KETOCONAZOLE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Strides Pharma Science Limited

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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. Drug Interactions 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 s

Resumo do produto:

Each ketoconazole tablet USP contains ketoconazole, USP 200 mg available in bottles of 100 (NDC 64380-827-06) and 500 (NDC 64380-827-07). The tablets are white to off white, round shaped flat-beveled debossed with "S" and "500" on the scored side and plain on the other side. Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from moisture. Keep this and all medications out of reach of children. Manufactured by: Strides Pharma Science Limited Puducherry - 605014, India. Distributed by: Strides Pharma Inc, East Brunswick, NJ 08816 Revised: 07/2023 Medication Guide available at: www.strides.com/medication-guides

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

KETOCONAZOLE - KETOCONAZOLE TABLET
Strides Pharma Science Limited
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MEDICATION GUIDE
Medication Guide available at: www.strides.com/medication-guides
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 eye
•
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?
•
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 nai

Características técnicas

KETOCONAZOLE - KETOCONAZOLE TABLET
STRIDES PHARMA SCIENCE LIMITED
----------
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, 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, 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 or almost white powder that is soluble in
acids.
CLI