LEXETTE™ (halobetasol propionate) topical foam

LEXETTE (halobetasol propionate) topical foam

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LEXETTE™ (halobetasol propionate) topical foam

LEXETTE is a hydroethanolic aerosol foam that contains a corticosteroid, halobetasol propionate. The chemical name of halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of C25H31ClF2O5.

It is practically insoluble in water and freely soluble in dichloromethane and in acetone. Each gram of LEXETTE contains 0.5 mg of halobetasol propionate in a white to off-white foam base consisting of alcohol (specially denatured alcohol [SDA]), benzoic acid, cetostearyl alcohol, emulsifying wax, polyoxyl 20 cetostearyl ether, propylene glycol and purified water. LEXETTE is dispensed from an aluminum can pressurized with a hydrocarbon (isobutane and propane) propellant.

Indications and usage

LEXETTE™ is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.

Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.

Dosage and administration

Shake can prior to use. Apply LEXETTE as a thin uniform film to the affected skin twice daily for up to two weeks. Rub in gently. Wash hands after applying the product.

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

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

Avoid use on the face, groin, or axillae.

Avoid contact with eyes. Wash hands after each application, unless it is for treatment of the hands.

LEXETTE is for topical use only.

LEXETTE is not for ophthalmic, oral, or intravaginal use.

Dosage forms and strengths

LEXETTE™ (halobetasol propionate) topical foam is a white to off-white topical foam. Each gram of LEXETTE, 0.05% contains 0.5 mg of halobetasol propionate.

Contraindications: None

Warnings and precautions

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects: LEXETTE is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitaryadrenal (HPA) axis.

Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment of the topical corticosteroid.

Local Adverse Reactions: Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including LEXETTE. Some local adverse reactions may be irreversible.

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Ophthalmic Adverse Reactions: Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products.

Concomitant Skin Infections: Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of LEXETTE until the infection has been adequately treated.

Allergic Contact Dermatitis: Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Consider confirmation of a clinical diagnosis of allergic contact dermatitis by appropriate patch testing. Discontinue LEXETTE if allergic contact dermatitis is established.

Flammability: LEXETTE is flammable. Avoid fire, flame, or smoking during and immediately following application.

Adverse reactions

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

Use in specific populations

Pregnancy: There are no available data on LEXETTE use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.

Lactation: There are no data on the presence of halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LEXETTE and any potential adverse effects on the breastfed infant from LEXETTE or from the underlying maternal condition.

Advise breastfeeding women not to apply LEXETTE directly to the nipple and/or areola to avoid direct infant exposure

Pediatric Use: Safety and effectiveness of LEXETTE in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended

Geriatric Use: Clinical studies with LEXETTE included 131 patients aged 65 years and over. No overall differences in safety or effectiveness were observed between these patients and those younger than 65 years.

Overdosage

Topically applied LEXETTE can be absorbed in sufficient amounts to produce systemic effects

Storage

Store at 20°-25°C (68°-77°F); excursions permitted to 15ºC and 30ºC (59ºF to 86ºF). Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Do not freeze.

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