Lamivudine 100 MG Oral Tablet
1 INDICATIONS AND USAGE Lamivudine tablets are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies (14.1 , 14.2) ] . The following points should be considered when initiating therapy with lamivudine tablets: • Due to high rates of resistance development in treated patients, initiation of treatment with lamivudine tablets should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate. • Lamivudine tablets have not been evaluated in patients co-infected with HIV, hepatitis C virus (HCV), or hepatitis delta virus. • Lamivudine tablets have not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease. Lamivudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. ( 1 )
Mylan Pharmaceuticals Inc.
OVAL ORANGE M LN4
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16 HOW SUPPLIED/STORAGE AND HANDLING Lamivudine Tablets, USP are available containing 100 mg of lamivudine, USP. The 100 mg tablets are peach, film-coated, capsule shaped, unscored tablets debossed with M on one side of the tablet and LN4 on the other side. They are available as follows: NDC 0378-5168-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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