SPL Set ID: 9cf11bd3-01b9-4ac8-96cc-55d57998b51d

Tenofovir disoproxil fumarate tablets is the brand name for tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) which is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5’-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of TDF is 9-[( R )-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C 19 H 30 N 5 O 10 P • C 4 H 4 O 4 and a molecular weight of 635.51 g/mol. It has the following structural formula: Tenofovir disoproxil fumarate is a white to off-white powder, slightly soluble in water. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25°C. Tenofovir disoproxil fumarate is available as tablets. Tenofovir disoproxil fumarate tablets are for oral administration in strength of 300 mg of TDF, which is equivalent to 245 mg of tenofovir disoproxil. Each tablet contains the following inactive ingredients: anhydrous lactose, calcium stearate, colloidal silicon dioxide, crospovidone, FD&C Blue No. 2 lake 12 to 14%, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. In this insert, all dosages are expressed in terms of TDF except where otherwise noted. image description