SPL Set ID: d4c5fead-bc4a-fb02-e053-2a95a90ae4fc
1 drug(s) with this SPL Set ID
RECORLEV (levoketoconazole) tablets contain levoketoconazole as the active ingredient. Levoketoconazole is the 2S,4R- enantiomer derived from racemic ketoconazole and is a cortisol synthesis inhibitor. The chemical name of levoketoconazole is 2S,4R cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl] methoxyl]phenyl] piperazine. The molecular formula of levoketoconazole is C 26 H 28 Cl 2 N 4 O 4 with a molecular mass of 531.43 g/mol. Levoketoconazole is a white or almost white crystalline powder. It is very slightly soluble in water but soluble in aqueous solutions below pH 2. RECORLEV tablets for oral administration contain 150 mg of levoketoconazole and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, modified corn starch, and silicified microcrystalline cellulose. The non-functional pink film-coating contains iron oxide red, macrogol/polyethylene glycol 3350, polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide. The tablets are printed with a black imprinting ink that contains ammonium hydroxide 28%, ferrosoferric oxide, isopropyl alcohol, propylene glycol, and shellac glaze 45% (20% esterified) in ethanol. Structure