Company: Thea Pharmaceuticals Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Dexamethasone (as sodium phosphate) 1mg/ml.
Description: Preservative-free sterile eye drops in single-dose container.
Presentation: 0.4ml-30, €7.20.
Indications: Treatment of non-infectious inflammatory conditions affecting anterior segment of eye.
Pharmacology: Dexamethasone sodium phosphate is a hydrosoluble inorganic ester of dexamethasone. It is a synthetic corticosteroid with an anti-inflammatory and anti-allergic action. Dexamethasone has more potent anti-inflammatory action compared to hydrocortisone (approximately 25:1) and prednisolone (approximately 5:1).
Dosage: Adult: Use only under close ophthalmic supervision. 1 drop 4-6 times daily in affected eye. If severe, start with 1 drop every hour and reduce to 1 drop every 4 hours when favourable response observed. Taper gradually. Maximum duration 14 days. Nasolacrimal occlusion by compression of lacrimal ducts may reduce systemic absorption. Elderly: As per adults. Children: Not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Eye infections not controlled by anti-infectious treatment, such as: Acute purulent bacterial infections including pseudomonas and mycobacterial infections, fungal infections, epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella zoster and most other viral infections of the cornea and conjunctiva, amoebic keratitis. Perforation, ulceration and injury of cornea with uncompleted epithelialisation, glucocorticosteroid-induced ocular hypertension. Pregnancy.
Special precautions: Not for undiagnosed red eye. Control eye infections prior to initiation and closely monitor during treatment. Monitor all patients frequently. Corneal ulcer (do not use unless inflammation is main cause of healing delay and appropriate aetiological treatment already prescribed); closely monitor. Particular inflammatory conditions such as episcleritis (only use if NSAIDS are contraindicated). Prolonged use may result in ocular hypertension/ glaucoma (especially for patients with previous intraocular pressure (IOP) induced by steroids or pre-existing high IOP or glaucoma) and cataract formation, especially in elderly. Thinning of cornea and sclera may increase risk of perforations during use. Switch to a phosphate-free preparation at first sign of corneal calcification. May occur: Posterior subcapsular cataract (cumulative doses), opportunistic ocular infections. Diabetics more prone to develop subcapsular cataracts following administration. Only use for severe forms of allergic conjunctivitis not responding to standard therapy and only for a short period. Avoid contact lenses. Ensure clear vision before driving/ using machines.
Drug interactions: Apply 15 minutes before or after other eye drops. Topical beta-blockers.
Adverse drug reactions: Increased IOP, discomfort, irritation, burning, stinging, itching, blurred vision.
Full prescribing information and references available from Thea Pharmaceuticals Ltd. Telephone: +44 (8701) 923283.