KETOCONAZOLE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

PD-Rx Pharmaceuticals, Inc.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

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 30 tablets (NDC 43063-882-30). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Keep out of reach of children.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

KETOCONAZOLE- ketoconazole tablet
PD-Rx Pharmaceuticals, 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,
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 not been approve

Toote omadused

KETOCONAZOLE- KETOCONAZOLE TABLET
PD-RX PHARMACEUTICALS, 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
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 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 PHARMACOLOGY
P