Composition: Each film-coated tablet contains:
Lamivudine. . . . . . . . . . . . . . . . . . . . . . .100 mg
Cardboard box containing 3 blisters of 10 film-coated tablets.
Agimidin tablets containing lamivudine is indicated for the treatment of chronic hepatitis B in adults with:
– Compensated liver disease (liver is damaged, but its function remains normal) with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and/or fibrosis.
– Decompensated liver disease: (liver is damaged and does not function normally) lamivudine should always be used in combination with a second agent, without cross-resistance to lamivudine, to reduce the risk of resistance and to achieve rapid viral suppression.
|Dosage and administration||
Lamivudine therapy should be initiated by a physician experienced in the treatment of chronic hepatitis B.
Hypersensitivity to lamivudine or any of excipients of the drug.
|Warnings and precautions for use||
Lactic acidosis and severe hepatomegaly with steatosis
|Recommendation for pregnancy and breastfeeding||
|Effects on ability to drive and use machines||
The influence of Agimidin on the ability to drive and use machines has not been studied. However dizziness, headache, fatigue may occur and may affect the patient's activity requiring alertness.
|Interactions, incompatibilities of medicine||
– HIV entry inhibitor and HIV fusion inhibitor (enfuvirtide, maraviroc): These drugs have synergistic anti-HIV effect when combined with lamivudine.
|Undesirable effects (ADRs)||
The incidence of side effects listed below is in adults, that HIV or HBV infection is treated with lamivudine in combination with other antiretroviral drugs.
|Overdose and management||
– Lamivudine (referred to as (-)2', 3'-dideoxy, 3'thiacytidine) is a nucleoside reverse transcriptase inhibitor. Lamivudine is structurally similar to zalcitabine. Lamivudine is converted by intracellular enzymes to the active metabolite, lamivudine-5'-triphosphate (3TC-TP). Because its structure is similar to that of deoxycytidine triphosphate, the natural substrate for reverse transcriptase, 3TC-TP competes with natural deoxycytidine triphosphate and for binding to reverse transcriptase, and incorporation into DNA results in chain termination. Lamivudine demonstrates low cytotoxicity to peripheral blood lymphocytes, to established lymphocyte and monocyte-macrophage cell lines, and to a variety of bone marrow progenitor cells in vitro.
Absorption: After oral administration, lamivudine is rapidly absorbed and peak serum concentrations occur about 1 hour (in the fasted state), 3.2 hours (in the fed state). Food slows down but does not reduce the absorption of the drug. Food delays the absorption, but it does not affect the amount absorbed. The oral bioavailability of lamivudine in adults is usually between 80 and 85%.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.