CLOBETASOL PROPIONATE solution

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

থেকে পাওয়া:

Lupin Pharmaceuticals,Inc.

INN (International Name):

CLOBETASOL PROPIONATE

রচনা:

CLOBETASOL PROPIONATE 0.5 mg in 1 mL

প্রশাসন রুট:

TOPICAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Clobetasol propionate topical solution, USP is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age. Clobetasol propionate topical solution is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.

পণ্য সারাংশ:

Clobetasol propionate topical solution USP, 0.05 % is supplied in plastic squeeze bottles, 25mL (NDC 43386-028-61) 50mL (NDC 43386-028-60) Store at 20o to  25o C (68o to 77o F) [see USP Controlled Room Temperature]. Do not refrigerate.   Do not use near an open flame.   Rx only Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) 454775, INDIA ID# 253308 September 2017

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE SOLUTION
LUPIN PHARMACEUTICALS,INC.
----------
CLOBETASOL PROPIONATE TOPICAL SOLUTION USP, 0.05%
(SCALP APPLICATION)
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE
DESCRIPTION
Clobetasol propionate topical solution USP, 0.05% contains the active
compound
clobetasol propionate, a synthetic corticosteroid, for topical
dermatologic use.
Clobetasol, an analog of prednisolone, has a high degree of
glucocorticoid activity and a
slight degree of mineralocorticoid activity.
Chemically, clobetasol propionate is
(11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-
methyl-17-(1-oxopropoxy)pregna-1, 4-diene-3,20-dione, and it has the
following
structural formula:
Clobetasol propionate has the molecular formula C
H
CIFO and a molecular weight of
467. It is a white to almost white colored crystalline powder
insoluble in water.
Clobetasol propionate topical solution, USP contains clobetasol
propionate 0.5 mg/g in a
base of purified water, isopropyl alcohol (39.3%), carbomer 934P and
sodium
hydroxide.
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 clobetasol propionate are effective in the
treatment of
corticosteroid-responsive dermatoses primarily because of their
anti-inflammatory,
antipruritic, and vasoconstrictive actions. However, while the
physiologic,
25
32
5
pharmacologic, and clinical effects of the corticosteroids are well
known, the exact
mechanisms of their actions in each disease are uncertain.
Clobetasol propionate, 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,
including clobetasol
propionate,