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SOFRACORT is a brand name for Dexamethasone, supplied as a drops. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SOFRACORT (framycetin sulfate, dexamethasone and gramicidin ophthalmic/otic solution) is indicated for: • 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…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 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. To avoid possibility of reinfection later, do not touch eye with dropper.
Ear:
Instill 2 or 3 drops in the ear canal 3 or 4 times daily by tilting head to one side. Squeeze the dropper 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.
1 Pediatrics). 5 Missed Dose If a dose is missed, it should be administered as soon as possible, and the regular dosage schedule should be resumed. If it is almost time for the next dose, the missed dose should be skipped, and the regular dosing schedule should be resumed.
A double dose should not be administered.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Eye disorders Increased intra-ocular pressure; perforation of the cornea; hypersensitivity; burning or stinging of the eye.
5 Post-Market Adverse Reactions Endocrine disorders Iatrogenic Cushing’s syndrome; adrenal atrophy. Eye disorders Blurred vision; chorioretinopathy; increased intra-ocular pressure leading to optic nerve damage, reduced visual acuity and visual field defects; glaucoma; cataracts.
Immune disorders Hypersensitivity reactions, usually of the delayed type, may occur, leading to irritation, burning, stinging, itching and dermatitis. Metabolism and nutrition disorders Diabetes mellitus; decreased glucose tolerance.
05 mg/mL Gramicidin Citric acid monohydrate, hydrochloric acid, industrial methylated spirit (IMS 66OP), lithium chloride, polysorbate 80, sodium citrate, sodium hydroxide, 2-phenyl ethanol, water for injection SOFRACORT (Framycetin sulfate, Dexamethasone and Gramicidin Ophthalmic/Otic Solution) Page 6 of 19 SOFRACORT may cause transient blurring of vision on instillation.
If blurred vision occurs after SOFRACORT administration, the patient must wait until vision clears before driving or operating machinery. Ear/Nose/Throat Aminoglycoside antibiotics may cause irreversible, partial or total deafness when applied topically to open wounds or damaged skin.
This effect is aggravated by renal or hepatic impairment and by prolonged duration of treatment. The treatment should not be continued after resolution of symptoms. There have been reported cases of an increased risk of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, particularly the nucleotide 1555 A to G substitution in the 12S rRNA gene, including cases where the patient's aminoglycoside serum levels were within the recommended range.
Some cases were associated with a maternal history of deafness and/or mitochondrial mutation. Mitochondrial mutations are rare, and the penetrance of this observed effect is unknown. Based on a shared mechanism of action with other aminoglycosides, the risk of ototoxicity with framycetin and other topical aminoglycosides cannot be ruled out.
5 Post-Market Adverse Reactions). Immune Discontinue SOFRACORT if there are signs of sensitivity to any of its ingredients. 5 Post- Market Adverse Reactions). In patients known to be allergic to other aminoglycoside antibiotics (neomycin, kanamycin), cross- sensitization to framycetin may occur, but not invariably so.
Neurologic Pheochromocytoma crisis, which can be fatal, has been reported after administration of corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.
SOFRACORT is contraindicated in patients with: • Known hypersensitivity to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
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.
• Glaucoma. Ear: • Viral and fungal infections. • Acute purulent, untreated infections. • Perforation of the eardrum because of the risk of ototoxicity. SOFRACORT (Framycetin sulfate, Dexamethasone and Gramicidin Ophthalmic/Otic Solution) Page 5 of 19
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dexamethasone in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Ophthalmologic Visual disturbance may be associated with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR).
Treatment with corticosteroid SOFRACORT (Framycetin sulfate, Dexamethasone and Gramicidin Ophthalmic/Otic Solution) Page 7 of 19 preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.
In conditions causing thinning of the cornea, topical steroids may cause perforation. 5 Post-Market Adverse Reactions). Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding.
Sensitivity/Resistance Treatment with corticosteroid/antibiotic combinations should not be continued in the absence of clinical improvement, since prolonged use may lead to occult extension of infections due to the masking effect of the steroid.
Prolonged use may also lead to skin sensitization and the emergence of resistant organisms.
Development of Drug Resistant Bacteria:
Prescribing SOFRACORT in the absence of the authorized indications is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
Potential for Microbial Overgrowth:
The use of SOFRACORT may promote the selection of non-susceptible organisms. Should superinfection occur during therapy, appropriate measures should be taken. 1 Pregnant Women There are no available data on SOFRACORT use in pregnant women.
The safety of prolonged use of topical steroids during pregnancy has not been substantiated. No conclusions can be drawn regarding whether or not SOFRACORT is safe for use during pregnancy. SOFRACORT should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus.
2 Breast-feeding There are no available data on the presence of SOFRACORT in human milk, milk production, or the effects on the breast-fed infant. No conclusions can be drawn regarding whether or not SOFRACORT is safe for use during breast-feeding.
SOFRACORT should be used during breast-feeding only if the potential benefits to the mother outweigh the potential risks, including those to the breast-fed child. 1 Pediatrics). There is a risk of adrenal suppression, even without occlusive dressings, after prolonged treatment of infants with topical steroids.
SOFRACORT (Framycetin sulfate, Dexamethasone and Gramicidin Ophthalmic/Otic Solution) Page 8 of 19