BETAMETHASONE DIPROPIONATE- betamethasone dipropionate ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Betamethasone Dipropionate (UNII: 826Y60901U) (Betamethasone - UNII:9842X06Q6M)

Available from:

Preferred Pharmaceuticals, Inc

INN (International Name):

Betamethasone Dipropionate

Composition:

Betamethasone 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Betamethasone dipropionate ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. Betamethasone dipropionate ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in these preparations.

Product summary:

Betamethasone dipropionate ointment, USP 0. 05% is available in: 45 gram tube - 68788-0972-1 Store between 15° to 30°C (59° to 86°F). Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA GW7034-I600-5411-14A Rev. 06/15 Relabeled By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE OINTMENT
PREFERRED PHARMACEUTICALS, INC
----------
BETAMETHASONE DIPROPIONATE OINTMENT, USP 0.05%
(POTENCY EXPRESSED AS BETAMETHASONE)
FOR DERMATOLOGIC USE ONLY –
NOT FOR OPHTHALMIC USE
DESCRIPTION
Betamethasone dipropionate ointment contains betamethasone
dipropionate, USP, a synthetic
adrenocorticosteroid, for dermatologic use. Betamethasone, an analog
of prednisolone, has high
corticosteroid activity and slight mineralocorticoid activity.
Betamethasone dipropionate is the 17,21-
dipropionate ester of betamethasone.
Chemically, betamethasone dipropionate is 9-Fluoro-11 β,
17,21-trihydroxy-16β-methylpregna-1,4-
diene-3,20-dione 17,21-dipropionate, with the empirical formula C
H FO , a molecular weight of
504.6, and the following structural formula:
Betamethasone dipropionate is a white to creamy white, odorless
crystalline powder, insoluble in
water.
Each gram of betamethasone dipropionate ointment 0.05% contains: 0.64
mg betamethasone
dipropionate USP (equivalent to 0.5 mg betamethasone) in an ointment
base consisting of mineral oil and
white petrolatum.
CLINICAL PHARMACOLOGY
The corticosteroids are a class of compounds comprising steroid
hormones, secreted by the adrenal
cortex and their synthetic analogs. In pharmacologic doses
corticosteroids are used primarily for their
anti-inflammatory and/or immunosuppressive effects.
Topical corticosteroids, such as betamethasone dipropionate, are
effective in the treatment of
corticosteroid-responsive dermatoses primarily because of their
anti-inflammatory, antipruritic, and
vasoconstrictive actions. However, while the physiologic,
pharmacologic, and clinical effects of the
corticosteroids are well known, the exact mechanisms of their actions
in each disease are uncertain.
Betamethasone dipropionate, a corticosteroid, has been shown to have
topical (dermatologic) and
systemic pharmacologic and metabolic effects characteristic of this
class of drugs.
PHARMACOKINETICS: The extent of percutaneous absorption of top