PENICILLIN G SODIUM FOR INJECTION, USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PENICILLIN G (PENICILLIN G SODIUM)

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

J01CE01

INN (International Name):

BENZYLPENICILLIN

Dosage:

5000000UNIT

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

PENICILLIN G (PENICILLIN G SODIUM) 5000000UNIT

Administration route:

INTRAMUSCULAR

Units in package:

1 VIAL OF 5,000,000 I.U.

Prescription type:

Prescription

Therapeutic area:

NATURAL PENICILLINS

Product summary:

Active ingredient group (AIG) number: 0131382003; AHFS:

Authorization status:

APPROVED

Authorization date:

1998-01-06

Summary of Product characteristics

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
PR
PENICILLIN G SODIUM FOR INJECTION, USP
POWDER FOR SOLUTION
1 MILLION, 5 MILLION AND 10 MILLION UNITS PER VIAL
PENICILLIN G (AS PENICILLIN G SODIUM)
FOR INTRAMUSCULAR OR INTRAVENOUS USE
STERILE
ANTIBIOTIC
FRESENIUS KABI CANADA LTD.
Date of Preparation
:
165 Galaxy Blvd, Suite 100
July 3, 2019
Toronto, ON M9W 0C8
CONTROL NUMBER: 218533
Penicillin G Sodium for Injection, USP- Prescribing Information
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PRESCRIBING INFORMATION
PR
PENICILLIN G SODIUM FOR INJECTION, USP
Powder for Solution
Sterile
PHARMACOLOGICAL CLASSIFICATION
Antibiotic
ACTIONS AND CLINICAL PHARMACOLOGY
Penicillin G is bactericidal against penicillin-susceptible
microorganisms during the stage of
active multiplication. It acts by inhibiting biosynthesis of cell-wall
mucopeptide. It is not active
against the penicillinase-producing bacteria, which include many
strains of staphylococci.
Penicillin G is highly active in vitro against staphylococci (except
penicillinase-producing
strains), streptococci (groups A, C, G, H, L and M) and pneumococci.
Other organisms
susceptible in vitro to penicillin G are Neisseria gonorrhoeae,
Corynebacterium diphtheriae,
Bacillus anthracis, Clostridia, Actinomyces bovis, Streptobacillus
moniliformis, Listeria
monocytogenes, and Leptospira; Treponema pallidum is extremely
susceptible. Some species of
gram-negative bacilli are susceptible to moderate to high
concentrations of penicillin G obtained
with intravenous administration. These include most strains of
Escherichia coli, all strains of
Proteus mirabilis, Salmonella, and Shigella; and some strains of
Enterobacter aerogenes
(formerly Aerobacter aerogenes) and Alcaligenes faecalis.
Aqueous penicillin G is rapidly absorbed following both intramuscular
and subcutaneous
injection. Approximately 60 percent of a total dose of 300 000 units
is excreted in the urine
within the first five-hour period. Therefore, high and frequent doses
are required to maintain the
elevated serum levels desirable in tre