CLOBETASOL PROPIONATE cream CLOBETASOL PROPIONATE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Available from:

Akorn

INN (International Name):

CLOBETASOL PROPIONATE

Composition:

CLOBETASOL PROPIONATE 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clobetasol propionate cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 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 pediatric patients 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. Clobetasol Propionate Cream and Ointment, USP, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Product summary:

Clobetasol Propionate Cream, USP, 0.05% is supplied in 15-g tubes (NDC 50383-267-15), 30-g tubes (NDC 50383-267-30), 45-g tubes (NDC 50383-267-45), and 60-g tubes (NDC 50383-267-60). Clobetasol Propionate Ointment, USP, 0.05% is supplied in 15-g tubes (NDC 50383-268-15), 30-g tubes (NDC 50383-268-30), 45-g tubes (NDC 50383-268-45), and 60-g tubes (NDC 50383-268-60). Store cream between 15° and 30° C (59° and 86° F). Store ointment at controlled room temperature 20°-25° C (68°-77° F). Clobetasol propionate cream and ointment should not be refrigerated. Rx only Rev. 267/268:05 09/22 Distributed by: Akorn Operating Company LLC Gurnee, IL 60031

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
AKORN
----------
CLOBETASOL PROPIONATE CREAM, USP, 0.05% CLOBETASOL PROPIONATE
OINTMENT,
USP, 0.05%
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE.
DESCRIPTION
Clobetasol Propionate Cream and Ointment USP, 0.05% contain the active
compound
clobetasol propionate, a synthetic corticosteroid, for topical
dermatologic use.
Clobetasol, an analog of prednisolone, has a high degree of
glucocorticoid activity and a
slight degree of mineralocorticoid activity.
Chemically, clobetasol propionate is
(11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-
methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the
following
structural formula:
Clobetasol propionate has the molecular formula C
H
CIFO and a molecular weight of
467. It is a white to cream-colored crystalline powder insoluble in
water.
Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in
a cream base
composed of cetyl alcohol, citric acid, glycol stearate, lanolin oil,
methylparaben, PEG-8
stearate, polysorbate 60, propylene glycol, propylparaben, purified
water, sodium
citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may
be used to adjust
pH.
Clobetasol propionate ointment contains clobetasol propionate 0.5 mg/g
in an ointment
base composed of propylene glycol, sorbitan sesquioleate, and white
petrolatum.
CLINICAL PHARMACOLOGY
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32
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Like other topical corticosteroids, clobetasol propionate has
anti-inflammatory,
antipruritic, and vasoconstrictive properties. The mechanism of the
anti-inflammatory
activity of the topical steroids, 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, arachido