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:

Fresenius Kabi USA, LLC

INN (International Name):

POLYMYXIN B SULFATE

Composition:

POLYMYXIN B 500000 [USP'U]

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 blood-stream 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 should be use

Product summary:

Each vial of Polymyxin B for Injection contains polymyxin B sulfate equivalent to 500,000 polymyxin B units. It is supplied in rubber-stoppered glass vial with flip off cap, carton of 10. 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: Fresenius Kabi USA, LLC Lake Zurich, IL 60047 Made in India 451432A Issued: May 2018 LEA-019647-01 Code No: AP/DRUGS/103/97

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POLYMYXIN B - POLYMYXIN B SULFATE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
FRESENIUS KABI USA, LLC
----------
451432A/Issued: May 2018
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 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 _Baci