HALOBETASOL PROPIONATE ointment
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
29-01-2020
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Active ingredient:
Halobetasol Propionate (UNII: 91A0K1TY3Z) (Halobetasol - UNII:9P6159HM7T)
Available from:
Taro Pharmaceuticals U.S.A., 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 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 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 5 g physician samples (tubes only - NDC 51672-1322-5), 15 g (NDC 51672-1322-1) and 50 g (NDC 51672-1322-3) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
HALOBETASOL PROPIONATE- HALOBETASOL PROPIONATE OINTMENT
TARO PHARMACEUTICALS U.S.A., INC.
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HALOBETASOL PROPIONATE
OINTMENT, 0.05%
RX ONLY
FOR DERMATOLOGICAL USE ONLY
NOT FOR OPHTHALMIC USE.
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 antiinflammatory 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 contains 0.5 mg/g of
halobetasol propionate in a base of
aluminium stearate, pentaerythritol cocoate, propylene glycol,
sorbitan sesquioleate, stearyl citrate,
white petrolatum and white wax.
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 enhances
penet
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