Calcipotriene and betamethasone dipropionate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Allison Tu [2]
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Overview
Calcipotriene and betamethasone dipropionate is a combination of a vitamin D analog and a corticosteroid that is FDA approved for the treatment of plaque psoriasis in patients 18 years of age and older. Common adverse reactions include tingling of skin, burning sensation, stinging sensation, and skin rash.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Enstilar Foam is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. Dosing Information
- Apply Enstilar Foam to affected areas once daily for up to 4 weeks. Rub in Enstilar Foam gently. Discontinue use when control is achieved.
- Instruct patients not to use more than 60 g every 4 days.
- Enstilar Foam should not be used with occlusive dressings unless directed by a physician. Enstilar Foam is not for oral, ophthalmic, or intravaginal use.
- Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Calcipotriene and betamethasone dipropionate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcipotriene and betamethasone dipropionate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Calcipotriene and betamethasone dipropionate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Calcipotriene and betamethasone dipropionate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcipotriene and betamethasone dipropionate in pediatric patients.
Contraindications
There is limited information regarding Calcipotriene and betamethasone dipropionate Contraindications in the drug label.
Warnings
- Flammability
- The propellants in Enstilar Foam are flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.
- 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 4 weeks has not been evaluated.
- Effects on Endocrine System
- Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. 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 the drug, reduce the frequency of application, or substitute with a less potent corticosteroid.
- Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria.
- Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios.
- Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure.
- 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.
- Risks of Ultraviolet Light Exposures
- Patients who apply Enstilar® Foam to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc.
- Physicians may wish to limit or avoid use of phototherapy in patients who use Enstilar® Foam.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Calcipotriene and betamethasone dipropionate Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Calcipotriene and betamethasone dipropionate Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Calcipotriene and betamethasone dipropionate Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Calcipotriene and betamethasone dipropionate in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Calcipotriene and betamethasone dipropionate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Calcipotriene and betamethasone dipropionate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Calcipotriene and betamethasone dipropionate in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Calcipotriene and betamethasone dipropionate in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Calcipotriene and betamethasone dipropionate in geriatric settings.
Gender
There is no FDA guidance on the use of Calcipotriene and betamethasone dipropionate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Calcipotriene and betamethasone dipropionate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Calcipotriene and betamethasone dipropionate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Calcipotriene and betamethasone dipropionate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Calcipotriene and betamethasone dipropionate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Calcipotriene and betamethasone dipropionate in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Calcipotriene and betamethasone dipropionate Administration in the drug label.
Monitoring
There is limited information regarding Calcipotriene and betamethasone dipropionate Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Calcipotriene and betamethasone dipropionate and IV administrations.
Overdosage
There is limited information regarding Calcipotriene and betamethasone dipropionate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Calcipotriene and betamethasone dipropionate Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Calcipotriene and betamethasone dipropionate Mechanism of Action in the drug label.
Structure
There is limited information regarding Calcipotriene and betamethasone dipropionate Structure in the drug label.
Pharmacodynamics
There is limited information regarding Calcipotriene and betamethasone dipropionate Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Calcipotriene and betamethasone dipropionate Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Calcipotriene and betamethasone dipropionate Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Calcipotriene and betamethasone dipropionate Clinical Studies in the drug label.
How Supplied
There is limited information regarding Calcipotriene and betamethasone dipropionate How Supplied in the drug label.
Storage
There is limited information regarding Calcipotriene and betamethasone dipropionate Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Calcipotriene and betamethasone dipropionate Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Calcipotriene and betamethasone dipropionate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Calcipotriene and betamethasone dipropionate Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Calcipotriene and betamethasone dipropionate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.