HALOBETASOL PROPIONATE cream

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

Halobetasol Propionate (UNII: 91A0K1TY3Z) (Halobetasol - UNII:9P6159HM7T)

Dostępny od:

Rebel Distributors Corp

INN (International Nazwa):

Halobetasol Propionate

Skład:

Halobetasol Propionate 0.5 mg in 1 g

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Halobetasol Propionate Cream, 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two 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 children 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. Halobetasol Propionate Cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Podsumowanie produktu:

Halobetasol Propionate Cream, 0.05% is supplied in thefollowing tube sizes: 15 g (NDC 42254-250-15) Store between 15°C and 30°C (59°F and 86°F).

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

HALOBETASOL PROPIONATE- HALOBETASOL PROPIONATE CREAM
REBEL DISTRIBUTORS CORP
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HALOBETASOL PROPIONATE CREAM, 0.05%
FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC USE.
RX ONLY
DESCRIPTION
Halobetasol Propionate Cream, 0.05% contains halobetasol propionate, a
synthetic corticosteroid for
topical dermatological use. The corticosteroids constitute a class of
primarily synthetic steroids used
topically as an anti-inflammatory and antipruritic agent.
Chemically halobetasol propionate is 21-chloro-6α, 9-difluoro-11β,
17-dihydroxy-16β -methylpregna-
1, 4-diene-3-20-dione, 17-propionate, C
H ClF O . It has the following structural formula:
Halobetasol propionate has the molecular weight of 485. It is a white
crystalline powder insoluble in
water.
Each gram of Halobetasol Propionate Cream contains 0.5 mg/g of
halobetasol propionate in a cream
base of cetyl alcohol, glycerin, isopropyl isostearate, isopropyl
palmitate, steareth-21, diazolidinyl
urea, methylchloroisothiazolinone,(and) methylisothiazolinone and
water.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, halobetasol propionate has
anti-inflammatory, antipruritic and
vasoconstrictive actions. The mechanism of the anti-inflammatory
activity of the topical corticosteroids,
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 dressings with
hydrocortisone for up to 24 hours have not been demonstrated to
increase penetration; however,
occlusion of hydrocortisone for 96 hours mark