BETAMETHASONE DIPROPIONATE lotion

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Cosette Pharmaceuticals, Inc.

INN (Medzinárodný Name):

Betamethasone Dipropionate

Zloženie:

Betamethasone 0.5 mg in 1 mL

Spôsob podávania:

TOPICAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Prehľad produktov:

Betamethasone Dipropionate Lotion, USP 0.05% is supplied as follows: 60 mL bottles (NDC 0713-0807-53) Shake well before using. Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Iss. 03/2021 8-0807CPLNC1         VC7520

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE LOTION
COSETTE PHARMACEUTICALS, INC.
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BETAMETHASONE DIPROPIONATE LOTION, USP 0.05%
(POTENCY EXPRESSED AS BETAMETHASONE)
RX ONLY
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Betamethasone Dipropionate Lotion, USP 0.05% contains betamethasone
dipropionate
USP, a synthetic adrenocorticosteroid, for dermatologic use.
Betamethasone, an analog
of prednisolone, has a high degree of glucocorticoid activity and a
slight degree of
mineralocorticoid activity.
Betamethasone dipropionate is a white to cream white odorless
crystalline powder
insoluble in water. Chemically, it is
9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-
diene-3,20-dione 17,21-dipropionate. The structural formula is:
Molecular Formula: C
H
FO
Molecular Weight: 504.60
Each gram contains 0.64 mg betamethasone dipropionate (equivalent to
0.5 mg
betamethasone) in a vehicle of isopropyl alcohol and purified water
slightly thickened
with carbomer 974P. Sodium hydroxide solution to adjust pH, if
required.
CLINICAL PHARMACOLOGY:
Topical corticosteroids share anti-inflammatory, antipruritic and
vasoconstrictive actions.
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37
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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 corticosteroids
(See DOSAGE