KETOCONAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, 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 tha

Product summary:

Ketoconazole Tablets, USP are available containing 200 mg of ketoconazole, USP. The 200 mg tablets are white to off-white round, scored tablets 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 available as follows:     NDC 43063-036-30     bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep out of reach of children. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PD-Rx Pharmaceuticals, Inc.
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MEDICATION GUIDE
Ketoconazole Tablets, USP
(kee” toe kon’ a zole)
What is the most important information I should know about
ketoconazole tablets?
Ketoconazole tablets are 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 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,
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?
•
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 not been approved for the treatment of
advanced prostate cance

Summary of Product characteristics

KETOCONAZOLE- KETOCONAZOLE TABLET
PD-RX PHARMACEUTICALS, INC.
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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 are 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-[p-[[2-(2,4-dichlorophenyl)-2-(imidazol-
1-ylmethyl)-1,3-dioxolan-4-yl]methoxyl]phenyl] piperazine and has the
following structural formula:
Ketoconazole, USP is a white or almost white powder, odorless powder,
soluble in acids, with a
molecular weight of 531.43.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
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