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:

Padagis Israel Pharmaceuticals Ltd

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 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 cream, 0.05% 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 45802-129 -35) and 50 g (NDC 45802-129 -32) Store at 20-25°C (68-77°F) (See USP Controlled Room Temperature).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HALOBETASOL PROPIONATE- HALOBETASOL PROPIONATE CREAM
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
HALOBETASOL PROPIONATE CREAM, 0.05%
For Dermatologic 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
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 cream, 0.05% contains 0.5 mg of
halobetasol
propionate in a cream base of cetyl alcohol, diazolidinyl urea,
glycerin, isopropyl
isostearate, isopropyl palmitate, methylchloroisothiazolinone, (and)
25
31
2
5
methylisothiazolinone, steareth-21 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 hydroc