Buy Sofradex eye drops 5 ml
  • Buy Sofradex eye drops 5 ml

Sofradex®

Sanofi-aventis
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Clinical Pharmacology

Framycetin sulfate - an antibiotic from the group of aminoglycosides, bactericidal. It has a wide spectrum of antibacterial action, is active against gram-positive microorganisms, including Staphylococcus aureus, and most of the clinically significant gram-negative microorganisms (E. coli, Dysterium bacillus, Proteus, etc.). Ineffective against steptococci. Does not affect pathogenic fungi, viruses, anaerobic flora. The resistance of microorganisms to framycetin sulfate develops slowly. Gramicidin - has a bactericidal and bacteriostatic effect, expands the spectrum of the antimicrobial action of framycetin due to its activity against staphylococci, since it also has an anti-staphylococcal effect.

Dexamethasone - GCS, which has a pronounced anti-inflammatory, anti-allergic and desensitizing effect. Dexamethasone inhibits inflammatory processes by inhibiting the release of inflammatory mediators, the migration of mast cells and reducing capillary permeability. When instilled into the eyes, pain, burning, tearing, photophobia will be reduced. When instilled into the ears, it reduces the symptoms of otitis media in the outer ear (redness of the skin, pain, itching, burning sensation in the external auditory canal, feeling of ear congestion).

Indications

Bacterial diseases of the anterior segment of the eye:

  • Blepharitis
  • Conjunctivitis.
  • Keratitis (without damage to the epithelium).
  • Iridocyclitis.
  • Sclerites, episclerites.
  • Infected eczema of the eyelid skin.

Otitis otitis of the outer ear.

Composition

1 ml of solution contains:

Active ingredients

  • Framycetin sulfate - 5.00 mg.
  • Gramicidin - 0.05 mg.
  • Dexamethasone (as sodium metasulfobenzoate) - 0.50 mg.

Lithium chloride, sodium citrate, citric acid monohydrate, phenylethanol (phenylethyl alcohol), denatured ethanol (industrial methylated alcohol) 95%, polysorbate 80, water for injection.

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Sofradex®

Dosage and Administration

If the infection is mild, 1-2 drops of the drug are instilled into the conjunctival sac every 4 hours.

In the case of a severe infectious process, the drug is instilled every hour.

As the inflammation decreases, the frequency of drug instillations decreases.

 

For ear diseases

Instill 2-3 drops 3-4 times a day, a gauze pad moistened with a solution can be put into the external auditory canal.

The duration of the drug should not exceed 7 days, except in cases of obvious positive dynamics of the disease (glucocorticoid can mask hidden infections, and long-term use of antimicrobial components of the drug to contribute to the development of sustainable flora).

Adverse reactions

Allergic reactions are usually of a delayed type, manifested by:

Contraindications

  • Irritation.
  • Burning sensation.
  • Pain.
  • Itch.
  • Dermatitis.

With prolonged use of local corticosteroids, intraocular pressure may increase with the development of glaucoma symptom complex (damage to the optic nerve, reduced visual acuity and visual field defects), therefore with more than 7-day use of drugs containing glucocorticosteroids, intraocular pressure should be regularly measured.

The development of posterior subcapsular cataracts (especially with frequent instillation).

Thinning of the cornea or sclera, which can lead to perforation.

Accession of a secondary (fungal) infection.

Carefully:

Young children (especially with the appointment of the drug in large doses and for a long time - the risk of systemic effects and adrenal suppression)

Drug interactions

Framycetin sulfate should not be used with other antibiotics that have ototoxic and nephrotoxic effects (streptomycin, monomitsin, kanamycin, gentamicin).

Pregnancy and Lactation

Contraindicated use during pregnancy and breastfeeding.

Special instructions

With prolonged use of the drug, as with the long-term use of other antimicrobial agents, the development of superinfections caused by drug-resistant microorganisms, including fungi, is possible.

Prolonged instillation of the drug into the eyes can lead to thinning of the cornea with the development of its perforation, as well as to an increase in intraocular pressure.

Treatment with drugs containing corticosteroids should not be repeated or long-term without regular monitoring of intraocular pressure, eye examinations for cataracts or secondary infections.

Local corticosteroids should never be used in patients with hyperemia of an eye of unknown etiology; as inappropriate use of the drug can lead to significant visual impairment.

Framycetin sulfate, which is a component of the drug, is an antibiotic from the group of aminoglycosides, which is characterized by the development of nephro and ototoxic effects upon systemic application or topical application to open wounds or damaged skin.

These effects are dose dependent and increase with renal or hepatic insufficiency.

Although the development of these effects was not observed when instillation of the drug in the eye, the possibility of their occurrence in the case of local application of high doses of the drug in children should be taken into account.

Duration of the drug should not exceed 7 days, except in cases of obvious positive dynamics of the disease, as long-term use of glucocorticosteroid, which is part of it, can mask hidden infections and prolonged use of antimicrobial components - contribute to the emergence of sustainable microflora.

Patients who, after instillation into the eye of the drug, temporarily lose the clarity of vision, are not recommended immediately after the instillation of the drug to drive a car or work with complex equipment, machines or any other complex equipment that requires clarity of vision. The bottle must be closed after each use.

Do not touch the eye with a pipette tip. After opening the bottle, the drug should be used within 1 month.

Overdosage

If one vial is swallowed (up to 10 ml of solution), serious side effects are unlikely to develop.

  • Brand name: Sofradex
  • Active ingredient: Dexamethasone, Framycetin

Studies and clinical trials of Sofradex (Click to expand)

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