Product Profile
TEXAVIR Tablets
TEXAVIR contains tenofovir disoproxil fumarate, TDF 300mg as its active pharmaceutical ingredient.
Pharmaceutical Form
TEXAVIR is a light blue capsule shaped, biconvex, film coated tablet embossed with 'TNV' on one side and plain on the other side.
Mechanism of Action
TDF is the fumarate salt of the prodrug tenofovir disoproxil. Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate (nucleotide) analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and after incorporation into DNA, by DNA chain termination.
Therapeutic Indication
TEXAVIR is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults over 18 years of age.
TEXAVIR is 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/or fibrosis. Considerations should be given to official treatment guidelines for HIV-1 and HBV.
TEXAVIR is 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/or fibrosis. Considerations should be given to official treatment guidelines for HIV-1 and HBV.
Method of Administration
TEXAVIR is administered by the oral route. Therapy should be initiated by a physician who is experienced in the management of HIV infection and/or treatment of chronic Hepatitis B.
Contra-indication
Hypersensitivity to the active pharmaceutical ingredient or to any of the excipients.
For more information, please see your physician or pharmacist for professional opinion and advice.