البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)
MINT PHARMACEUTICALS INC
J01MA02
CIPROFLOXACIN
500MG
TABLET
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 500MG
ORAL
100
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0123207001; AHFS:
MARKETED
2008-10-29
1 PRODUCT MONOGRAPH MINT-CIPROFLOXACIN CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, 750 MG CIPROFLOXACIN AS CIPROFLOXACIN HYDROCHLORIDE ANTIBACTERIAL AGENT Manufactured for: Mint Pharmaceuticals Canada Inc., 1 First Canadian Place, Suite 5600 100 King Street West Toronto, Ontario M5X 1E2 Date of Preparation: September 29, 2008 CONTROL NO. 124988 2 PRODUCT MONOGRAPH MINT-CIPROFLOXACIN CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, 750 MG CIPROFLOXACIN AS CIPROFLOXACIN HYDROCHLORIDE THERAPEUTIC CLASSIFICATION ANTIBACTERIAL AGENT ACTION AND CLINICAL PHARMACOLOGY ACTION Ciprofloxacin, a synthetic fluoroquinolone, has _in vitro_ activity against a wide range of gram- negative and gram-positive microorganisms. Its bactericidal action is achieved through inhibition of topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination. Ciprofloxacin retained some of its bactericidal activity after inhibition of RNA and protein synthesis by rifampin and chloramphenicol, respectively. These observations suggest ciprofloxacin may possess two bactericidal mechanisms, one mechanism resulting from the inhibition of DNA gyrase and a second mechanism which may be independent of RNA and protein synthesis. The mechanism of actions of fluoroquinolones, including ciprofloxacin, is different from that of penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines. Therefore, microorganisms resistant to these classes of drugs may be susceptible to ciprofloxacin. Conversely, microorganisms resistant to fluoroquinolones may be susceptible to these other classes of antimicrobial agents, (see MICROBILOGY ) There is not cross-resistance between ciprofloxacin and the mentioned classes of antibiotics. 3 CLINICAL PHARMACOLOGY (See HUMAN PHARMACOLOGY ) ABSORPTION Following oral administration of single doses of 250 mg, 500 mg, and 750 mg of MINT- Ciprofloxacin tablets, ciprofloxacin is absorbed rapidly and extensively mainly from اقرأ الوثيقة كاملة