Lamivudine 100 MG Oral Tablet

1 INDICATIONS AND USAGE Lamivudine tablets (HBV) 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 (HBV): Due to high rates of resistance development in treated patients, initiation of treatment with lamivudine tablets (HBV) 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 (HBV) have not been evaluated in patients co-infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis delta virus. Lamivudine tablets (HBV) have not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease. Lamivudine tablets (HBV) are a nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation. (1)

apotex corp.

FDA Reported Adverse Reactions
`[1] virologic failure` `[2] drug resistance` `[3] foetal exposure during pregnancy` `[4] pathogen resistance` `[5] drug interaction` `[6] viral mutation identified` `[7] drug ineffective` `[8] pyrexia` `[9] depression` `[10] treatment failure`

3 years ago

OVAL ORANGE APO LMV100

16 HOW SUPPLIED/STORAGE AND HANDLING

LAMIVUDINE tablets (HBV), 100 mg, are orange-brown, capsule shaped, biconvex film-coated tablets engraved “APO” on one side, “LMV 100” on the other side. Bottles of 60 tablets (NDC 60505-3250-6) with child-resistant closures. Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].

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Lamivudine 100 MG Oral Tablet

FDA Reported Adverse Reactions [1] virologic failure [2] drug resistance [3] foetal exposure during pregnancy [4] pathogen resistance [5] drug interaction [6] viral mutation identified [7] drug ineffective [8] pyrexia [9] depression [10] treatment failure

OVAL ORANGE APO LMV100

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FDA Reported Adverse Reactions
`[1] virologic failure` `[2] drug resistance` `[3] foetal exposure during pregnancy` `[4] pathogen resistance` `[5] drug interaction` `[6] viral mutation identified` `[7] drug ineffective` `[8] pyrexia` `[9] depression` `[10] treatment failure`