Betamethasone Dipropionate

Betamethasone dipropionate ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older.

Apply a thin film of betamethasone dipropionate ointment 0.05% to the affected skin areas once daily. In some cases, a twice-daily dosage may be necessary.

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

The following local adverse reactions are reported infrequently when betamethasone dipropionate ointment is used as recommended in the DOSAGE AND ADMINISTRATION section. These reactions are listed 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.

Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate ointment during a pediatric clinical study include signs of skin atrophy (telangiectasia, thinness, shininess, bruising, loss of skin markings). Cutaneous atrophy of the face occurred in 1/6 (17%) of infants, 2/9 (22%) of 2 to 5 year olds, and 2/6 (33%) of the 6 to 8 year olds. Non-facial atrophy occurred in 15%, 8%, and 9% of 2 to 5 year olds, 6 to 8 year olds, and 9 to 12 year olds, respectively. 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.

To report SUSPECTED ADVERSE EVENTS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

Chemically, betamethasone dipropionate is 9-Fluoro-11 β, 17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical 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 0.05% contains: 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in an ointment base consisting of mineral oil 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, 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, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION).

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Eighty pediatric patients ages 6 months to 12 years, with atopic dermatitis, were enrolled in an open-label hypothalamic-pituitary-adrenal (HPA) axis safety study. Betamethasone dipropionate ointment was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 99%). In 15 of 53 (28%) evaluable patients, adrenal suppression was indicated by either a pre-stimulated cortisol concentration less than or equal to 5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol less than or equal to 18 mcg/dL and an increase of less than 7 mcg/dL from the baseline cortisol. Follow-up testing 2 weeks after study completion available for 2 of the 15 patients demonstrated a normally responsive HPA axis.

Studies performed with betamethasone dipropionate ointment indicate that it is in the high range of potency as compared with other topical corticosteroids.

Betamethasone dipropionate ointment, USP 0.05% is available in:

• 15 gram (0.53 oz) NDC 0472-0381-15
• 45 gram (1.59 oz) NDC 0472-0381-45

Store between 15° to 30°C (59° to 86°F).

Manufactured For:
Teva Pharmaceuticals
Parsippany, NJ 07054

Rev. B 2/2023