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Betamethasone Valerate 0.1% Lotion 60 Ml By Fougera Co.

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Betamethasone Valerate 0.1% Lotion 60 Ml By Fougera Co.

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Betamethasone Valerate 0.1% Lotion 60 Ml By Fougera Co. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD1152123/RXB10024644/RXA391356
Size : 60 ML
Selling UoM : EA
NDC: 00168-0041-60
UPC Barcode :301680041605
Supplier: 0050001620 FOUGERA E AND CO INC
Supplier Material : 004160
Generic Code : 007574 BETAMETHASONE VALERATE TOPICAL LOTION 0.
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type

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Product Description.:

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 C27H37FO6 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.

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

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

PRECAUTIONS

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-adrenal (HPA) axis suppression, manifestations of Cushing?s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate anti-fungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

DOSAGE AND ADMINISTRATION

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.