Colistimethate Sodium
Generic Name: colistimethate sodium
Brand Names:
Colistimethate Sodium
DESCRIPTION Colistimethate for Injection, USP is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution ), 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.
Overview
DESCRIPTION Colistimethate for Injection, USP is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution ), 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.
Uses
INDICATIONS AND USAGE 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 Pseudomonas aeruginosa . This antibiotic is not indicated for infections due to Proteus or Neisseria . Colistimethate for Injection, USP has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.
Dosage
DOSAGE AND ADMINISTRATION Important: Colistimethate for Injection, USP is supplied in vials containing colistimethate sodium equivalent to 150 mg colistin base activity per vial. Reconstitution for Intravenous or Intramuscular Administration: The 150 mg vial should be reconstituted with 2 mL Sterile Water for Injection, USP. The reconstituted solution provides colistimethate sodium at a concentration equivalent to 75 mg/mL colistin base activity. During reconstitution swirl gently to avoid frothing. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions are observed, the product should not be used.
Side Effects
ADVERSE REACTIONS The following adverse reactions have been reported: Gastrointestinal: gastrointestinal upset Nervous System: tingling of extremities and tongue, slurred speech, dizziness, vertigo, paresthesia, and seizures Integumentary: generalized itching, urticaria and rash Body as a Whole: fever and anaphylaxis Laboratory Deviations: increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance Respiratory System: respiratory distress and apnea Renal System: electrolyte and acid/base abnormalities (i.e., Pseudo-Bartter syndrome), nephrotoxicity and decreased urine output To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.
Interactions
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.
Warnings
WARNINGS 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. CONTRAINDICATIONS The use of Colistimethate for Injection, USP is contraindicated for patients with a history of sensitivity to the drug or any of its components.
Pregnancy
Pregnancy - Teratogenic Effects Colistimethate sodium given intramuscularly during organogenesis to rabbits at 4.15 and 9.3 mg/kg resulted in talipes varus in 2.6% and 2.9% of fetuses, respectively. These doses are 0.25 and 0.55 times the maximum daily human dose based on mg/m 2 . In addition, increased resorption occurred at 9.3 mg/kg. Colistimethate sodium was not teratogenic in rats at 4.15 or 9.3 mg/kg. These doses are 0.13 and 0.30 times the maximum daily human dose based on mg/m 2 . There are no adequate and well-controlled studies in pregnant women.
Storage
HOW SUPPLIED 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: NDC Packing configuration 23155-193-31 1 Single-Dose Vial in a carton 23155-193-41 12 Single-Dose Vials in a carton Store unreconstituted product at 20° to 25°C (68° to 77°F); excu...
Frequently Asked Questions
What is Colistimethate Sodium used for?▼
INDICATIONS AND USAGE 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 Pseudomonas aeruginosa . This antibiotic is not indicated for infections due to Proteus or Neisseria . Colistimethate for Injection, USP has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.
What are the side effects of Colistimethate Sodium?▼
ADVERSE REACTIONS The following adverse reactions have been reported: Gastrointestinal: gastrointestinal upset Nervous System: tingling of extremities and tongue, slurred speech, dizziness, vertigo, paresthesia, and seizures Integumentary: generalized itching, urticaria and rash Body as a Whole: fever and anaphylaxis Laboratory Deviations: increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance Respiratory System: respiratory distress and apnea Renal System: electrolyte and acid/base abnormalities (i.e., Pseudo-Bartter syndrome), nephrotoxicity and decreased urine output To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.
Can I take Colistimethate Sodium during pregnancy?▼
Pregnancy - Teratogenic Effects Colistimethate sodium given intramuscularly during organogenesis to rabbits at 4.15 and 9.3 mg/kg resulted in talipes varus in 2.6% and 2.9% of fetuses, respectively. These doses are 0.25 and 0.55 times the maximum daily human dose based on mg/m 2 . In addition, increased resorption occurred at 9.3 mg/kg. Colistimethate sodium was not teratogenic in rats at 4.15 or 9.3 mg/kg. These doses are 0.13 and 0.30 times the maximum daily human dose based on mg/m 2 . There are no adequate and well-controlled studies in pregnant women.
What are the important warnings for Colistimethate Sodium?▼
WARNINGS 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. CONTRAINDICATIONS The use of Colistimethate for Injection, USP is contraindicated for patients with a history of sensitivity to the drug or any of its components.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.