Betamethasone Ointment

Apply a thin film of Augmented Betamethasone Dipropionate Ointment to the affected skin areas once or twice daily.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Augmented Betamethasone Dipropionate Ointment is a super-high-potency topical corticosteroid. Treatment with Augmented Betamethasone Dipropionate Ointment should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Augmented Betamethasone Dipropionate Ointment should not be used with occlusive dressings unless directed by a physician.

Augmented Betamethasone Dipropionate Ointment is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

Ointment, 0.05%. Each gram of Augmented Betamethasone Dipropionate Ointment, 0.05% contains 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a white to off-white ointment base.

Effects on Endocrine System

Augmented Betamethasone Dipropionate Ointment can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a trial evaluating the effects of Augmented Betamethasone Dipropionate Ointment on the HPA axis, at 14 g per day, Augmented Betamethasone Dipropionate Ointment was shown to suppress the plasma levels of adrenal cortical hormones following repeated application to diseased skin in subjects with psoriasis. These effects were reversible upon discontinuation of treatment. At 7 g per day, Augmented Betamethasone Dipropionate Ointment was shown to cause minimal inhibition of the HPA axis when applied 2 times daily for 2 to 3 weeks in healthy subjects and in subjects with psoriasis and eczematous disorders.

With 6 g to 7 g of Augmented Betamethasone Dipropionate Ointment applied once daily for 3 weeks, no significant inhibition of the HPA axis was observed in subjects with psoriasis and atopic dermatitis, as measured by plasma cortisol and 24-hour urinary 17-hydroxy-corticosteroid levels.

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Cushing's syndrome and hyperglycemia may also occur with topical corticosteroids. These events are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].

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.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In controlled clinical trials, adverse reactions associated with the use of Augmented Betamethasone Dipropionate Ointment reported at a frequency of less than 1% included erythema, folliculitis, pruritus, and vesiculation.

Postmarketing Experience

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Postmarketing reports for local adverse reactions to topical corticosteroids may also include: skin atrophy, telangiectasias, burning, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, striae, and miliaria.

Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported.

The safety and efficacy of Augmented Betamethasone Dipropionate Ointment for the treatment of corticosteroid-responsive dermatoses, psoriasis and atopic dermatitis, have been evaluated in three randomized active-controlled trials, two in psoriasis and one in atopic dermatitis. A total of 378 subjects, of whom 152 received Augmented Betamethasone Dipropionate Ointment, were included in these trials. These trials evaluated Augmented Betamethasone Dipropionate Ointment applied twice daily, for 14 days. Augmented Betamethasone Dipropionate Ointment was shown to be effective in relieving signs and symptoms of psoriasis and atopic dermatitis.

Augmented Betamethasone Dipropionate Ointment 0.05% is a white ointment supplied in 15-g (NDC 66993-897-15) and 50-g (NDC 66993-897-49) tubes.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].