KETOCONAZOLE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Burel Pharmaceuticals, LLC

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

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 bottles of 30 tablets (NDC 35573-433-30) and 100 tablets (NDC 35573-433-02) with a child-resistant cap. 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. Dispense with medication guide available at: https://www.burelpharma.com

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

KETOCONAZOLE- KETOCONAZOLE TABLET
Burel Pharmaceuticals, LLC
----------
MEDICATION GUIDE
Dispense with medication guide available at:
https://www.burelpharma.com
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

Αρχείο Π.Χ.Π.

KETOCONAZOLE- KETOCONAZOLE TABLET
BUREL PHARMACEUTICALS, LLC
----------
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, 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 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, 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 SPECIFICA