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

Excipients: benzalkonium chloride - 0.1 mg; sodium chloride - 4.0 mg; disodium edetate - 1.5 mg; sorbitol liquid non-crystallized - 20.0 mg; sodium dihydrogen phosphate dihydrate 1.0 mg; disodium hydrogen phosphate dodecahydrate - 5.0 mg; sodium hydroxide - up to pH 7.0; water for injection - 0.9661 ml.

Description:Transparent colorless to slightly yellowish solution without mechanical inclusions.

Pharmacotherapeutic group:Antiallergic agent - stabilizer of membranes of mast cells

ATX: & nbsp

S.01.G.X.01 Cromoglycic acid

R.03.B.C.01 Cromoglycic acid

Pharmacodynamics:

Antiallergic, has a membrane-stabilizing effect, blocks the entry of calcium ions into the mast cell, preventing its degranulation and release of histamine, bradykinin, prostaglandins, leukotrienes (including slow reacting substances) and other biologically active substances. The drug is most effective as a means of prevention. A noticeable clinical effect occurs within a few days or weeks after admission.

Pharmacokinetics:

Absorption through the mucous membrane of the eye is negligible. Systemic bioavailability - less than 0.03%. The half-life is 5-10 minutes. Relationship with plasma proteins - 65%. It is not metabolized, excreted by the kidneys and through the intestines in unchanged form (approximately in equal amounts within 24 hours after application).

Indications:

Prevention and treatment:

- allergic conjunctivitis;

- allergic keratitis, keratoconjunctivitis;

- irritation of the mucous membrane of the eye, due to allergic reactions (environmental factors, occupational hazards, household chemicals, cosmetics, ophthalmic medicinal forms, plants and domestic animals).

Contraindications:

- Hypersensitivity to sodium cromoglycate or any other component of the drug;

- children under 2 years.

Carefully:

- Children under 4 years;

- pregnancy and lactation.

Pregnancy and lactation:

The safety of the use of the drug Kromogeksal® during pregnancy is not established, so the use of the drug during this period is recommended only for the doctor's prescription. The use of the drug during pregnancy and during lactation is possible only if the expected benefit for the mother exceeds the potential risk to the fetus or the baby.

Kromogeksal® is excreted in breast milk, therefore, when it is necessary to use the drug during lactation, it is necessary to resolve the issue of stopping breastfeeding.

Dosing and Administration:

Adults and children over the age of 2 years instilled 1-2 drops in each conjunctival sac 4 times a day at intervals of 4-6 hours. If necessary, the dose can be increased to 6-8 instillations.

After achieving the therapeutic effect, the frequency of application of the drug can be reduced and used Cromohexal only in contact with allergens, house dust, spores of fungi, pollen).

Side effects:

Undesirable effects are classified according to their frequency of development as follows: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

On the part of the organs of vision:

infrequent: impaired visual clarity, burning in the eye, conjunctival edema, foreign body sensation, dry eyes, lacrimation, meibomite (barley), superficial lesion of the corneal epithelium.

Other:

Very rarely: Cromohexal® eye drops contain benzalkonium chloride, which can cause such side effects as allergic reactions or changes in taste sensations;

the frequency is unknown: in very rare cases, severe anaphylactic reactions (bronchospasm) have been observed in some patients receiving treatment with preparations containing cromoglycic acid.

Overdose:

Data on drug overdose are absent.

Interaction:

Reduces the need for ophthalmic drugs containing glucocorticosteroids.

Special instructions:

When using drops, because of the content of benzalkonium chloride, you should avoid wearing soft contact lenses; Strict contact lenses should be removed 15 minutes before instillation and dress after 15 minutes. The bottle must be closed after each use. Do not touch the tip of the pipette to the eye.

There is no need for special precautions when destroying an unused preparation.

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

In the first few minutes after instillation in the eye, Cromogexal® drops can cause visual impairment, therefore, during the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.After the drug has been installed, it is necessary to wait for the resolution of the symptoms of visual acuity reduction before proceeding to the management of vehicles and performing other activities requiring an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Eye drops 2%.

Packaging:For 10 ml in polyethylene bottles - droppers with a screw cap and a ring of the first opening. Bottle and instructions for use in a cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C in a dark place. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date stated on the package. Open vials can be used within 6 weeks.

Terms of leave from pharmacies:Without recipe

Registration number:П N012390 / 01

Date of registration:30.06.2010 / 26.08.2014

Expiration Date:Unlimited

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

Dr. GERHARD MANN Chem.-Pharm. Fabrik, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp23.01.2018

Illustrated instructions

Instructions

Cromohexal® (Cromohexal)