SOFRADEX EYE/EAR

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FRAMYCETIN SULFATE DEXAMETHASONE GRAMICIDIN

Available from:

Roussel Laboratories Limited

Dosage:

0.5/0.05/0 %v/v

Pharmaceutical form:

Ointment

Authorization date:

1977-04-01

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sofradex Ear/Eye Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The ointment contains Framycetin Sulphate 5mg/g (0.5% w/w),
Dexamethasone 0.5mg/g (0.05% w/w)
and Gramicidin 0.05mg/g (0.005% w/w).
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Ointment.
A clear to white, translucent, smooth homogenous sterile, greasy
ointment.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
In the  eye: For the short-term  treatment  of  steroid responsive conditions of  the eye, when prophylactic  antibiotic 

treatment is also required, after excluding
the presence of fungal and viral disease.
In the ear: Otitis externa.
Application to the eyelid: Blepharitis.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Route of administration: Topical
ADULTS (AND THE ELDERLY) AND CHILDREN:
In the eye: Apply sparingly two or three times daily,
or at night if drop treatment is given during the day.
In the ear: Apply once or twice daily.
4.3 CONTRAINDICATIONS
Use in patients hypersensitive to the active ingredients.
Use in the presence of infections of viral, treponemal,
tuberculous or of non-sensitive fungal origin.
Use in infants.
The product should not be used if there is a perforation of the tympanic membrane, as entry into the middle ear could 
lead to ototoxicity.
Use is contraindicated if glaucoma is present or herpetic keratitis (e.g. dendritic ulcer) is considered a possibility. Use 
of topical steroids in the latter condition can lead to extension
of the ulcer and marked visual deterioration.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 24/08/2005_
_CRN 2014117_
_page number: 1_
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Prolonged use of an anti-infective may