CLOBETASOL PROPIONATE aerosol, foam

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Mylan Pharmaceuticals Inc.

প্রশাসন রুট:

TOPICAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Clobetasol propionate foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses 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 with human exposure was computed. The background risk of major birth defects and miscarriage for

পণ্য সারাংশ:

Clobetasol Propionate Foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. The white emulsion aerosol foam is available as follows: NDC 0378-8055-50 50 g aluminum can NDC 0378-8055-01 100 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.

অনুমোদন অবস্থা:

New Drug Application Authorized Generic

পণ্য বৈশিষ্ট্য

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 _(5.3) 5/2018
INDICATIONS AND USAGE
•
DOSAGE AND ADMINISTRATION
Clobetasol propionate foam is not for oral, ophthalmic, or
intravaginal use. (2)
•
•
DOSAGE FORMS AND STRENGTHS
Foam, 0.05%. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
•
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*
Clobetasol propionate foam is a corticosteroid indicated for the
treatment of inflammatory and pruritic manifestations
of corticosteroid-responsive dermatoses in patients aged 12 years and
older. (1)
Apply clobetasol propionate 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)
Avoid use on face, axillae, and groin, or if skin atrophy is present
at the treatment site. (2)
Clobetasol propionate foam has been shown to suppress the HPA axis.
Systemic absorption of clobetasol propionate
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