KETOCONAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

Ketoconazole

Composition:

Ketoconazole 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 a potentially serious adverse reaction may occur. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and sometimes resulting in life-threatening ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia. (See PRECAUTIONS: Drug Interactions.) Coadministration of ketoconazole tablets with lurasidone is contraindicated since it may result in an increase in lurasidone exposure and the potential for serious adverse reactions (see PRECAUTIONS: Drug Interactions). Additionally, the following other drugs are contraindicated with ketoconazole tablets: methadone, disopyramide, dronedarone, ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, irinotecan, lurasidone, oral midazolam, alprazolam, triazolam, felodipine, nisoldipine, ranolazine, tolvaptan, eplerenone, lovastatin, simvastatin and colchicine. (See PRECAUTIONS: Drug Interactions.) Coadministration of ketoconazole tablets with oral midazolam, oral triazolam or alprazolam has resulted in elevated plasma concentrations of these drugs. This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. Concomitant administration of ketoconazole tablets with oral triazolam, oral midazolam or alprazolam is contraindicated. (See PRECAUTIONS: Drug Interactions.) Coadministration of CYP3A4 metabolized HMG-CoA reductase inhibitors such as simvastatin, and lovastatin is contraindicated with ketoconazole tablets. (See PRECAUTIONS: Drug Interactions.) Concomitant administration of ergot alkaloids such as dihydroergotamine and ergotamine with ketoconazole tablets is contraindicated. (See PRECAUTIONS: Drug Interactions.) The use of ketoconazole tablets is contraindicated in patients with acute or chronic liver disease. Ketoconazole tablets USP, 200 mg is contraindicated in patients who have shown hypersensitivity to the drug.

Product summary:

Ketoconazole tablets USP, 200 mg are white to off-white round, flat tablets, one side scored and engraved with "T" above the score and "57" below the score. The other side is plain. They are supplied in bottles of 100 tablets (NDC 60429-020-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

KETOCONAZOLE- KETOCONAZOLE TABLET
Golden State Medical Supply, Inc.
----------
MEDICATION GUIDE
Ketoconazole
(KEE-toe-KON-a-zole)
Tablets USP, 200 mg
What is the most important information I should know about
ketoconazole tablets USP?
Ketoconazole tablets is not the only medicine available to treat
fungal infections and should only be used
when other medicines are not right for you. Talk to your healthcare
provider to find out if ketoconazole
tablets are right for you.
Ketoconazole tablets USP can cause serious side effects, including:
•
liver problems (hepatotoxicity). Some people who were treated with
ketoconazole the active
ingredient in ketoconazole tablets, had serious liver problems that
led to death or the need for a
liver transplant.Call your healthcare provider right away if you have
any of the following
symptoms:
•
loss of appetite or start losing weight (anorexia)
•
nausea or vomiting
•
feel tired
•
stomach pain or tenderness
•
dark urine or light colored stools
•
yellowing of your skin or the whites of your eyes
•
fever or rash
•
changes in the electrical activity of your heart called QT
prolongation. QT prolongation can cause
irregular heart beats that can be life threatening.This can happen
when ketoconazole tablets are
taken with certain medicines, such as dofetilide, quinidine, pimozide,
lurasidone, cisapride,
methadone, disopyramide, dronedarone, and ranolazine. Talk to your
healthcare provider about
other medicines you are taking before you start taking ketoconazole
tablets. Tell your healthcare
provider right away if you feel faint, lightheaded, dizzy, or feel
your heart beating irregularly or
fast. These may be symptoms related to QT prolongation.
What are ketoconazole tablets USP?
•
Ketoconazole tablets are prescription medicine used to treat serious
fungal infections including:
blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and
paracoccidioidomycosis.
•
Ketoconazole tablets are not for people with fungal nail infections.
•
Ketoconazole tablets have

Summary of Product characteristics

KETOCONAZOLE- KETOCONAZOLE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
KETOCONAZOLE
TABLETS USP,
200 MG
RX ONLY
WARNING
Because ketoconazole tablets have been associated with serious adverse
reactions
(see WARNINGSsection), 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
WARNINGSsection.
QT PROLONGATION AND DRUG INTERACTIONS LEADING TO QT PROLONGATION
Coadministration of the following drugs with ketoconazole is
contraindicated:
dofetilide, quinidine, pimozide, lurasidone, 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
Interactionssections.
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