Betamethasone Valerate Prescribing Information
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Betamethasone Valerate Cream 0 .1% and Betamethasone Valerate Ointment 0 .1% are generally applied to the affected area as a thin film one to three times daily depending on the severity of the condition. Dosage once or twice a day is often effective. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. 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 and Miliaria.
Betamethasone Valerate Cream and Betamethasone Valerate Ointment contain Betamethasone Valerate USP (9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-valerate); its empirical formula is C 27H 37FO 6; its molecular weight is 476 .59 (CAS Registry Number 2152-44-5); its structural formula is:
Each gram of the 0 .1% cream contains 1 .2 mg betamethasone valerate (equivalent to 1 .0 mg betamethasone) in a hydrophilic cream base consisting of purified water, mineral oil, white petrolatum, polyethylene glycol 1000 monocetyl ether, cetostearyl alcohol, monobasic sodium phosphate, phosphoric acid or sodium hydroxide and 4-chloro-m-cresol as a preservative. Each gram of the 0 .1% ointment contains 1 .2 mg betamethasone valerate (equivalent to 1 .0 mg betamethasone) in an ointment base consisting of mineral oil, white petrolatum and hydrogenated lanolin.
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.
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. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (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 Valerate Cream USP, 0 .1% is supplied in:
NDC 66267-984-15 Box of 15g
Betamethasone Valerate Ointment USP, 0 .1% is supplied in:
Manufactured by
Actavis Mid Atlantic LLC
1877 Kawai Road
Lincolnton, NC 28092 USA
FORM NO. 0370/0371
VC2795
Rev. 2/06