Emtricitabine (Truvada)

truvada combination is used with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Emtricitabine (Truvada) and Truvada is also used as part of a complete prevention strategy (Pre-Exposure prophylaxis) to reduce the risk of getting HIV infection in adults that are at high risk.

Emtricitabine (Truvada) and Truvada combination will not cure or prevent HIV infection or the symptoms of AIDS. It helps keep HIV from reproducing, and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV infection. Emtricitabine (Truvada) and Truvada combination will not keep you from spreading HIV to other people. People who receive Emtricitabine (Truvada) and Truvada may continue to have other problems usually related to AIDS or HIV infection.

Emtricitabine (Truvada) is available only with your doctor’s prescription.

TRUVADA tablets are fixed dose combination tablets containing Emtricitabine (Truvada) and Truvada disoproxil fumarate. Emtricitabine (Truvada) is a synthetic nucleoside analog of cytidine. Truvada disoproxil fumarate (Truvada DF) is converted in vivo to Truvada, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both Emtricitabine (Truvada) and Truvada exhibit inhibitory activity against HIV-1 reverse transcriptase.

Emtricitabine (Truvada): The chemical name of Emtricitabine (Truvada) is 5-fluoro-1-(2R,5S)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Emtricitabine (Truvada) 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 (Truvada) 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 (Truvada) is -0.43 and the pKa is 2.65.

Truvada Disoproxil Fumarate: Truvada disoproxil fumarate is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of Truvada. The chemical name of Truvada 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.

Truvada 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 Truvada disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of Truvada disoproxil fumarate except where otherwise noted.

TRUVADA tablets are for oral administration. Each film-coated tablet contains 200 mg of Emtricitabine (Truvada) and 300 mg of Truvada disoproxil fumarate, (which is equivalent to 245 mg of Truvada disoproxil), as active ingredients.

Excipients/Inactive Ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (gluten free). The tablets are coated with Opadry II Blue Y-30-10701, which contains FD&C Blue #2 aluminum lake, hydroxypropyl methylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin.