KETOCONAZOLE- ketoconazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, 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

Product summary:

Each ketoconazole tablet USP contains ketoconazole, USP 200 mg available in bottles of 100 (NDC 0093-0900-01). The tablets are white, round, flat-beveled tablets, debossed “93”-“900” on the scored side, plain on the other side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Keep out of reach of children. Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. G 9/2017

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

KETOCONAZOLE- KETOCONAZOLE TABLET
Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
KETOCONAZOLE (KEE-toe-KON-a-zole) TABLETS USP
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 treatm

Summary of Product characteristics

KETOCONAZOLE- KETOCONAZOLE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
KETOCONAZOLE TABLETS USP, 200 MG
RX ONLY
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
Coadministration 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, USP is a synthetic broad-spectrum antifungal agent. Each
tablet, for oral administration,
contains 200 mg ketoconazole, USP 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, USP is a white to slightly beige, odorless powder that
is soluble in acids.
C