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TENOFOVIR DISOPROXIL FUMARATE TABLETS 300 MG
Tenofovir disoproxil 300 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults.
Hepatitis B infection
Tenofovir disoproxil 300 mg film-coated tablets are indicated 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.
Tenofovir Disoproxil Fumarate … 300 mg
Excipients … Q.s.
Color: Titanium Dioxide BP
Method of administration: Oral HIV-1 and Chronic hepatitis B
DOSAGE FOR ADULTS
Adults and adolescents aged 12 to < 18 years and weighing ≥ 35 kg:
The recommended dose of Tenofovir disoproxil for the treatment of HIV or for the treatment of chronic hepatitis B is 300 mg (one tablet) once daily taken orally with food. OR as directed by physician.
HIV-1 and hepatitis B: In patients receiving tenofovir disoproxil, rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures) have been reported. Monitoring of renal function is recommended for patients receiving tenofovir.
Co-administration of other medicinal products
• Tenofovir disoproxil should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide.
• Tenofovir disoproxil should not be administered concomitantly with adefovir dipivoxil.
• Co-administration of tenofovir disoproxil and didanosine is not recommended.
Tenofovir disoproxil is available in 30 Tablets pack of HDPE jar along with silica gel pouch. Such one jar is packed in a carton along with pack insert.