APO-AMOXI SUGAR FREE POWDER FOR SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Available from:

APOTEX INC

ATC code:

J01CA04

INN (International Name):

AMOXICILLIN

Dosage:

125MG

Pharmaceutical form:

POWDER FOR SUSPENSION

Composition:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 125MG

Administration route:

ORAL

Units in package:

75/100/150ML

Prescription type:

Prescription

Therapeutic area:

AMINOPENICILLINS

Product summary:

Active ingredient group (AIG) number: 0131314002; AHFS:

Authorization status:

MARKETED

Authorization date:

1997-04-15

Summary of Product characteristics

Page 1 of 21
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICIATION INFORMATION
PR
APO-AMOXI
Amoxicillin (as amoxicillin trihydrate)
125 mg / 5 mL, 250 mg / 5 mL Oral Suspension
- Sugar Free
Apotex
Standard
Antibiotic
APOTEX INC.
DATE OF REVISION:
150 Signet Drive
Toronto, Ontario
M9L 1T9
September 21, 2022
Submission Control Number: 266761
Page 2 of 21
NAME OF DRUG
PR
APO-AMOXI
Amoxicillin (as amoxicillin trihydrate)
THERAPEUTIC
CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Amoxicillin exerts its bactericidal action by interfering with
bacterial cell wall synthesis.
INDICATIONS AND CLINICAL USE
APO-AMOXI 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.
APO-AMOXI 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 prolapse with
valvular regurgitation or mitral valve prolapse without valvular
regurgitation but associated with
thickening and/or redundancy of the valve leaflets.
To reduce the development of drug-resistant bacteria and maintain the