CLOBETASOL PROPIONATE aerosol, foam

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Bryant Ranch Prepack

投与経路:

TOPICAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Clobetasol Propionate Foam, 0.05% 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. Risk Summary There are no available data on Clobetasol Propionate Foam, 0.05% use in pregnant women to inform of a drug-associated risk for adverse developmental outcomes. Published data report a significantly increased risk of low birth weight 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, 0.05% 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 estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality. However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants [adjusted RR, 7.74 (95% CI, 1.49–40.11)]. In addition, a small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. The majority of exposed subjects treated large areas of the body (a mean quantity of 60 g/month [range, 12–170g]) over long periods of time. Animal Data Embryofetal development studies conducted with clobetasol propionate in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and malformations at all dose levels tested down to 0.03 mg/kg. Malformations seen included cleft palate and skeletal abnormalities. In an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg. Malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities. Risk Summary There is no information regarding the presence of clobetasol propionate in breast milk or its effects on the breastfed infant or on milk production. Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of clobetasol propionate could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Clobetasol Propionate Foam, 0.05% and any potential adverse effects on the breastfed infant from Clobetasol Propionate Foam, 0.05% or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use Clobetasol Propionate Foam, 0.05% on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Clobetasol Propionate Foam, 0.05% directly to the nipple and areola to avoid direct infant exposure. Safety and effectiveness of clobetasol propionate foam, 0.05% in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when they are treated with topical drugs. They are, therefore, also at greater risk of adrenal insufficiency upon the use of topical corticosteroids. Rare systemic toxicities such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients especially those with prolonged exposure to large doses of high potency topical corticosteroids. Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients. Avoid use of Clobetasol Propionate Foam, 0.05% in the treatment of diaper dermatitis. Clinical studies of clobetasol propionate foam, 0.05% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range. Clobetasol Propionate Foam, 0.05% Important: Clobetasol Propionate Foam, 0.05% is for use on the skin only. Do not get Clobetasol Propionate Foam, 0.05% in your eyes, mouth, or vagina. How to apply Clobetasol Propionate Foam, 0.05%: Step 1: Remove the cap and save for further use. Figure A Step 2: Before applying Clobetasol Propionate Foam, 0.05% for the first time, break the tiny plastic piece at the base of the can’s rim by gently pushing back (away from the piece) on the nozzle. (See Figure A ) Figure B Step 3: Turn the can upside down. Push the button to dispense a small amount of Clobetasol Propionate Foam, 0.05% into the cap of the can, or on your affected skin area. (See Figure B ) This amount should be no more than 1 ½ capfuls, about the size of a golf ball. Figure C Figure D Step 4: Using your fingertips, gently massage a thin layer of Clobetasol Propionate Foam, 0.05% into the affected areas until the foam disappears. (see Figures C and D ) Figure E Step 5: If you are treating areas with hair, such as the scalp, move any hair away so that the foam can be applied directly to the affected areas. (see Figure E ) Keep the foam away from your eyes, as it will sting and may cause eye problems if there is frequent contact with your eyes. If the foam gets in your eyes, rinse them well with cold water right away. If the stinging continues, contact your healthcare provider right away. Figure F Step 6: Wash your hands after applying Clobetasol Propionate Foam, 0.05%. (see Figure F ) This Instructions for Use has been approved by the U.S. Food and Drug Administration.

製品概要:

Clobetasol Propionate Foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. The white aerosol foam is available as follows: 50 g aluminum can NDC 63629-9460-01 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

認証ステータス:

Abbreviated New Drug Application

製品の特徴

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE AEROSOL, FOAM
BRYANT RANCH PREPACK
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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, 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, 0.05% 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
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (≥ 4%) are application site burning
and other application site reactions.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PERRIGO 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: 1/2024
FULL PRESCRIBING INFORMATION: CONTENTS*
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, 0.05% 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 over a large surface area
or to areas under occlusion,
prolonged us