Country: Канада
Језик: Енглески
Извор: Health Canada
CIPROFLOXACIN
NU-PHARM INC
J01MA02
CIPROFLOXACIN
250MG
TABLET
CIPROFLOXACIN 250MG
ORAL
100
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0123207006; AHFS:
CANCELLED (UNRETURNED ANNUAL)
2018-03-28
PRODUCT MONOGRAPH NU-CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE TABLETS NU A PHARM STANDARD 100 MG, 250 MG, 500 MG AND 750 MG ANTIBACTERIAL AGENT NU A PHARM INC. DATE OF PREPARATION: 50 MURAL STREET, UNITS 1 & 2 APRIL 07, 2004 RICHMOND HILL, ONTARIO L4B 1E4 Control #: 067322 - 1 - PRODUCT MONOGRAPH NU-CIPROFLOXACIN (Ciprofloxacin Hydrochloride) Tablets Nu A Pharm Standard 100 mg, 250 mg, 500 mg and 750 mg THERAPEUTIC CLASSIFICATION Antibacterial Agent ACTIONS AND CLINICAL PHARMACOLOGY Ciprofloxacin, a synthetic fluoroquinolone, has a bactericidal mode of action. This action is achieved through inhibition of DNA gyrase, an essential component of the bacterial DNA replication system. Inhibition of the alpha subunit of the DNA gyrase blocks the resealing of the nicks on the DNA strands induced by this alpha subunit, leading to the degradation of the DNA by exonucleases. This bactericidal activity persists not only during the multiplication phase, but also during the resting phase of the bacterium. 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. Ciprofloxacin and metronidazole have been studied in combination and serum levels of ciprofloxacin are not significantly altered by metronidazole at the doses studied. Serum levels of metronidazole when administered orally at a dose of 500 mg q6h in combination with ciprofloxacin 500 mg PO q12h are: AUC 0-6 156.3 mg @ h/L, C MAX 31.3 mg/L and T MAX 1.71 hours (see HUMAN PHARMA-COLOGY). COMPARATIVE BIOAVAILABILITY A comparative bioavailability study was performed using healthy human volunteers. The rate and extent of absorption of ciprofloxacin following administration of a single (1 x 750 mg tablet) dose - 2 - of NU-CIPROFLOXACIN and Cipro ® were measured and co Прочитајте комплетан документ