Dexamethasone, eye drops 0.1%, 10ml

Composition

Active ingredient:  dexamethasone sodium phosphate 1 mg;

Auxiliary substances:  boric acid-15 mg; sodium tetraborate decahydrate (borax) — 0.6 mg; disodium edetate dihydrate-0.5 mg; benzalkonium chloride (based on 100% dry matter) – 0.04 mg; water for injection-up to 1 ml

Pharmacological action

Dexamethasone is a glucocorticoid drug for topical use in ophthalmology. It has anti-inflammatory, anti-allergic and anti-exudative effects.

Indications

Acute and chronic allergic and inflammatory diseases of the eye (including conjunctivitis, scleritis, deep keratitis without damage to the epithelium, iritis, iridocyclitis, choroiditis, chorioretinitis, optic neuritis); prevention and treatment of inflammatory processes in the postoperative and post-traumatic period.

Use during pregnancy and lactation

The safety and efficacy of the drug Farmadex for the treatment of children has not been established, so the drug is not prescribed to children.

The safety of using the drug during pregnancy and lactation has not been established. With topical application of eye drops, the systemic manifestation is low, so the risk is considered small, but the benefit/risk ratio should be carefully evaluated when prescribing to pregnant and breast-feeding women.

Contraindications

• Keratitis caused by Varicella zoster (tree keratitis), viral diseases of the cornea and conjunctiva (including chickenpox);
• mycobacterial eye infections;
• fungal eye diseases;
• acute purulent eye diseases;
• corneal epitheliopathy; 
• increased intraocular pressure;
• hypersensitivity to dexamethasone.

Side effects

Visual impairment: short-term burning sensation, eye discomfort, itching, tingling, hyperemia, lacrimation, local allergic reactions, edema and itching of the eyelids, decreased visual acuity, visual field disturbances, increased intraocular pressure, corneal perforation (with its thinning), mydriasis, keratitis, ptosis, photophobia, posterior subcapsular cataract formation, glaucoma, glaucoma with optic nerve damage.

When treated with glucocorticoids, bacterial, fungal or viral (Herpes simplex) eye infections, blepharitis or conjunctivitis associated with inhibition of the body’s response to infection may develop.

Interaction

Special studies of the drug’s interaction with other drugs have not been conducted.

There have been reports of interactions of the Active ingredient after systemic use. However, after instilling drops in the eye, the systemic absorption of dexamethasone is so low that the risk of any interaction is minimal.

When using other topical ophthalmic medications as concomitant therapy, an interval of 10-15 minutes between their use should be observed together with the drug.

With prolonged use with iodoxuridine, it is possible to increase destructive processes in the corneal epithelium.

How to take, course of use and dosage

Into the conjunctival sac.

With a pronounced inflammatory process-during the first 24-48 hours of treatment,1-2 drops are instilled every hour, with the inflammatory process subsiding-every 2-4 hours. Then the dose is reduced to 1 drop 3-4 times a day.

In chronic diseases,1-2 drops are instilled into the conjunctival sac of the affected eye every 3-6 hours or more often until the desired effect is achieved.

For allergic conditions,1-2 drops every 3-4 hours until the desired effect is achieved.

The course of treatment is selected individually, on average-1-1.5 weeks.

Overdose

There are no reports of severe systemic reactions due to drug overdose.

In case of overdose with topical application, rinse the eye (s) with warm water.

There is no specific antidote for topical corticosteroid use. Treatment is symptomatic.

Special instructions

Prolonged use of corticosteroids or an increase in the frequency of use can lead to ocular hypertension / glaucoma with damage to the optic nerve and deterioration of visual acuity and loss of the visual field, as well as to the formation of subcapsular cataracts of the posterior chamber of the eye.

After applying the usual doses, sensitive patients may experience increased intraocular pressure. It is recommended to constantly monitor intraocular pressure.

In patients with glaucoma, treatment with the drug should be limited to two weeks, except in cases where prolonged treatment is justified. Intraocular pressure should be constantly monitored.

With prolonged use of steroids, you may develop:

• fungal infections of the cornea (may develop a fungal infestation in any persistent ulceration of the cornea);
• secondary bacterial infection of the eyes may occur when the oppression of the body’s response to infection;
• to mask or enhance the activity of acute purulent infections of the eye;
• on the background of steroid therapy of diseases that cause thinning of the cornea or sclera, can lead to perforation;
• slow healing of wounds of the cornea.

Treatment should not be stopped prematurely, as sudden discontinuation of topical treatment with high doses of steroids can cause repeated inflammation of the eye.

Eye drops contain the preservative benzalkonium chloride, which can irritate the eyes and discolor soft contact lenses. Therefore, patients should remove their contact lenses before using Farmadex and should be informed to wait 15 minutes after instillation of Farmadex before inserting contact lenses.

The safety of use has not been studied in patients who have kidney or liver disease. However, due to the low systemic absorption of dexamethasone, after topical use of this drug, dose adjustment is not necessary.

Ability to influence the reaction rate when driving vehicles or mechanisms.

Temporary blurred vision or other visual disturbances may affect the ability to drive vehicles or mechanisms. If blurred vision occurs during instillation, the patient should wait until vision is restored before driving vehicles or working with other mechanisms.

Form of production

Eye drops.

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Dexamethasone

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Description

For adults as directed by your doctor

Indications

Iridocyclitis, Blepharitis, Inflammatory eye diseases, Allergies, Conjunctivitis