Hoechst Marion Roussel
Indications And Clinical Uses:
Ear: Otitis externa (acute and chronic) and other inflammatory and seborrheic conditions of the external ear.
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: Viral and fungal infections; acute purulent, untreated infections; perforation of the eardrum and known hypersensitivity to any of the ingredients.
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 microorganisms, may be masked or enhanced by the presence of the steroid. Known hypersensitivity to any of the ingredients.
Extended ophthalmic use of corticosteroids may increase intraocular pressure in some individuals in such cases, intraocular pressure should be checked regularly. In conditions causing thinning of the cornea, topical steroids may cause perforation. Cataract has occurred after prolonged treatment with topical steroids.
Pregnancy: The safety of prolonged use of topical steroids during pregnancy has not been substantiated. The benefits of use should be weighed against possible adverse effects 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.
Children: 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.
See Precautions. Increased intraocular 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.
Availability And Storage:
Drops: Each mL of sterile drops contains: framycetin sulfate BP 5 mg, gramicidin 0.05 mg and dexamethasone 0.5 mg. pH is 4.5 to 5.0. Calibrated dropper bottles of 8 mL.
Ointment: Each g of sterile ointment contains: framycetin sulfate BP 5 mg, gramicidin 0.05 mg and dexamethasone 0.5 mg. Also contains Plastibase 30W. Tubes of 5 g.
Store at controlled room temperature. Use within 4 weeks of opening.
SOFRACORT® Hoechst Marion Roussel Framycetin Sulfate-Gramicidin-Dexamethasone Compound Antibiotic-Corticosteroid