Sofradex, eye and ear drops 5 ml

The Sofradex eye drops are a combined preparation containing two antibiotics (Gramicidin + Framicetin) and a glucocorticosteroid (Dexamethasone) used in ophthalmology and otolaryngology.

The antibiotics complement each other’s antimicrobial and bactericidal effect and are active against most gram-negative and gram-positive microorganisms (staphylococci, streptococci, protists, Klebsiella, E. coli and others). Thanks to dexamethasone Sofradex also has antihistamine, anti-edematous and anti-inflammatory effects, effectively eliminating itching, burning, lacrimation and pain accompanying bacterial eye lesions.

Pharmacokinetics

When used topically, systemic absorption is low.

Framicetin sulfate may be absorbed through inflamed skin or open wounds. When entering the systemic bloodstream it is rapidly excreted by the kidneys in unchanged form. T1/2 of framicetin sulfate is 2-3 hours.

When administered orally, dexamethasone is able to be quickly absorbed from the gastrointestinal tract. T1/2 is 190 minutes.

Indications

In ophthalmology Sofradex is used to treat infectious and inflammatory diseases of the eyes and their appendages caused by microorganisms sensitive to the action of the drug:

• keratoconjunctivitis (including allergic)
• iridocyclitis
• uveitis
• blepharitis
• scleritis
• chalazione
• infected eyelid eczema

In otolaryngology, the drug is used to treat acute and chronic external otitis caused by sensitive microorganisms.

Active ingredient

Dexamethasone, Framicetin

Composition

The eye and ear drops are in the form of a clear, almost colorless solution, with a smell of phenylethyl alcohol.

1 ml of Framicetin

Sulfate 5 mg

Gramicidin 50 µ

dexamethasone (in the form of sodium metasulfobenzoate)500 mcg

Associated substances:

Lithium chloride,

Sodium citrate,

citric acid monohydrate,

phenylethanol,

ethanol 99.5%,

Polysorbate 80,

water d/i.

How to take, the dosage

In case of eye diseases: in case of mild infectious process the drug is put into the conjunctival sac of the eye every 4 hours in 1-2 drops. In case of a severe infectious process the drug is applied every hour. As inflammation decreases, the frequency of instillation decreases.

In case of ear diseases: the drug is applied in 2-3 drops 3-4 times a day; a gauze tampon moistened with the solution can be inserted into the external auditory canal.

The drug should not be used for more than 7 days unless there is a clear positive trend in the disease (GCS can mask hidden infections and long-term use of the antimicrobial components of the medication can help develop resistant flora).

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Interaction

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

Special Instructions

In long-term use of the drug, as well as with long-term use of other antimicrobials, superinfections caused by microorganisms resistant to the drug, including fungi, may develop.

In case of repeated use, treatment should be monitored by a physician to rule out cases of elevated intraocular pressure and development of lens opacities.

The use of soft contact lenses is not recommended during treatment of inflammatory eye disease.

Treatment with corticosteroid-containing medications should not be repeated or prolonged without regular monitoring of intraocular pressure and eye examinations for cataract development or secondary infections.

Topical corticosteroids should never be used in patients with ocular hyperemia of unspecified etiology; because inappropriate use of the drug may result in significant visual impairment.

Framicetin sulfate, the component of the drug, is an aminoglycoside antibiotic that has nephrotoxic and ototoxic effects when used systemically or topically on open wounds or broken skin.

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

While these effects have not been seen with eye drops, the possibility of these effects occurring when high doses of the drug are used topically in children should be considered.

The long-term use of the drug should not exceed 7 days unless there is a clear positive trend, because prolonged use of its glucocorticosteroid component may mask latent infections, and prolonged use of antimicrobial agents may contribute to resistant microflora.

Patients who temporarily lose visual acuity after injection are not recommended to drive or operate machinery, machines, or other complex equipment requiring visual acuity immediately after injection. The bottle should be closed after each use.

Do not touch the pipette tip to the eye.

Contraindications

• Individual sensitivity to any of the drug components
• For the treatment of viral, tuberculosis, fungal eye lesions;
• in the presence of purulent discharge from the eye;
• in glaucoma;
• in pregnancy and lactation

With caution:

In young children (especially when the drug is administered in high doses and for a long time – risk of systemic effects and suppression of adrenal function)

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Side effects

Allergic reactions may occur during treatment: irritation, burning, pain, itching.

Long-term use of topical corticosteroids may result in increased intraocular pressure with the development of a glaucoma complex (optic nerve damage, decreased visual acuity and visual field defects), so intraocular pressure should be measured regularly when using agents containing glucocorticosteroids for more than 7 days.

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

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

The occurrence of secondary (fungal) infection.

Overdose

Serious side effects are unlikely if the contents of a single vial (up to 10 ml of solution) are swallowed.

Long-term and intensive topical use may lead to systemic effects. The treatment is symptomatic.

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