"The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these product"...
POLYMYXIN B FOR INJECTION (polymyxin b (polymyxin b sulfate) sulfate)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B (polymyxin b sulfate) and other antibacterial drugs, polymyxin B (polymyxin b sulfate) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
CAUTION: WHEN THIS DRUG IS GIVEN INTRAMUSCULARLY AND/OR INTRATHECALLY, IT SHOULD BE GIVEN ONLY TO HOSPITALIZED PATIENTS, SO AS TO PROVIDE CONSTANT SUPERVISION BY A PHYSICIAN.
RENAL FUNCTION SHOULD BE CAREFULLY DETERMINED AND PATIENTS WITH RENAL DAMAGE AND NITROGEN RETENTION SHOULD HAVE REDUCED DOSAGE. PATIENTS WITH NEPHROTOXICITY DUE TO POLYMYXIN B (polymyxin b sulfate) SULFATE USUALLY SHOW ALBUMINURIA, CELLULAR CASTS, AND AZOTEMIA. DIMINISHING URINE OUTPUT AND A RISING BUN ARE INDICATIONS FOR DISCONTINUING THERAPY WITH THIS DRUG.
NEUROTOXIC REACTIONS MAY BE MANIFESTED BY IRRITABILITY, WEAKNESS, DROWSINESS, ATAXIA, PERIORAL PARESTHESIA, NUMBNESS OF THE EXTREMITIES, AND BLURRING OF VISION. THESE ARE USUALLY ASSOCIATED WITH HIGH SERUM LEVELS FOUND IN PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR NEPHROTOXICITY.
THE CONCURRENT OR SEQUENTIAL USE OF OTHER NEUROTOXIC AND/OR NEPHROTOX-IC DRUGS WITH POLYMYXIN B (polymyxin b sulfate) SULFATE, PARTICULARLY BACITRACIN, STREPTOMYCIN, NEOMYCIN, KANAMYCIN, GENTAM-ICIN, TOBRAMYCIN, AMIKACIN, CEPHALORI-DINE, PAROMOMYCIN, VIOMYCIN, AND COLISTIN SHOULD BE AVOIDED.
THE NEUROTOXICITY OF POLYMYXIN B (polymyxin b sulfate) SULFATE CAN RESULT IN RESPIRATORY PARALYSIS FROM NEUROMUSCULAR BLOCKADE, ESPECIALLY WHEN THE DRUG IS GIVEN SOON AFTER ANESTHESIA AND/OR MUSCLE RELAXANTS.
USAGE IN PREGNANCY: THE SAFETY OF THIS DRUG IN HUMAN PREGNANCY HAS NOT BEEN ESTABLISHED.
Polymyxin B for Injection (polymyxin b (polymyxin b sulfate) sulfate) is one of a group of basic polypeptide antibiotics derived from B polymyxa (B aerosporous). Polymyxin B (polymyxin b sulfate) sulfate is the sulfate salt of Polymyxins B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillacea).It has a potency of not less than 6000 polymyxin B (polymyxin b sulfate) units per mg, calculated on the anhydrous basis.The structural formulae are:
Each vial contains 500,000 polymyxin B (polymyxin b sulfate) units for parenteral or ophthalmic administration.
Polymyxin B (polymyxin b sulfate) forInjection is in powder form suitable for preparation of sterile solutions for intramuscular, intravenous drip, intrathecal, or ophthalmic use.
In the medical literature, dosages have frequently been given in terms of equivalent weights of pure polymyxin B (polymyxin b sulfate) base.Each milligram of pure polymyxin B (polymyxin b sulfate) base is equivalent to 10,000 units of polymyxin B (polymyxin b sulfate) and each microgram of pure polymyxin B (polymyxin b sulfate) base is equivalent to 10 units of polymyxin B.
Aqueous solutions of polymyxin B (polymyxin b sulfate) sulfate may be stored up to 12 months without significant loss of potency if kept under refrigeration.In the interest of safety, solutions for parenteral use should be stored under refrigeration and any unused portion should be discarded after 72 hours. Polymyxin B (polymyxin b sulfate) sulfate should not be stored in alkaline solutions since they are less stable.
Last reviewed on RxList: 9/10/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Polymyxin B Information
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