KETOCONAZOLE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Avera McKennan Hospital

INN (Tarptautinis Pavadinimas):

Ketoconazole

Sudėtis:

Ketoconazole 200 mg

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

KETOCONAZOLE- KETOCONAZOLE TABLET
AVERA MCKENNAN HOSPITAL
----------
KETOCONAZOLE
TABLETS USP,
200 MG
RX ONLY
WARNING
Ketoconazole tablets USP, 200 mg should be used only when other
effective antifungal therapy is
not available or tolerated and the potential benefits are considered
to outweigh the potential risks.
HEPATOTOXICITY
Serious hepatotoxicity, including cases with a fatal outcome or
requiring liver transplantation has
occurred with the use of oral ketoconazole. Some patients had no
obvious risk factors for liver
disease. Patients receiving this drug should be informed by the
physician of the risk and should be
closely monitored. See WARNINGS section.
QT PROLONGATION AND DRUG INTERACTIONS LEADING TO QT PROLONGATION
Co-administration of the following drugs with ketoconazole is
contraindicated: dofetilide,
quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone,
ranolazine. Ketoconazole
can cause elevated plasma concentrations of these drugs and may
prolong QT intervals,
sometimes resulting in life-threatening ventricular dysrhythmias such
as torsades de pointes. See
CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Drug Interactions
sections.
DESCRIPTION
Ketoconazole tablets USP 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 monohydrate, magnesium
stearate, microcrystalline
cellulose, and povidone. Ketoconazole is
cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-
ylmethyl)-1,3-dioxolan-4-yl] methoxyl]phenyl] piperazine and has the
following structural formula:
Ketoconazole is a white to slightly beige, odorless powder, soluble in
acids, with a molecular weight
of 531.44.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Absorption
Ketoconazole is a weak dibasic agent and thus requires acidity for
dissolution and absorption.
Mean peak plasma concentrations of approximately 3.5 μg/mL are
reached within 1 to 2 hours,
following o