Betamethasone dipropionate (Betamethasone valerate) cream, 0.05% (augmented) contains Betamethasone dipropionate (Betamethasone valerate) , USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate (Betamethasone valerate) is the 17, 21-dipropionate ester of betamethasone.

Chemically, Betamethasone dipropionate (Betamethasone valerate) is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula CHFO, a molecular weight of 504.6, and the following structural formula :

Betamethasone dipropionate (Betamethasone valerate) is a white to creamy white, odorless crystalline powder, insoluble in water.

Each gram of Betamethasone dipropionate (Betamethasone valerate) cream, 0.05% (augmented) contains: 0.643 mg Betamethasone dipropionate (Betamethasone valerate) USP (equivalent to 0.5 mg betamethasone) in an emollient cream base of purified water USP; chlorocresol NF; propylene glycol USP; white petrolatum USP; white wax NF; cyclomethicone NF; sorbitol solution USP; glyceryl oleate/propylene glycol; ceteareth-30; carbomer homopolymer NF; and sodium hydroxide NF.

The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects.

Topical corticosteroids, such as Betamethasone dipropionate (Betamethasone valerate) , are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Betamethasone dipropionate (Betamethasone valerate) , a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

Betamethasone dipropionate (Betamethasone valerate) cream, 0.05% (augmented) is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.

Betamethasone dipropionate (Betamethasone valerate) cream, 0.05% (augmented) is contraindicated in patients who are hypersensitive to Betamethasone dipropionate (Betamethasone valerate) , to other corticosteroids, or to any ingredient in this preparation.

Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure. (See section.)

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. In an open-label pediatric study of 60 evaluable patients, of the 19 who showed evidence of suppression 4 patients were tested 2 weeks after discontinuation of Betamethasone dipropionate (Betamethasone valerate) cream, 0.05% (augmented) and 3 of the 4 (75%) had complete recovery of HPA axis function. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See .)

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

The following tests may be helpful in evaluating HPA axis suppression:

Urinary free cortisol testACTH stimulation test

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Betamethasone dipropionate (Betamethasone valerate) .

Betamethasone was negative in the bacterial mutagenicity assay ( and ), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the human lymphocyte chromosome aberration assay, and equivocal in the mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone.

Reproductive studies with Betamethasone dipropionate (Betamethasone valerate) carried out in rabbits at doses of 1.0 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species. These doses are approximately 5- and 38-fold the human dose based on a mg/m comparison, respectively.

Use of Betamethasone dipropionate (Betamethasone valerate) cream, 0.05% (augmented) in pediatric patients 12 years of age and younger is not recommended. (See and sections.) In an open-label study, 19 of 60 (32%) evaluable pediatric patients (aged 3 months-12 years old) using Betamethasone dipropionate (Betamethasone valerate) cream, 0.05% (augmented) for treatment of atopic dermatitis demonstrated HPA axis suppression. The proportion of patients with adrenal suppression in this study was progressively greater, the younger the age group. (See )

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Chronic corticosteroid therapy may interfere with the growth and development of children.

The only local adverse reaction reported to be possibly or probably related to treatment with Betamethasone dipropionate (Betamethasone valerate) cream, 0.05% (augmented) during adult controlled clinical studies was stinging. It occurred in 1 patient, 0.4%, of the 242 patients or subjects involved in the studies.

Adverse reactions reported to be possibly or probably related to treatment with Betamethasone dipropionate (Betamethasone valerate) cream, 0.05% (augmented) during a pediatric clinical study include signs of skin atrophy (telangiectasia, bruising, shininess). Skin atrophy occurred in 7 of 67 (10%) patients, involving all age groups from 3 months - 12 years of age.

The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See .)

Apply a thin film of Betamethasone dipropionate (Betamethasone valerate) cream, 0.05% (augmented) to the affected skin areas once or twice daily. Treatment with Betamethasone dipropionate (Betamethasone valerate) cream, 0.05% (augmented) should be limited to 45 g per week.

Betamethasone dipropionate (Betamethasone valerate) cream, 0.05% (augmented) is supplied in 15 g (NDC 68462-290-17) and 50 g (NDC 68462-290-52); boxes of one.