enstilar
Enstilar is a combination medicine containing Betamethasone Dipropionate and Calcipotriene.
Betamethasone Dipropionate and Calcipotriene · by Leo Pharma As
Available as a generic: Calcipotriene and Betamethasone Dipropionate
Key facts
- Active ingredient
- Betamethasone Dipropionate and Calcipotriene
- Form
- Spray/Inhaler, Topical
- Strength
- Betamethasone Dipropionate 0.064%; Calcipotriene 0.005%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Leo Pharma As
- FDA application
- NDA207589
What is Enstilar?
From the FDA label:Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only. Calcipotriene Hydrate Calcipotriene hydrate is a synthetic vitamin D analog and has the chemical name 9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol,24-cyclo-propyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C 27 H 40 O 3 ∙H 2 O), a molecular weight of 430.6, and the following structural formula (calcipotriene hydrate is a white to almost white, crystalline compound): Chemical Structure Betamethasone Dipropionate Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11β,16β), with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder): Chemical Structure Enstilar ® Foam Each gram of Enstilar Foam contains 50 mcg of calcipotriene (equivalent to 52.2 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of white petrolatum, polyoxypropylene stearyl ether, mineral oil, all- rac -alpha-tocopherol, and butylhydroxytoluene. Enstilar Foam is a white to off-white opalescent liquid in a pressurized aluminum spray can with a continuous valve and actuator. The…
How to use
Enstilar is sold in more than one form (Spray/Inhaler and Topical), and each is dosed differently. The instructions below come from the FDA label for application NDA207589 — follow the label that came with the product you were actually prescribed.
Shake can prior to using Enstilar Foam. Apply Enstilar Foam to affected areas once daily for up to 4 weeks. The maximum dose should not exceed 60 grams every 4 days. Rub in Enstilar Foam gently. Wash hands after applying the product. Discontinue Enstilar Foam when control is achieved. Enstilar Foam should not be used: with occlusive dressings unless directed by a healthcare provider. on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Enstilar Foam is not for oral, ophthalmic, or intravaginal use. Shake before use. Apply Enstilar Foam to affected area(s) once daily for up to 4 weeks. Discontinue therapy when control is achieved. Do not use more than 60 grams every 4 days. ( 2 ) Do not use with occlusive dressings unless directed by a healthcare provider. ( 2 ) Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )
Side effects
Adverse reactions reported in < 1% of subjects included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Conducted in Subjects 18 years and older with Psoriasis The rates of adverse reactions described below were from three randomized, multicenter, vehicle and/or active-controlled clinical trials in adult subjects with plaque psoriasis [see Clinical Studies (14) ] . Subjects applied study product once daily for 4 weeks, and the median weekly dose of Enstilar Foam was 25 grams. Adverse reactions reported in <1% of adult subjects treated with Enstilar Foam included: application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis. Clinical Trials Conducted in Subjects 12 to 17 years with Psoriasis In one uncontrolled clinical trial, 106 subjects aged 12 to…
Warnings
Important safety information
Flammability: 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: Hypercalcemia and hypercalciuria have been observed with use of Enstilar Foam. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. ( 5.2 ) Effects on Endocrine System: 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 ) Ophthalmic Adverse Reactions: Topical corticosteroid products may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.5 ) 5.1 Flammability The propellants in Enstilar Foam are flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. 5.2 Hypercalcemia and Hypercalciuria Hypercalcemia and hypercalciuria have been observed with use of Enstilar Foam. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. The incidence of hypercalcemia and hypercalciuria following Enstilar Foam treatment of more than 56 weeks has not been evaluated [ s ee Clinical Pharmacology (12.2) ]. 5.3 Effects on Endocrine System Hypothalamic-Pituitary-Adrenal Axis Suppression Systemic absorption of topical corticosteroids can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. If HPA axis suppression is documented, gradually withdraw Enstilar Foam, reduce the frequency of application, or substitute with a less potent corticosteroid. The following trials evaluated the effects of Enstilar Foam on HPA axis suppression [ see Clinical Pharmacology (12.2) ]: In a trial evaluating the effects of Enstilar Foam on the HPA axis, 35 adult subjects applied Enstilar Foam on the body and scalp. Adrenal suppression was not observed in any subjects after 4 weeks of treatment. In another trial, 33 adolescent subjects age 12 to 17 years applied Enstilar Foam on the body and scalp. Adrenal suppression occurred in 3 (9%) of the subjects. In a trial, 21 subjects aged 18 years and older with plaque psoriasis applied Enstilar Foam once daily for 4 weeks and then twice weekly on 2 non-consecutive days for 52 weeks, including once daily for 4 weeks if loss of response occurred. Adrenal suppression was observed in 2 (10%) of the subjects. Cushing's Syndrome and Hyperglycemia Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. Additional Considerations for Endocrine Adverse Reactions Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) ] . Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. 5.4 Allergic Contact Dermatitis Allergic contact dermatitis has been observed with topical calcipotriene and topical corticosteroids. Allergic contact dermatitis to a topical corticosteroid is usually diagnosed by observing a failure to heal rather than a clinical exacerbation. Corroborate such an observation with appropriate diagnostic patch testing. 5.5 Ophthalmic Adverse Reactions Use of topical corticosteroids, including Enstilar ® Foam, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported with the postmarketing use of topical corticosteroid products. Avoid contact with Enstilar Foam with eyes. Enstilar Foam may cause eye irritation. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation .
Who should not take Enstilar
None. None. ( 4 )
Dosage forms
Spray/Inhaler and Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- Is there a coupon or discount for Enstilar?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Enstilar. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Enstilar?
- Enstilar is marketed by Leo Pharma As. You can see Leo Pharma As's full profile, rating, and other products on pharmaranks.
- Is Enstilar a brand-name or generic drug?
- Enstilar is a brand-name product with the active ingredient Betamethasone Dipropionate and Calcipotriene. Lower-cost generic equivalents containing Betamethasone Dipropionate and Calcipotriene are available — ask your pharmacist.
- Is Enstilar available over the counter?
- No. Enstilar is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Enstilar come in?
- Enstilar is currently marketed as spray/inhaler and topical, per the FDA's National Drug Code Directory.
- Is Enstilar FDA-registered?
- Enstilar is on record with the U.S. FDA under application number NDA207589. You can verify this on its official FDA label.
- Is Enstilar safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Enstilar. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Enstilar?
- Enstilar's side effects are taken directly from its FDA label. From the label: Adverse reactions reported in < 1% of subjects included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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