DROPODEX Eye drops, solution

Active ingredients: Dexamethasone

Product name and form

Dropodex 0.1% w/v Eye Drops, solution.

Pharmaceutical Form

Eye drops, solution.

Single-use eye drops which are sterile and preservative free.

A colourless solution when examined under suitable conditions of visibility, clear and free from particles.

Qualitative and quantitative composition

Dexamethasone sodium phosphate Ph Eur equivalent to 0.1% w/v dexamethasone.

Each ml of solution contains 1 mg dexamethasone phosphate (as dexamethasone sodium phosphate).

Each individual single-dose unit contains 0.4 mg dexamethasone phosphate (as dexamethasone sodium phosphate) in 0.4 ml of solution.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. At high doses it reduces the immune response.

List of Excipients

Sodium chloride
Disodium edetate
Disodium phosphate dodecahydrate (E339)
Water, purified

Pack sizes and marketing

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.

Marketing authorization holder

Rayner Pharmaceuticals Ltd, 10 Dominion Way, Worthing, West Sussex, BN14 8AQ, United Kingdom

Marketing authorization dates and numbers

PL 47069/0003

Date of first authorisation: 30 January 2013

Date of latest renewal: 28 September 2017

Drugs

Drug
Countries
United Kingdom