XOLEGEL- ketoconazole gel

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Almirall, LLC

INN (Algemene Internationale Benaming):

KETOCONAZOLE

Samenstelling:

KETOCONAZOLE 20 mg in 1 g

Toedieningsweg:

TOPICAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

XOLEGEL is indicated for the topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older. Safety and efficacy of XOLEGEL for treatment of fungal infections have not been established. None. Risk Summary There are no available data on XOLEGEL use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies with pregnant rats, structural abnormalities (syndactylia and oligodactylia) were observed following oral doses of ketoconazole during organogenesis (see Data ). The available data do not allow calculation of relevant comparisons between the systemic exposure of ketoconazole observed in animal studies to the systemic exposure observed in humans after topical use of XOLEGEL. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other advers

Product samenvatting:

XOLEGEL® (ketoconazole) Gel, 2% is supplied in 45-gram (NDC 16110-080-45) white-coated aluminum tubes with white caps, and is dispensed with FDA-Approved Patient Labeling. Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). Contents are flammable. Keep out of reach of children.

Autorisatie-status:

New Drug Application

Productkenmerken

XOLEGEL- KETOCONAZOLE GEL
ALMIRALL, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XOLEGEL GEL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XOLEGEL GEL.
XOLEGEL (KETOCONAZOLE) GEL FOR TOPICAL USE
FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
XOLEGEL is an azole antifungal indicated for topical treatment of
seborrheic dermatitis in
immunocompetent adults and children 12 years of age and older. (1,
12.1)
Safety and efficacy of XOLEGEL for treatment of fungal infections have
not been established. (1)
DOSAGE AND ADMINISTRATION
XOLEGEL is for topical use only, and not for oral, ophthalmic, or
intravaginal use. (2)
XOLEGEL should be applied once daily to the affected area for 2 weeks.
(2)
DOSAGE FORMS AND STRENGTHS
Gel containing 2% ketoconazole. (3)
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
XOLEGEL is flammable. Avoid using near fire, flame, or smoking during
and immediately following
application of XOLEGEL. (5.1)
ADVERSE REACTIONS
The most common treatment-related adverse reaction was application
site burning (4%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALMIRALL AT
1-866-665-2782 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Flammable Contents
5.2 Systemic Effects
5.3 Local Effects
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
®
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Stora