SPL Set ID: de27413a-6579-4586-80dc-39c712652952

Tenofovir disoproxil fumarate (a prodrug of tenofovir) 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 635.52. It has the following structural formula: Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in distilled water at 25°C. It has an octanol/phosphate buffer (pH 6.5) partition coefficient (log p) of 1.25 at 25°C. Tenofovir disoproxil fumarate tablets are for oral administration. Each tablet contains 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, and the following inactive ingredients: Lactose monohydrate, Croscarmellose sodium, Corn starch, Polysorbate 80, Microcrystalline cellulose, Magnesium stearate, Opadry II Y-30-10671-A Light blue. (Lactose monohydrate, HPMC2910/Hypromellose 15cP, Titanium dioxide, Triacetin / Glycerol triacetate, FD&C Blue #2/Indigo carmine Aluminum Lake). In this insert, all dosages are expressed in terms of TDF except where otherwise noted. Image