Halobetasol Propionate Lotion 0.05%

SUMMARY

Halobetasol is a lipocortin corticosteroid used to treat inflammatory and pruritic corticosteroid responsive dermatoses.

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

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 {see Warnings and Precautions 5.1].Do not use with occlusive dressings unless directed by a physician.

Halobetasol Propionate Lotion 0.05% is for external use only.

Avoid use on the face, scalp, groin, or axillae.

Halobetasol Propionate Lotion 0.05% is 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 with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis. Adverse reactions may be more likely to occur 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 tor 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 Coral Way Pharma, LLC at 1-888-403-8874 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT CONSELING INFORMATION

HOW SUPPLIED / STORAGE AND HANDLING

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

• 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.

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Full Prescribing Information: DailyMed

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