Lamimac 150 (Lamivudine Tablets 150mg)

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

LAMIVUDINE

Dostupné z:

Paxten Sdn Bhd

INN (Medzinárodný Name):

LAMIVUDINE

Počet v balení:

60tablet Tablets

Výrobca:

Macleods Pharmaceuticals Ltd.

Súhrn charakteristických

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