|
TOP
|
|
ENSTILAR ® (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ENSTILAR ® Foam safely and effectively. See Full Prescribing Information for ENSTILAR ® Foam.
ENSTILAR ® (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% for topical use
Initial U.S. Approval: 2006
INDICATIONS AND USAGE
Enstilar® Foam is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. (1)
DOSAGE AND ADMINISTRATION
-
Shake before use. (2)
-
Apply Enstilar® Foam to affected area(s) once daily for up to 4 weeks. Discontinue therapy when control is achieved. (2)
-
Do not use more than 60 g every 4 days. (2)
-
Do not use with occlusive dressings unless directed by a physician. (2)
-
Not for oral, ophthalmic, or intravaginal use. (2)
-
Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. (2)
DOSAGE FORMS AND STRENGTHS
Foam, 0.005%/0.064%
Each gram of Enstilar® Foam contains 52.2 mcg calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone). (3)
WARNINGS AND PRECAUTIONS
-
The propellants in Enstilar® Foam are flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. (5.1)
-
Hypercalcemia and hypercalciuria have been observed with use of Enstilar® Foam. If hypercalcaemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. (5.2)
-
Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroids, use over a large surface area or on areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. (5.3, 8.4)
ADVERSE REACTIONS
Adverse reactions reported in < 1% of subjects included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerabation of psoriasis. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
| |
