KETOCONAZOLE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

REMEDYREPACK INC.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

Ketoconazole tablets USP, 200 mg are white to off-white, round, flat faced bevel edge, scored tablets, debossed "A" over "35" on one side and plain with bisect on the other side. They are supplied in NDC: 70518-2831-00 NDC: 70518-2831-01 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 7 in 1 BOTTLE PLASTIC Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Keep out of reach of children. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

KETOCONAZOLE- KETOCONAZOLE TABLET
REMEDYREPACK INC.
----------
MEDICATION GUIDE
Dispense with medication guide available at:
https://www.burelpharma.com
Ketoconazole
(KEE-toe-KON-a-zole)
Tablets USP, 200 mg
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
[phone]
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, hist

Prekės savybės

KETOCONAZOLE- KETOCONAZOLE TABLET
REMEDYREPACK 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
Co-administration 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, croscarmellose
sodium, magnesium
stearate and methylcellulose. 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 531.44g/mol.
FDA APPROVED DISSOLUTION TEST SPECIFICATIONS DIFFER