Hofovir 300mg FC Tablet

INDICATION

• For the treatment of HIV-1 infection in combination with other antiretroviral medicinal products for adults

• For the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.

• For the treatment of chronic hepatitis B in adults with:

  • compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis

  • evidence of lamivudine-resistant hepatitis B virus

  • decompensated liver disease

• For the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.

DOSAGE AND ADMINISTRATION

Recommended Dose in Adults

For the treatment of HIV-1 or Chronic hepatitis B: The dose is one 300 mg Tenofovir disoproxil fumarate (Hofovir) tablet once daily taken orally, without regard to food.

Recommended Dose in Renally Impaired Adult Patients:

> CrCl 30-49 mL/min: 300 mg every 48 hours

> CrCl 10-29 mL/min: 300 mg every 72 to 96 hours

> Hemodialysis: 300 mg every 7 days or after approximately 12 hours of dialysis

Recommended Dose in Pediatric Patients (2 toLess Than 18 Years of Age)

HIV-1: In adolescents aged 12 to < 18 years and weighing ≥ 35 kg, the recommended dose of Tenofovir disoproxil fumarate (Hofovir) tablet is 300 mg (one tablet) once daily taken orally with food. The safety and efficacy of tenofovir disoproxil in HIV-1 infected children under 2 years of age have not been established.

Chronic hepatitis B: In adolescents aged 12 to <18 years and weighing ≥ 35 kg, the

recommended dose of Tenofovir disoproxil fumarate (Hofovir) is one tablet once daily, taken orally with food. The optimal duration of treatment is currently unknown. The safety and efficacy of tenofovir disoproxil in children with chronic hepatitis B aged 2 to < 12 years or weighing < 35 kg have not been established.

Caution: Foods, Drugs, Devices & Cosmetics Act prohibits dispensing without prescription.

Note: The information given here is limited. For further information, kindly consult your doctor or pharmacist.

Caution: Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.