Therapeutic Category:

Anti-retroviral reverse transcriptase inhibitor.


Composition:

LAVIR
Each tablet contains: Lamivudine - 150 mg.

Indications:

Treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral drugs.


Adverse Reactions:

Headache, malaise, nausea/vomiting, diarrhea, anorexia, abdominal cramps, dyspepsia, cough, rhinorrhea, peripheral neuropathy, dizziness, insomnia, depression, arthralgia, myalgia, alopecia, neutropenia, anemia, thrombocytopenia, pancreatitis (in pediatric patients), skin rashes, lipodystrophy syndrome, gynecomastia.


Warnings:

Lactic acidosis and severe hepatomegaly with steatosis have been reported; In non-HIV-infected patients treated with lamivudine for chronic hepatitis B, evidence of exacerbations of hepatitis has occurred after discontinuation of lamivudine; The liver function in these patients should be followed-up for at least 4months. Patients dually infected with HBV and HIV should not be treated in an appropriate combination regimen.


Precautions:

Pregnancy: Category C;
Lactation: Lamivudine treated mothers should be instructed to discontinue breast-feeding;
Elderly: Monitor renal function.


Drug Interactions:

Co-administration of sulfamethoxazole-trimethoprim increases AUC of lamivudine by 44%. Zalcitabine and lamivudine may inhibit the intracellular phosphorylation of one another. Therefore lamivudine is not recommended with Zalcitabine.


Contraindications:

Hypersensitivity to any of the components of the formulation.


Dosage and administration:

Administer with or without food.
Adults and adolescents (12 to 16 years): Lavir 150 mg per bid
Paediatrics (3 months to 12 years): Lavir 4 mg/kg bid, maximum 150 mg bid


Renal impairment:

CrCl =50min/mL=150 mg twice daily, CrCl 30-49 min/mL=150 mg once daily, CrCl 15-29 min/mL=150 mg first dose, then 100mg once daily, CrCl 5-14 min/mL=150 mg first dose then 50mg once daily.


Hepatitis B:

100mg once daily. For patients co-infected with HBV and HIV, a higher dose is indicated as a part of an appropriate treatment regimen. Renal impairment: CrCl =50min/mL=100 mg once daily, CrCl 30-49 min/mL=100 mg first dose, then 50mg once daily, CrCl 15-29 min/mL=100 mg first dose, then 25mg once daily.


Storage:

Store in a cool, dark and dry place.