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

Excipients: sodium hydrogen phosphate dodecahydrate 0.267 mg, sodium dihydrogen phosphate monohydrate 2,195 mg, sodium chloride 8.0 mg, disodium edetate 0.5 mg, benzalkonium chloride solution 0.2 mg, polysorbate 80 0.1 mg, ethanol 96% 5.0 mg sodium hydroxide 10% (to pH 5.0-6.5), water purified to 1.0 ml.

Description:The suspension is white after shaking for 15 seconds.

Pharmacotherapeutic group:Anti-inflammatory agent, glucocorticosteroid

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 thus affects protein synthesis.

Reduces the formation, release and activity of inflammatory mediators (histamine, kinin, Pg, 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; inhibits the synthesis of kinins, mitosis and migration of leukocytes; 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:

With topical application, systemic absorption is low.

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.

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. T_1/2eye drops - about 3 hours.

Indications:

- Acute and chronic allergic and inflammatory eye diseases, incl. conjunctivitis (non-inflammatory and allergic), keratitis, keratoconjunctivitis (without epithelial damage), blepharitis, scleritis, episcleritis, iritis, iridocyclitis;

- superficial injuries of the cornea of various etiologies (after complete epithelialization of the cornea);

- prevention of inflammation after surgery;

- sympathetic ophthalmia.

Contraindications:

- Children's age (up to 18 years);

- keratitis or conjunctivitis caused by Nerpes simplex and other 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);

- tuberculosis of the eye;

- use of soft contact lenses;

- hypersensitivity to the components of the drug.

Carefully:

Long-term use of dexamethasone, significantly exceeding the recommended time, increases the risk of secondary infection caused by fungi,bacteria and viruses; leads to the appearance or acceleration of cataract development, increased intraocular pressure in predisposed individuals, and in some cases even to the appearance of glaucoma. The risk of these diseases is more susceptible to patients with diabetes mellitus.

During prolonged treatment with dexamethasone, it is recommended to check the condition of the cornea with a fluorescein test, and also to measure intraocular pressure. In the case of a positive result of a fluorescein test or an increase in intraocular pressure, the drug should be discontinued.

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.

During the use of dexamethasone in persons with a history of disease, leading to thinning of the cornea or sclera, care must be taken to avoid the formation of perforation.

Use with caution in pregnancy and lactation (tolerable therapy for no more than 10 days).

Pregnancy and lactation:

Before use, consult a physician.

Dexamethasone may be used during pregnancy if the expected benefit to the mother exceeds the potential risk to the fetus or child.

Women who breast-feed should not use dexamethasone, since there is a probability of getting the active substance in breast milk (for a long period of the drug - more than 10 days).

Dosing and Administration:

The drug is intended for external use only - topically in the conjunctival sac.

Shake before use.

In acute inflammatory conditions bury in a conjunctival bag 1-2 drops 4-5 times a day for 2 days, then 1-2 drops 3-4 times a day for 4-6 days.

In chronic inflammatory conditions Bury 1-2 drops 2 times a day for 3-6 weeks. The duration of treatment should not exceed 6 weeks.

After ophthalmic surgeries and injuries (on the day of the operation or the day after the filtering antiglaucoma operation, starting from the 8th day after the operation to remove cataracts, the operation associated with strabismus, detachment of the retina, and from the time of injury): depending on the intensity of inflammatory symptoms, instill 1-2 drops 2-4 times a day for 2-4 weeks.

Side effects:

Immediately after instillation of the drug may appear: a slight burning sensation and tingling in the eye, congestion hyperemia of low intensity, as well as lacrimation. These symptoms disappear through 5-15 seconds and are not an indication to stop the use of the drug.

In patients with hypersensitivity to dexamethasone or benzalkonium, chloride may develop allergic conjunctivitis and blepharitis. Irritation, itching and burning of the skin; dermatitis.

In rare cases: thinning of the cornea or perforation of the eyeball (vision disorders, lachrymation), glaucoma, increased intraocular pressure, changes in the optic nerve, posterior subcapsular cataract, decreased visual acuity, narrowing of the field of vision, fuzzy vision, loss of vision, pain in the eyeball , nausea, vomiting, the development of secondary eye infection.

Frequent instillation of corticosteroids may cause a longer course of the corneal healing process.

Overdose:

Overdosage of the drug with local administration to the conjunctival sac is rare. Long-term use of the drug may lead to the onset of systemic effects of dexamethasone.

Accidental ingestion of the suspension does not cause serious adverse reactions.

Interaction:

Do not combine dexamethasone with drugs used in glaucoma, especially these combinations should not be used for a long time and in large doses, since it is possible to increase intraocular pressure.

Prolonged use of anticholinergic drugs, especially atropine (as well as chemical compounds with a similar structure, for example, tropicamide), in combination with dexamethasone, creates the risk of increased intraocular pressure.

The risk of increased intraocular pressure occurs when dexamethasone is used together with agents that damage the accommodation of the eye or dilate the pupil, especially in patients predisposed to the closed-angle form of glaucoma.

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

Special instructions:

Before using the drug, contact lenses should be removed and installed again no earlier than 30 minutes after instillation of the drug.

Dexamethasone can cause irritation of the mucous membrane of the eye.

Do not use corticosteroids in case of an unsettled cause of redness in the eyes.

When using the drug, avoid touching the tip of the dropper with any surface to avoid microbial contamination.

Effect on the ability to drive transp. cf. and fur:

Dexamethasone does not affect the ability to drive vehicles and service moving machinery. However, given the possibility of lacrimation after instillation, the drug should not be used immediately before driving vehicles and servicing moving mechanisms.

Form release / dosage:

Eye drops, 0,1%.

Packaging:

5 ml are packed in a polyethylene bottle with a dropper, closed with a screw cap with a warranty ring.

1 bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

Store in a dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Shelf life after opening the bottle is 4 weeks.

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

Terms of leave from pharmacies:On prescription

Registration number:П N014218 / 01

Date of registration:10.09.2008 / 07.03.2013

Expiration Date:Unlimited

The owner of the registration certificate:Warsaw Pharmaceutical Plant Polfa, JSCWarsaw Pharmaceutical Plant Polfa, JSC Poland

Manufacturer: & nbsp

Pharmaceutical Works POLPHARMA, S.A. Poland

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp21.03.2017

Illustrated instructions

Instructions

Dexamethasone (Dexamethasone)