BACITRACIN USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BACITRACIN

Available from:

PFIZER CANADA ULC

ATC code:

J01XX10

INN (International Name):

BACITRACIN

Dosage:

50000UNIT

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

BACITRACIN 50000UNIT

Administration route:

INTRAMUSCULAR

Units in package:

5X10ML VIALS

Prescription type:

Ethical

Therapeutic area:

BACITRACINS

Product summary:

Active ingredient group (AIG) number: 0105859001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-03-31

Summary of Product characteristics

PRESCRIBING INFORMATION
BACITRACIN USP
(BACITRACIN FOR INJECTION USP)
FOR TOPICAL OR INTRAMUSCULAR USE IN SOLUTION
50 000 IU Sterile Powder
Pfizer Canada ULC
Date of Revision:
17,300 Trans-Canada Highway
15 September 2021
Kirkland, Quebec H9J 2M5
Control No.
251282
©
Pfizer Canada ULC, 2021
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PRESCRIBING INFORMATION
BACITRACIN USP
FOR TOPICAL OR INTRAMUSCULAR USE IN SOLUTION
ACTION AND CLINICAL PHARMACOLOGY
Bacitracin, an antibiotic substance derived from cultures of _Bacillus
subtilis_ (Tracey), exerts pronounced
antibacterial action _in vitro_ against a variety of gram-positive and
a few gram-negative organisms.
However, among systemic diseases, only staphylococcal infections
qualify for consideration of bacitracin
therapy. Bacitracin is assayed against a standard and its activity is
expressed in units, 1 mg, having a
potency of not less than 50 units.
Susceptibility plate testing: If the Kirby-Bauer method of disc
susceptibility is used, a 10-unit bacitracin disc
should give a zone over 13 mm when tested against a
bacitracin-susceptible strain of _Staphylococcus aureus_.
Absorption of bacitracin following intramuscular injection is rapid
and complete. A dose of 200 or
300 units/kg every six hours gives serum levels of 0.2 to 2 mcg/mL in
individuals with normal renal function.
The drug is excreted slowly by glomerular filtration. It is widely
distributed in all body organs and is
demonstrable in ascitic and pleural fluids after intramuscular
injection.
INDICATIONS AND CLINICAL USE
The use of intramuscular bacitracin is indicated in the treatment of
infants with pneumonia and empyema
caused by staphylococci shown to be susceptible to the drug.
Bacitracin solutions, applied locally in the form of compresses or
instillations, may be used once or twice daily
in secondarily infected wounds, ulcers, pyodermas and other
superficial skin infections and in superficial
infections of the eye caused by bacitracin-susceptible organisms.
Bacitracin solutions may be instilled into
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the nasal cavities or administered by inha