Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ASPEN LEVOFLOXACIN 250 mg ASPEN LEVOFLOXACIN 500 mg SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ASPEN LEVOFLOXACIN 250 mg (film coated tablets) ASPEN LEVOFLOXACIN 500 mg (film coated tablets) COMPOSITION: Each 250 mg film coated tablet contains Levofloxacin Hemihydrate equivalent to 250 mg Levofloxacin Each 500 mg film coated tablet contains Levofloxacin Hemihydrate equivalent to 500 mg Levofloxacin PHARMACOLOGICAL CLASSIFICATION: A.20.1.1 Broad and Medium Spectrum Antibiotics. PHARMACOLOGICAL ACTION: Levofloxacin is a broad spectrum bactericidal agent from the chemical group fluoroquinolone. Levofloxacin is the pure (-)-(S)-enantiomer of ofloxacin. Levofloxacin’s bactericidal action results from interference with the enzymes topoisomerase IV and DNA gyrase, which are needed for the DNA replication, transcription, repair and recombination. Levofloxacin is bactericidal in-vitro. Cross-resistance exists between levofloxacin and other fluoroquinolones in-vitro. Generally there is no cross-resistance between levofloxacin and other classes of antibacterial agents, due to the mechanism of action of levofloxacin. The antibacterial spectrum of levofloxacin covers many Gram-positive and Gram- negative bacteria. In vitro sensitivity does not imply in vivo efficacy. Gram-negative organisms: Acinetobacter calcoaceticus, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis and Pseudomonas aeruginosa. Gram-positive organisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes and Streptococcus faecalis. Other organisms: Chlamydia pneumoniae, Legionella pneumophila and Mycoplasma pneumoniae. Pharmacokinetics: Absorption: After oral administration levofloxacin is rapidly and almost completely absorbed with Read the complete document