CLOBETASOL PROPIONATE EMULSION- clobetasol propionate aerosol, foam

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Available from:

Renaissance Pharma, Inc.

INN (International Name):

CLOBETASOL PROPIONATE

Composition:

CLOBETASOL PROPIONATE 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clobetasol Propionate Emulsion Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. None. Teratogenic Effects. Pregnancy Category C. There are no adequate and well-controlled studies of Clobetasol Propionate Emulsion Foam in pregnant women. Clobetasol Propionate Emulsion Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously, it was a significant teratogen in both the rabbit and the mouse. Clobetasol propionate has greater teratogenic potential than steroids that a

Product summary:

Clobetasol Propionate Emulsion Foam, 0.05% is a white to off-white aerosol foam supplied as follows: Store at controlled room temperature 68°F to 77°F (20°C to 25°C) with excursions permitted between 59°F to 86°F (15°C to 30°C). FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Keep out of reach of children.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CLOBETASOL PROPIONATE EMULSION- CLOBETASOL PROPIONATE AEROSOL, FOAM
RENAISSANCE PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL PROPIONATE EMULSION FOAM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CLOBETASOL PROPIONATE EMULSION FOAM.
CLOBETASOL PROPIONATE EMULSION FOAM, 0.05%
FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
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Limitations of Use
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DOSAGE AND ADMINISTRATION
Clobetasol Propionate Emulsion Foam is not for oral, ophthalmic, or
intravaginal use. (2)
Apply Clobetasol Propionate Emulsion Foam to the affected area(s)
twice daily, morning and evening for up to 2
consecutive weeks. The maximum weekly dose should not exceed 50 g. (2)
DOSAGE FORMS AND STRENGTHS
Foam, 0.05%. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FDA AT 1-800-FDA-1088
ORWWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Indication
1.2 Limitations of Use
Clobetasol Propionate Emulsion Foam is a corticosteroid indicated for
the treatment of inflammatory and pruritic
manifestations of corticosteroid-responsive dermatoses in patients 12
years and older. (1.1)
Avoid face, axillae, and groin. (1.2)
Avoid use if skin atrophy is present at the treatment site. (1.2)
Clobetasol Propionate Emulsion Foam has been shown to suppress the HPA
axis. Systemic absorption of Clobetasol
Propionate Emulsion Foam may produce reversible HPA axis suppression,
Cushing’s syndrome, hyperglycemia, and
unmask latent diabetes. (5.1)
Because of the potential for systemic absorption, use of topical
corticosteroids may require that patients be
periodically evaluated for HPA axis suppression. (5.1)
Modify use should HPA axis suppression develop. (5.1)
High potency corticosteroids, large treatment surface areas, prolonged
use, use of occlusiv