BETAMETHASONE DIPROPIONATE
OINTMENT USP (AUGMENTED*), 0.05%

(Potency expressed as betamethasone)

* Vehicle augments the penetration of the steroid.

FOR DERMATOLOGICAL USE ONLY
NOT FOR OPHTHALMIC USE

Rx only

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

Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methyl-pregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C₂₈H₃₇FO₇, a molecular weight of 504.6, and the following structural formula:

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

Each gram of betamethasone dipropionate ointment (augmented) contains: 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in an augmented vehicle of propylene glycol, propylene glycol stearate, white wax and white petrolatum.

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, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, anti-pruritic, 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, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

Betamethasone dipropionate ointment (augmented), is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Betamethasone dipropionate ointment (augmented), is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are uled in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.

The following adverse reactions have also been reported with betamethasone dipropionate ointment (augmented): erythema and vesiculation.

Systemic absorption of topical corticosteroids has produced reversible 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 PRECAUTIONS.)

Apply a thin film of betamethasone dipropionate ointment (augmented) to the affected skin areas once or twice daily. Treatment with betamethasone dipropionate ointment (augmented) should be limited to 45 g per week.

Betamethasone dipropionate ointment (augmented) is not to be used with occlusive dressings.

Betamethasone Dipropionate Ointment USP (Augmented*), 0.05%, is supplied as follows:

Store between 2° and 25°C (36° and 77°F).

E. FOUGERA & CO.
a division of Altana Inc., MELVILLE, NEW YORK 11747

I268
#240
R10/98