CLOBETASOL PROPIONATE ointment

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Clobetasol Propionate (UNII: 779619577M) (Clobetasol - UNII:ADN79D536H)

Dostupno od:

Teligent Pharma, Inc.

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Clobetasol Propionate Ointment USP, 0.05% is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Clobetasol Propionate Ointment USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Proizvod sažetak:

Clobetasol Propionate Ointment USP, 0.05% is supplied in: 15 gram tubes (NDC 52565-039-15), 30 gram tubes (NDC 52565-039-30), 45 gram tubes (NDC 52565-039-45), and 60 gram tubes (NDC 52565-039-60). Store at 20° to 25°C (68° to 77 °F) excursions permitted between  15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 PI-039-00 Rev. 07/2016

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
TELIGENT PHARMA, INC.
----------
CLOBETASOL PROPIONATE OINTMENT USP, 0.05%
FOR TOPICAL DERMATOLOGIC USE ONLY—
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
RX ONLY
DESCRIPTION
Clobetasol Propionate Ointment USP, 0.05% contain 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
(11ß,16ß)-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 cream-colored crystalline powder insoluble in water.
Clobetasol Propionate Ointment USP, 0.05% contains clobetasol
propionate 0.5 mg/g in a base of
propylene glycol, sorbitan sesquioleate, and white petrolatum.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, clobetasol propionate has
anti-inflammatory, antipruritic, and
vasoconstrictive properties. The mechanism of the anti-inflammatory
activity of the topical steroids, in
general, is unclear. However, corticosteroids are thought to act by
the induction of phospholipase A
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the
biosynthesis of potent mediators of inflammation such as
prostaglandins and leukotrienes by inhibiting
the release of their common precursor, arachidonic acid. Arachidonic
acid is released from membrane
phospholipids by phospholipase A .
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many factors,
including the vehicle and the integrity of the epidermal barrier.
Occlusive dressing with hydrocortisone
for up to 24 hours has not been demonstrated to increase penetration;
however, occlusion of
hydrocortisone for 96 hours markedly enhances penetrat