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:

Rebel Distributors Corp

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 hypothalamicpituitary- 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 42254-153-15) and 30-g tubes (NDC 42254-153-30). Clobetasol Propionate Ointment, USP, 0.05% is supplied in 45-g tubes (NDC 42254-174-45). 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 Distributed by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 267/268:00 10/09 129159-1009 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
REBEL DISTRIBUTORS CORP
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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
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
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the release of their common