HALOBETASOL PROPIONATE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

Halobetasol Propionate

Composition:

Halobetasol Propionate 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Halobetasol propionate ointment, 0.05% is a super-high potency corticosteroid indictated 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. Halobetasol propionate ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Product summary:

Halobetasol propionate ointment, 0.05% is supplied in the following tube sizes: 15 g (NDC 45802-131-35) and 50 g (NDC 45802-131-32) Store between 15°C and 30°C (59°F and 86°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HALOBETASOL PROPIONATE - HALOBETASOL PROPIONATE OINTMENT
H.J. HARKINS COMPANY, INC.
----------
HALOBETASOL PROPIONATE OINTMENT, 0.05%
For Dermatologic Use Only. Not for Ophthalmic Use.
_RX ONLY_
DESCRIPTION
Halobetasol propionate ointment, 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 ointment, 0.05% contains 0.5 mg of
halobetasol propionate in a
base of aluminum stearate, beeswax, pentaerythritol cocoate, stearyl
citrate, petrolatum, propylene
glycol and sorbitan sesquioleate.
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
25
31
2
5
2
2
hydrocortisone for up to 24 hours have not been demonstrated to
increase penetration; however,
occlusion of hydrocortisone for 96 hours markedly enhance