BETAMETHASONE DIPROPIONATE

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

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

If an infection develops, appropriate antimicrobial therapy should be instituted.

Betamethasone dipropionate ointment should not be used with occlusive dressings.

The following local adverse reactions are reported infrequently when betamethasone dipropionate products are 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 infections, skin atrophy, striae and 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.

Betamethasone dipropionate ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21- dipropionate. The structural formula is:

Each gram of the 0.05% ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum.

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man (See DOSAGE AND ADMINISTRATION).

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.

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.

Betamethasone Dipropionate Ointment USP, 0.05% is supplied as follows:

15 g tubes NDC 45802-505-14

45 g tubes NDC 45802-505-84

Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing.

Made in Israel

Manufactured By Padagis
Yeruham, Israel

Distributed By Padagis
Allegan, MI 49010

www.padagis.com

Rev 08-21
65M00 RC J1