BETAMETHASONE VALERATE cream BETAMETHASONE VALERATE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M)

Available from:

Cosette Pharmaceuticals, Inc.

INN (International Name):

Betamethasone Valerate

Composition:

Betamethasone Valerate 1.2 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topic

Product summary:

Betamethasone Valerate Cream USP, 0.1% is supplied as follows: 15 g tubes NDC 0713-0326-15 45 g tubes NDC 0713-0326-37 Betamethasone Valerate Ointment USP, 0.1% is supplied as follows: 15 g tubes NDC 0713-0327-15 45 g tubes NDC 0713-0327-37 Store at room temperature 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 03/2022   8-BETVCPLNC3   VC7618

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE VALERATE- BETAMETHASONE VALERATE CREAM
BETAMETHASONE VALERATE- BETAMETHASONE VALERATE OINTMENT
COSETTE PHARMACEUTICALS, INC.
----------
BETAMETHASONE VALERATE CREAM USP, 0.1%
BETAMETHASONE VALERATE OINTMENT USP, 0.1%
(POTENCY EXPRESSED AS BETAMETHASONE)
RX ONLY
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION
Betamethasone Valerate Cream and Ointment contain betamethasone
valerate 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 valerate is a white to practically white odorless
crystalline powder
practically insoluble in water, freely soluble in acetone and
chloroform, soluble in alcohol,
and slightly soluble in benzene and ether. Chemically, it is
9-fluoro-11β,17,21-trihydroxy-
16β-methylpregna-1,4-diene-3,20-dione 17-valerate. The structural
formula is:
Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate
(equivalent to 1
mg betamethasone) in a soft, white, hydrophilic cream of purified
water, mineral oil,
sodium phosphate monobasic (monohydrate), white petrolatum,
polyethylene glycol
1000, ceteareth-15, stearyl alcohol, cetyl alcohol, propylene glycol,
phosphoric acid (to
adjust pH, if required); chlorocresol is present as a preservative.
Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate
(equivalent to
1 mg betamethasone) in an ointment base of white petrolatum, mineral
oil, and
hydrogenated lanolin.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic 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