APO-AMOXICILLIN CAPSULE

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Fáanlegur frá:

APOTEX INC

ATC númer:

J01CA04

INN (Alþjóðlegt nafn):

AMOXICILLIN

Skammtar:

250MG

Lyfjaform:

CAPSULE

Samsetning:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

AMINOPENICILLINS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2021-04-13

Vara einkenni

Page 1 of 23
PRODUCT
MONOGRAPH
INCLUDING PATIENT MEDICIATION INFORMATION
PR
APO-AMOXICILLIN
Amoxicillin Capsules USP
250 mg and 500 mg Amoxicillin (as amoxicillin trihydrate)
Amoxicillin Powder for Oral Suspension USP
125 mg / 5 mL, 250 mg / 5 mL Amoxicillin (as amoxicillin trihydrate)
Antibiotic
APOTEX
INC.
150 Signet
Drive
Toronto, Ontario
M9L
1T9
Date of Preparation:
April 1, 2021
Submission Control Number: 246500
Page 2 of 23
PR
APO-AMOXICILLIN
Amoxicillin
Capsules USP
250 mg and 500 mg
Amoxicillin (as amoxicillin trihydrate)
Amoxicillin Powder for Oral Suspension USP
125 mg / 5 mL, 250 mg / 5 mL Amoxicillin (as amoxicillin trihydrate)
THERAPEUTI
C
CLASSIFICATION
Antibiotic
ACTION AND CLINICAL
PHARMACOLOGY
Amoxicillin exerts its bactericidal action by interfering with
bacterial cell wall synthesis.
INDICATIONS AND CLINICAL
USE
APO-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.
APO-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, m