Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Rayner Pharmaceuticals Ltd, 10 Dominion Way, Worthing, West Sussex, BN14 8AQ, United Kingdom
Dropodex 0.1% w/v Eye Drops are indicated for inflammatory conditions of the anterior segment of the eye, such as marginal keratitis, stromal oedema in keratitis, anterior uveitis, episcleritis (if NSAIDs are contraindicated or insufficient), scleritis, acute phase of severe allergic conjunctivitis not responding to standard therapy.
The usual dose in adults, including the elderly, is 1 drop, 4 to 6 times daily.
In severe conditions, the treatment can be used more frequently at first (1 drop every hour), and then reduced to 1 drop every 4 hours as the eye inflammation subsides. Dexamethasone sodium phosphate dosage should be progressively reduced.
Use of Dropodex 0.1% w/v Eye Drops, solution in children and adolescents must be restricted. No data on safety and efficacy are available for children aged less than 2 years. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made. In children, long-term continuous corticosteroid therapy should be avoided due to possible adrenal suppression (see section 4.4).
Ocular use.
Overdose is unlikely to occur as Dropodex 0.1% w/v Eye Drops are single-dose units. Excess Dropodex 0.1% w/v Eye Drops may be wiped away with a clean tissue.
Unopened: 30 months.
After opening the sachet: use contents within 28 days.
After opening the single-dose unit: use immediately after opening the single-dose unit. Discard any unused content.
Keep out of sight and reach of children.
Do not store above 25°C. Do not refrigerate or freeze. Store in original package.
Discard any remaining single-dose units 28 days after opening the sachet.
Dropodex 0.1% w/v Eye Drops are available in 0.4 ml transparent low density polyethylene single-dose units. Each pre-formable PET metal/PE transparent and PET metal/PE peelable sachet contains 5 single-dose units. 20 single-dose units are packed into one carton.
Any unused product or waste material should be disposed of in accordance with local requirements.
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