KETOCONAZOLE aerosol, foam

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Bryant Ranch Prepack

投与経路:

TOPICAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Ketoconazole Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Limitations of Use Safety and efficacy of Ketoconazole Foam, 2% for treatment of fungal infections have not been established. None. Risk Summary There are no available data on ketoconazole foam, 2% use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. No reproductive studies in animals have been performed with ketoconazole foam, 2%. In animal reproduction studies with pregnant mice, rats and rabbits both embryotoxic and developmental effects (structural abnormalities) were observed following oral dosing of ketoconazole during organogenesis. Assuming equivalent systemic absorption of topical and oral ketoconazole doses and a ketoconazole foam, 2% maximum recommended human dose (MRHD) of 8 grams (equivalent to 160 mg ketoconazole), embryotoxic effects were observed at 0.8 to 2.4 times the MRHD an

製品概要:

Ketoconazole Foam, 2% contains 20 mg of ketoconazole, USP per gram. The thermolabile hydroethanolic foam is available as follows: NDC 63629-8677-1 100 g aluminum can Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Do not store under refrigerated conditions. Contents are flammable. Do not expose containers to heat and/or store at temperatures above 49°C (120°F). Do not store in direct sunlight. Contents under pressure. Do not puncture and/or incinerate container. Keep out of reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

認証ステータス:

Abbreviated New Drug Application

製品の特徴

KETOCONAZOLE- KETOCONAZOLE AEROSOL, FOAM
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KETOCONAZOLE FOAM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
KETOCONAZOLE FOAM.
KETOCONAZOLE FOAM, 2%
FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
Ketoconazole Foam, 2% is indicated for topical treatment of seborrheic
dermatitis in immunocompetent
patients 12 years of age and older. (1)
Limitations of Use (1)
Safety and efficacy of Ketoconazole Foam, 2% for treatment of fungal
infections have not been
established. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Foam: 2% ketoconazole in 50 g and 100 g containers. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common adverse reactions observed in clinical studies
(incidence >1%) were application site
burning and application site reaction (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PERRIGO AT
1-866-634-9120 OR
WWW.PERRIGO.COM AND FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 11/2023
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 Contact Sensitization
5.2 Flammable Contents
5.3 Systemic Effects
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Ketoconazole Foam, 2% should be applied to the affected area(s) twice
daily for four weeks (2).
Ketoconazole Foam, 2% is not for ophthalmic, oral, or intravaginal use
(2).
Ketoconazole Foam, 2% may result in contact sensitization, including
photoallergenicity (5.1, 6.2).
The contents of Ketoconazole Foam, 2% are flammable. Avoid fire,
flame, or smoking during and
immediately following application. (5.2).
6.2 Dermal Safety Studies
6.3 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males