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:

Cosette Pharmaceuticals, Inc.

INN (International Name):

Halobetasol Propionate

Composition:

Halobetasol Propionate .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 thefollowing tube sizes: 15 g (NDC 0713-0640-15) 50 g (NDC 0713-0640-86) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0640CPLNC2 Rev. 08/2022     VC7645

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HALOBETASOL PROPIONATE- HALOBETASOL PROPIONATE CREAM
COSETTE PHARMACEUTICALS, INC.
----------
HALOBETASOL PROPIONATE CREAM, 0.05%
FOR DERMATOLOGICAL 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
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 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
25
31
2
5
2
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 hydrocortison