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

Excipients: benzalkonium chloride 0.1 mg; disodium hydrogen phosphate anhydrous 2.0 mg; polysorbate 80 0.5 mg; disodium edetate 0.1 mg; sodium chloride 7.0 mg; hypromellose 5.0 mg; acid citric monohydrate and / or sodium hydroxide to adjust the pH; water purified to 1.0 ml.

Description:Opaque suspension from white to light yellow

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 glucocorticoid, does not have mineralocorticoid activity. Has a pronounced anti-inflammatory, antiallergic and desensitizing effect. Dexamethasone actively suppresses inflammatory processes, inhibiting the eosinophilic ejection of inflammatory mediators, migration of mast cells and decreasing permeability, capillaries, vasodilation.

Pharmacokinetics:

With topical application, it penetrates well into the corneal epithelium and conjunctiva: in the aqueous humor of the eye, therapeutic concentrations are achieved; with inflammation or damage to the mucous membrane, the penetration rate increases.

Indications:

- Inflammation of the anterior part of the eye: acute and chronic uveitis, iridocyclitis, iritis and cyclilit;

- blepharitis, keratoconjunctivitis, conjunctivitis - allergic, seasonal, catarrhal;

- prevention and treatment of inflammatory phenomena in the postoperative period;

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

Contraindications:

- Hypersensitivity to any of the components of this drug;

- toeradite caused by Herpes simplex (dendritic keratitis), chicken pox and other viral diseases of the cornea and conjunctiva;

- mycobacterial infections of the eyes;

- fungal diseases of the eyes;

- acute purulent diseases of the eyes;

- damage to the integrity of the corneal epithelium;

- the period of breastfeeding;

- age to 18 years (safety and efficacy of the drug in children have not been studied).

Pregnancy and lactation:

Sufficient experience in the use of the drug during pregnancy is not present. It is possible to use the treatment for pregnant women on prescription of the attending physician if the expected curative effect exceeds the risk of development of possible side effects.

Dosing and Administration:

Locally.

One or two drops in the conjunctival sac of the eye every 3-6 hours. Shake the bottle before use.

You can combine the use of "MAXIDEX®", ophthalmic ointment and "MAXIDEX®", eye drops: ointment - in the evening before going to bed, eye drops - during the day. The duration of therapy is 2-3 weeks or as recommended by a doctor.

The frequency of instillations and the duration of administration depend on the severity of the disease and the response to treatment. In severe inflammatory processes, 1-2 drops of the drug should be instilled every 30-60 minutes until a satisfactory response is achieved. In the absence of a response, subconjunctival or systemic administration of glucocorticoids is necessary. When a satisfactory answer is reached, the drug is administered 1 drop every 4 hours.

Side effects:

With prolonged use of steroid drugs, the following can be observed:

- increased intraocular pressure with possible subsequent development of steroid glaucoma with damage to the optic nerve and the visual fields (therefore, when using preparations containing glucocorticosteroids for more than 10 days, the intraocular pressure should be measured regularly);

- formation of posterior subcapsular cataract;

- slowing down the process of wound healing (with diseases that cause thinning of the cornea, its perforation is possible).

Allergic reactions are possible.

Secondary bacterial infection may occur as a consequence of 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.

Fungal infection of the cornea tends to occur especially often with prolonged use of steroids. The appearance of non-healing ulcers on the cornea after prolonged treatment with steroid preparations may indicate the development of fungal infestation.

Overdose:Symptoms: local manifestations are possible.

Treatment: symptomatic.

Interaction:

Interaction with other drugs is not currently known.

In the case of use with other local ophthalmic preparations, the interval between their use should be at least 10 minutes.

Special instructions:

Eye drops contain a preservative benzalkonium chloride, which can be absorbed by contact lenses. Before using the drug, contact lenses should be removed and installed back no earlier than 20 minutes after using the drug.

If the duration of therapy is more than 2 weeks, the condition of the cornea should be monitored.

Before use, shake the bottle (eye drops).

The bottle must be closed after each use.

Do not touch the tip of the pipette with any surfaces.

Effect on the ability to drive transp. cf. and fur:If the patient after the application of the drug temporarily reduces clearness of vision, it is not recommended to drive the car and engage in activities requiring increased attention before its restoration.

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

Packaging:

To 5 ml in the bottle-dropper "Droptainer ™" from low density polyethylene.

For 1 bottle with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of 8 to 25 ° C, out of the reach of children.

Shelf life:

2 years.

Use within 4 weeks after opening the vial.

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

Terms of leave from pharmacies:On prescription

Registration number:П N013731 / 01

Date of registration:11.12.2008 / 15.09.2014

The owner of the registration certificate:Alkon-Kouvreur N.V. S.A.Alkon-Kouvreur N.V. S.A. Belgium

Manufacturer: & nbsp

ALCON-COUVREUR, n.v. s.a. Belgium

Representation: & nbspALKON PHARMACEUTICS LLCALKON PHARMACEUTICS LLCRussia

Information update date: & nbsp07.01.2016

Illustrated instructions

Instructions

Maxidex® (Maxidex®)