CLOBETASOL PROPIONATE aerosol, foam

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Mylan Pharmaceuticals Inc.

Az alkalmazás módja:

TOPICAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 available data on Clobetasol Propionate Foam use in pregnant women to inform of a drug-associated risk for adverse developmental outcomes. Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use Clobetasol Propionate Foam on the smallest area of skin and for the shortest duration possible (see Data ). In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparison of animal exposure w

Termék összefoglaló:

Clobetasol Propionate Foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. The white aerosol foam is available as follows: NDC 0378-8167-50 50 g aluminum can NDC 0378-8167-01 100 g aluminum can Store at 20 ° to 25 °C (68 ° to 77 °F). [See USP Controlled Room Temperature.] 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.

Engedélyezési státusz:

New Drug Application Authorized Generic

Termékjellemzők

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE AEROSOL, FOAM
MYLAN PHARMACEUTICALS 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
RECENT MAJOR CHANGES
Warnings and Precautions, _Ophthalmic Adverse Reactions_ (5.2) 04/2018
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
•
CONTRAINDICATIONS
•
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 MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 5/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
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
corticosteroid, use ov