Dexamethasone Reneval, eye drops 0.1% 10 ml

Pharmacodynamics

Fluorinated glucocorticosteroid, has a pronounced anti-inflammatory, anti-allergic and anti-exudative effect. Interacting with specific protein receptor in target tissues it regulates the expression of corticoid-dependent genes and thus affects protein synthesis. It decreases formation, release and activity of inflammatory mediators (histamine, bradykinin, prostaglandins, lysosomal enzymes).

Inhibits cell migration to the site of inflammation, decreases vasodilation and increased vascular permeability in the inflammation area. Stabilizes lysosomal enzymes in leukocyte membranes, inhibits antibody synthesis and disrupts antigen recognition. Inhibits release of interleukin-1 and interleukin-2, interferon gamma from lymphocytes and macrophages.

Induces lipocortin formation, inhibits release of inflammatory mediators by eosinophils and stabilizes mast cell membranes. All of these effects are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical or immune damage. Duration of anti-inflammatory action after 1 drop of solution is 4 to 8 h.

Pharmacokinetics

After injection into the conjunctival sac it penetrates well into corneal epithelium and conjunctiva; therapeutic concentrations are reached in aqueous humor of eye; when inflammation or mucous membrane damage occurs the penetration rate increases. About 60-70% of dexamethasone entering the systemic bloodstream is bound to plasma proteins.

Metabolized in the liver under the action of cytochrome-containing enzymes; metabolites are excreted through the intestine. The elimination half-life is on average 3 hours.

Indications

Iridocyclitis, Inflammatory eye disease, Conjunctivitis, Blepharitis, Allergy

Conjunctivitis (non-pulmonary and allergic), keratitis, keratoconjunctivitis (without epithelium damage), blepharitis, scleritis, episcleritis, iritis, iridocyclitis and other uveitis of various genesis, blepharoconjunctivitis, surface corneal injuries of various etiology (after complete epithelization of the cornea), prevention of inflammation after surgical intervention, sympathetic ophthalmia.

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Active ingredient

Dexamethasone

Composition

1 ml of the solution contains:
active ingredient:
dexamethasone sodium phosphate – 1.0 mg
excipients:
boric acid – 15.0 mg
sodium tetraborate decahydrate (sodium tetraboronate 10-water) – 0.6 mg
dinatrate edetate (trilon B) – 0.5 mg
benzalkonium chloride – 0.04 mg
water for injection – up to 1 ml

How to take, the dosage

In adults with severe inflammatory process during the first 24-48 hours of treatment the drug is instilled into the conjunctival sac 1-2 drops every two hours, when the inflammation decreases – every 4-6 hours. For prophylaxis of inflammatory processes after eye surgery and trauma the drug is injected 4 times a day during first 24 hours after surgery, then 3 times a day for 2 weeks.

Interaction

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

Special Instructions

In the course of treatment of ophthalmic diseases (for a duration of more than 2 weeks) the control of intraocular pressure and corneal condition is necessary after 10 days.

In case of eye drops application the soft contact lenses shall be taken off and put on again not earlier than 15-20 min.
For 30 min after instillation of the eye drops it is necessary to refrain from activities which require high concentration and quick psychomotor reactions.

The treatment with the drug may mask the picture of bacterial or fungal infection, that is why in case of eye and ear infections the drug should be combined with adequate antimicrobial therapy.

Contraindications

• keratitis caused by Herpes simplex or Varicella zoster viruses (tree keratitis), viral diseases of the cornea and conjunctiva (including varicella zoster).
• mycobacterial eye infections;
• fungal eye diseases;
• acute purulent eye diseases;
• corneal epitheliopathy;
• high intraocular pressure;
• high sensitivity to the components of the drug.

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Side effects

In prolonged use of eye drops (more than 10 days) there may be an increase in intraocular pressure, development of glaucoma with optic nerve damage, decreased visual acuity and visual field loss, as well as formation of posterior subcapsular cataract, also possible thinning and perforation of the cornea; very rarely – spread of herpetic and bacterial infection.

In patients with hypersensitivity to dexamethasone or benzalkonium chloride (preservative) – allergic conjunctivitis and blepharitis.

When using ear drops: itching of the external auditory canal, sensation of a foreign body in the ear or blockage of the ear, ear pain, development of superinfection, discomfort in the ear, tingling sensation in the ear, temporary hearing loss, erythema.

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Overdose

Symptoms: dose-dependent side effects described may worsen.
Treatment: There is no specific antidote. The drug should be discontinued and symptomatic therapy should be carried out.

Similarities

Oftan Dexamethasone, Maxidex, Dexamethasone-Vial, Dexamethasone, Megadexan