Land: Sør-Afrika
Språk: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Ranbaxy
ZANOCIN 200 Tablets ZANOCIN 400 Tablets SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ZANOCIN 200 Tablets ZANOCIN 400 Tablets COMPOSITION: Zanocin 200 Tablets Each tablet contains Ofloxacin 200 mg Zanocin 400 Tablets Each tablet contains Ofloxacin 400 mg PHARMACOLOGICAL CLASSIFICATION: A 20.1.1 Broad and medium spectrum antibiotics Mechanism of Action Ofloxacin is a quinolone carboxylic acid derivative which has a broad spectrum of antibacterial activity against both Gram-positive and Gram-negative bacteria. Ofloxacin exerts its effect by inhibiting the bacterial DNA gyrase, which is responsible for coiling the genetic material as a prerequisite for bacterial multiplication. The mode of action, range of activities, duration of action and MIC levels have been established mainly by means of in vitro studies using bacterial isolates. Antibacterial Spectrum Ofloxacin has a bactericidal effect. In vitro tests show that strains in which the sensitivity varies include pneumococci andureaplasma urealyticum. Strains that are normally resistant are: Peptococcus, Peptostreptococcus, Eubacterium spp., Fusobacterium spp. and Treponema pallidum. Pharmacokinetics Ofloxacin is readily absorbed and excreted mainly unchanged in the urine. The serum elimination half-life is approximately 6 to 8 hours. Following oral administration, ofloxacin peak serum concentrations are reached within one to two hours. The plasma level usually achieved by the recommended dosage regimes (3 to 4 micrograms/mL) is in excess of the average MIC which is 1 to 2 micrograms/mL for susceptible organisms. Ofloxacin has a low (9.4%) plasma protein binding. INDICATIONS Ofloxacin is indicated for the treatment of the following bacterial infections if these are due to ofloxacin-sensitive pathogens: i) Lower respiratory tract read_full_document