País: Canadá
Idioma: inglés
Fuente: Health Canada
AMOXICILLIN (AMOXICILLIN TRIHYDRATE)
SIVEM PHARMACEUTICALS ULC
J01CA04
AMOXICILLIN
125MG
GRANULES FOR SUSPENSION
AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 125MG
ORAL
75/100/150ML
Prescription
AMINOPENICILLINS
Active ingredient group (AIG) number: 0131314002; AHFS:
CANCELLED PRE MARKET
2018-03-09
1 PRODUCT MONOGRAPH PR AMOXICILLIN AMOXICILLIN CAPSULES 250 MG AND 500 MG AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE) AMOXICILLIN CHEWABLE TABLETS 125 MG AND 250 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 Sivem Pharmaceuticals ULC 4705 Dobrin Street Saint-Laurent, Quebec H4R 2P7 Control # 174978 Date of Revision: July 4, 2014 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 BIOAVAILABILITY 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 (Sivem Pharmaceuticals ULC) † 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 Leer el documento completo