Company: Santen UK Limited.
Legal category: Prescription. GMS reimbursable. Sport permitted.
Active ingredient: Ciclosporin 1mg/ml.
Description: Eye drops.
Presentation: 30 x 0.3ml single-dose containers, €86.50.
Indications: Treatment of severe keratitis in patients with dry eye disease not improved by tear substitutes.
Pharmacology: Ciclosporin is a cyclic polypeptide immunomodulator with immunosuppressant properties and an anti-inflammatory effect. Following ocular administration, ciclosporin is passively absorbed into T-lymphocyte infiltrates in the cornea and conjunctiva and inactivates calcineurin phosphatase. Ciclosporin-induced inactivation of calcineurin inhibits the dephosphorylation of the transcription factor NF-AT and prevents NF-AT translocation into the nucleus, thus blocking the release of pro-inflammatory cytokines such as IL-2.
Dosage: Adult: Must be initiated by an ophthalmologist or HCP qualified in ophthalmology. One drop to affected eye(s) once daily at bedtime (maximum). Review at least every 6 months. Elderly: As per adults. Children: Under 18 years, no relevant use.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active or suspected ocular or peri-ocular infection. Pregnancy, lactation; assess risk/benefit.
Special precautions: Remove contact lenses before instillation (may reinsert at wake-up time); carefully monitor patients with severe keratitis. Caution: Glaucoma (especially with beta-blockers), history of ocular herpes. May affect immune system. Driving/usingmachines (ensure clear vision). Contains cetalkonium chloride.
Drug interactions: Administer other ophthalmic products at least 15 minutes apart with Ikervis last. Corticosteroids.
Adverse drug reactions: Instillation site pain, instillation site irritation, instillation site erythema, instillation site lacrimation, eyelid erythema, eyelid oedema, increased lacrimation, ocular hyperaemia, blurred vision, conjunctival hyperaemia, eye irritation, eye pain.
Full prescribing information and references available from Santen. Telephone: (01) 695 0008. E-mail: medinfo@santen.co.uk
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