Betamethasone Dipropionate Usp, 0.05%

Description

DESCRIPTION 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. chemical-structure

What Is Betamethasone Dipropionate Usp, 0.05% Used For?

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

Dosage and Administration

DOSAGE AND ADMINISTRATION 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.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS 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 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.

Contraindications

CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Pregnancy and Breastfeeding

PREGNANCY Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

NURSING MOTHERS It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Overdosage

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

How Supplied

HOW SUPPLIED Betamethasone dipropionate ointment USP, 0.05% is supplied as follows: 15 g tubes NDC 52817-824-15 45 g tubes NDC 52817-824-45 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and freezing.