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

Excipients: boric acid 15 mg, sodium tetraborate decahydrate (borax) 0.6 mg, disodium edetate dihydrate 0.5 mg, benzalkonium chloride in terms of 100% dry matter 0.04 mg, water for injection up to 1 ml.

Description:Transparent colorless 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 affects protein synthesis. Reduces the formation, release and activity of inflammatory mediators (histamine, kinin, 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, gamma-interferon 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.

Duration anti-inflammatory effect 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, and therapeutic concentrations are achieved in the aqueous humor of the eye. 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. Half-life (T_1/2) eye drops - about 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 diseases of the eyes, 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), eye tuberculosis.

Carefully:Pregnancy, lactation period (therapy is allowed for not more than 7-10 days).

Pregnancy and lactation:

The safety of the drug during the period of pregnancy and lactation is not established, so it should be used with caution in this category of patients. The course of treatment should not exceed 10 days.

Dosing and Administration:

They are used in the conjunctival sac.

At the expressed inflammatory process - During the first 24-48 hours of treatment, 1-2 drops are injected into the conjunctival sac every 2 hours, with the inflammation subsiding every 4-6 hours.

For the prevention of inflammatory processes after ophthalmic surgeries and injuries: during the first 24 hours after the operation - 1-2 drops 4 times a day, then - 3 times a day for 2 weeks.

The course of treatment is selected individually, on average - 2-3 weeks.

Side effects:

With prolonged use of eye drops (more than 10 days), it is possible to increase intraocular pressure, glaucoma development with optic nerve damage, decreased visual acuity and loss of visual fields, as well as formation of posterior subcapsular cataract, thinning and perforation of the cornea.

Very rarely - the spread of herpetic and bacterial infection.

Allergic conjunctivitis and blepharitis in patients with hypersensitivity to dexamethasone or excipients of the drug.

Overdose:

Not described.

Interaction:

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

Special instructions:

During the treatment of ophthalmic diseases (with a duration of more than 2 weeks) through 10 days, monitoring of intraocular pressure and corneal conditions is necessary.

When dropping eye drops soft contact lenses should be removed and re-dressed no earlier than 15-20 minutes.

Within 30 minutes after instillation of eye drops, it is necessary to refrain from occupations requiring an increased concentration of attention and speed of psychomotor reactions.

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:

As with the application of other eye drops, temporary blurred vision or other visual impairments may affect the ability to drive vehicles or mechanisms. If blurred vision occurs when instilled, the patient must wait until vision is restored, before driving or working with other mechanisms.

Form release / dosage:Eye drops, 0,1%.

Packaging:For 5 ml or 10 ml in polyethylene bottles, ukuporennye caps.

Each bottle, along with instructions for medical use, is put in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:3 years.

Shelf life after opening the bottle is 28 days.

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

Terms of leave from pharmacies:On prescription

Registration number:LS-001351

Date of registration:05.08.2011 / 06.07.2015

Expiration Date:Unlimited

The owner of the registration certificate:FARMAK, PAO FARMAK, PAO Ukraine

Manufacturer: & nbsp

FARMAK, PAO Ukraine

Representation: & nbspFARMAK PAOFARMAK PAO

Information update date: & nbsp21.03.2017

Illustrated instructions

Instructions

Dexamethasone (Dexamethasone)