Inograf
Generic Name: Tacrolimus Cap. 0.5mg, 1mg & 5mg
Packing: 3 x 10 & 1 x 10
Registration # 45490
Description
Inograf (tacrolimus) is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg and 5 mg of anhydrous tacrolimus. Tacrolimus, previously known as FK506, is the active ingredient in Inograf. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S- [3R*[Ė 1 S*,3S*, 4S*)], 4S*,5R*,8S*,9E, 12R*,14R*,15S*,16R*,18S*,19S*, 26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl) -1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate.
Tacrolimus has an empirical formula of C4 Heg NO, H,O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform.
Prescribing Information
Inograf (tacrolimus) is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg and 5 mg of anhydrous tacrolimus. Tacrolimus, previously known as FK506, is the active ingredient in Inograf. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S- [3R*[Ė 1 S*,3S*, 4S*)], 4S*,5R*,8S*,9E, 12R*,14R*,15S*,16R*,18S*,19S*, 26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl) -1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate.
Tacrolimus has an empirical formula of C4 Heg NO, H,O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform.