial per carton (NDC 23155-193-31).Store unreconstituted product at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.Rx only.Manufactured by:Emcure Pharmaceuticals Ltd.,Hinjawadi, Pune, India.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901.DRUG (3784)Rev. 04/17Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium (equivalent to 150 mg colistin base activity per vial) as a white to pale yellow lyophilized cake and is available as one vial per carton (NDC 23155-193-31).Store unreconstituted product at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.Rx only.Manufactured by:Emcure Pharmaceuticals Ltd.,Hinjawadi, Pune, India.Manufactured for:Heritage Pharmaceuticals Inc.Eatontown, NJ 077241.866.901.DRUG (3784)Rev. 04/17
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Colistimethate sodium is a surface active agent which penetrates into and disrupts the bacterial cell membrane. It has been shown to have bactericidal activity against most strains of the following microorganisms, both and in clinical infections as described in the section:
Aerobic gram-negative microorganisms:
Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae
Pseudomonas aeruginosa.
Susceptibility Tests
Colistimethate sodium is no longer listed as an antimicrobial for routine testing and reporting by clinical microbiology laboratories.
Non-Clinical Toxicology
The use of Colistimethate for Injection, USP is contraindicated for patients with a history of sensitivity to the drug or any of its components.Maximum daily dose calculated from colistin base activity should not exceed 5 mg/kg/day with normal renal function.
Transient neurological disturbances may occur. These include circumoral paresthesia or numbness, tingling or formication of the extremities, generalized pruritus, vertigo, dizziness, and slurring of speech. For these reasons, patients should be warned not to drive vehicles or use hazardous machinery while on therapy. Reduction of dosage may alleviate symptoms. Therapy need not be discontinued, but such patients should be observed with particular care.
Nephrotoxicity can occur and is probably a dose-dependent effect of colistimethate sodium. These manifestations of nephrotoxicity are reversible following discontinuation of the antibiotic.
Overdosage can result in renal insufficiency, muscle weakness, and apnea (see section). See subsection for use concomitantly with other antibiotics and curariform drugs.
Respiratory arrest has been reported following intramuscular administration of colistimethate sodium. Impaired renal function increases the possibility of apnea and neuromuscular blockade following administration of colistimethate sodium. Therefore, it is important to follow recommended dosing guidelines. See section for use in renal impairment.
Clostridium difficile
C. difficile
C. difficile
C. difficile
C
difficile
C. difficile
Certain other antibiotics (aminoglycosides and polymyxin) have also been reported to interfere with the nerve transmission at the neuromuscular junction. Based on this reported activity, they should not be given concomitantly with Colistimethate for Injection, USP except with the greatest caution.
Curariform muscle relaxants (e.g., tubocurarine) and other drugs, including ether, succinylcholine, gallamine, decamethonium and sodium citrate, potentiate the neuromuscular blocking effect and should be used with extreme caution in patients being treated with Colistimethate for Injection, USP.
Sodium cephalothin may enhance the nephrotoxicity of Colistimethate for Injection, USP. The concomitant use of sodium cephalothin and Colistimethate for Injection, USP should be avoided.
Since Colistimethate for Injection, USP is eliminated mainly by renal excretion, it should be used with caution when the possibility of impaired renal function exists. The decline in renal function with advanced age should be considered.
When actual renal impairment is present, Colistimethate for Injection, USP may be used, but the greatest caution should be exercised and the dosage should be reduced in proportion to the extent of the impairment. Administration of amounts of Colistimethate for Injection, USP in excess of renal excretory capacity will lead to high serum levels and can result in further impairment of renal function, initiating a cycle which, if not recognized, can lead to acute renal insufficiency, renal shutdown, and further concentration of the antibiotic to toxic levels in the body. At this point, interference of nerve transmission at neuromuscular junctions may occur and result in muscle weakness and apnea (see section).
Signs indicating the development of impaired renal function include: diminishing urine output, rising BUN and serum creatinine and decreased creatinine clearance. Therapy with Colistimethate for Injection, USP should be discontinued immediately if signs of impaired renal function occur. However, if it is necessary to reinstate the drug, dosing should be adjusted accordingly after drug plasma levels have fallen (seesection).
Prescribing Colistimethate for Injection, USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
The following adverse reactions have been reported:
Gastrointestinal:
Nervous System:
Integumentary:
Body as a Whole:
Laboratory Deviations:
Respiratory System:
Renal System:
To report SUSPECTED ADVERSE REACTIONS, contact Heritage Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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