Država: Kanada
Jezik: angleščina
Source: Health Canada
OFLOXACIN
AA PHARMA INC
J01MA01
OFLOXACIN
400MG
TABLET
OFLOXACIN 400MG
ORAL
100
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0122759002; AHFS:
CANCELLED POST MARKET
2016-08-02
0 PRODUCT MONOGRAPH OFLOXACIN TABLETS HOUSE STANDARD 200 MG, 300 MG AND 400 MG ANTIBACTERIAL AGENT AA PHARMA INC. DATE OF REVISION: 1165 CREDITSTONE ROAD, UNIT #1 JULY 20, 2015 VAUGHAN, ONTARIO L4K 4N7 Control#: 183164 1 PRODUCT MONOGRAPH OFLOXACIN TABLETS House Standard 200 mg, 300 mg and 400 mg THERAPEUTIC CLASSIFICATION Antibacterial Agent ACTIONS AND CLINICAL PHARMACOLOGY Ofloxacin is a broad–spectrum, synthetic fluoroquinolone antibacterial agent for oral administration. Ofloxacin is thought to exert a bactericidal effect on susceptible bacterial cells by inhibiting the essential bacterial enzyme DNA gyrase, a critical catalyst in the duplication, transcription and repair of bacteria. The bioavailability of ofloxacin in the tablet formulation is approximately 98%. Ofloxacin is rapidly and completely absorbed from the upper small bowel following oral administration. The pharmacokinetic parameters of ofloxacin following single doses of 200, 300 and 400 mg and multiple doses of 400 mg to healthy males are summarized below. Dose C max µg/mL S.D. AUC 0-last point µg x hr/mL S.D. T max S.D. t ½ 200 mg -single dose 1.7 0.3 14.1 2.3 1.5 0.3 4.9 300 mg -single dose 2.6 0.4 21.2 2.5 1.7 0.5 4.6 400 mg -single dose 3.7 0.7 31.4 4.7 1.8 0.6 3.8 400 mg -steady state 5.0 1.0 62.9 14.5 1.7 0.5 5.2 Elimination is mainly by renal excretion. Ofloxacin undergoes minimal biotransformation. 2 Comparative Bioavailability A comparative bioavailability study was performed using healthy human volunteers. The rate and extent of absorption of ofloxacin was measured and compared following a single oral 400 mg dose (one 400 mg tablet) of either OFLOXACIN TABLETS or Floxin. The results from measured data are summarized as follows: Geometric Mean Arithmetic Mean (CV%) Parameter OFLOXACIN TABLETS Floxin † Ratio of Means (%)* AUC T 30.9 31.0 99.5 (µg • hr/mL) 31.7 (22) 31.7 (21) AUC I 33.3 33.2 100.0 (µg • hr/mL) 34.2 (23) 34.1 (22) C max 3.75 3.69 102.4 (µg/mL) 3.82 Preberite celoten dokument