KETOCONAZOLE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Havix Group Inc d-b-a Aavis Pharmaceuticals

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets 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. Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with ketoconazole tablets. Coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that

Produkto santrauka:

Ketoconazole tablets USP, 200 mg are white to off-white, round, flat faced bevel edge, scored tablets, debossed "A" over "35" on one side and plain with bisect on the other side. They are supplied in bottles of 30 tablets (NDC 71337-035-03) and 100 tablets (NDC 71337-035-01) with a child-resistant cap. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Keep out of reach of children. Manufactured by: Aavis Pharmaceuticals, Hoschton, GA 30548 Code. L7016/02 Rev. 10/2020

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

KETOCONAZOLE - KETOCONAZOLE TABLET
HAVIX GROUP INC D-B-A AAVIS PHARMACEUTICALS
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KETOCONAZOLE TABLETS, USP
200 MG
RX ONLY
WARNING
Because ketoconazole tablets have been associated with serious adverse
reactions (see
WARNINGS section), ketoconazole tablets are not indicated for
treatment of onychomycosis,
cutaneous dermatophyte infections, or Candida infections.
Ketoconazole tablets 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, crosscarmellose sodium, magnesium stearate
and methylcellulose.
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
Ketoconazole is a white to slightly beige, odorless powder, soluble in
acids, with a molecular weight
of 531.44g/mol.
CLINICAL PHARMACOLOG