HALOBETASOL PROPIONATE- 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:

E. FOUGERA & CO., A division of Fougera Pharmaceuticals 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 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 corticosteroid, 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 ointment 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: Store at 20°-25°C (68°-77°F), with excursions permitted between 15°-30°C (59°-86°F). E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I2356B R1/12 #86

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HALOBETASOL PROPIONATE- HALOBETASOL PROPIONATE OINTMENT
E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.
----------
HALOBETASOL PROPIONATE OINTMENT, 0.05%
Rx Only
FOR DERMATOLOGICAL USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION
Halobetasol propionate ointment 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 CIF 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 contains 0.5 mg/g
of halobetasol propionate in a
base of aluminum stearate, beeswax, pentaerythritol cocoate,
petrolatum, propylene glycol, sorbitan
sesquioleate, and stearyl citrate.
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 markedly enha