POLYMYXIN B- polymyxin b sulfate injection, powder, 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:

Xellia Pharmaceuticals USA LLC

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 should be used only to treat or prevent infections that are proven or strongly suspected

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, as a single vial carton (NDC 70594-049-01) and ten vials per carton (NDC 70594-049-02). 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. 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POLYMYXIN B- POLYMYXIN B SULFATE INJECTION, POWDER, FOR SOLUTION
XELLIA PHARMACEUTICALS USA LLC
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POLYMYXIN B FOR INJECTION, USP
500,000 UNITS/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 CARFULLY 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 BLUR-RING OF VISION. THESE ARE USUALLY ASSOCIATED
WITH HIGH SERUM LEVELS FOUND IN PATIENTS WITH IMPAIRED RENALFUNCTION
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 _Bacillus polymyxa_
(Prazmowski) Migula (Fam.
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