Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
AMOXICILLIN (AMOXICILLIN TRIHYDRATE)
PRO DOC LIMITEE
J01CA04
AMOXICILLIN
500MG
CAPSULE
AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 500MG
ORAL
15G/50G
Prescription
AMINOPENICILLINS
Active ingredient group (AIG) number: 0131314006; AHFS:
APPROVED
2019-09-13
_PAGE 1 OF 23_ PRODUCT MONOGRAPH PR PRO-AMOX-250 PR PRO-AMOX-500 Amoxicillin Capsules BP 250 mg & 500 mg amoxicillin (as amoxicillin trihydrate) Antibiotic PRO DOC LTÉE Date of Revision: 2925 boul. Industriel March 11, 2021. Laval, Québec H7L 3W9 Submission Control No: 249475 _PAGE 2 OF 23_ PRODUCT MONOGRAPH PR PRO-AMOX-250 PR PRO-AMOX-500 Amoxicillin Capsules BP 250 mg & 500 mg amoxicillin (as amoxicillin trihydrate) THERAPEUTIC CLASSIFICATION Antibiotic ACTIONS AND CLINICAL PHARMACOLOGY Amoxicillin exerts its bactericidal action by interfering with bacterial cell wall synthesis. CLINICAL TRIALS COMPARATIVE BIOAVAILABILITY DATA A double blind, randomized, two treatment, two sequence, two period, crossover, single dose comparative oral bioavailability study of PRO-AMOX capsules (amoxicillin trihydrate) 500 mg capsules (Pro Doc Ltée) and Apo-Amoxi (amoxicillin trihydrate) 500mg capsules (Apotex Inc.) was conducted in 26 healthy, adult, human Asian male subjects under fasting conditions. SUMMARY TABLE OF THE COMPARATIVE BIO-AVAILABILITY DATA AMOXICILLIN (1 X 500 mg) From measured data Geometric Mean Arithmetic Mean (CV %) PARAMETER TEST* REFERENCE † % RATIO OF GEOMETRIC MEANS # 90% CONFIDENCE INTERVAL # AUC T (hr.ng/mL) 27554.36 28467.18 (22.9) 26519.07 27339.12 (23.6) 103.90 96.00-112.46 AUC I (hr.ng/mL) 27833.34 28763.40 (23.1) 26791.54 27631.25 (23.9) 103.89 96.00-112.42 C max (ng/mL) 8004.72 8328.68 (23.4) 7896.32 8276.50 (27.8) 101.37 92.75-110.79 T max § (h) 2.13 (1.25-3.50) 2.25 (1.00-4.00) T ½ $ (h) 1.66 (15.4) 1.62 (15.3) _PAGE 3 OF 23_ * PRO-AMOX (Amoxicillin trihydrate) 500 mg (Pro Doc Ltée) † APO-AMOXI 500 mg Capsules (Apotex Inc) were purchased in Canada. § Expressed as Median (Range). $ Expressed as arithmetic mean (CV %) only INDICATIONS AND CLINICAL USE PRO-AMOX 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 Διαβάστε το πλήρες έγγραφο