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:

Physicians Total Care, Inc.

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

Produktu pārskats:

Ketoconazole is available as white to off-white round, flat tablets, scored on one side, engraved T57 on the side of the score, containing 200 mg of ketoconazole. They are supplied in Store at room temperature (59°-86°F/15°-30°C). Protect from moisture. Revised March 1999 Mfd. by: Taro Pharmaceutical Industries Ltd Haifa Bay, Israel 26110 79775-0499

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

KETOCONAZOLE - KETOCONAZOLE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
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:
Ketoconazole is a white to slightly beige, odorless powder, soluble in
acids with