CLOBETASOL PROPIONATE- 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 Foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. None. There are no adequate and well-controlled studies in pregnant women. Clobetasol Propionate 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. 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 are less potent. Teratogenicity studi

Product summary:

Clobetasol Propionate Foam is a white aerosol foam, supplied as follows: Store at controlled room temperature 68ºF to 77ºF (20ºC to 25ºC). 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- 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 FOAM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOBETASOL
PROPIONATE FOAM.
CLOBETASOL PROPIONATE FOAM, 0.05% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
Clobetasol Propionate Foam is a corticosteroid indicated for treatment
of moderate to severe plaque psoriasis of the scalp
and mild to moderate plaque psoriasis of non-scalp regions of the body
excluding the face and intertriginous areas in
patients 12 years and older. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (≥ 4%) are application site burning
and other application site reactions. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT RENAISSANCE PHARMA,
INC. AT 1-866-897-5002 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 10/2014
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 Effects on Endocrine System
Apply a thin layer to the affected skin areas twice daily. (2)
Limit treatment to 2 consecutive weeks. (2)
Do not use more than 50 grams per week or more than 21 capfuls per
week. (2)
Discontinue therapy when control is achieved. (2)
Do not use with occlusive dressings unless directed by physician. (2)
Avoid use on the face, groin, or axillae, or if skin atrophy is
present at the treatment site. (2)
Foam, 0.05% (3)
None. (4)
Clobetasol Propionate Foam can cause reversible HPA axis suppression
with the potential for glucocorticosteroid
insufficiency during and after withdrawal of treatment. Risk factors
include the use of high-potency topical
corticost