Oftan Dexamethasone eye drops 1mg/ml, 5ml

Composition

>1 ml of the drug contains: Active ingredient: Dexamethasone sodium Phosphate 1.32 mg (equivalent to dexamethasone 1.0 mg)Auxiliary substances: Benzalkonium chloride 40.0 mcg, boric acid 15.0 mg, sodium tetraborate 600.0 mcg, disodium edetate 500.0 mcg, water for injection up to 1 ml

Pharmacological action

Pharmacological action

Pharmacotherapy group: Glucocorticosteroid for topical applicationacod ATX S01BAO1 Pharmacological action Pharmacodynamics ynthetic fluorinated glucocorticosteroid. It has a pronounced anti-inflammatory and anti-allergic effect. Interacting with a specific protein receptor in target tissues, it regulates the expression of corticoid-dependent genes and thus affects protein synthesis. Stabilizes lysosomal enzymes of leukocyte membranes; inhibits kinin synthesis, mitosis and migration of leukocytes; suppresses antibody synthesis and disrupts antigen recognition. All of these effects are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical, or immune damage. The duration of the anti-inflammatory effect after instillation of 1 drop of the solution is from 4 to 8 hours. Pharmacokineticaprime When applied topically, systemic absorption is low. After instillation in the conjunctival sac, it penetrates well into the corneal epithelium and conjunctiva; at the same time, therapeutic concentrations are achieved in the watery moisture of the eye; with inflammation or damage to the mucous membrane, the penetration rate increases. About 60-70% of dexamethasone entering the systemic circulation binds to plasma proteins. It is metabolized in the liver by cytochrome P 450-containing enzymes (CYP3A4); metabolites are excreted through the intestine. The plasma half-life (t1/2) averages 3.6 ± 0.9 hours.

Indications

Acute and chronic inflammatory processes: – non-purulent forms of conjunctivitis, keratitis, keratoconjunctivitis without damage to the epithelium and blepharitis; – scleritis and episcleritis; – iritis, iridocyclitis and other uveitis of various origins;- superficial corneal injuries of various etiologies (chemical, physical or immune mechanisms) after complete corneal epithelialization; – inflammation of the posterior segment of the eye (choroiditis, chorioretinitis);- sympathetic ophthalmia. Allergic eye diseases: allergic conjunctivitis or keratoconjunctivitis. Prevention and treatment of inflammatory phenomena in the postoperative and post-traumatic period.

Use during pregnancy and lactation

To date, there are no data from clinical trials regarding the use of Oftan Dexamethasone during pregnancy and lactation. Oftan Dexamethasone can only be used during pregnancy and breast-feeding as prescribed by the attending physician, if the expected therapeutic effect justifies the potential risk to the fetus and child. The duration of therapy is no more than 7-10 days.

Contraindications

• Keratitis associated with herpes simplex, chickenpox, and other viral diseases of the cornea and conjunctiva.
• Tuberculosis of the eyes.
• Mycobacterial eye infections.
• Fungal infections of the eyes.
• Acute purulent eye diseases.
• Damage to the corneal epithelium (including the condition after corneal foreign body removal).
• Corneal epitheliopathy.
• Increased intraocular pressure.
• Glaucoma.
• Age up to 18 years (due to the lack of data on the effectiveness and safety of the drug in children and adolescents under 18 years of age).
• Hypersensitivity to the components of the drug.

Side effects

After instillation, a rapid burning sensation and allergic reactions may occur.

With prolonged use

• , secondary glaucoma and steroid cataracts may develop, as well as ulceration, opacification, thinning or/and perforation of the cornea;
• rarely, the spread of bacterial or herpetic infections.

The drug contains the preservative benzalkonium chloride, which can cause eye irritation.

Interaction

Interaction with other drugs is mainly due to the involvement of the CYP3A4 isoenzyme in the elimination of dexamethasone. Dexamethasone induces the CYP3A4 isoenzyme, thus reducing the effectiveness of calcium channel blockers, quinidine and erythromycin. With the usual topical regimen, the dose of the drug is insufficient to cause induction or saturation of liver enzymes.

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

How to take, course of use and dosage

In acute conditions

• ,1-2 drops in the conjunctival sac every 1-2 hours.

After reducing inflammation

• ,1-2 drops in the conjunctival sac 3-5 times / day.

The duration of treatment should not exceed 2-3 weeks.

The decision on the duration of treatment is based on objective data, including the effectiveness of the drug, the severity of clinical symptoms and the possible risk of side effects.

Overdose

Overdose with topical application of Oftan Dexamethasone eye drops is unlikely.

• Symptoms: possible local irritation.
• Treatment: there is no specific antidote. The drug should be discontinued and symptomatic therapy should be prescribed.

Special instructions

If it is necessary to use contact lenses during treatment with Oftan Dexamethasone, they should be removed before using the drug and, if necessary, installed no earlier than 15 minutes after installation, since Oftan Dexamethasone contains the preservative benzalkonium chloride, which can be absorbed by soft contact lenses and cause discoloration and have an adverse effect on eye tissue.

If the treatment lasts more than 2 weeks, intraocular pressure and corneal condition should be monitored regularly.

Corticosteroid therapy can mask ongoing bacterial or fungal infections. In the presence of infection, the use of drops should be combined with appropriate antimicrobial therapy.

Influence on the ability to drive motor vehicles and manage mechanisms

Due to possible lacrimation after instillation, the drug is not recommended to be used immediately before driving vehicles or operating mechanical equipment.

Form of production

Eye drops in the form of a clear colorless solution.

Storage conditions

The drug should be stored out of the reach of children at a temperature of 2° to 8°C.

Shelf life

2 years

Active ingredient

Dexamethasone

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Description

For adults as directed by your doctor

Indications

Conjunctivitis, Blepharitis, Inflammatory Eye Diseases, Iridocyclitis, Allergy