SPL Set ID: fc9c2149-8d40-401b-af13-5ae7f953950a
1 drug(s) with this SPL Set ID
Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing EFV USP, FTC, and TDF. EFV, USP 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 USP, 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: carmine, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, povidone, sodium starch glycolate, talc, and titanium dioxide. Efavirenz, USP: EFV, USP is chemically described as (4 S )-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2 H -3,1-benzoxazin-2-one. Its structural formula is: C 14 H 9 ClF 3 NO 2 M.W. 315.68 Efavirenz, USP is a white to slightly pink crystalline powder. It is freely soluble in methanol and practically insoluble in water (less than 10 mcg/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 the following structural formula: C 8 H 10 FN 3 O 3 S M.W. 247.24 Emtricitabine is a white to off-white colored crystalline powder. It is freely soluble in water and in methanol. 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. It has the following structural formula: C 19 H 30 N 5 O 10 P•C 4 H 4 O 4 M.W. 635.52 TDF is a white to off-white crystalline powder. It is practically insoluble in water. efavirenz structural formula emtricitabine structural formula tenofovir disoproxil fumarate structural formula