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

Synthetic fluorinated glucocorticoid. Has a pronounced anti-inflammatory and antiallergic effect, desensitizing effect. Dexamethasone does not have mineralocorticoid activity.

Interacting with a specific protein receptor in target tissues, regulates the expression of corticoid-dependent genes and thus influences the synthesis of the protein. Stabilizes lysosomal enzymes of leukocyte membranes; inhibits the synthesis of kinins, mitosis and migration of leukocytes,mast cells; inhibits the synthesis of antibodies and disrupts the recognition of the antigen. All these effects are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical or immune damage. The eosinophilic ejection of inflammatory mediators is suppressed. The permeability of capillaries decreases.

Dexamethasone phosphate penetrates into the intraocular fluid, the cornea, the iris, the choroid of the eye, the ciliary body, the retina. The drug can have a systemic effect only when used in large doses or with prolonged use in children, since with topical application systemic absorption is low.

After instillation into the eye, 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.

The duration of anti-inflammatory action after instillation of 1 drop of solution is from 4 to 8 hours.

Pharmacokinetics:A small amount of dexamethasone enters the systemic circulation. 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:

Acute and chronic inflammatory processes:

- neogenic forms of conjunctivitis, keratitis, keratoconjunctivitis and blepharitis;

- scleritis and episcleritis;

- irit, iridocyclitis and other uveitis of various genesis;

- superficial injuries of the cornea of various etiologies (chemical, physical or immune mechanisms) after complete corneal epithelialization;

- inflammation of the posterior segment of the eye (choroiditis, chorioretinitis);

- sympathetic ophthalmia;

- thermal and chemical burn (after complete corneal epithelialization).

Allergic eye diseases:

- allergic conjunctivitis;

- allergic keratoconjunctivitis.

Allergic and inflammatory diseases (including microbial) of the ears, otitis media.

Prevention and treatment of inflammatory phenomena in the postoperative and post-traumatic period.

Contraindications:

Keratitis caused by Herpes simplex; varicella and other viral diseases of the cornea and conjunctiva; mycobacterial infections of the eyes; fungal diseases of the eyes; acute purulent eye diseases withdefeat of the corneal epithelium; corneal epitheliopathy; increased intraocular pressure (for prolonged use); trachoma, eye tuberculosis; condition after removal of the foreign body of the cornea; perforation of the tympanic membrane; hypersensitivity to any of the components of the drug.

Pregnancy and lactation:

To date, clinical trials regarding the use of the drug during pregnancy, lactation, and also in children are not available. However, the drug can be used if the intended benefit to the mother exceeds the possible risk to the fetus.

During application, breastfeeding should be discontinued.

Dosing and Administration:

In the conjunctival sac 1-2 drops 3-5 times a day.

3-4 drops to the affected ear 2-3 times a day.

After achieving the desired effect, you should gradually reduce the frequency of application of the drug to the required, providing control over the symptoms of the disease.

The duration of treatment should not exceed 2-3 weeks.

The decision on the duration of treatment is based on objective data, including the effectiveness of the drug, the severity of the symptoms,the possibility of side effects.

Side effects:

- Local reactions - a rapid burning sensation, skin itching, dermatitis.

- In patients with hypersensitivity, allergic conjunctivitis or blepharitis may develop.

- Prolonged use of the drug may cause secondary glaucoma and steroid cataract (formation of posterior subcapsular cataracts).

- Slow down the process of wound healing.

- Thinning of the cornea or sclera, possibly corneal perforation.

- Distribution of secondary herpetic and bacterial infections due to suppression of the protective reaction of the patient's body.

- In acute purulent diseases of the eye, glucocorticosteroids can mask or strengthen the existing infectious process.

- With prolonged use of steroids, the appearance of non-healing ulcers on the cornea may indicate the development of fungal infestation. In case of side effects, stop using the medication and contact the ophthalmologist as soon as possible.

Overdose:

It is possible to intensify the manifestations of local reactions. There is no specific antidote.The drug should be withdrawn and symptomatic therapy prescribed.

Interaction:

Interaction with other drugs is mainly due to the participation of the same cytochrome-containing enzymes in excretion. Dexamethasone can enhance the effects of phenytoin, barbiturates and warfarin. It induces isoenzyme CYP3A4, thus reducing the effectiveness of calcium channel blockers, quinidine and erythromycin. In normal local administration, the dose is not sufficient to induce the induction or saturation of liver enzymes.

With prolonged use with iodoxuridine, the destructive processes in the corneal epithelium can be intensified.

Special instructions:

Do not use this medication with undiagnosed eye diseases, especially with eye irritation (a symptom of "red eyes").

As a result of prolonged use of drops, it is possible to increase the ophthalmotonus. If the drug is used for 2 weeks or more, as well as in patients who have a history of glaucoma, it is recommended to regularly check the intraocular pressure.

Corticosteroid therapy can mask the current bacterial or fungal infection.

Children during prolonged treatment need careful monitoring of the dynamics of growth and development.

Children who were in contact with sick measles or chickenpox during the treatment period prophylactically prescribe specific immunoglobulins.

Do not touch the tip of the pipette to any surface to prevent bacteria from entering the vial.

Do not wear contact lenses during treatment.

Before use, shake the bottle.

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

Since within a few minutes after instillation, vision loss is possible, care should be taken when working with mechanisms and driving a car. Due to possible lacrimation after instillation of the drug, it is not recommended to apply it directly before driving vehicles or servicing mechanical equipment. Within 30 minutes after instillation, it is necessary to refrain from occupations requiring attention.

Form release / dosage:Drops of eye and ear, 0.1%.

Packaging:

For 10 ml in a bottle-dropper polymer with a screw cap polymer coating with the control of the first autopsy.

For 1 bottle of polymer dropper with the drug, along with the instructions for use are placed in a pack of cardboard.

Storage conditions:

AT protected from the light at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Shelf life after opening - 14 days.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002286/07

Date of registration:17.08.2007

Expiration Date:Unlimited

The owner of the registration certificate:BETA-LEK, LLC BETA-LEK, LLC Russia

Manufacturer: & nbsp

BETA-LEK, LLC Russia

Information update date: & nbsp21.03.2017

Illustrated instructions

Instructions

Dexamethasone-Betalec (Dexamethasone-Betalek)