Composition:

LAVIR ORAL SOLUTION
Each 5 ml containsLamivudine I.P - 50 mg

Indications:

HIV infection: For the treatment of HIV infection in combination with other antiretroviral agents.
Chronic Hepatitis B: Treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation.


Contraindications:

Lamivudine is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the product.


Warnings and Precautions:

Use lamivudine with extreme caution in pediatric patients with a history of prior antiretroviral nucleoside exposure, pancreatitis, or other risk factors for developing pancreatitis; caution should be exercised when administering lamivudine to those patients with known risk factors for liver disease; treatment with lamivudine should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity; some patients with HIV and chronic liver disease due to hepatitis B have experienced recurrent hepatitis B upon disontinuation of lamivudine; individuals with hepatitis B and HIV coinfection safety and efficacy have not been established; renal impairment.


Drug Interactions:

Trimethoprim 160 mg and sulfamethoxazole 800 mg once daily has been shown to increase lamivudine exposure (AUC). The effect of higher doses of trimethoprim and sulfamethoxazole on lamivudine pharmacokinetics has not been investigated. Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of lamivudine in combination with zalcitabine is not recommended.


Adverse reactions:

  • Adults and adolescents: Diarrhea and other gastrointestinal disturbances, headache, fatigue, insomnia, arthralgias, myalgias, neuropathy, nasal signs and symptoms, elevated liver enzymes, skin rash, fever or chills, ear, nose, and throat infections. Lactic acidosis and severe hepatomegaly with steatosis, including fatalities, have been reported. Pancreatitis has been reported.

  • Children: Hepatomegaly, nausea, vomiting, stomatitis, splenomegaly, cough, abnormal breath sounds/ wheezing, nasal discharge or congestion, ear signs or symptoms which includes pain, discharge, erythema or swelling of an ear; fever, skin rashes, lymphadenopathy, paresthesias and peripheral neuropathies, elevated liver enzymes, neutropenia. Fatal pancreatitis has been reported.


Dosage And Administration:

HIV Infection:

  • Adults and adolescents: 300 mg/day orally, administered as either 150 mg twice daily or 300 mg once daily, in combination with other antiretroviral agents.

  • Children: (3 months to 12 years of age): 4 mg/kg orally twice daily (up to a maximum of 150 mg twice a day) administered with other antiretroviral agents.

  • Dosage adjustment: Adjust dose of lamivudine in accordance with renal function. Insufficient data are available to recommend dosage of lamivudine in patients undergoing dialysis. Although there are insufficient data to recommend a specific dose adjustment of lamivudine in pediatric patients with renal impairment, consider a reduction in the dose and/or an increase in the dosing interval.

  • Adjustment of Lamivudine Dosage In HIV Infected Adult and Adolescent Patients With Renal Function Impairment.
    Ccr (mL/min) Recommended lamivudine dosage
    =50 150 mg twice daily or 300 mg once daily
    30-49 150 mg once daily
    15-29 150 mg first dose, then 100 mg once daily
    5-14 150 mg first dose, then 50 mg once daily
    <5 50 mg first dose, then 25 mg once daily

Chronic Hepatitis B:

  • Adults and adolescents: 100 mg orally once daily. Safety and effectiveness of treatment beyond 1 year have not been established and the optimum duration of treatment is not known.

  • Children: (2 yrs to 12 years of age): 3 mg/kg orally once daily up to a maximum daily dose of 100 mg. Safety and effectiveness of treatment beyond 1 year have not been established and the optimum duration of treatment is not known.

  • Dosage adjustment: It is recommended that doses of lamivudine be adjusted in accordance with renal function. Although there are insufficient data to recommend a specific dose adjustment of lamivudine in pediatric patients with renal impairment, a dose reduction should be considered. No additional dosing of lamivudine is required after routine (4 hour) hemodialysis. Insufficient data are available to recommend a dosage of lamivudine in patients undergoing peritoneal dialysis.

  • Adjustment Of Lamivudine Dosage In Chronic hepatitis B Adult With Renal Function Impairment.
    Ccr (mL/min) Recommended lamivudine dosage
    =50 No dosage adjustment needed.
    30-49 100 mg first dose, then 50 mg once daily
    15-29 100 mg first dose, then 25 mg once daily.
    5-14 35 mg first dose, then 15 mg once daily.
    <5 35 mg first dose, then 10 mg once daily