Enstilar Calcipotriol and Betamethasone Foam

1. Indications and Usage
Plaque Psoriasis:
Treatment of plaque psoriasis in adults (≥18 years of age).
Target: Effective for reducing the thickness and redness of psoriatic plaques.
2. Dosage and Administration
Route of Administration:
For Dermatologic Use Only. Not for ophthalmic, oral, or intravaginal use.
Recommended Dosage:
Frequency: Apply a thin layer to the affected skin areas once daily.
Duration: Treatment is typically recommended for up to 4 weeks.
Critical Administration Instructions:
Application: Dispense onto a piece of paper or into a gloved hand (not directly onto hands to avoid absorption). Apply only to affected areas.
Wash Hands: Wash hands immediately after application.
Avoid Sensitive Areas: Do not apply to the face, axillae (armpits), or groin.
Maximum Dose: Do not exceed 100 g per week.
3. Mechanism of Action
Synergistic Action:
Combines the anti-proliferative and anti-inflammatory effects of two active ingredients.
Calcipotriol: A synthetic Vitamin D3 analogue that binds to vitamin D receptors, inhibiting keratinocyte proliferation and inducing differentiation.
Betamethasone: A potent corticosteroid that inhibits inflammatory mediators, reduces swelling (edema), and alleviates itching.
4. Safety and Warnings
Dermatologic Atrophy:
May cause skin thinning (atrophy), striae (stretch marks), and telangiectasia (spider veins), especially with prolonged use or occlusion.
HPA Axis Suppression:
Systemic absorption of corticosteroids may lead to hypothalamic-pituitary-adrenal (HPA) axis suppression.
Action: Limit total weekly dose and duration of treatment.
Hypercalcemia:
Excessive use of Calcipotriol may lead to hypercalcemia (elevated blood calcium levels).
Contraindications:
Hypersensitivity to ingredients.
Patients with disorders of calcium metabolism.
5.Adverse Reactions and Clinical Research
Most Common Adverse Reactions:
Application site disorders (e.g., burning, stinging, itching, irritation, erythema).
Psoriasis aggravated (transient).
Folliculitis.
Skin atrophy (with prolonged use).
Clinical Research Highlights:
In pivotal clinical trials, significantly more patients treated with the foam combination achieved a clear or almost clear skin rating compared to vehicle or monotherapy groups after 4 weeks.
The foam vehicle was generally well-tolerated, though application site irritation was the most common reason for discontinuation.
6.Drug Interactions
Other Topical Products:
Concomitant use with other topical corticosteroids or Vitamin D analogues is not recommended due to the risk of additive toxicity.
Photosensitizing Agents:
No specific data, but caution is advised with agents that increase photosensitivity.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredients: Calcipotriol (50 µg/g) and Betamethasone (0.5 mg/g).
Appearance: White to off-white foam.
Packaging: Pressurized aluminum can.
Storage: Store at controlled room temperature (20°C to 25°C).