SPL Set ID: a7d94a1c-31b0-4272-8f8d-186d580e16e0

Efavirenz, Emtricitabine and Tenofovir disoproxil fumarate tablet is a fixed-dose combination tablet containing EFV, FTC, and TDF. EFV is a non-nucleoside reverse transcriptase inhibitor (NNRTI). FTC is a synthetic nucleoside analog of cytidine. TDF, which is converted in vivo to tenofovir, is an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'‑monophosphate. Efavirenz, Emtricitabine and Tenofovir disoproxil fumarate tablets are for oral administration. Each tablet contains 600 mg of EFV, 200 mg of FTC, and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: Croscarmellose sodium, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, magnesium stearate, red iron oxide, sodium lauryl sulfate. The tablets are film-coated with a coating material opadry AMB 80W54485 pink containing polyvinyl alcohol-part, hydrolyzed, titanium dioxide, talc, lecithin (soya), xanthan gum, iron oxide yellow, iron oxide red and opadry AMB 80W56843 brown containing polyvinyl alcohol-part, hydrolyzed, titanium dioxide, talc, lecithin (soya), xanthan gum, iron oxide red. Efavirenz: EFV is chemically described as ( S )-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2 H -3,1-benzoxazin-2-one. Its molecular formula is C 14 H 9 ClF 3 NO 2 and its structural formula is: Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (less than 10 µg/mL). Emtricitabine: The chemical name of FTC is 5-fluoro-1-(2 R ,5 S )-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC 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 C 8 H 10 FN 3 O 3 S and a molecular weight of 247.24. It has the following structural formula: Emtricitabine is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25°C. Tenofovir DF: TDF is a fumaric acid salt of the bis -isopropoxycarbonyloxymethyl ester derivative of tenofovir. 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: TDF is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25°C. Image Image Image