Colistimethate 150 mg/2mL
COLISTIMETHATE SODIUM · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Fresenius Kabi USA, LLC
Colistimethate is a injection, powder, lyophilized, for solution containing colistimethate sodium at 150 mg/2mL, taken intramuscular. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Colistimethate
- Generic Name
- COLISTIMETHATE SODIUM
- NDC Code (Product)
63323-393- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 150 mg/2mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA065364
- Marketing Start
- 12/04/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. 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, the…
Dosage & Administration
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. Dosage Adults and Pediatric Patients - Intravenous or Intramuscular Administration The dose of Colistimethate for Injection, USP should be 2.5 to 5 mg/kg per day of colistin base in 2 to 4 divided doses for patients with normal renal function, depending on the severity of the infection. In obese individuals, dosage should be based on ideal body weight. The daily dose and frequency should be reduced for the patients with renal impairment. Suggested modifications of d…
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 dosedependent 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 OVERDOSAGE section). See PRECAUTIONS, Drug Interactions 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 co…
Contraindications
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.
Drug 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.
Adverse Reactions
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: nephrotoxicity and decreased urine output For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Xellia Pharmaceuticals USA, LLC at 1-833-295-6953, or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch/.
Frequently Asked Questions
What is Colistimethate used for?
Colistimethate contains COLISTIMETHATE SODIUM. It is a injection, powder, lyophilized, for solution taken intramuscular. Consult your doctor for specific uses.
Is Colistimethate a controlled substance?
Colistimethate is not classified as a controlled substance by the DEA.
What is the generic name for Colistimethate?
The generic name for Colistimethate is COLISTIMETHATE SODIUM. There are 1 other brand versions of COLISTIMETHATE SODIUM.
What is the NDC code for Colistimethate 150 mg/2mL?
The NDC (National Drug Code) for Colistimethate 150 mg/2mL is 63323-393, listed by Fresenius Kabi USA, LLC.