Betamethasone Dipropionate

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Betamethasone Dipropionate Prescribing Information

Apply a thin film of betamethasone dipropionate cream (augmented) to the affected skin areas once or twice daily.
Therapy should be discontinued when control is achieved. Betamethasone dipropionate cream (augmented) is a high-potency corticosteroid. Treatment with betamethasone dipropionate cream (augmented) should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis
[see Warnings and Precautions (5.1)]
.
Betamethasone dipropionate cream (augmented) should not be used with occlusive dressings unless directed by a physician.
Avoid contact with eyes. Wash hands after each application.
Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
Betamethasone dipropionate cream (augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Risk Summary
There are no available data on betamethasone dipropionate cream (augmented) 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 birth weight 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 (augmented) may increase the risk of having a low birth weight infant and to use betamethasone dipropionate cream (augmented) 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 (augmented)
(see Data)
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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.

•Effects on endocrine system: Betamethasone dipropionate cream (augmented) 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. Modify use should HPA axis suppression develop. (
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8.4 Pediatric Use
- Use of betamethasone dipropionate cream (augmented) 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), 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 (augmented) in the treatment of diaper dermatitis.
)
•Ophthalmic Adverse Reactions: Betamethasone dipropionate cream (augmented) may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. (
5.3 Allergic Contact Dermatitis
- Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
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Betamethasone Dipropionate

Betamethasone Dipropionate Prescribing Information

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