Dropodex 0.1% w/v Eye Drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DEXAMETHASONE PHOSPHATE

Available from:

Rayner Pharmaceuticals Limited

ATC code:

S01BA; S01BA01

INN (International Name):

DEXAMETHASONE PHOSPHATE

Dosage:

0.1 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids, plain; dexamethasone

Authorization status:

Not marketed

Authorization date:

2013-05-03

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dropodex 0.1% w/v Eye Drops, solution.
2 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.
3 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.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly)_
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.
_Paediatric population_
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).
Method of administration
Ocular use.
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