Land: Zuid-Afrika
Taal: Engels
Bron: South African Health Products Regulatory Authority (SAHPRA)
Hexal
ROXITHROMYCIN - HEXAL 150 mg SCHEDULING STATUS: Schedule 4 PROPRIETARY NAME (and dosage form): ROXITHROMYCIN - HEXAL 150 mg (film-coated tablet) COMPOSITION: Each tablet contains Roxithromycin 150 mg. PHARMACOLOGICAL CLASSIFICATION A.20.1.1. Broad and medium spectrum antibiotics PHARMACOLOGICAL ACTION Roxithromycin is a semi-synthetic antibiotic belonging to the macrolide class. It has the following antibacterial spectrum in vitro: - Streptococcus agalactiae - Streptococcus pneumoniae (Pneumococcus) - Neisseria meningitides (Meningococcus) - Listeria monocytogenes - Mycoplasma pneumoniae - Chlamydia trachomatis - Ureaplasma urealyticum - Legionella pneumophila - Helicobacter (campylobacter) - Gardnerella vaginalis - Bordetella pertussis - Moraxella catarrhalis (Branhamella catarrhalis) - Haemophilus ducreyi The following organisms show variable in vitro sensitivity: - Group A beta-haemolytic Streptococci (Streptococcus pyogenes) - Staphylococcus aureus - Haemophilus influenzae - Staphylococcus epidermidis Roxithromycin is highly concentrated in polymorphonuclear leucocytes and macrophages achieving intracellular concentrations greater than those outside the cell. Roxithromycin enhances the adhesive and chemotactic functions of these cells, which in the presence of infection produce phagocytosis and bacterial lysis. Roxithromycin also possesses intracellular bactericidal activity. ABSORPTION Roxithromycin is rapidly absorbed. The peak serum level is reached 2,2 hours after oral administration of 150 mg in the fasting subject. Administration of one tablet 15 minutes before a meal has no effect on the pharmacokinetics in a healthy subject. DISTRIBUTION AND ELIMINATION Following administration of a single oral dose of roxithromycin 150 mg to healthy subjects, mean plasma concentrations ranging from 6.6-7.9 mg/L are reache Lees het volledige document