KETOCONAZOLE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

STAT RX USA LLC

INN (Διεθνής Όνομα):

KETOCONAZOLE

Σύνθεση:

KETOCONAZOLE 200 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebral-spinal fluid. Ketoconazole tablets are also indicated for the treatment of patients with severe recalcitrant cutaneous dermatophyte infections who have not responded to topical therapy or oral griseofulvin, or who are unable to take griseofulvin. Coadministration of terfenadine or astemizole with ketoconazole tablets is contraindicated. (See BOX WARNING, WARNINGS, and PRECAUTIONS sections.) Concomitant administration of ketoconazole tablets with cisapride is contraindicated. (See BOX WARNINGS, WARNINGS and PRECAUTIONS sections.) Concomitant administration of ketoconazole tablets with oral triazolam is contraindicated. (See PRECAUTIONS se

Περίληψη προϊόντος:

Each ketoconazole tablet, USP contains ketoconazole 200 mg available in bottles of 100 and 500. The tablets are white, round, flat-beveled tablets, debossed “93”-“900” on the scored side, plain on the other side. Store at controlled room temperature between 20° and 25° C (68° and 77° F) (see USP). Protect from moisture. Manufactured By: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Printed in USA Rev. C 11/2003

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

KETOCONAZOLE - KETOCONAZOLE TABLET
STAT RX USA 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
Ketoconazole is a white to slightly