BETAMETHASONE DIPROPIONATE ointment

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)

זמין מ:

H.J. Harkins Company, Inc.

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

Betamethasone dipropionate ointment, USP 0.05% is available in: 15 gram (0.53 oz) NDC 52959-262-15 45 gram (1.59 oz) NDC 52959-262-00 Store between 15° to 30°C (59° to 86°F).

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE OINTMENT
H.J. HARKINS COMPANY, INC.
----------
0262 BETAMETHASONE DIPRO OINT
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
C28H37FO7, 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.
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 topical
corticosteroids is determined by
many factors including the vehicle, the integrity of the epidermal
barrier, and the use of occlusive
dres