Halobetasol Propionate
Generic Name: halobetasol propionate
Brand Names:
Lexette
11 DESCRIPTION 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 C 25 H 31 ClF 2 O 5 .
Overview
11 DESCRIPTION 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 C 25 H 31 ClF 2 O 5 .
Uses
1 INDICATIONS AND USAGE LEXETTE ® is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. LEXETTE is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients twelve (12) years of age and older. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Shake can prior to use and turn can completely upside down to dispense. 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-pituitary-adrenal (HPA) axis [see Warnings and Precautions ( 5.1 )] . Do not use with occlusive dressings unless directed by a physician. Avoid use on the face, groin, or axillae. Avoid contact with eyes.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects [see Warnings and Precautions ( 5.1 )] • Allergic Contact Dermatitis [see Warnings and Precautions ( 5.5 )] The most commonly reported adverse reactions (≥1%) are application site pain and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
5 WARNINGS AND PRECAUTIONS • Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. ( 5.1 ) • Systemic effects following prolonged exposure of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. ( 5.1 ) • Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure. ( 5.1 ) • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) • Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis. 4 CONTRAINDICATIONS None. None.
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on LEXETTE use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of LEXETTE [see Clinical Pharmacology ( 12.3 )] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied LEXETTE (halobetasol propionate) topical foam, 0.05% is a white to off-white foam. It is supplied in aluminum cans of: 50 grams (NDC 51862-618-50) 16.2 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.
Frequently Asked Questions
What is Halobetasol Propionate used for?▼
1 INDICATIONS AND USAGE LEXETTE ® is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. LEXETTE is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients twelve (12) years of age and older. ( 1 )
What are the side effects of Halobetasol Propionate?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects [see Warnings and Precautions ( 5.1 )] • Allergic Contact Dermatitis [see Warnings and Precautions ( 5.5 )] The most commonly reported adverse reactions (≥1%) are application site pain and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Halobetasol Propionate during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on LEXETTE use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of LEXETTE [see Clinical Pharmacology ( 12.3 )] .
What are the important warnings for Halobetasol Propionate?▼
5 WARNINGS AND PRECAUTIONS • Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. ( 5.1 ) • Systemic effects following prolonged exposure of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. ( 5.1 ) • Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure. ( 5.1 ) • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) • Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis. 4 CONTRAINDICATIONS None. None.
Related Medications
5-amino-1-methylquinolinium Chloride
5-amino-1-methylquinolinium chloride
Dosage form: POWDER. Active ingredients: 5-AMINO-1-METHYLQUINOLINIUM CHLORIDE (100 g/100g). Category: BULK INGREDIENT.
American Elm
american elm
Dosage form: INJECTION, SOLUTION. Route: PERCUTANEOUS. Active ingredients: ULMUS AMERICANA POLLEN (.05 g/mL). Category: BLA.
Eucalyptus Oil
eucalyptus oil
Dosage form: LIQUID. Active ingredients: EUCALYPTUS OIL (1 kg/kg). Category: BULK INGREDIENT.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.