Product Description.:
67 Y
tablet , film-coated , white , oval oblong
White to off-whiteDebossed
The new generic form of Epivir? (lamivudine) tablets has just been released and is being added to the Generics offering. It is anticipated that other suppliers to enter the market as well. Having U.S. brand sales of more than $77 million, Epivir? is used to control HIV infection.
DESCRIPTION
EPIVIR (also known as 3TC) is a brand name for lamivudine, a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4- amino-l-(2-hydroxymethyl-l,3-oxathiolan-5-yl)-(lH)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has, also been referred to as (-)2',3'- dideoxy, 3'-thiacytidine.
EPIVIR Tablets are for oral administration. Each scoredl50-mg film-coated tablet contains 150 mg of lamivudine and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.
Each 300-mg film-coated tablet contains 300 mg of lamivudine and the inactive ingredients black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.
EPIVIR Oral Solution is for oral administration. One, milliliter (1 mL) of EPIVIR Oral Solution contains 10 mg of lamivudine (10 mg/mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg).
INDICATIONS
EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Limitation of use: The dosage of this product is for HIV-1 and not for HBV.
SIDE EFFECTS
Clinical Trials Experience
The following adverse reactions are discussed in greater detail in other sections of the labeling:
* Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, WARNINGS and PRECAUTIONS].
* Hepatic decompensation in patients co-infected with HIV-1 and Hepatitis C [see WARNINGS and PRECAUTIONS].
* Pancreatitis [see WARNINGS and PRECAUTIONS].
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults - Clinical Trials in HIV-1: The safety profile of EPIVIR in adults is primarily based on 3,568 HIV-1-infected patients in 7 clinical trials.
