Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
AMOXICILLIN (AMOXICILLIN TRIHYDRATE)
TEVA CANADA LIMITED
J01CA04
AMOXICILLIN
125MG
TABLET (CHEWABLE)
AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 125MG
ORAL
100
Prescription
AMINOPENICILLINS
Active ingredient group (AIG) number: 0131314009; AHFS:
CANCELLED POST MARKET
2021-07-29
1 PRODUCT MONOGRAPH PR NOVAMOXIN AMOXICILLIN CAPSULES, USP 250 MG AND 500 MG AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE) AMOXICILLIN CHEWABLE TABLETS, USP 125 MG AND 250 MG AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE) AMOXICILLIN GRANULES FOR ORAL SUSPENSION, USP 125 MG/5 ML AND 250 MG/5 ML AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE) AFTER RECONSTITUTION AMOXICILLIN SUGAR-REDUCED GRANULES FOR ORAL SUSPENSION, TEVA STANDARD 125 MG/5 ML AND 250 MG/5 ML AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE) AFTER RECONSTITUTION Antibiotic Teva Canada Limited Date of Revision: 30 Novopharm Court March 20, 2020 Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Control # 233622 2 NAME OF DRUG NOVAMOXIN (AMOXICILLIN TRIHYDRATE) THERAPEUTIC CLASSIFICATION Antibiotic ACTION AND CLINICAL PHARMACOLOGY Novamoxin (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, Novamoxin 250 mg and Amoxil 250 mg chewable tablets. The pharmacokinetic data of fifteen subjects calculated for the Novamoxin 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) - * Novamoxin 250 mg Chewable Tablet (Novopharm Ltd.). † Amoxil ® 250 mg Chewable Tablet (purchased in Canada). § Expressed as the arithmetic mean (standard deviation) only. 3 INDICATIONS AND CLINICAL USE Novamoxin (amoxicillin) may be indicated in the treatment of infections due to susceptible strains of the following m Διαβάστε το πλήρες έγγραφο