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 SOFRACORT® (Framycetin sulphate - Gramicedin-dexamethasone

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تاريخ التسجيل : 23/02/2008

مُساهمةموضوع: SOFRACORT® (Framycetin sulphate - Gramicedin-dexamethasone   الأحد أبريل 27, 2008 6:37 am

PRESCRIBING INFORMATION
SOFRACORT®
(Framycetin sulphate - Gramicedin-dexamethasone)
Antibiotic - Corticosteroid
sanofi-aventis Canada Inc. Date of Revision:
2150 St. Elzear Blvd. West April 21, 2006
Laval, Quebec H7L 4A8
Submission Control No. 105341 s-a Version 1.0 dated April 21, 2006
-2-
PRESCRIBING INFORMATION
NAME OF DRUG
SOFRACORT®
(Framycetin sulphate - Gramicedin-dexamethasone)
THERAPEUTIC CLASSIFICATION
Antibiotic - Corticosteroid
Indications:
Eye: Blepharitis and infected eczema of the eyelid; allergic, infective and rosacea
conjunctivitis; rosacea keratitis; scleritis and episcleritis; iridocyclitis, and other inflammatory
conditions of the anterior segment of the eye.
Ear: Otitis externa (acute and chronic) and other inflammatory and sebhorrheic conditions
of the external ear.
Contraindications:
Eye: Herpes simplex and other viral diseases of the cornea and conjunctiva; tuberculosis
and fungal diseases of the eye; trachoma. Acute purulent, untreated infections of the eye,
which, like other diseases caused by micro-organisms, may be masked or enhanced by the
presence of the steroid. Known hypersensitivity to any of the ingredients.
Ear: Viral and fungal infections. Acute purulent, untreated infections. Perforation of the
eardrum. Known hypersensitivity to any of the ingredients.
Precautions:
Extended ophthalmic use of corticosteroids may increase intra-ocular pressure in some
individuals in such cases, intra-ocular pressure should be checked regularly. In conditions
causing thinning of the cornea, topical steroids may cause perforation. Cataract has
-3-
occurred after prolonged treatment with topical steroids. The safety of prolonged use of
topical steroids during pregnancy has not been substantiated. The benefits of use should
be weighed against possible adverse affects on the fetus. The drug should be discontinued
if there are signs of sensitivity to any of its ingredients. Patients are advised to inform the
physicians of the prior use of corticosteroids. Although it is unlikely that infants will be
treated with SOFRACORT for prolonged periods, there is a risk of adrenal suppression,
even without occlusive dressings, after prolonged treatment of these patients with topical
steroids.
Adverse Reactions: (see Precautions)
Increased intra-ocular pressure; perforation of the cornea; hypersensitivity; burning or
stinging of the eye.
Dosage and Administration:
Drops
Ear: Instill 2 or 3 drops in the ear canal 3 or 4 times daily by tilting head to one side.
Squeeze bottle carefully. To avoid possibility of reinfection later, do not touch ear with
dropper. Alternatively, a saturated gauze wick may be inserted by the physician into the
external auditory meatus.
Eye: In acute conditions, 1 or 2 drops every 1 to 2 hours may be instilled (generally for 2
or 3 days). Subsequently, 1 or 2 drops 3 or 4 times daily.
Ointment
Ear: Apply 2 or 3 times a day, including bedtime, to the outer portion of, and inside the ear
canal and to adjacent areas if the infection has spread.
Eye: 2 or 3 times a day, or at bedtime if drops have been used during the day.
-4-
Composition:
In each millilitre of drops, 5mg Soframycin (framycetin sulphate B.P.); 0.05 mg gramicidin
and dexamethasone sodium metasulphobenzoate equivalent to 0.5 mg dexamethasone.
In each gram of ointment, 5mg Soframycin (framycetin sulphate B.P.); 0.05 mg gramicidin,
0.5 mg dexamethasone and Plastibase 30W.
Use within four weeks of opening.
sanofi-aventis Canada INC.
2150 St-Elzéar Blvd. West
Laval, Québec H7L 4A8
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