KETOCONAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

KETOCONAZOLE

Composition:

KETOCONAZOLE 200 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

KETOCONAZOLE- KETOCONAZOLE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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KETOCONAZOLE TABLETS USP, 200 MG
0900
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. Each
tablet, for oral administration,
contains 200 mg ketoconazole base. In addition, each tablet contains
the following inactive ingredients:
colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium
stearate, microcrystalline
cellulose, and povidone. Ketoconazole is
(±)_cis_-1-Acetyl-4-[_p_-[[2-(2,4-dichlorophenyl)-2-(imidazol-1-
ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-piperazine and has the
following structural formula:
C
H Cl
N O M.W. 531.44
Keto