KETOCONAZOLE- ketoconazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

KETOCONAZOLE

Composition:

KETOCONAZOLE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 a potentially serious adverse reaction may occur. For example, increased plasma concentrations of some of these drugs can lead

Product summary:

Ketoconazole Tablets, USP are available containing 200 mg of ketoconazole, USP. The 200 mg tablet is a white to off-white round, scored tablet debossed with M above the score and 261 below the score on one side of the tablet and blank on the other side. They are available as follows: Unit dose packages of 30 (3x10) NDC 68084-552-21 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Keep out of reach of children. PHARMACIST: Dispense a Medication Guide with each prescription. American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Mylan Pharmaceuticals, Inc. as follows: (200 mg / 30 UD) NDC 68084-552-21 packaged from NDC 0378-0261 Distributed by: American Health Packaging Columbus, OH 43217 8255221/0516OS

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

KETOCONAZOLE- KETOCONAZOLE TABLET
American Health Packaging
----------
MEDICATION GUIDE
8255221/0516OS
KETOCONAZOLE TABLETS, USP
(kee” toe kon’ a zole)
200 mg
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.
Ketoconazoletablets can cause serious side effects, including:
•
liver problems (hepatotoxicity). Some people who were treated with
ketoconazole, the active
ingredient in ketoconazoletablets, 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

Summary of Product characteristics

KETOCONAZOLE- KETOCONAZOLE TABLET
AMERICAN HEALTH PACKAGING
----------
KETOCONAZOLE TABLETS, USP
8255221/0516OS
RX ONLY
WARNING
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.
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 are a synthetic broad spectrum antifungal
agent available in scored white
tablets, each containing 200 mg ketoconazole base for oral
administration. In addition, each tablet also
contains the following inactive ingredients: 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 and molecular formula:
Ketoconazole, USP is a white to slightly beige, odorless powder,
soluble in acids, with a molecular
weight of 531.44.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
ABS ORPTION
Ketoconazole is a weak dibasic agent and thus requires acidity for
dissolution and absorption.
Mean peak plasma concentrations of approximately 3.5 mcg/mL are
reache