ACRIPTEGA DOLUTEGRAVIR/ LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE FILM COATED TABLETS (50 MG/300 MG/300 MG)

Manufacturer
Mylan Laboratories Limited(INDIA)

Registraction Number
MAL24066028AZ

Content:

• Active Ingredients:
  • Dolutegravir 50 mg (as dolutegravir sodium)
  • Lamivudine 300 mg
  • Tenofovir disoproxil fumarate 300 mg
• Inactive Ingredients: Mannitol, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, Opadry II (coating material), macrogol/PEG, polyvinyl alcohol-part hydrolysed, talc, titanium dioxide

• HIV-1 Infection: ACRIPTEGA is indicated for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older weighing at least 40 kg. It is not recommended for use in patients younger than 12 years of age.

• Dosage: One tablet taken orally, once daily, without regard to food.
• Administration: May be taken with or without food.
• Precautions:
  • Not suitable for patients with renal impairment (creatinine clearance < 80 ml/min).
  • Rifampicin decreases the blood levels of dolutegravir; a supplementary dose of dolutegravir may be needed.
  • Isoniazid concentration is increased by dolutegravir.
  • Overdose: Monitor for evidence of toxicity and apply supportive treatment as necessary.