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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (K's) » Ketoconazole


When used orally, ketoconazole has been associated with hepatic toxicity, including some fatalities. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. See WARNINGS and PRECAUTIONS.

Coadministration of terfenadine with ketoconazole tablets is contraindicated. Rare cases of serious cardiovascular adverse events including death, ventricular tachycardia and torsades de pointes have been observed in patients taking ketoconazole concomitantly with terfenadine, due to increased terfenadine concentrations induced by ketoconazole tablets. See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS.

Pharmacokinetic data indicate that oral ketoconazole inhibits the metabolism of astemizole, resulting in elevated plasma levels of astemizole and its active metabolite desmethylastemizole which may prolong QT intervals. Coadministration of astemizole with ketoconazole tablets is therefore contraindicated. See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS.

Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxyl]phenyl] piperazine.

Ketoconazole is a white to slightly beige, odorless powder, soluble in acids, with a molecular weight of 531.44.

Tablets: Ketoconazole is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, corn starch, lactose, magnesium stearate, microcrystalline cellulose, and povidone.

Shampoo: Ketoconazole 2% Shampoo is a red-orange liquid for topical application, containing the broad-spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension. It also contains: coconut fatty acid diethanolamide, disodium monolauryl ether sulfosuccinate, FD&C Red No. 40, hydrochloric acid, imidurea, laurdimonium hydrolyzed animal collagen, macrogol 120 methyl glucose dioleate, perfume bouquet, sodium chloride, sodium hydroxide, sodium lauryl ether sulphate, and purified water.

Cream: Ketoconazole 2% cream contains the broad-spectrum synthetic antifungal agent ketoconazole 2% formulated in an aqueous cream vehicle consisting of propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80 and purified water.


CATEGORIES: Blastomycosis; Candidiasis; Coccidioidomycosis; Histoplasmosis; Infection, Fungal; Infection, Skin; Tinea Corporis; Tinea Cruris; Tinea Pedis; Tinea Versicolor; Pregnancy Category C; FDA Approved 1981 Jun; WHO Formulary

FDA Drug Class: Antifungals; Dermatologics; Topical Anti-Infectives

BRAND NAMES: Akorazol; Anfuhex; Aquarius; Conazol; Formyco; Funazole; Funazole Tabs; Fungarest; Fungazol; Fungazol Tabs; Fungicide; Fungicide Tabs; Funginox; Funginox Tabs; Fungoral; Kenazol; Ketoconazol; Ketoderm; Ketoisdin; Ketomicon; Ketozol; Mycofebrin; Nazoltec; Niz Creme; Niz Shampoo; Nizoral; Nizoral 2% Cream; Nizoral Cream and Tablets; Nizoral Shampoo; Nizoral Tablets; Nizoral Tabs and Cream; Panfungol; Pasalen; Spike; Sporozol; Termizol; Unidox; Zoralin; Zoralin Tabs
(Foreign brand names outside U.S. in italics)

COST OF THERAPY: $21.47 (Candidiasis; Tablet; 200 mg; 1/day; 7 days)

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