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

Excipients: boric acid 15 mg, sodium tetraborate decahydrate 0.6 mg, disodium edetate dihydrate 0.5 mg, benzalkonium chloride 0.04 mg, water for injection up to 1 ml.

Description:

A clear, colorless solution.

Pharmacotherapeutic group:Ulykokortikosteroid 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:

Synthetic fluorinated glucocorticoid, has a pronounced anti-inflammatory, anti-allergic and antiexudative action. Interacting with a specific protein receptor in target tissues, regulates the expression of corticoid-dependent genes and influences thereby. on protein synthesis. Reduces the formation, release and activity of inflammatory mediators (histamine, bradykinin, prostaglandins, lysosomal enzymes). Suppresses the migration of cells to the site of inflammation, reduces vasodilation and increased vascular permeability in the focus of inflammation.Stabilizes the lysosomal enzymes of leukocyte membranes, inhibits 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 subconjunctival 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% Dexamethasone, which enters the systemic circulation, binds to plasma proteins. Metabolised in the liver by the action of cytochrome-containing enzymes, metabolites are excreted through the intestine. The half-life (T₁_/₂) - about 3 hours.

Indications:

Conjunctivitis (not purulent and allergic), keratitis, keratoconjunctivitis (without damage to the epithelium), blepharitis, scleritis, episcleritis, iritis, iridocyclitis and other uveitis of various genesis, blepharoconjunctivitis, superficial traumas of various etiology cornea (after total epithelization of the cornea), inflammation prophylaxis after eye injuries and surgical interventions, sympathetic ophthalmia.

Contraindications:

Hypersensitivity to the drug, viral and fungal diseases of the eye, purulent eye infections (without concomitant antimicrobial therapy), trachoma, glaucoma, damage to the integrity of the corneal epithelium (including the state of the cornea after removal of a foreign body), eye tuberculosis, children's age ( 18 years).

Pregnancy and lactation:

During pregnancy, the drug with caution and only in those cases where the intended benefits to the mother outweighs the potential risk to the fetus.

During lactation, therapy is allowed for no more than 7-10 days.

Dosing and Administration:

In the presence of an inflammatory process: Within the first 24-48 hours of treatment was instilled 1-2 drops into the conjunctival sac of each eye after 1-2 h; after the improvement of the condition (when the inflammatory process subsides) - 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 - 2-5 weeks.

Side effects:

Immediately after instillation, a brief burning sensation, lacrimation, hyperemia of the conjunctiva is possible.

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

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

Overdose:

Symptoms: local reactions are possible (short-term burning sensation, lacrimation, conjunctival hyperemia).

Treatment: withdrawal of the drug, symptomatic therapy (there is no specific antidote).

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) after 10 days, monitoring of intraocular pressure and corneal status is required.

When instilling eye drops soft contact lenses should be removed and re-installed no earlier than 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.

With prolonged use, the condition of the cornea and the intraocular pressure should be monitored.

Effect on the ability to drive transp. cf. and fur:Within 30 minutes after instillation of the drug, it is necessary to refrain from driving vehicles, as short-term visual acuity and lacrimation are possible.

Form release / dosage:

Eye drops, 0,1%.

Packaging:

For 10 ml in sterile polymer bottles-droppers, hermetically sealed with polymer stoppers, droppers and caps screwed.

By 10 ml in sterile polymer bottles-droppers, made by technology "blow-fill-seal" "blow-fill-seal", hermetically sealed with screw caps.

For 1 polymer bottle-dropper with the instruction for use is placed in a pack of cardboard or in an opaque polymeric unit blister pack of the type Flow-Pack Polyvinyl chloride (PVC) with a flat foil substrate of aluminum printed lacquered or cardboard.

Storage conditions:

In the dark place at a temperature of 12 to 15 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

The bottle-dropper should be used after opening for 30 days.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-001835

Date of registration:13.09.2012 / 26.05.2016

Expiration Date:13.09.2017

The owner of the registration certificate:SLAVYANSKAYA APTEKA, LLC SLAVYANSKAYA APTEKA, LLC Russia

Manufacturer: & nbsp

SLAVYANSKAYA APTEKA, LLC Russia

Information update date: & nbsp22.03.2017

Illustrated instructions

Instructions

Dexamethasone (Dexamethasone)