Dexamethasone - instructions for use, dose, side effects, contraindications

Excipients: boric acid 15.0 mg, sodium tetraborate decahydrate (sodium tetraborate 10-water) 0.6 mg, disodium edetate (trilon B) 0.5 mg, benzalkonium chloride 0.04 mg, water for injection up to 1 ml.

Description: Colorless, clear liquid.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

H.02.A.B.02 Dexamethasone

S.01.B.A.01 Dexamethasone

H.02.A.B Glucocorticoids

S.01.B.A Corticosteroids

Pharmacodynamics:

Fluorinated glucocorticosteroid, has a pronounced anti-inflammatory, anti-allergic and anti-exsudative action. Interacting with a specific protein receptor in target tissues, regulates the expression of corticoid-dependent genes and thus influences protein synthesis. Reduces the formation, release and activity of inflammatory mediators (histamine, bradykinin, prostaglandin, lysosomal enzymes). Suppresses the migration of cells to the site of inflammation; reduces vasodilation and increased vascular permeability in the focus of inflammation. Stabilizes lysosomal enzymes of leukocyte membranes; Suppresses the synthesis of antibodies and disrupts the recognition of the antigen. It inhibits the release of interleukin-1 and interleukin-2, interferon gamma from lymphocytes and macrophages. It induces the formation of lipocortin, inhibits the release of eosinophils by inflammatory mediators and stabilizes the membranes of mast cells. All these effects are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical or immune damage. The duration of anti-inflammatory action after instillation of 1 drop of solution is from 4 to 8 hours.

Pharmacokinetics:

After instillation into the conjunctival sac it penetrates well into the epithelium of the cornea and conjunctiva; while in the aqueous humor of the eye, therapeutic concentrations are achieved; with inflammation or damage to the mucous membrane, the penetration rate increases. About 60-70% of dexamethasone entering the systemic circulation communicates with plasma proteins. Metabolised in the liver by the action of cytochrome-containing enzymes; metabolites are excreted through the intestine. The half-life period averages 3 hours.

Indications:

Conjunctivitis (nerve and allergic), keratitis, keratoconjunctivitis (without epithelial damage), blepharitis, scleritis, episcleritis, iritis, iridocyclitis and other uveitis of various genesis, blepharoconjunctivitis, superficial corneal traumas of various etiologies (after complete corneal epithelialization), prevention of inflammation after surgical interventions , sympathetic ophthalmia.

Contraindications:

Hypersensitivity, children's age (under 18 years).

Viral and fungal eye diseases, purulent infection of the eyes (without concomitant antimicrobial therapy), trachoma, glaucoma, damage to the integrity of the epithelium of the cornea (including the condition after removal of the foreign body of the cornea); tuberculosis of the eye.

Pregnancy and lactation:

Studies on the safety and efficacy of dexamethasone in pregnant and lactating mothers have not been conducted. The drug can be used only if the significance of the effect for the mother exceeds the risk of side effects of the fetus and the child.

Dosing and Administration:

Adults with a pronounced inflammatory process - during the first 24-48 hours of treatment instill in the conjunctival sac 1-2 drops every two hours, with a decrease in inflammation - every 4-6 hours.

For the prevention of inflammatory processes after eye operations and injuries within the first 24 hours after the operation, the drug is instilled 4 times a day, then for 2 weeks - 3 times a day.

Side effects:

With prolonged use (more than 3 weeks), an increase in intraocular pressure is possible; the development of glaucoma with optic nerve damage, reduced visual acuity and loss of visual fields, as well as the formation of posterior subcapsular cataract, and also the thinning and perforation of the cornea; very rarely - the spread of herpetic and bacterial infection.

In patients with hypersensitivity to dexamethasone or benzalkonium, chloride may develop allergic conjunctivitis and blepharitis.

Irritation, itching and burning of the skin; dermatitis.

Overdose:

Symptoms: it is possible to enhance the dose-dependent described side effects actions.

Treatment: there is no specific antidote. The drug should be withdrawn and symptomatic therapy should be performed.

Interaction:

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

Special instructions:

During treatment (with a duration of more than 2 weeks), it is necessary to monitor the intraocular pressure and the condition of the cornea.

At instillation soft contact lenses should be removed, they can be put on again not earlier than in 15-20 minutes.

Treatment with the drug can mask the picture of a bacterial or fungal infection, so when treating infectious eye diseases the drug should be combined with adequate antimicrobial therapy.

Effect on the ability to drive transp. cf. and fur:Within 30 minutes after instillation, it is necessary to refrain from occupations that require increased attention.

Form release / dosage:

Eye drops, 0,1%.

Packaging:

For 1 ml, 1.5 ml, 2 ml in a tube of a dropper with a valve or 5 ml. 10 ml and a tube-dropper with a screw neck of polyethylene.

Tube-dropper with screw throatsmoke caps screwed from polymeric materials.

2, 5 tubes of 1 drop, 1 ml, 2 ml or 2 tubes of 1.5 ml or 1 tube of a dropper of 5 ml, 10 ml with instructions for use are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of 2 to 18 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

After opening, use within 14 days.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006566/10

Date of registration:09.07.2010 / 02.10.2015

Expiration Date:Unlimited

The owner of the registration certificate:UPDATE OF PFC, CJSC UPDATE OF PFC, CJSC Russia

Manufacturer: & nbsp

UPDATE, PFC CJSC Russia

Representation: & nbspUPDATE OF PFC, CJSCUPDATE OF PFC, CJSC

Information update date: & nbsp21.03.2017

Illustrated instructions

Instructions

Dexamethasone (Dexamethasone)