HEPDOZE 300 MG
(Tenofovir Disoproxil Fumarate Tablets IP)
INDICATIONS: HEPDOZE 300 MG is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection
DOSAGE AND ADMINISTRATION:
The dose of HEPDOZE 300 mg once daily taken orally, without regard to food. Therapy should be initiated by a physician experienced in the management of HIV infection and/or treatment of chronic hepatitis B.
Adults: The recommended dose for the treatment of HIV or for the treatment of chronic hepatitis B is 245 mg (one tablet) once daily taken orally with food.
Chronic hepatitis B: The optimal duration of treatment is unknown. Treatment discontinuation may be considered as follows:
Pediatric patients: Hepdoze 300 mg (Tenofovir Disoproxil Fumarate) Tablets is not recommended for use in children below the age of 18 years due to insufficient data on safety and efficacy.
Elderly: No data are available on which to make a dose recommendation for patients over the age of 65 years.
Hepdoze tablet is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.
PRECAUTIONS AND WARNING:
Lactic Acidosis/Severe Hepatomegaly with Steatosis: 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. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors.
Patients Co-infected with HIV and Hepatitis B Virus: It is recommended that all patients with HIV be tested for the presence of chronic Hepatitis B virus (HBV) before initiating antiretroviral therapy. It is not indicated for the treatment of chronic HBV infection and the safety and efficacy of tenofovir disoproxil fumarate have not been established in patients co-infected with HBV and HIV.
Common: A headache, diarrhoea, vomiting, abdominal pain, nausea, abdominal distension, flatulence, fatigue
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