Dexapos - instructions for use, doses, side effects, contraindications

Interacting with a specific protein receptor in target tissues, regulates the expression of corticoid-dependent genes and, thus, affects the synthesis of the protein. 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 lysosomal enzymes of leukocyte membranes; Suppresses the synthesis of antibodies and disrupts the recognition of the antigen. 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.

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. 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 is an average of 3 hours.

Indications:

Acute and chronic inflammatory processes:

- inflammation of the anterior part of the eye (nasal conjunctivitis, scleritis, deep keratitis without epithelial damage, iritis, iridocyclitis and other uveitis of various genesis);

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

- sympathetic ophthalmia.

Allergic eye diseases:

- allergic conjunctivitis and keratoconjunctivitis.

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

Contraindications:

- Hypersensitivity to any of the components of this drug;

- keratitis caused by Herpes zoster (dendritic keratitis), chicken pox and others viral diseases of the cornea and conjunctiva;

- trachoma;

- mycobacterial infections of the eyes;

- fungal diseases of the eyes;

- bacterial infections of the eyes (without concomitant antimicrobial therapy);

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

- corneal epitheliopathy;

- increased intraocular pressure;

- immunosuppression;

- children's age till 18 years.

Pregnancy and lactation:

Dexamethasone can be used during pregnancy and during breastfeeding only for the purpose of the attending physician, unless the expected curative effect justifies the potential risk to the fetus and the baby. In the first 3 months of pregnancy, the drug should be administered with extreme caution, taking into account the risk of possible fetal development disorders in animal experiments ("wolf mouth").

Dosing and Administration:

Adults with a pronounced inflammatory process - during the first 24-48 hours of treatment they instill in the conjunctival sac 1-2 drops every 2 hours, with a decrease in inflammation - every 4-6 hours.

The duration of treatment usually does not exceed 2 weeks.

For the prevention of inflammatory processes during the first 24 hours after eye operations and day.

Side effects:

After instillation of eye drops Dexapos®, dermatitis, eye irritation, foreign body sensation, tingling, itching and burning sensation in the eye may occur.

In patients with hypersensitivity to the components of the drug, allergic conjunctivitis and blepharitis may develop.

Rarely - mydriasis, ptosis and transient disorders of accommodation.

Prolonged use of the drug (more than 14 days) can cause increased intraocular pressure, the emergence of secondary glaucoma with optic nerve damage, decreased visual acuity and loss of visual fields. It is also possible to form a posterior subcapsular steric cataract and thinning and perforating the cornea; occurrence of irite.

Overdose:

Overdose is unlikely.

Interaction:

When combined with atropine, other cholinergic or mydriatic drugs, an increase in intraocular pressure may be possible.

Interaction with other drugs is mainly due to the participation in the excretion of dexamethasone by cytochrome P450 containing enzymes (CYP3A4). It induces an enzyme CYP3A4, thereby reducing the effectiveness of calcium channel blockers, quinidine and erythromycin. In the usual topical regimen, the dose of the drug is not sufficient to induce induction or saturation of the liver enzymes.

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

Special instructions:

Before instillation of the drug is recommended to remove contact lenses and re-put them no earlier than 20 minutes after instillation.

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 treatment with the drug for more than 10 days, it is necessary to regularly monitor the intraocular pressure and the condition of the cornea.

Drops containing corticosteroids, with prolonged use, can cause a decrease in wound healing speed, bullous changes in the cornea.

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

Immediately after the use of eye drops, Dexapos®, a brief disturbance of visual acuity may occur, it is not recommended to drive the car and engage in activities requiring increased attention until its recovery.

Form release / dosage:

Eye drops, 0,1%.

Packaging:

For 5 ml in polyethylene bottles-droppers with a screwed protective cap, equipped with a safety ring.

1 bottle-dropper along with the instruction for use is placed in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

In closed original packaging: 2 years.

After opening the vial, the drug should be used within 4 weeks.

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

Terms of leave from pharmacies:On prescription

Registration number:P N015079 / 01-2003

Date of registration:17.06.2008 / 18.05.2012

Expiration Date:Unlimited

Date of cancellation:2017-04-24

The owner of the registration certificate:Ursafarm Artsnaymittel GmbHUrsafarm Artsnaymittel GmbH Germany

Manufacturer: & nbsp

URSAPHARM Arzneimittel, GmbH Germany

Representation: & nbspURSAFARM ARTSNAYMITTEL GmbH URSAFARM ARTSNAYMITTEL GmbH Germany

Information update date: & nbsp24.04.2017

Illustrated instructions

Instructions

Dexapos® (DEXAPOS®)