Halobetasol Propionate Lotion 0.05%

SUMMARY

Halobetasol is a highly potent corticosteroid, structurally related to clobetasol, used to treat inflammatory and pruritic corticosteroid-responsive dermatoses. Due to its high potency, it is mainly prescribed in the treatment of severe plaque psoriasis.

INDICATIONS & USAGE

Halobetasol Propionate Lotion 0.05% is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.

DOSAGE AND ADMINISTRATION

Apply a thin layer of Halobetasol Propionate Lotion 0.05% to the affected skin twice daily for up to two weeks. Rub in gently.

Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary.

Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams (50 mL) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Do not use with occlusive dressings unless directed by a physician.

For external use only. Avoid use on the face, scalp, groin, or axillae. Not for ophthalmic, oral, or intravaginal use.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. Systemic absorption may require evaluation for HPA axis suppression.
• Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure.
• Children may be more susceptible to systemic toxicity when treated with topical corticosteroids.
• Local adverse reactions may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis, and may be more likely with occlusive use or more potent corticosteroids.
• Topical corticosteroids may increase the risk of cataract and glaucoma formation. If visual symptoms occur, consider referral to an ophthalmologist for evaluation.
• Initiate appropriate therapy if concomitant skin infections develop.

ADVERSE REACTIONS

The most commonly reported adverse reactions (≥1%) are telangiectasia, application site atrophy, and headache.

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

HOW SUPPLIED / STORAGE AND HANDLING

Halobetasol Propionate Lotion 0.05% is a white to off-white lotion supplied in an oval tapered white high-density polyethylene bottle with a white polypropylene disc cap. Each bottle contains 60 mL (59 g).

• NDC 85437-008-60 — 60 mL (59 g) bottle

Store at 25°C (77°F); excursions permitted to 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

Full Prescribing Information: DailyMed