Avilam in combination with other antiretroviral agents is indicated for the treatment of HIV infection.
Lamivudine is a synthetic nucleoside analogue. Lamivudine is phosphorylated intracellularly to lamivudine triphosphate. Incorporation of the monophosphate form into viral DNA occurs by hepatitis B virus (HBV) polymerase. As a result DNA chain is terminated. Lamivudine triphosphate also inhibits the RNA and DNA dependent DNA polymerase activities of HIV-1 reverse transcriptase (RT). Lamivudine triphosphate is a very weak inhibitor of mammalian alpha, beta, and gamma-DNA polymerases.
Adults and adolescents over 12 years of age : The recommended dose for HIV infection is 300 mg daily. This is administered as 150 mg twice daily. Children: Three months to 12 years of age : The recommended dose for HIV infection is 4 mg/kg twice daily up to a maximum of 300 mg daily. Less than three months of age : The limited data available are insufficient to propose specific dosage recommendations.
The following adverse events have been reported during therapy for HIV disease with Avilam. Blood and lymphatic systems disorders- Uncommon : Neutropenia, anaemia and thrombocytopenia Very rare : Pure red cell aplasia Nervous system disorders- Common : Headache, insomnia Very rare : Cases of peripheral neuropathy (or paraesthesia). Respiratory, thoracic and mediastinal disorders Common : Cough, nasal symptoms- Gastrointestinal disorders- Common : Nausea, vomiting, abdominal pain or cramps, diarrhea Rare : Rises in serum amylase. Cases of pancreatitis have been reported. Hepatobiliary disorders- Uncommon : Transient rises in liver enzymes (AST, ALT). Rare : Hepatitis Skin and subcutaneous tissue disorders- Common : Rash, alopecia Musculoskeletal and connective tissue disorders- Common : Arthralgia, muscle disorders Rare : Rhabdomyolysis, Lipodystrophy General disorders and administration site conditions- Common : Fatigue, malaise, fever. Cases of lactic acidosis, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues.
Always consult a registered doctor before taking any medicine. This information is for general knowledge only.
Hypersensitivity to Lamivudine or to any of the excipients.
The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion. Administration of trimethoprim/sulfamethoxazole 160 mg/800 mg results in a 40% increase in Avilam exposure. Avilam and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of Avilam in combination with zalcitabine is not recommended.
Lamivudin is not recommended for use as monotherapy. In pediatric patients with a history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or other significant risk factors for the development of pancreatitis, Avilam should be used with caution. Treatment with Avilam should be stopped immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur Lactic Acidosis/Severe Hepatomegaly with Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including Avilam and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering Avilam to any patient with known risk factors for liver disease. In patients with moderate to severe renal impairment, the dose should be adjusted. Patients receiving Lamivudin or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with associated HIV diseases.