HALOBETASOL PROPIONATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HALOBETASOL PROPIONATE (UNII: 91A0K1TY3Z) (HALOBETASOL - UNII:9P6159HM7T)

Available from:

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 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.

Product summary:

Halobetasol Propionate Cream, 0.05% is supplied in the following tube sizes:  15 g NDC 0168-0355-15  50 g NDC 0168-0355-50 Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 46254615A R 01/2020 #49

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HALOBETASOL PROPIONATE- HALOBETASOL PROPIONATE CREAM
FOUGERA PHARMACEUTICALS INC.
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HALOBETASOL PROPIONATE CREAM, 0.05%
Rx Only
FOR DERMATOLOGICAL USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION
Halobetasol Propionate Cream, 0.05% contains halobetasol propionate,
USP 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, USP 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