Tenof-Em Description

Each FC tab contains 200 mg emtricitabine and 300 mg of tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil fumarate).
Emtricitabine and tenofovir disoproxil fumarate tablets are fixed dose combination tablets containing emtricitabine and tenofovir disoproxil fumarate. Emtricitabine, a synthetic nucleoside analog of cytidine. Tenofovir DF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5’-monophosphate. Both emtricitabine and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase.
Emtricitabine: The chemical name of emtricitabine is 5-fluoro-1-(2R,5S)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl] cytosine. Emtricitabine is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position.
It has a molecular formula of C₈H₁₀FN₃O₃S and a molecular weight of 247.24.
Emtricitabine is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25°C. The partition coefficient (log p) for emtricitabine is -0.43 and the pKa is 2.65.
Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir disoproxil fumarate is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C₁₉H₃₀N₅O₁₀P ● C₄H₄O₄ and a molecular weight of 635.52.
Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25°C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of tenofovir disoproxil fumarate except where otherwise noted.
Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each film-coated tablet contains 200 mg of Emtricitabine and 300 mg of Tenofovir disoproxil fumarate, (which is equivalent to 245 mg of Tenofovir disoproxil), as active ingredients.
Excipients/Inactive Ingredients: Pregelatinized starch, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium and magnesium stearate. The tablets are coated with Opadry II Blue which contains lactose monohydrate, titanium dioxide, triacetin, hypromellose and FD&C Blue # 2 Aluminum Lake.