POLYMYXIN B- polymyxin b injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)

Available from:

X-GEN Pharmaceuticals, Inc.

INN (International Name):

POLYMYXIN B SULFATE

Composition:

POLYMYXIN B 500000 [USP'U]

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 and other antibacterial drugs, polymyxin B for Injec

Product summary:

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 39822-0171-6) and ten vials per carton (NDC 39822-0171-7). 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 NOVAPLUS is a registered trademark of Novation, LLC. Manufactured in India. LEA-019563-01 Code No: AP/DRUGS/103/97 POLY-NP-XE-PI-02 May 2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POLYMYXIN B- POLYMYXIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
X-GEN PHARMACEUTICALS, INC.
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POLYMYXIN B FOR INJECTION, USP
FOR PARENTERAL AND OPTHALMIC ADMINISTRATION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of polymyxin 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 B1 and B2, which are produced
by the growth of _Bacillu