BETAMETHASONE VALERATE lotion

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M)

थमां उपलब्ध:

STI Pharma LLC

INN (इंटरनेशनल नाम):

Betamethasone Valerate

रचना:

Betamethasone Valerate 1.0 mg in 1 mL

प्रशासन का मार्ग:

CUTANEOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

उत्पाद समीक्षा:

Betamethasone Valerate Lotion USP, 0.1% is supplied as follows: 60ml bottles NDC 54879-004-60 Shake well before using. Store at controlled room temperature 15° - 30°C (59° - 86°F). To report SUSPECTED ADVERSE REACTIONS, contact STI Pharma,LLC at 1-888-301-9680 or FDA at 1-800-FDA-1088 or ww.fda.gov/medwatch Manufactured for : STI Pharma LLC Newtown, PA 18940

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

BETAMETHASONE VALERATE- BETAMETHASONE VALERATE LOTION
STI PHARMA LLC
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BETAMETHASONE VALERATE LOTION USP 0.1%
(POTENCY EXPRESSED AS BETAMETHASONE)
RX ONLY
FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE
DESCRIPTION:
Betamethasone Valerate Lotion contains betamethasone valerate USP, a
synthetic
adrenocortico-steroid for dermatologic use. Betamethasone, an analog
of prednisolone,
has a high degree of glucocorticoid activity and a slight degree of
mineralocorticoid
activity.
Betamethasone valerate is a white to practically white odorless
crystalline powder
practically insoluble in water, freely soluble in acetone and
chloroform, soluble in alcohol,
and slightly soluble in benzene and ether. Chemically, it is
9-fluoro-11β,17,21-trihydroxy-
16β-methylpregna-1,4-diene-3,20-dione 17-valerate. The structural
formula is:
Each gram of the 0.1% Lotion contains 1.2 mg of betamethasone valerate
(equivalent to
1 mg betamethasone) in a vehicle of isopropyl alcohol and water
slightly thickened with
carbomer 934P. Phosphoric acid or sodium hydroxide is used to adjust
the pH.
CLINICAL PHARMACOLOGY:
Topical corticosteroids share anti-inflammatory, anti-pruritic, and
vasoconstrictive
actions.
The mechanism of anti-inflammatory activity of the topical
corticosteroids is unclear.
Various laboratory methods, including vasoconstrictor assays, are used
to compare and
predict potencies and/or clinical efficacies of the topical
corticosteroids. There is some
evidence to suggest that a recognizable correlation exists between
vasoconstrictor
potency and therapeutic efficacy in man.
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 dressings.
Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or
other disease processes in the skin increase percutaneous absorption.
Occlusive
dressings substantially increase the percutaneous absorption of
topical cortico