Rx Item-Epivir HBV 100Mg Tab 60 By Glaxosmithkline Rx

EPIVIR- lamivudine tablet, film coated
EPIVIR- lamivudine solution
ViiV Healthcare Company

WARNING: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, EXACERBATIONS OF HEPATITIS B, and DIFFERENT FORMULATIONS OF EPIVIR�

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. Discontinue EPIVIR if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [see Warnings and Precautions (5.1)].



Exacerbations of Hepatitis B

Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued EPIVIR. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue EPIVIR and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.2)].

Important Differences among Lamivudine-Containing Products

EPIVIR tablets and oral solution (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than EPIVIR-HBV� tablets and oral solution (used to treat chronic HBV infection). Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1 [see Warnings and Precautions (5.2)].

1 INDICATIONS AND USAGE

EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV?1) infection.

Limitations of Use:

�
The dosage of this product is for HIV?1 and not for HBV.
2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for Adult Patients
The recommended dosage of EPIVIR in HIV?1-infected adults is 300 mg daily, administered as either 150 mg taken orally twice daily or 300 mg taken orally once daily with or without food. If lamivudine is administered to a patient infected with HIV?1 and HBV, the dosage indicated for HIV?1 therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions (5.2)].

RX ITEM-Epivir HBV 100Mg Tab 60 By Glaxo
NDC 00173-0662-00 UPC/GTIN No.3-01730-66200-2 Mfg.Part No.66200

Epivir HBV 100Mg Tab 60 By Glaxosmithkli
BRAND: EPIVIR HBV NDC: 00173-0662-00,173066200 UPC: 3-01730-66200-2,301730662002 Glaxosmithkline/Rx

LAMIVUDINE ORAL TABLET 10
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