KETOCONAZOLE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

State of Florida DOH Central Pharmacy

SNN (starptautisko nepatentēto nosaukumu):

KETOCONAZOLE

Kompozīcija:

KETOCONAZOLE 200 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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.) Concomitant administration of ketoconazole tablets with cisapride is contraindicated. (See BOX WARNING, WARNINGS and PRECAUTIONS.) Concomitant administration of ketoconazole tablets with oral triazolam is contraindicated. (See PRECAUTIONS.) Ketoconazole is contrain

Produktu pārskats:

Ketoconazole Tablets, USP are available containing 200 mg of ketoconazole, USP. The 200 mg tablet is a white to off-white round tablet debossed with M above the score and 261 below the score on one side of the tablet and blank on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. www.mylan.com This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

KETOCONAZOLE - KETOCONAZOLE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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.)
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.)
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.)
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.)
DESCRIPTION
Ketoconazole tablets, USP are 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 corn starch.
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, USP is a white to slightly beige, odorless powder,
soluble in acids, with a molecular