INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo SOFRADEX®

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

SOFRADEX®
Ear/Eye Drops

COMPOSITION:
Each mL of drops contains :
Framycetin Sulphate                                5 mg
Gramicidin         0,05 mg
Dexamethasone
(as sodium metasulphobenzoate)
        0,5 mg
Phenylethanol         0,5%

PHARMACOLOGICAL CLASSIFICATION
A. 15.3 Ophthalmic preparations containing antibiotics and corticosteroids.

PHARMACOLOGICAL ACTION:
The antibiotics soframycin (framycetin sulphate) and gramicidin will control and eradicate most superficial bacterial infections of the eye and ear, whilst the dexamethasone will suppress inflammation and control any pruritus and exudate which may be present.

INDICATIONS:
Eye: - Blepharitis
  - Infected eczema of the eyelid
  - Post-operatively
Ear: - Otitis externa

CONTRA-INDICATIONS:
Previous known sensitisation to any of the ingredients. Known or suspected herpes simplex infections, tuberculosis, fungal infections and in acute purulent infections of the eye where diagnosis may be in doubt. Preparations containing framycetin should not be used for treating otitis externa when the ear drum is perforated, because of the risk of ototoxicity.

WARNINGS:
It is recommended that this preparation is used only by Ophthalmologists for eye conditions, or only after exclusion of herpes infections in the eye. As a result of the possibility of inducing fungal keratopathy or glaucoma the patient must be referred to an Ophthalmologist if the condition has not responded within 48 hours.
Do not use more than 30 days after opening.

DOSAGE AND DIRECTIONS FOR USE:
Eye:
1 - 2 drops every one or two hours for 2 - 3 days, then reducing to 1 - 3 drops three or four times daily.
Ear:
2 - 3 drops should be instilled into the ear three or four times daily. Alternatively, a gauze wick kept saturated with the drops may be inserted into the external auditory meatus.
Change the wick at least every 36 - 48 hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
These are the same as would apply to the use of any topical steroid therapy. It is, therefore, advisable that Sofradex be used with extreme caution in patients who have previously had glaucoma and where extended therapy with Sofradex is indicated. Intra-ocular pressure should be checked frequently. In those diseases which cause thinning of the cornea, perforation has been known to occur with the use of topical corticosteroids.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Not applicable.

IDENTIFICATION:
A clear, bright, colourless, aqueous solution with a rose-like odour.

PRESENTATION:
Individual amber glass vial fitted with a blue and white plastic cap containing a chlorbutyl rubber teat.
Each vial contains 8 mL of Sofradex drops.

STORAGE INSTRUCTIONS:
Store in a cool, dry place, below 25°C. Keep out of reach of children.

REFERENCE NUMBER:
H 1482 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Aventis Pharma (Pty) Ltd
2 Bond Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 May 1986

SDE 58232

Updated on this site: April 2005
Source: Hospital Pharmacy

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