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

Boric acid 15.0 g; sodium tetraborate decahydrate (sodium tetraborate 10-water) 0.6 g; disodium edetate (Trilon B) 0.5 g; benzalkonium chloride 0.04 g; water for injection - up to 1 liter.

Description:Colorless transparent 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:

Dexamethasone is a synthetic fluorinated glucocorticosteroid. Has a pronounced anti-inflammatory, antiallergic and desensitizing effect.

Suppresses cell migration to the site of inflammation; reduces vasodilation and increased vascular permeability in the focus of inflammation. Stabilizes the lysosomal enzymes of leukocyte membranes, suppresses the synthesis of antitheses 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 and 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.

Indications:

Acute and chronic inflammatory processes:

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

- scleritis and episcleritis;

- iritis, iridocyclitis, 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.

Allergic eye diseases:

- allergic conjunctivitis or keratoconjunctivitis.

Prevention and treatment of inflammatory phenomena in the postoperative period.

Contraindications:

- Keratitis caused by Herpes simplex and other viral diseases of the cornea and conjunctiva;

- tuberculosis of the eye;

- fungal diseases of the eyes;

- acute purulent diseases of the eyes with defeat of the corneal epithelium;

- corneal epitheliopathy;

- increased intraocular pressure;

- condition after removal of the foreign body of the cornea;

- hypersensitivity to one of the components of the drug.

Carefully:Pregnancy.

The efficacy and safety of the drug in patients under the age of 18 years is not established.

Pregnancy and lactation:The drug may be used if the intended benefit to the mother exceeds the possible risk to the fetus.

Admissible therapy is not more than 7-10 days.

Dosing and Administration:

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

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

Side effects:

After instillation, a rapid burning sensation may occur.

Long-term use of the drug may cause the occurrence of steroid glaucoma.

In patients with hypersensitivity to dexamethasone or benzalkonium, chloride may develop allergic blepharoconjunctivitis.

If side effects occur, discontinue use and consult a doctor.

With prolonged use (more than 3 weeks), it is possible to increase intraocular pressure, as well as the formation of posterior subcapsular cataract.

Overdose:

With topical application of the drug, an overdose is unlikely.

Interaction:

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

Interaction with other drugs is mainly due to the participation of the same cytochrome-containing enzymes in excretion.

Dexamethasone can strengthen the action phenytoin, barbiturates and warfarin.

It induces the isoenzyme CYP3A4, thus reducing the effectiveness calcium channel blockers, quinidine and erythromycin.

In normal local administration, the dose is not sufficient to induce the induction or saturation of liver enzymes.

Special instructions:

Before using the drug, remove contact lenses and re-dress no earlier than 15 minutes.

As a result of prolonged use of dexamethasone, intraocular pressure may increase. If the drug is used for 2 weeks or more, intraocular pressure should be measured regularly.

Corticosteroid therapy can mask the current bacterial or fungal infection. In the presence of infection, the use of drops with appropriate antimicrobial therapy should be combined.

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

Due to possible lacrimation after instillation of the drug, it is not recommended to apply it directly before driving vehicles or servicing mechanical equipment.

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

Packaging:

5 ml or 10 ml in bottles of glass. To 5, 10 ml in bottles-droppers from polymeric materials, or vials polymeric.

On 1 glass vial or a dropper-vial, or a vial of polymer together with instructions for use in a pack of cardboard.

On 1 glass vial together with the instruction on application complete with a lid-dropper polyethylene in a pack of cardboard.

Storage conditions:

In a cool place inaccessible to children, protected from light.

Shelf life:

2 years.

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

Terms of leave from pharmacies:On prescription

Registration number:P N000230 / 01

Date of registration:12.03.2012 / 08.08.2016

Expiration Date:Unlimited

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Information update date: & nbsp21.03.2017

Illustrated instructions

Instructions

Dexamethasone-LENS® (Dexamethasone-LANS®)