Finished product reference

Clobetasol Propionate

Shampoo · Topical · 0.05 % · 150 mL

List code
53669

What it is and how it works

Mechanism of Action Like other topical corticosteroids, clobetasol propionate shampoo, 0.05%, 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 2 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 2 .

Indications

Clobetasol propionate shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older . Limitations of Use: Do not use on the face, axillae or groin. Avoid any contact with the eyes and lips. Indication Clobetasol propionate shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week. Patients should be instructed to use clobetasol propionate shampoo, 0.05%, for the minimum time period necessary to achieve the desired results . Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression . Limitations of Use Clobetasol propionate shampoo, 0.05%, should not be used on the face, groin or axillae. Avoid any contact of the drug product with the eyes and lips.

Dosage and administration (summary)

Clobetasol propionate shampoo, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use. Clobetasol propionate shampoo, 0.05%, should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week. Move the hair away from the scalp so that one of the affected areas is exposed. Position the bottle over the lesion.

Contraindications

None None

Warnings and precautions

Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis at the lowest doses tested. Cushing's syndrome, hyperglycemia and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. Children may be more susceptible to systemic toxicity from use of topical corticosteroids.

Pregnancy

Pregnancy Teratogenic effects : There are no adequate and well-controlled studies in pregnant women. Therefore, clobetasol propionate shampoo, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Storage and supply

Storage: Keep tightly closed. Store 20° to 25°C (68° to 77°F) .

Source: Clobetasol Propionate (Clobetasol Propionate) — US FDA prescribing information, 2025-07-07, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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