APO-AMOXICILLIN CAPSULE

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

متاح من:

APOTEX INC

ATC رمز:

J01CA04

INN (الاسم الدولي):

AMOXICILLIN

جرعة:

250MG

الشكل الصيدلاني:

CAPSULE

تركيب:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

AMINOPENICILLINS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2021-04-13

خصائص المنتج

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