Oftan Dexamethasone, eye drops 1 mg/ml 5 ml

Pharmacological action Pharmacotherapeutic group: Glucocorticosteroids for topical use

ATC code S01BAO1

Pharmacological action

Pharmacodynamics

Synthetic fluorinated glucocorticosteroid. It has a strong anti-inflammatory and anti-allergic effect.

Interacting with specific protein receptor in the target tissues it regulates the expression of corticoid-dependent genes and thus affects protein synthesis. Stabilizes lysosomal membrane enzymes of leukocytes; inhibits kininin synthesis, mitosis and leukocyte migration; inhibits antibody synthesis and impairs antigen recognition. All these effects are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical or immune damage. Duration of anti-inflammatory effect after 1 drop of the solution is from 4 to 8 hours.

Pharmacokinetics

When applied topically systemic absorption is low. After injection into the conjunctival sac penetrates well into the corneal epithelium and conjunctiva; therapeutic concentrations are achieved in the aqueous humor of the eye; in inflammation or mucosal damage penetration rate increases.

About 60-70% of dexamethasone entering the systemic bloodstream is bound to plasma proteins. It is metabolized in the liver under the action of cytochrome P450 containing enzymes (CYP3A4); metabolites are excreted through the intestine. Plasma half-life (t1/2) averages 3.6 ± 0.9 hours.

Indications

Active ingredient

Composition

How to take, the dosage

In acute conditions

After the inflammation has subsided

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

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

Interaction

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

Long-term use with iodoxuridine may increase destructive processes in the corneal epithelium.

Special Instructions

If contact lenses must be used during treatment with Ophthane Dexamethasone, they should be removed before the drug is administered and if necessary no earlier than 15 min after installation, because Ophthane Dexamethasone contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses and cause discoloration and adverse effects on the eye tissue.

If treatment is longer than 2 weeks, intraocular pressure and corneal condition should be monitored regularly.

Corticosteroid therapy may mask an ongoing bacterial or fungal infection. If infection is present, the use of drops should be combined with appropriate antimicrobial therapy.

Impact on driving and operating machinery

In view of possible lacrimation after injection, the drug is not recommended immediately before driving vehicles or operating mechanical equipment.

Contraindications

Side effects

A quick burning sensation and allergic reactions are possible after injection.

Long-term use may lead to secondary glaucoma and steroid cataracts, as well as corneal ulceration, clouding, thinning or/and perforation; often – the spread of bacterial or herpetic infections.

The drug contains the preservative benzalkonium chloride which may irritate the eyes.

Overdose

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

Pregnancy use

Similarities