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.

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 the following tube sizes: 15 g (NDC 0713-0758-15) 50 g (NDC 0713-0758-86) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured for: Cosette Pharmaceuticals, Inc. 111 Coolidge Street, South Plainfield, NJ 07080 GW 7304 Rev. 08/2019 8-0758ALMLNC2

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 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 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, propylene
glycol, sorbitan sesquioleate, stearyl citrate, and white petrolatum.
CLINICAL PHARMACOLOGY
25
31
2
5
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 pene