Enstilar的注意事项是什么？

The main precautions include flammability, hypercalcemia and hypercalciuria, impact on the endocrine system, allergic contact dermatitis, and ophthalmic adverse reactions.

About calcipotriol and betamethasone dipropionate (Enstilar)

Currently, the compound preparations of calcipotriol and betamethasone dipropionate are available in ointment, gel, foam and other dosage forms, and are widely used in the treatment of psoriasis on the trunk, limbs, and scalp.

1. In 2006, the FDA approved an ointment preparation (taclonex ointment) for the treatment of psoriasis vulgaris in people 18 years of age and older.

2. In 2008, the FDA approved gel (taclonex gel) for the scalp and body treatment of psoriasis in patients over 18 years of age.

3. In 2010, the European Medicines Agency approved Deveba ointment and gel preparations for the treatment of mild to moderate plaque psoriasis on the body and scalp psoriasis.

4. In 2014, the FDA also approved topical treatment of scalp psoriasis in patients aged 12 to 17 years old.

5. The foam formula was approved by the FDA in October 2015 for the topical treatment of psoriasis in people 18 years of age and older.

The following mainly introduces the Enstilar foam formula:

Flammability

The propellant in Enstilar foam is flammable. Instruct patients to avoid starting fires, slapping skin, and smoking during and immediately after administration.

Hypercalcemia and hypercalciuria

Hypercalcemia and hypercalciuria have been observed with the use of Enstilar foam. If hypercalcemia or hypercalciuria occurs, discontinue treatment until calcium metabolism parameters return to normal. The incidence of hypercalcemia and hypercalciuria after more than 56 weeks of Enstilar foam treatment has not been evaluated.

Effects on the endocrine system

1. Hypothalamic-pituitary-adrenal axis inhibition

Systemic absorption of topical corticosteroids can lead to reversible hypothalamic-pituitary-adrenal (HPA) axis suppression and may lead to clinical glucocorticoid insufficiency. This may occur during treatment or when treatment is stopped. Factors that contribute to HPA axis suppression in patients include use of highly potent steroids, large treatment surface area, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

HPA axis suppression can be assessed by using the adrenocorticotropic hormone (ACTH) stimulation test. If HPA axis suppression is documented, Enstilar foam is gradually discontinued, dosing less frequent, or replaced with a less potent corticosteroid.

2. Cushing’s syndrome and hyperglycemia

Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glycosuria.

3. Other precautions for adverse endocrine reactions

Pediatric patients may be more susceptible to systemic toxicities due to their larger skin surface to body mass ratio. Concurrent use of multiple corticosteroid-containing products may increase systemic corticosteroid exposure.

allergic contact dermatitis

Allergic contact dermatitis has been observed with topical calcipotriene and topical corticosteroids. Contact dermatitis allergic to topical corticosteroids is usually diagnosed by observing failure to heal rather than clinical deterioration. Confirm such observations using appropriate diagnostic patch testing.

Ophthalmic adverse reactions

Use of topical corticosteroids, including Enstilar foam, may increase the risk of posterior subcapsular cataracts and glaucoma.

Cataracts have been reported during marketed use of topical corticosteroid products. Avoid eye contact with Enstilar foam. Styrofoam may cause eye irritation. Advise patients to report visual symptoms and consider referral to an ophthalmologist for evaluation.

Summary

The above are the precautions for Enstilar. It is recommended that patients should be cautious when using this drug and strictly follow the doctor's instructions for treatment. If adverse reactions occur, they should contact the doctor in time and the attending doctor will give corresponding treatment measures.

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