Company: Leo Pharma.
Legal category: Prescription. GMS reimbursable. Sport permitted.
Active ingredient: Calcipotriol (hydrate)/betamethasone (dipropionate) 50mcg/0.5mg per g.
Description: Gel with applicator.
Presentation: 1 applicator-60g, €37.97.
Indications: Topical treatment of mild to moderate non-scalp plaque psoriasis vulgaris and scalp psoriasis.
Pharmacology: Calcipotriol is a vitamin D analogue. It induces differentiation and suppresses proliferation of keratinocytes. Betamethasone dipropionate has anti-inflammatory, antipruritic, vasoconstrictive and immunosuppresive properties.
Dosage: Adult: Apply once daily for 4 weeks (scalp), 8 weeks (non-scalp areas); if necessary, can be continued thereafter under medical supervision. Max. 15g daily. Do not exceed application to >30% body surface area. 1-4g/day is sufficient if used on scalp. Elderly: As per adults. Children: <18 years, not recommended.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients. Calcium metabolism disorders. Erythrodermic, exfoliative and pustular psoriasis. Viral skin lesions, fungal/ bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds.
Special precautions: Avoid face, mouth, eyes, genitals. Wash hands after application. Avoid use on large areas of damaged skin, under occlusive dressings, mucous membranes, skin folds. Avoid excessive exposure to natural/ artificial sunlight. Risk of hypercalcaemia at doses >15g daily. Treat secondary infections (discontinue if worsen). Risk of generalised pustular psoriasis/rebound effects on discontinuation; continue medical supervision post-treatment. Long-term use, discontinue if adverse reactions occur. Guttate psoriasis; severe renal/hepatic impairment (no data). Pregnancy (assess risk/benefit), lactation (do not use on breast). Contains butylhydroxytoluene (E321).
Drug interactions: Avoid: Other steroids.
Adverse drug reactions: Pruritus.
Full prescribing information and references available from Leo Pharma. Telephone: (01) 490 8924.