BETAMETHASONE DIPROPIONATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Betamethasone Dipropionate (UNII: 826Y60901U) (Betamethasone - UNII:9842X06Q6M)

Available from:

Preferred Pharmaceuticals, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Betamethasone Dipropionate Cream USP (Augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. Betamethasone Dipropionate Cream USP (Augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. Risk Summary There are no available data on Betamethasone Dipropionate Cream USP (Augmented), 0.05% use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that Betamethasone Dipropionate Cream USP (Augmented), 0.05% may increase the risk of having a low birthweight infant and to use Betamethasone Dipropionate Cream USP (Augmented), 0.05% on the smallest area of skin and for the shortest duration possible. In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. The available data do not allow the calculation of relevant comparisons between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of Betamethasone Dipropionate Cream USP (Augmented), 0.05% (see Data). The 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Betamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate. Risk Summary There are no data regarding the excretion of betamethasone dipropionate in breast milk, the effects on the breastfed infant, or the effects on milk production after topical application of Betamethasone Dipropionate Cream USP (Augmented), 0.05% to women who are breastfeeding. It is possible that topical administration of large amounts of betamethasone dipropionate 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 Betamethasone Dipropionate Cream USP (Augmented), 0.05% and any potential adverse effects on the breastfed infant from Betamethasone Dipropionate Cream USP (Augmented), 0.05% or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use Betamethasone Dipropionate Cream USP (Augmented), 0.05% on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Betamethasone Dipropionate Cream USP (Augmented), 0.05% directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.4) ]. Use of Betamethasone Dipropionate Cream USP (Augmented), 0.05% in pediatric patients younger than 13 years of age is not recommended due to the potential for HPA axis suppression [see Warnings and Precautions (5.1) ]. In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, betamethasone dipropionate cream (augmented), 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dL and/or an increase of <7 mcg/dL from the baseline cortisol. Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), 0.05%, and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group. 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 treated with topical drugs. They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids. Rare systemic effects 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 skin atrophy have also been reported with use of topical corticosteroids in pediatric patients. Avoid use of Betamethasone Dipropionate Cream USP (Augmented), 0.05% in the treatment of diaper dermatitis. Clinical trials of betamethasone dipropionate cream (augmented), 0.05% included 104 subjects who were 65 years of age and over and 8 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

Product summary:

Betamethasone Dipropionate Cream USP (Augmented), 0.05% is available as follows: 15 g tube (NDC 68788-9219-1) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM
PREFERRED PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BETAMETHASONE
DIPROPIONATE CREAM USP (AUGMENTED), 0.05% SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR BETAMETHASONE DIPROPIONATE CREAM USP (AUGMENTED),
0.05%.
BETAMETHASONE DIPROPIONATE CREAM USP (AUGMENTED), 0.05% FOR TOPICAL
USE
INITIAL U.S. APPROVAL: 1983
INDICATIONS AND USAGE
Betamethasone Dipropionate Cream USP (Augmented), 0.05% is a
corticosteroid indicated for the relief of
the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses in patients 13 years
of age 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
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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: 3/2024
FULL PRESCRIBING INFORMATION: CONTENTS*
Apply a thin film to the affected skin areas once or twice daily. (2)
Discontinue therapy when control is achieved. (2)
Use no more than 50 g per week. (2)
Do not use with occlusive dressings unless directed by a physician.
(2)
Avoid use on the face, groin, or axillae, or if skin atrophy is
present at the treatment site. (2)
Not for oral, ophthalmic, or intravaginal use. (2)
Cream, 0.05% (3)
Hypersensitivity to any component of this medicine. (4)
Effects on endocrine system: Betamethasone Dipropionate Cream USP
(Augmented), 0.05% can
cause reversible HPA axis suppression with the potential for
glucocorticosteroid insufficiency during
and after withdrawal of treatment. Risk factor(s) include the use of
high-potency topical
corticosteroids, use over a large surface area or to areas under
occlusion, prolonged use, altered skin
barrier, liver failure, and use in pediatric patients. Mo