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
sclerites
chalazion
infected eyelid eczema

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

Pharmacological effect

Sofradex eye drops are a combination drug containing two antibiotics (gramicidin + framycetin) and a glucocorticosteroid (dexamethasone), used in ophthalmology and otolaryngology.

Antibiotics complement the antimicrobial and bactericidal effect of each other, showing activity against most gram-negative and gram-positive microorganisms (staphylococci, streptococci, Proteus, Klebsiella, E. coli, etc.). Thanks to dexamethasone, Sofradex also has antihistamine, anti-edematous and anti-inflammatory effects, effectively eliminating itching, burning, lacrimation and pain that accompany bacterial eye lesions.

Pharmacokinetics

When applied topically, systemic absorption is low.

Framycetin sulfate can be absorbed through inflamed skin or open wounds. Once it enters the systemic circulation, it is quickly excreted unchanged by the kidneys. 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.

Special instructions

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

In case of re-prescription, treatment should be carried out under the supervision of a physician to exclude cases of increased intraocular pressure and the development of lens opacification.

During treatment of inflammatory eye diseases, it is not recommended to use soft contact lenses.

Treatment with drugs containing corticosteroids should not be repeated or prolonged without regular monitoring of intraocular pressure and eye examination for the development of cataracts or secondary infections.

Topical corticosteroids should never be used in patients with ocular hyperemia of unknown etiology; since 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 topically on open wounds or damaged skin.

These effects are dose dependent and are increased with 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 should be taken into account in the case of topical use of high doses of the drug in children.

The duration of use of the drug should not exceed 7 days, except in cases of obvious positive dynamics of the disease, since long-term use of the glucocorticosteroid included in its composition can mask hidden infections, and long-term use of antimicrobial components can contribute to the emergence of resistant microflora.

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

Do not touch the tip of the pipette to your eye.

Active ingredient

Framycetin, Gramicidin, Dexamethasone

Composition

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

1 ml framycetin

sulfate 5 mg

gramicidin 50 mk

dexamethasone (in the form of sodium metasulfobenzoate) 500 mcg

Excipients:

lithium chloride,

sodium citrate,

citric acid monohydrate,

phenylethanol,

ethanol 99.5%,

polysorbate 80,

water d/i.

Contraindications

with increased individual sensitivity to any of the components of the drug;
for the treatment of viral, tuberculosis, fungal eye infections;
in the presence of purulent discharge from the eyes;
for glaucoma;
during pregnancy and lactation;

With caution:

Young children (especially when the drug is prescribed in large doses and for a long time – the risk of developing systemic effects and suppression of adrenal function)

Side Effects

During treatment, allergic reactions are possible: irritation, burning, pain, itching.

With long-term use of topical corticosteroids, intraocular pressure may increase with the development of the glaucoma symptom complex (damage to the optic nerve, decreased 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 regularly measured.

Development of posterior subcapsular cataract (especially with frequent instillation).

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

Attachment of a secondary (fungal) infection.

Interaction

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

Overdose

It is unlikely that serious side effects will develop if the contents of one bottle are swallowed (up to 10 ml of solution).

Prolonged and intensive topical use may lead to systemic effects. Treatment is symptomatic.

Storage conditions

The drug should be stored in a cool, dry place at a temperature not exceeding 25°C.

Shelf life

2 years. After opening the bottle, the drug should be used within 1 month.

Manufacturer

Sanofi India Ltd, India