KETOCONAZOLE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I)

Verfügbar ab:

KAISER FOUNDATION HOSPITALS

INN (Internationale Bezeichnung):

Ketoconazole

Zusammensetzung:

Ketoconazole 200 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

KETOCONAZOLE - KETOCONAZOLE TABLET
KAISER FOUNDATION HOSPITALS
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KETOCONAZOLE TABLETS, USP
200 MG
RX ONLY
WARNING
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 sections.)
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 tablets
concomitantly with terfenadine,
due to increased terfenadine concentrations induced by ketoconazole
tablets. (See
CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections.)
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
sections.)
Coadministration of cisapride with ketoconazole is contraindicated.
Serious cardiovascular
adverse events including ventricular tachycardia, ventricular
fibrillation and torsades de pointes
have occurred in patients taking ketoconazole concomitantly with
cisapride. (See
CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections.)
DESCRIPTION
Ketoconazole is a synthetic broad-spectrum antifungal agent available
in scored white tablets, each
containing 200 mg ketoconazole base for oral administration. In
addition, each tablet also contains the
following inactive ingredients: colloidal silicon dioxide, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, povidone and starch (corn). 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, odo