Dropodex 0.1% w/v Eye Drops, solution

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

DEXAMETHASONE PHOSPHATE

Verfügbar ab:

Rayner Pharmaceuticals Limited

ATC-Code:

S01BA; S01BA01

INN (Internationale Bezeichnung):

DEXAMETHASONE PHOSPHATE

Dosierung:

0.1 percent weight/volume

Darreichungsform:

Eye drops, solution

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Corticosteroids, plain; dexamethasone

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2013-05-03

Fachinformation

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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