ATRIPLA (Tablet, Multilayer)

ATRIPLA (Tablet, Multilayer)

WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals [See Warnings and Precautions (5.1)]. ATRIPLA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of ATRIPLA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued EMTRIVA or VIREAD, which are components of ATRIPLA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue ATRIPLA. If appropriate, initiation of anti-hepatitis B therapy may be warranted [See Warnings and Precautions (5.2)].

dailymed-ingredient:Croscarmellose_Sodium, dailymed-ingredient:Hydroxypropyl_cellulose, dailymed-ingredient:Magnesium_Stearate, dailymed-ingredient:Microcrystalline_Cellulose, dailymed-ingredient:Opadry_II_Pink_85F94172, dailymed-ingredient:Sodium_lauryl_sulfate, dailymed-ingredient:black_iron_oxide, dailymed-ingredient:polyethylene_glycol, dailymed-ingredient:polyvinyl_alcohol, dailymed-ingredient:red_iron_oxide, dailymed-ingredient:talc, dailymed-ingredient:titanium_dioxide

ATRIPLA (Tablet, Multilayer)

http://www4.wiwiss.fu-berlin.de/dailymed/resource/routeOfAdministration/Oral