BETAMETHASONE DIPROPIONATE AUGMENTED- betamethasone dipropionate lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

betamethasone dipropionate (UNII: 826Y60901U) (betamethasone dipropionate - UNII:826Y60901U)

Available from:

Physicians Total Care, Inc.

INN (International Name):

betamethasone dipropionate

Composition:

betamethasone dipropionate 0.64 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Betamethasone dipropionate lotion (augmented) is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. The total dose should not exceed 50 mL per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Betamethasone dipropionate lotion (augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

Product summary:

Betamethasone Dipropionate Lotion USP 0.05% (Augmented) is supplied as follows: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)[see USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Nycomed US Inc. MELVILLE, NEW YORK 11747 I2267A R1/08 #105 Relabeling (Additional barcode label) by: Physicians Total Care, Inc. Tulsa, OK         74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE AUGMENTED- BETAMETHASONE DIPROPIONATE
LOTION
PHYSICIANS TOTAL CARE, INC.
----------
BETAMETHASONE DIPROPIONATE LOTION USP 0.05% (AUGMENTED*)
(POTENCY EXPRESSED AS BETAMETHASONE)
* VEHICLE AUGMENTS THE PENETRATION OF THE STEROID.
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Betamethasone Dipropionate Lotion USP 0.05% (Augmented) contains
betamethasone dipropionate,
USP, a synthetic adrenocorticosteroid, for dermatologic use.
Betamethasone, an analog of
prednisolone, has a high degree of corticosteroid activity and a
slight degree of mineralocorticoid
activity. Betamethasone dipropionate is the 17, 21-dipropionate ester
of betamethasone.
Chemically, betamethasone dipropionate is 9-fluoro-11β,
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:
It is a white to creamy-white, odorless powder insoluble in water;
freely soluble in acetone and in
chloroform; sparingly soluble in alcohol.
Each gram of Betamethasone Dipropionate Lotion USP 0.05% (Augmented)
contains 0.643 mg
betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone),
in an augmented lotion base of
purified water; isopropyl alcohol (30%); hydroxypropyl cellulose;
propylene glycol; monobasic
sodium phosphate and phosphoric acid used to adjust the pH.
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
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