Finished product reference

Calcipotriol / Betamethasone Dipropionate

Ointment · Topical · 0.005 %/0.064 % · 30 g

List code
17677
Pharmacologic class
Topical antipsoriatic: vitamin D analogue / corticosteroid combination

What it is and how it works

Calcipotriol is a vitamin D3 analogue that binds the vitamin D receptor, inhibiting keratinocyte proliferation and promoting normal differentiation. Betamethasone dipropionate is a potent corticosteroid with anti-inflammatory, antiproliferative and immunosuppressive effects; the combination is more effective than either component alone.

Indications

Topical treatment of stable plaque psoriasis vulgaris of the body (ointment/gel) and of the scalp (gel) in adults.

Dosage and administration (summary)

Apply once daily to affected areas for up to 4 weeks (scalp up to 4 weeks, or 8 weeks for some formulations), with repeated courses under supervision. Maximum 15 g daily or 100 g weekly; treated area should not exceed 30% of body surface.

Contraindications

Erythrodermic, exfoliative or pustular psoriasis; known disorders of calcium metabolism; severe renal or hepatic disease; viral, fungal, bacterial or parasitic skin infections, skin atrophy, acne, rosacea, perioral dermatitis and ulcers.

Warnings and precautions

Hypercalcaemia may occur if the maximum dose is exceeded. Avoid use on the face, genitals and skin folds, and under occlusion, because of the risk of local corticosteroid adverse effects and systemic absorption. Rebound flare may occur on discontinuation; avoid excessive sunlight or UV exposure.

Pregnancy

Use in pregnancy only when the potential benefit justifies the potential risk.

Storage and supply

Store below 25 °C (some products below 30 °C); do not refrigerate gel; use within the in-use period after opening.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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