Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)
X-GEN Pharmaceuticals, Inc.
INTRAMUSCULAR
PRESCRIPTION DRUG
Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa. Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps . aeruginosa . It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps . aeruginosa . It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated: H influenzae , specifically meningeal infections. Escherichia coli , specifically urinary tract infections. Aerobacter aerogenes , specifically bacteremia. Klebsiella pneumoniae , specifically bacteremia. NOTE: IN MENINGEAL INFECTIONS, POLYMYXIN B SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Polymyxin B for Injection USP and other antibacterial drugs, Pol
Each vial of Polymyxin B for Injection, USP contains polymyxin B sulfate equivalent to 500,000 polymyxin B units per vial. It is supplied in a rubber-stoppered glass vial with flip off cap, as a single-vial carton (NDC 39822-0170-1) and ten vials per carton (NDC 39822-0170-2). Storage recommendations: Before reconstitution : Store at 20° to 25° C (68° to 77°F) (See USP controlled Room Temperature) Protect from light . Retain in carton until time of use. After reconstitution: Product must be stored under refrigeration, between 2° to 8°C (36° to 46°F) and any unused portion should be discarded after 72 hours. Manufactured for: Xellia Pharmaceuticals, Inc. Grayslake, Il 60030 Distributed by: X-GEN Pharmaceuticals, Inc. Big Flats, NY 14814 Manufactured in India. LEA-019560-01 Code No: AP/DRUGS/103/97 POLY--XE-PI-03 May 2015
Abbreviated New Drug Application
POLYMYXIN B- POLYMYXIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION X-GEN PHARMACEUTICALS, INC. ---------- POLYMYXIN B FOR INJECTION, USP FOR PARENTERAL AND OPTHALMIC ADMINISTRATION To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. WARNINGS CAUTION: WHEN THIS DRUG IS GIVEN INTRAMUSCULARLY, INTRAVENOUSLY 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 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 NEPHROTOXIC DRUGS WITH POLYMYXIN B SULFATE, PARTICULARLY BACITRACIN, STREPTOMYCIN, NEOMYCIN, KANAMYCIN, GENTAMICIN, TOBRAMYCIN, AMIKACIN, CEPHALORIDINE, PAROMOMYCIN, VIOMYCIN, AND COLISTIN SHOULD BE AVOIDED. THE NEUROTOXICITY OF POLYMYXIN B 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. DESCRIPTION Polymyxin B for Injection is one of a group of basic polypeptide antibiotics derived from_ B polymyxa_ _(B aerosporous)_. Polymyxin B sulfate is the sulfate salt of Polymyxins B and B , which are produced by the growth of _Bacill Прочитать полный документ