KETOCONAZOLE aerosol, foam

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Padagis Israel Pharmaceuticals Ltd

SNN (starptautisko nepatentēto nosaukumu):

KETOCONAZOLE

Kompozīcija:

KETOCONAZOLE 2 g in 100 g

Ievadīšanas:

TOPICAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

Ketoconazole Foam, 2% contains 20 mg of ketoconazole, USP per gram. The thermolabile hydroethanolic foam is available as follows: NDC 45802-532-32 50 g aluminum can NDC 45802-532-33 100 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.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

KETOCONAZOLE- KETOCONAZOLE AEROSOL, FOAM
PADAGIS ISRAEL PHARMACEUTICALS LTD
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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 PADAGIS AT
1-866-634-9120 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 9/2022
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 of Re