Instruction for use: Oftan Dexamethason

Active substance: Dexamethasone

ATX Code S01BA01 Dexamethasone

Pharmacological group

Glucocorticosteroids

Ophthalmic products

The nosological classification (ICD-10)

H10.1 Acute atopic conjunctivitis

Allergic conjunctivitis, Allergic eye disease, Allergic conjunctivitis, Allergic conjunctivitis is caused by chemical and physical factors, Allergic rhinoconjunctivitis,Allergic inflammation of the eye, Spring catarrh, Spring keratitis, Spring conjunctivitis, allergic Conjunctivitis, Perennial allergic conjunctivitis,Exacerbation of pollen allergy in the form of Syndrome rinokonyunktivalnogo, Acute allergic keratoconjunctivitis, Acute allergic conjunctivitis,Superficial bacterial eye infections,rhinoconjunctivitis, Seasonal allergic conjunctivitis, Seasonal conjunctivitis, Sennoz, Chronic allergic keratoconjunctivitis, Chronic allergic conjunctivitis

H10.4 Chronic conjunctivitis

Chronic allergic conjunctivitis, Chronic inflammation of the conjunctivam, Papillary conjunctivitis, Phlyctenular keratoconjunctivitis, Chronic blepharoconjunctivitis, blepharoconjunctivitis, stafillokokk blepharoconjunctivitis

H10.9 Conjunctivitis, unspecified

Trahomny conjunctivitis, catarrhal conjunctivitis, Giperpapillyarny conjunctivitis, Non-infectious conjunctivitis, purulent conjunctivitis, Purulent conjunctivitis form, Year-round conjunctivitis, purulent conjunctivitis, Subacute conjunctivitis, Secondarily infected with conjunctivitis

H16 Keratitis

Adenoviral keratitis, Bacterial keratitis, Spring keratitis, Deep keratitis without epithelial damage, Discoid keratitis, Dendritic keratitis, Keratitis rosacea, Keratitis with destruction of the cornea, Superficial keratitis, Point keratitis, Traumatic keratitis, Superficial point keratitis

H16.2 Keratoconjunctivitis

Chronic allergic keratoconjunctivitis, Bacterial keratoconjunctivitis, Deep forms of adenovirus keratoconjunctivitis, Infectious conjunctivitis and keratoconjunctivitis caused by Chlamydia trachomatis, Acute allergic keratoconjunctivitis, Spring keratoconjunctivitis, Phlyctenular keratoconjunctivitis

H20 Iridocyclitis

recurrent iritis, sympathetic iridocyclitis, Sluggish posterior uveitis, Sluggish posterior uveitis, Posterior uveitis, the posterior segment of the eye Iridocyclitis, Iridocyclitis and other uveitis, Irit, Keratoiridotsiklit, Acute iritis, uveitis, cycle of Acute iridocyclitis, Acute non-infectious uveitis

S05 Injury of the eye and orbit

Wounds of the eye penetrating, Non-penetrating wound of the eyeball, Superficial injury of the cornea, Post-traumatic keratopathy, Post-traumatic central retinal dystrophy, Penetrating wound of the cornea, Condition after eye injuries, Condition after eyeball injuries, Penetrating corneal wounds, Injuries to eye tissues, Injuries to the cornea, Injury of anterior part of eye

Composition and form of release

Eye drops 1 ml

Dexamethasone sodium phosphate (in terms of dexamethasone) 1 mg

Auxiliary substances: benzalkonium chloride; boric acid; Borax; Disodium edetate; water for injections

In plastic bottles-droppers of 5 ml; In a pack of cardboard 1 bottle.

Description of dosage form

Colorless transparent solution.

pharmachologic effect

Pharmacological action - anti-inflammatory, anti-allergic.

Indications

Acute and chronic inflammatory processes: non-neural forms of conjunctivitis, keratitis, keratoconjunctivitis and blepharitis, scleritis and episcleritis, iritis, iridocyclitis and other uveitis of various origins, superficial injuries of the cornea of various etiologies (chemical, physical or immune mechanisms) after complete epithelialization of the cornea, inflammation of the posterior segment Eyes (choroiditis, chorioretinitis), sympathetic ophthalmia.

Allergic conjunctivitis or keratoconjunctivitis.

Prevention and treatment of inflammatory phenomena in the postoperative and post-traumatic period.

Contraindications

Keratitis caused by Herpes simplex, chicken pox and other viral diseases of the cornea and conjunctiva, mycobacterial eye infections, fungal eye diseases, acute purulent eye diseases with corneal epithelium, epitheliopathy of the cornea, increased intraocular pressure, hypersensitivity to any of the components of the drug.

pregnancy and lactation

Perhaps, if the expected effect of therapy exceeds the potential risk for the fetus (up to now, clinical trials data regarding the use of the drug during pregnancy, lactation, and also in children are absent)

Side effects

Quickly burning feeling.

With prolonged use, there may be a secondary glaucoma and steroid cataract, so when using the drug for more than 2 weeks, and in patients with a history of glaucoma, it is recommended to regularly monitor the intraocular pressure.

Interaction

Can enhance the effects of phenytoin, barbiturates and warfarin. Reduces the effectiveness of CCB, quinidine and erythromycin (induces the isoenzyme CYP3A4). In normal local administration, the dose is not sufficient to induce induction or saturation of liver enzymes.

Dosing and Administration

Conjunctival. 1-2 drops in the conjunctival sac 3-5 times a day.

Course - no more than 2-3 weeks.

Overdose

With topical application, an overdose is unlikely.

Precautionary measures

Use within 2 weeks or more should be carried out under the control of intraocular pressure.

In the presence of a bacterial or fungal infection, treatment should be carried out in combination with appropriate antimicrobial therapy.

Before instillation contact lenses should be removed and reestablished 15 minutes after application (to avoid deposition of preservative - benzalkonium chloride on them).

Due to possible lacrimation after instillation, it is not recommended to apply the drug directly before driving a vehicle or servicing mechanical equipment.

special instructions

Eye drops in the opened vial should be used within 1 month.

storage Conditions

At a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life

2 years. After opening the bottle - 1 month.

Do not use after the expiry date printed on the package.