Lamivudine 100 MG Oral Tablet
1 INDICATIONS & USAGE Lamivudine tablets (HBV) are indi cat ed for the t r e atm ent of ch ronic h ep atitis B vi rus ( H B V) in f ection asso ci at ed with evid e n ce of h ep atitis B vi ral r epli c ation and active liv er in f l amm ation [s ee Clini cal Studi es ( 14.1 , 14.2 ) ] . The follo wing points sh ould be consid ered wh en initi ating th era py with lamivudine tablets (HBV): Due to hi gh rat es of resi st an ce d e v elopm ent in t r e at ed p ati ents, initi ation of t reatm ent with lamivudine tablets (HBV) should only be consid e r ed wh en the use of an alt e rn ative ant ivi ral a g ent with a hi gh er g en etic b arri er to r esist an ce is not av ail able or app rop ri a t e. Lamivudine tablets (HBV) h ave not b e en ev alu a t ed in p ati ents co -in fect ed with H I V, h e p atitis C vi rus (HC V), or h e p atitis d elta vi rus. Lamivudine tablets (HBV) h ave not b e en ev alu a t ed in liv er t ra nspl ant recipi ents or in p a ti ents with ch ronic h ep atitis B vi rus in fecti on with d ecomp ens at ed l iv er dis eas e. • Lamivudine tablets (HBV) 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)
camber pharmaceuticals, inc.
OVAL PINK I 37
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16 HOW SUPPLIED/STORAGE AND HANDLING
LAMIVUDINE tablets (HBV), 100 mg are pink colored, capsule shaped, biconvex, film coated tablets, debossed with ‘37’ on one side and ‘I’ on the other side. Bottle of 60 tablets NDC 31722--752-60 Bottle of 600 tablets NDC 31722--752-06 Blister card of 10 Unit-dose tablets NDC 31722--752-31 Blister pack of 100 (10x10) Unit-dose tablets NDC 31722--752-32 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preserve in well-closed, light-resistant containers.
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