BETAMETHASONE DIPROPIONATE AUGMENTED- betamethasone dipropionate lotion

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Physicians Total Care, Inc.

INN (Tên quốc tế):

betamethasone dipropionate

Thành phần:

betamethasone dipropionate 0.64 mg in 1 mL

Tuyến hành chính:

TOPICAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

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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