PMS-AMOXICILLIN CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Available from:

PHARMASCIENCE INC

ATC code:

J01CA04

INN (International Name):

AMOXICILLIN

Dosage:

250MG

Pharmaceutical form:

CAPSULE

Composition:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

Administration route:

ORAL

Units in package:

500/1000

Prescription type:

Prescription

Therapeutic area:

AMINOPENICILLINS

Product summary:

Active ingredient group (AIG) number: 0131314001; AHFS:

Authorization status:

APPROVED

Authorization date:

1996-12-19

Summary of Product characteristics

PRODUCT MONOGRAPH
PR PMS-AMOXICILLIN
Amoxicillin Capsules
250 mg and 500 mg amoxicillin (as amoxicillin trihydrate)
Amoxicillin Granules for Oral Suspension
125 mg/5 mL and 250 mg/5 mL
amoxicillin (as amoxicillin trihydrate) after reconstitution
USP Standard
ANTIBIOTIC
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Ave. Royalmount Avenue, Suite #100
October 30, 2020
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control No.: 243965
_ pms-AMOXICILLIN Product Monograph _
_Page 2 of 24_
NAME OF DRUG
PR
PMS-AMOXICILLIN
Amoxicillin Capsules, USP
Amoxicillin Granules for Oral Suspension, USP
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
pms-AMOXICILLIN (amoxicillin) exerts its bactericidal action by
interfering with bacterial cell
wall synthesis.
INDICATIONS AND CLINICAL USE
pms-AMOXICILLIN (amoxicillin) may be indicated in the treatment of
infections due to
susceptible strains of the following micro-organisms: Gram-negative
organisms: H. influenzae,
P. mirabilis and N. gonorrhoeae. Gram-positive organisms: Streptococci
(including
Streptococcus faecalis and Streptococcus pneumoniae).
Amoxicillin is not active against Pseudomonas aeruginosa,
indole-positive Proteus species,
Serratia marcescens, Klebsiella and Enterobacter species.
In emergency cases, where the causative organism is not yet
identified, therapy may be initiated
with amoxicillin on the basis of clinical judgment while awaiting
bacteriologic tests to determine
its antimicrobial sensitivity.
pms-AMOXICILLIN may be indicated as a prophylaxis against
alpha-hemolytic (Viridan's
group) Streptococci before dental, oral or upper respiratory tract
surgery or instrumentation.
It may be also indicated as a prophylaxis of bacterial endocarditis in
patients with any of the
following conditions: congenital cardiac malformations, rheumatic and
other acquired valvular
lesions, prosthetic heart valves, previous history of bacterial
endocarditis, hypertrophic
cardiomyopathy, surgically constructed systemic pulmonary shunts,
mitral valve prol