"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(colistimethate) for Injection, USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M and other antibacterial drugs, Coly-Mycin M should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Coly-Mycin® M Parenteral (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).
Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The empirical formula is C58H105N16Na5O28S5 and the structural formula is represented below:
What are the possible side effects of colistimethate (Coly Mycin M)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- diarrhea that is watery or bloody;
- urinating less than usual or not at all;
- muscle weakness; or
- trouble breathing.
Less serious side effects may include:
- mild numbness or tingling in your hands or feet;
- dizziness, spinning feeling;
- itching, mild skin...
What are the precautions when taking colistimethate injection (Coly-Mycin M)?
Before using colistimethate, tell your doctor or pharmacist if you are allergic to it; or to polymyxin B or colistin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diseases of the nerves/muscles (such as myasthenia gravis), kidney disease.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery or any procedure requiring anesthesia or medications that block nerve or muscle activity, tell...
Last reviewed on RxList: 3/15/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Coly-Mycin M Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.