Sofradex eye / ear drops, 5ml

Bacterial diseases of the anterior segment of the eye.

• blepharitis;

• conjunctivitis;

• keratitis (without damage to the epithelium);

• iridocyclitis;

• sclerites, episclerites;

• infected eczema of the skin of the eyelids;

• otitis media of the outer ear.

In case of eye diseases: in case of a mild course of the infectious process, 1-2 drops of the drug are instilled into the conjunctival sac of the eye every 4 hours. In the case of a severe infectious process, the drug is instilled every hour. As the inflammatory phenomena decrease, the frequency of instillation of the drug decreases.

In case of ear diseases: 2-3 drops are instilled 3-4 times / day, a gauze swab moistened with a solution can be placed in the external auditory canal.

The duration of use of the drug should not exceed 7 days, except in cases of obvious positive dynamics of the disease (GCS can mask hidden infections, and prolonged use of antimicrobial components of the drug will contribute to the development of a stable flora).

Eye and ear drops in the form of a transparent, almost colorless solution, with the smell of phenylethyl alcohol.

1 ml

framycetin sulfate 5 mg

gramicidin 50 mcg

dexamethasone (as sodium metasulfobenzoate) 500 mcg

Excipients: lithium chloride, sodium citrate, citric acid monohydrate, phenylethanol, ethanol 99.5%, polysorbate 80, water d / i.

• Hypersensitivity to any of the components of the drug;

• viral or fungal infections, tuberculosis, purulent inflammation of the eyes, trachoma;

• violation of the integrity of the corneal epithelium and thinning of the sclera;

• herpetic keratitis (dendritic corneal ulcer) (possibly an increase in the size of the ulcer and a significant deterioration in vision);

• glaucoma;

• perforation of the tympanic membrane (penetration of the drug into the middle ear can lead to the development of an ototoxic effect);

• pregnancy and lactation;

• infants.

• With caution: young children (especially when prescribing the drug in large doses and for a long time - the risk of developing systemic effects and suppression of adrenal function).

pharmachologic effect

Framycetin sulfate is an antibiotic from the aminoglycoside group, it has a bactericidal effect. It has a wide spectrum of antibacterial action, is active against gram-positive microorganisms, including Staphylococcus aureus, and most clinically significant gram-negative microorganisms (Escherichia coli, Diznteria 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 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 suppresses inflammatory processes by inhibiting the release of inflammatory mediators, migration of mast cells and decreasing capillary permeability. When instilled in the eyes, they will reduce pain, burning, lacrimation, and photophobia. When instilled into the ears, it reduces the symptoms of otitis media (redness of the skin, pain, itching, burning sensation in the external auditory canal, a feeling of ear congestion).

Pharmacokinetics

When applied topically, systemic absorption is low.

Framycetin sulfate can be absorbed through inflamed skin or open wounds. When it enters the systemic circulation, it is rapidly excreted by the kidneys unchanged. T1 / 2 of framycetin sulfate is 2-3 hours.

When taken orally, dexamethasone is rapidly absorbed from the gastrointestinal tract. T1 / 2 is 190 min.

Side effect

Allergic reactions are usually of a delayed type, manifested by irritation, burning, pain, itching, dermatitis.

With prolonged use of topical corticosteroids, it is possible: an increase in intraocular pressure with the development of a symptom of a complex of glaucoma (damage to the optic nerve, a decrease in visual acuity and the appearance of visual field defects), therefore, with more than 7 days of use of drugs containing glucocorticosteroids, intraocular pressure should be measured regularly; the development of posterior supracapsular cataract (especially with frequent instillation); thinning of the cornea or sclera, which can lead to perforation; accession of a secondary (fungal) infection.

Application during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Application in children

The drug is contraindicated in infants.

Use with caution in young children.

special instructions

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

Prolonged instillation of the drug into the eye 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 prolonged without regular monitoring of intraocular pressure, eye examination for the development of cataracts or secondary infections.

Local corticosteroids should never be used in patients with ocular hyperemia of unknown eliology, because inappropriate use of the drug can lead to significant visual impairment.

Framycetin sulfate, which is part of the drug, is an antibiotic from the group of aminoglycosides, which are characterized by the development of nephro- and ototoxic effects when used systemically or applied topically to an open wound or damaged skin. These effects are dose dependent and are increased in renal or hepatic impairment. Although the development of these effects was not observed when the drug was instilled into the eyes, the possibility of their occurrence in the case of topical application of high doses of the drug in children should be taken into account.

The duration of use of the drug should not exceed 7 days, except in cases of obvious positive dynamics of the disease, because long-term use of GCS, which is part of it, can mask hidden infections, and long-term use of antimicrobial components can contribute to the development of a stable flora.

Influence on the ability to drive vehicles and mechanisms.

Patients who temporarily lose vision clarity after instilling the drug into the eye are not recommended to drive a car or work with complex equipment, machine tools or any other complex equipment that requires clear vision immediately after instillation of the drug.

The bottle must be closed after each use. Do not touch the eye with the pipette tip. After opening the bottle, the drug should be used within 1 month.

Overdose

Long-term and intensive local use can lead to systemic effects. Treatment is symptomatic.

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

Drug interactions

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