Country: Canada
Language: English
Source: Health Canada
AMOXICILLIN (AMOXICILLIN TRIHYDRATE)
SANIS HEALTH INC
J01CA04
AMOXICILLIN
125MG
GRANULES FOR SUSPENSION
AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 125MG
ORAL
75/100/150ML
Prescription
AMINOPENICILLINS
Active ingredient group (AIG) number: 0131314002; AHFS:
CANCELLED POST MARKET
2017-07-31
1 PRODUCT MONOGRAPH PR AMOXICILLIN AMOXICILLIN CAPSULES 250 MG AND 500 MG AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE) AMOXICILLIN GRANULES FOR ORAL SUSPENSION 125 MG/5ML AND 250 MG/5ML AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE) AFTER RECONSTITUTION AMOXICILLIN SUGAR-REDUCED GRANULES FOR ORAL SUSPENSION 125 MG/5ML AND 250 MG/5ML AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE) AFTER RECONSTITUTION Antibiotic Sanis Health Inc. 333 Champlain Street, Suite 102 Dieppe, New Brunswick Canada, E1A 1P2 Submission Control No: 167414 Date of Preparation: September 3, 2013 2 NAME OF DRUG AMOXICILLIN (AMOXICILLIN TRIHYDRATE) THERAPEUTIC CLASSIFICATION Antibiotic ACTION AND CLINICAL PHARMACOLOGY AMOXICILLIN (amoxicillin) exerts its bactericidal action by interfering with bacterial cell wall synthesis. COMPARATIVE BIOAVAILABITY STUDIES - TABLETS A comparative two-way, single-dose bioavailability study was carried out in sixteen healthy, male volunteers on two 250 mg amoxicillin tablet products, AMOXICILLIN 250 mg and Amoxil 250 mg chewable tablets. The pharmacokinetic data of fifteen subjects calculated for the AMOXICILLIN and Amoxil chewable tablet formulations is tabulated below: AMOXICILLIN TRIHYDRATE CHEWABLE TABLETS 250 MG FROM MEASURED DATA Geometric Mean Arithmetic Mean (C.V.%) PARAMETER TEST * REFERENCE † % RATIO OF GEOMETRIC MEANS 95% CONFIDENCE INTERVAL AUC T (µg*h/mL) 20.3 20.4 (10) 20.5 20.7 (16) 99 91.8 – 108.4 AUC I (µg• h/mL) 20.5 20.5 (10) 20.5 20.8 (16) 100 91.8 – 108.5 C max (µg/mL) 7.4 7.5 (13) 7.7 8.0 (26) 96 84.8 – 109.1 T max § (h) 1.37 (0.40) 1.43 (0.46) - T 1/2 § (h) 0.95 (0.11) 0.92 (0.09) - * AMOXICILLIN 250 mg Chewable Tablet ( Sanis Health Inc.) † Amoxil® 250 mg Chewable Tablet (purchased in Canada). § Expressed as the arithmetic mean (standard deviation) only 3 INDICATIONS AND CLINICAL USE 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. Gr Read the complete document