Avilam

Avilam in combination with other antiretroviral agents is indicated for the treatment of HIV infection.

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.

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.

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.