Overdose : מינון יתר

12 OVERDOSAGE
In the event of acute accidental overdose, treatment consists of supportive and symptomatic measures. Within the first hour after ingestion, activated charcoal may be administered.


13 DESCRIPTION
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 C26H28Cl2N4O4 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: lactose monohydrate, silicified microcrystalline cellulose, modified corn starch, magnesium stearate and colloidal silicon dioxide.

The non-functional pink film-coating contains polyvinyl alcohol partially hydrolyzed, titanium dioxide, macrogol/polyethylene glycol 3350, talc and iron oxide red.

The tablets are printed with a black imprinting ink that contains shellac glaze 45% (20% esterified) in ethanol, ferrosoferric oxide, isopropyl alcohol, propylene glycol and ammonium hydroxide 28%.