Dexamethasone eye drops 10 ml (Dexamethasone)

dexamethasone release form. Eye drops

Packing

10 ml - polymer dropper bottle (1) - packs of cardboard.

Pharmacological action of

GCS for topical use in ophthalmology. It has a pronounced anti-inflammatory, anti-allergic and antiexudative effect.

Interacting with specific protein receptors in target tissues, it regulates the expression of corticoid-dependent genes and thus affects protein synthesis. Reduces the formation, release and activity of inflammatory mediators (including histamine, kinin, prostaglandins, lysosomal enzymes).

Suppresses cell migration to the site of inflammation. Reduces vasodilation and increased vascular permeability in the focus of inflammation. Stabilizes lysosomal enzymes of leukocyte membranes. Suppresses antibody synthesis and disrupts antigen recognition. It inhibits the release of interleukin 1 and interleukin 2, -Interferon from lymphocytes and macrophages. It induces the formation of lipocortin, inhibits the release of inflammatory mediators by eosinophils and stabilizes mast cell membranes. All 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 of the drug after instillation of 1 drop of the solution is from 4 to 8 hours.

Pharmacokinetics

Absorption and distribution of

After instillation in the conjunctival sac, dexamethasone penetrates well into the corneal epithelium and conjunctiva, while the eye is hydrated. With inflammation or damage to the mucous membrane, the penetration rate increases.

Systemic absorption of the drug is minimal. About 60-70% of dexamethasone entering the systemic circulation binds to plasma proteins.

Metabolism and excretion

Dexamethasone is metabolized in the liver by cytochrome-containing enzymes. Metabolites are excreted in the feces. T1 / 2 averages 3 hours.

Indications

conjunctivitis (purulent and allergic)

keratitis

keratoconjunctivitis (without epithelial injury)

blepharitis

scleritis

episcleritis

chorioretinitis

uveitis

Blepharoconjunctivitis

optic neuritis

sympathetic ophthalmia

prophylaxis and treatment of inflammation after surgical interventions and

recovery injuries corneal transparency and a decrease in neovascularization after keratitis, burns.

Contraindications

viral eye diseases

fungal diseases of the eyes

purulent eye diseases (without concomitant antimicrobial therapy)

trachoma

increased intraocular pressure

damage to the corneal epithelium srdlkrpc

hypersensitivity to the components of the drug.

Use during pregnancy and lactation

Use of the drug during pregnancy during lactation (breastfeeding) is contraindicated.

Composition

Eye drops 0.1% in the form of a suspension of white color, a precipitate may be present, which is rapidly resuspended with slight agitation.

1 ml

dexamethasone 1 mg

Excipients: polysorbate 80, hypromellose (hydroxypropyl methylcellulose 4000), disodium phosphate dodecahydrate, citric acid monohydrate, sodium chloride, disodium edetate dihydrate, benzalkonium chloride.

Side effects

Basically, the drug has good tolerance.

Local reactions: immediately after instillation of the drug, a rapidly passing burning sensation, lacrimation, blurred vision is possible.

With prolonged use of the drug (more than 2 weeks) may increase intraocular pressure, the development of glaucoma with damage to the optic nerve, decreased visual acuity and loss of visual fields, as well as the formation of posterior subcapsular cataracts, thinning and perforation of the cornea are very rare - the spread of herpetic and bacterial infections.

Patients with hypersensitivity to dexamethasone or benzalkonium chloride may develop allergic conjunctivitis and blepharitis.

Perhaps the development of pruritus, palpebral or conjunctival erythema.

When corneal or scleral ulcers appear, the drug may slow healing and contribute to the development of reinfection.

With prolonged use, an increased risk of developing systemic side effects characteristic of GCS is possible.

From the endocrine system: decreased glucose tolerance, steroid diabetes mellitus or the manifestation of latent diabetes mellitus, inhibition of adrenal function, Itsenko-Cushing's syndrome.

From the digestive system: nausea, vomiting, increased or decreased appetite, exacerbation of chronic gastrointestinal diseases.

From the cardiovascular system: arrhythmia, bradycardia, increased blood pressure.

From the side of the central nervous system: increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, headache.

Drug Interaction

Extensive use of dexamethasone with idoxuridine may lead to an increase in destructive processes in the corneal epithelium.

Dexamethasone can enhance the action of barbiturates.

Co-administration of phenytoin with dexamethasone results in a lower concentration of the latter.

Warfarin in combination with dexamethasone increases the risk of bleeding.

In normal topical administration, the dose is insufficient to induce induction or saturation of hepatic enzymes.

With the simultaneous use of dexamethasone with diuretics (especially thiazide and carbonic anhydrase inhibitors) and amphotericin B, potassium excretion and increased risk of heart failure may increase.

The concomitant use of dexamethasone with cardiac glycosides impairs their tolerability and increases the likelihood of ventricular extrasystole (due to hypokalemia).

The simultaneous use of dexamethasone with ethanol and NSAIDs increases the risk of erosive-ulcerative lesions of the gastrointestinal tract.

Estrogens and oral estrogen-containing contraceptives reduce the clearance of dexamethasone, which may be accompanied by an increase in the severity of its action.

Co-administration of antiarrhythmic drugs with dexamethasone can reduce the effect of the latter.

Overdose

Overdose when used in ophthalmology is unlikely.

Symptoms: Local manifestations are possible. There is no specific antidote. The drug should be discontinued and symptomatic therapy prescribed.

Prolonged administration or high-dose administration may increase systemic absorption of dexamethasone, as well as the development of ocular hypertension and certain diseases of the cornea or lens.

Storage conditions

The drug should be stored out of the reach of children, in a dry, dark place at a temperature of no higher than 25 ° C.

Expiration

3 years. After opening the vial, the drug should be stored for no more than 4 weeks.



pharmacy terms and conditions

prescription

Dosage form

Dosage form

eye drops

K.O. Rompharm Company S.R.L., Romania



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