TEVA-AMPICILLIN CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMPICILLIN (AMPICILLIN TRIHYDRATE)

Available from:

TEVA CANADA LIMITED

ATC code:

J01CA01

INN (International Name):

AMPICILLIN

Dosage:

500MG

Pharmaceutical form:

CAPSULE

Composition:

AMPICILLIN (AMPICILLIN TRIHYDRATE) 500MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

AMINOPENICILLINS

Product summary:

Active ingredient group (AIG) number: 0105872001; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-07-09

Summary of Product characteristics

Page 1 of 9
PRESCRIBING INFORMATION
Including Patient Medication Information
PR
TEVA-AMPICILLIN
Ampicillin Capsules
250 mg and 500 mg ampicillin (as ampicillin trihydrate)
BP
ANTIBIOTIC
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
CONTROL NO: 234940
DATE OF PREPARATION:
March 26, 2020
Page 2 of 9
PHARMACOLOGY:
Ampicillin, a semisynthetic penicillin, is similar to benzylpenicillin
in its bactericidal action against
sensitive organisms during the stage of active multiplication. It acts
through the inhibition of biosynthesis of
cell wall mucopeptide.
Ampicillin differs in vitro spectrum from benzylpenicillin in the
gram-negative spectrum. It exerts high in
vitro activity against many strains of H. influenzae, N. gonorrhoeae,
N. meningitidis, B. catarrhalis, E.
coli,
P. mirabilis, B. funduliformis, Salmonellae and Shigellae.
In vitro studies have also demonstrated the sensitivity of many
strains of the following gram positive
bacteria: alpha-and beta-hemolytic streptococci, S. pneumoniae,
non-beta-lactamase (penicillinase)-
producing staphylococci, B. anthracis, and most strains of enterococci
and clostridia. Ampicillin generally
provides less in vitro activity than penicillin G against gram
positive bacteria. Because it does not resist
destruction by beta-lactamase, it is not effective against
beta-lactamase-producing bacteria, particularly
resistant staphylococci. All strains of Pseudomonas and most strains
of Klebsiella and Aerobacter are
resistant. Ampicillin is not active against Rickettsia, Mycoplasma and
'large viruses' (Chiamydia).
Ampicillin is acid stable and therefore, well absorbed. Food, however,
retards absorption. Ampicillin
diffuses readily into most body tissues and fluids; however,
penetration into the cerebrospinal fluid and
brain occurs only with meningeal inflammation. Ampicillin is excreted
largely unchanged in the urine; its
excretion can be delayed by concurrent administration of probenecid.
In blood serum, ampicillin is the
least
bound of all the