Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
INDICATIONS [/za_1028.html#1] [/za_1028.html#1] [/za_1028.html#1] CONTRA-INDICATIONS [/za_1028.html#1] [/za_1028.html#1] DOSAGE [/za_1028.html#1] [/za_1028.html#1] SIDE-EFFECTS [/za_1028.html#1] [/za_1028.html#1] [/za_1028.html#1] PREGNANCY [/za_1028.html#1] [/za_1028.html#1] OVERDOSE [/za_1028.html#1] IDENTIFICATION [/za_1028.html#1] [/za_1028.html#1] PATIENT INFORMATION FACTIVE ® SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): FACTIVE ® FILM-COATED TABLETS COMPOSITION: Each tablet contains gemifloxacin mesylate equivalent to 320 mg GEMIFLOXACIN . PHARMACOLOGICAL CLASSIFICATION: A. 20.1.1 Antimicrobial agents: Broad and medium spectrum antibiotics. PHARMACOLOGICAL ACTION: MICROBIOLOGY Gemifloxacin is a fluoroquinolone antibiotic. Gemifloxacin is bactericidal with minimum bactericidal concentrations generally within one dilution of the minimum inhibitory concentrations. Gemifloxacin acts by inhibiting DNA synthesis through inhibition of the bacterial type II topoisomerases, DNA gyrase, and/or topoisomerase IV (TOPO IV) which are both essential for bacterial growth. The primary target for gemifloxacin in pneumococci is TOPO IV and the strong affinity of gemifloxacin for this enzyme correlates well with the high potency demonstrated against pneumococci. Gemifloxacin has a higher affinity than other fluoroquinolones for TOPO IV enzymes of Streptococcus pneumoniae, including those with resistance mutations. Most strains of streptococci showing mutations in both DNA gyrase and TOPO IV are resistant to all fluoroquinolones in clinical use. However, gemifloxacin maintains activity against most of these double mutants. Gemifloxacin is highly selective for bacterial rather than human topoisomerase II. There is generally no cross-resistance between gemifloxacin a Read the complete document