Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
GATIFLOXACIN
BRISTOL-MYERS SQUIBB CANADA
J01MA16
GATIFLOXACIN
200MG
TABLET
GATIFLOXACIN 200MG
ORAL
30
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0142621001; AHFS:
CANCELLED POST MARKET
2006-06-29
PRODUCT MONOGRAPH Pr TEQUIN* (Gatifloxacin) 200 and 400 mg Tablets Pr TEQUIN* I.V.* (Gatifloxacin Injection - 2 mg/mL) (Gatifloxacin for Injection - 10 mg/mL) Antibacterial Agent Bristol-Myers Squibb Canada Date of Preparation: Montreal, Canada January 3, 2001 Date of Revision: May 8, 2006 * TM of Bristol-Myers Squibb Company used under licence by Bristol-Myers Squibb Canada Control No.: 104074 1 PRODUCT MONOGRAPH Pr TEQUIN* (Gatifloxacin) 200 and 400 mg Tablets Pr TEQUIN* I.V.* (Gatifloxacin Injection - 2 mg/mL) (Gatifloxacin for Injection - 10 mg/mL) THERAPEUTIC CLASSIFICATION Antibacterial Agent ACTION AND CLINICAL PHARMACOLOGY TEQUIN (gatifloxacin) is available as TEQUIN Tablets for oral administration and as TEQUIN I.V. for intravenous administration. Gatifloxacin is a synthetic broad-spectrum 8-methoxyfluoroquinolone antibacterial agent for oral or intravenous administration, with activity against both gram-negative and gram-positive microorganisms. Gatifloxacin has _in vitro _activity against a wide range of gram-negative and gram-positive aerobic and anaerobic microorganisms. Gatifloxacin also has activity against clinically important atypical microorganisms. The antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. The mechanism of action of fluoroquinolones including gatifloxacin is different from that of penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines. Therefore, fluoroquinolones may be active against pathogens that are resistant to these antibiotics. Conversely, microorganisms resistant to fluoroquinolones may be susceptible to these other classes of anti-microbial agents (see MICROBIOLOGY). There is no cross-resistance between gatifloxacin and the mentioned classes of antibiotics. CLINICAL P Prečítajte si celý dokument