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:

Eugia US LLC

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,

Product summary:

Polymyxin B for Injection, USP is a sterile, white lyophilized cake or powder and is supplied as follows: 500,000 Units per Vial 10 Vials in a Carton                                            NDC 55150-234-10 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. The vial stoppers are not made with natural rubber latex. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: June 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POLYMYXIN B - POLYMYXIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
EUGIA US LLC
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POLYMYXIN B FOR INJECTION, USP
500,000 UNITS PER VIAL
RX ONLY
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.
WARNING
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, USP 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 _Bacillus polymyxa
_(Prazmowski)