País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
Rifampicin
Sanofi-Aventis Australia Pty Ltd
Rifampicin
rifadin-ccdsv8-piv9-31jul17 _ _ _ _1 PRODUCT INFORMATION RIFADIN ® NAME OF THE MEDICINE NON-PROPRIETARY NAME rifampicin CHEMICAL STRUCTURE C 43 H 58 N 4 O 12 DESCRIPTION Rifampicin is a semisynthetic antibiotic derivative of rifamycin B. Specifically, rifampicin is the hydrazone, 3-(4-methylpiperazinyliminomethyl) rifamycin SV. It is only slightly soluble in water and is rather unstable to light and moisture. Excipients present in the capsules are maize starch, magnesium stearate, titanium dioxide, erythrosine, indigo carmine and gelatin. Excipients present in the tablets are sodium lauryl sulfate, microcrystalline cellulose, lactose monohydrate, calcium stearate, carmellose sodium, maize starch, magnesium stearate, acacia, povidone, erythrosine, titanium dioxide, sucrose, purified talc, magnesium carbonate hydrate, kaolin, colloidal anhydrous silica and gelatin. Excipients present in the injection are sodium formaldehyde sulfoxylate and sodium hydroxide, the diluent is water for injections. Excipients present in the syrup are agar, sucrose, methyl hydroxybenzoate, propyl hydroxybenzoate, potassium sorbate, saccharin, sodium metabisulfite, polysorbate 80, raspberry essence (PI 458), diethanolamine and purified water. PHARMACOLOGY Rifampicin is particularly active against rapidly growing extracellular organisms but it also has bactericidal activity intracellularly and against slow and intermittently growing _Mycobacterium _ _tuberculosis. _ Rifampicin inhibits DNA dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase, but does not inhibit the mammalian enzyme. Cross resistance to rifampicin has only been shown with other rifamycins. PHARMACOKINETICS Rifampicin is readily absorbed from the stomach and the duodenum. Peak serum concentrations of the order of 7 microgram/mL (range 6 to 32 microgram/mL) occur about 2 to 4 hours after an oral dose of 600 mg on an empty stomach. In normal subjects the biological half-life of rifampicin in serum averages about 3 Leia o documento completo