Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LAMIVUDINE
Paxten Sdn Bhd
LAMIVUDINE
60tablet Tablets
Macleods Pharmaceuticals Ltd.
LAMIMAC 150 (Lamivudine Tablet 150mg) MACLEODS PHARMACEUTICALS LTD For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory LAMIMAC 150 (Lamivudine Tablet 150mg) COMPOSITION: Each film coated tablet contains: Lamivudine USP…………………..150 mg PRODUCT DESCRIPTION: White coloured capsule shaped , biconvex film coated tablet, having score on one side and ‘ML 1’ debossed on the other side of the tablet. PHARMACOLOGICAL CLASSIFICATION: THERAPEUTIC CODE: _ATC CODE :_ J05 A F05 PHARMACOTHERAPEUTIC GROUP : Nucleoside analogue CLINICAL PHARMACOLOGY: ABSORPTION: Lamivudine was rapidly absorbed after oral administration in HIV-1-infected patients. The peak serum lamivudine concentration (Cmax) was 1.5 ± 0.5 mcg/mL (mean ± SD). The accumulation ratio of lamivudine in HIV-1-positive asymptomatic adults with normal renal function was 1.50 DISTRIBUTION: Binding of lamivudine to human plasma proteins is low (< 36%). In vitro studies showed that over the concentration range of 0.1 to 100 mcg/mL, the amount of lamivudine associated with erythrocytes ranged from 53% to 57% and was independent of concentration. METABOLISM: Metabolism of lamivudine is a minor route of elimination. Metabolite of lamivudine is the trans-sulfoxide metabolite. Within 12 hours after a single oral dose of lamivudine in HIV-1- infected adults, 5.2% ± 1.4% (mean ± SD) of the dose was excreted as the trans-sulfoxide metabolite in the urine. Serum concentrations of this metabolite have not been determined. LAMIMAC 150 (Lamivudine Tablet 150mg) MACLEODS PHARMACEUTICALS LTD EXCRETION: The majority of lamivudine is eliminated unchanged in urine by active organic cationic secretion. In healthy subjects given a single 300-mg oral dose of lamivudine, renal clearance was 199.7 ± 56.9 mL/min. PHARMACODYNAMICS Lamivudine is a synthetic nucleoside analogue. Intracellularly, lamivudine is phosphorylated to its active 5′-triphosphate metabolite, lamivudine triphosphate (3TC-TP). The principal mode of action of 3TC-TP is the read_full_document