CLOBETASOL PROPIONATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Torrent Pharmaceuticals Limited

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clobetasol propionate cream USP is super-high potency corticosteroid formulation 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 is 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 (NDC 13668-569-01), 30-g (NDC 13668-569-02), 45-g (NDC 13668-569-04) and 60-g (NDC 13668-569-05) tubes. Store between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature]. Do not refrigerate. Manufactured by: TORRENT PHARMACEUTICALS LTD., Pithampur-454775, INDIA. Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920 August 2022                                                                  RL-no. 8088990

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
TORRENT PHARMACEUTICALS LIMITED
----------
CLOBETASOL PROPIONATE CREAM USP, 0.05%
FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE
PRODUCT INFORMATION
DESCRIPTION
Clobetasol propionate cream, USP contains 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 empirical formula C
H
ClFO
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 of
cetyl alcohol, citric acid anhydrous, glycol stearate, lanolin oil,
methylparaben, polyoxyl 8
stearate, polysorbate 60, propylene glycol, propylparaben, purified
water, sodium
citrate, stearyl alcohol, and white petrolatum (white soft paraffin).
Sodium hydroxide
may be used to adjust pH.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, clobetasol propionate has
anti-inflammatory,
25
32
5
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, 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 th