POLYMYXIN B- polymyxin b sulfate 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:

FOSUN PHARMA USA INC

Administration route:

INTRAVENOUS

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, p

Product summary:

Polymyxin B for Injection, USP is supplied as follows: NDC Polymyxin B for Injection, USP Package Factor 72266-249-10 500,000 units per vial 10 vials per carton Storage Conditions 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° and 8°C (36° and 46°F), and any unused portion should be discarded after 72 hours. Lyophilized. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Distributed by: Fosun Pharma USA Inc. Princeton, NJ 08540 Made in India May 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POLYMYXIN B- POLYMYXIN B SULFATE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
FOSUN PHARMA USA INC
----------
POLYMYXIN B FOR INJECTION, USP
50,000 UNITS
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 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)
Migula