מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
NORFLOXACIN
AA PHARMA INC
J01MA06
NORFLOXACIN
400MG
TABLET
NORFLOXACIN 400MG
ORAL
100
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0116961001; AHFS:
APPROVED
2018-02-08
Page 1 of 42 PRODUCT MONOGRAPH PR NORFLOXACIN Norfloxacin Tablets, USP 400mg Antibacterial Agent AA Pharma Inc. DATE OF REVISION: 1165 Creditstone Road, Unit#1 June 25, 2019 Vaughan, Ontario Canada L4K 4N7 Control # 226592 Page 2 of 42 PRODUCT MONOGRAPH PR NORFLOXACIN Norfloxacin Tablets, USP 400 mg THERAPEUTIC CLASSIFICATION Antibacterial Agent ACTIONS AND CLINICAL PHARMACOLOGY Norfloxacin is a quinolone carboxylic acid antibacterial agent for oral administration. Norfloxacin inhibits bacterial deoxyribonucleic acid synthesis and is bactericidal. At the molecular level, three specific actions have been attributed to norfloxacin in the inhibition of E.coli cells: 1. inhibition of the ATP-dependent DNA supercoiling reaction catalyzed by DNA gyrase, 2. inhibition of the relaxation of supercoiled DNA, 3. promotion of double-stranded DNA breakage. Comparative Bioavailability A comparative bioavailability study was performed using healthy human volunteers. The rate and extent of absorption of norfloxacin following administration of a single (one 400 mg tablet) dose of Apo-Norflox and Noroxin were measured and compared. The results are summarized as follows: Summary Table of the Comparative Bioavailability Data Norfloxacin (Dose: 400 mg) From Measured Data Parameter Geometric Mean Arithmetic Mean (CV%) Ratio of Geometric Means (%)** Apo-Norflox Noroxin ® † AUC T (ng•hr/ml) 7480 7870 (32) 7927 8247 (28) 94.3 AUC I (ng•hr/ml) 7895 8312 (33) 8367 8708 (28) 94.3 C max 1501 1597 93.9 Page 3 of 42 Summary Table of the Comparative Bioavailability Data Norfloxacin (Dose: 400 mg) From Measured Data Parameter Geometric Mean Arithmetic Mean (CV%) Ratio of Geometric Means (%)** (ng/ml) 1562 (28) 1679 (31) T max (hr)* 1.40 (51) 1.20 (30) -- t 1/2 (hr)* 5.87 (15) 5.79 (14) -- *Arithmetic means (CV%). **Based on the least squares estimate. †Noroxin ® is manufactured by Merck, Sharp & Dohme, Div. of Merck Frosst Canada, and was purchased in Canada. INDICATIONS AND CLINICAL USE The treatment of upper and lower urinary tract i קרא את המסמך השלם