Expiration date: 01/2028

Dosage form

Transparent or almost transparent, colorless or slightly colored liquid.

Composition

1 ml of the drug contains:

Active substance:

Sodium cromoglycate 20.0 mg

Auxiliary substances:

Glycerol anhydrous 18.0 mg

Macrogol 300 1,125 mg

Sodium hyaluronate 0.9 mg

Disodium Edetate Dihydrate (trilon B) 0.1 mg

Water for injection up to 1 ml

Pharmacotherapeutic group

antiallergic agent stabilizer of mast cell membranes

Pharmacodynamics

An antiallergic agent, it prevents the degranulation of mast cells and the release of mediators of allergic reactions from them - histamine and leukotrienes (especially SRS-A). The mechanism of action is probably based on stabilization of mast cell membranes and blocking of calcium channels, which causes inhibition of the release of mediators. Cromoglycic acid blocks both early and late allergic reactions.

The drug does not have an antihistamine or vasoconstrictor effect.

Pharmacokinetics

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

Indications

Seasonal and year-round allergic conjunctivitis.

Contraindications

• hypersensitivity to the components of the drug;
• children under 4 years of age.

With caution

• children's age.

Use during pregnancy and lactation

The safety of using the drug during pregnancy and lactation has not been established, therefore, during this period, the drug should be used with caution and only if the intended benefit to the mother outweighs the potential risk to the fetus and child. The drug is excreted into breast milk; during treatment with the drug, the issue of stopping breastfeeding should be resolved.

Method of administration and dosage

The drug is most effective for preventive use. A noticeable clinical effect occurs after a few days or weeks of use.

Treatment begins with instillation of the drug 1 drop 2 times a day in both eyes, if necessary, the dosage regimen can be changed to instillation of 1 drop 4 times a day in both eyes.

In case of seasonal allergic conjunctivitis, treatment should begin immediately after the first symptoms appear or be used prophylactically before the start of the pollen season. Treatment is continued throughout the flowering season or longer if symptoms persist.

Instructions for use

Wash your hands thoroughly before using the drug. If the drop does not enter the conjunctival sac, the instillation should be repeated. After instillation, close your eyes, do not blink or open them for about 2 minutes for better contact of the eye mucosa with the drug.

How to use the dropper tube:

1. Open the bag, separate one dropper tube, and put the rest back into the bag.

2. Open the dropper tube (after making sure that the solution is in the bottom of the dropper tube, rotate and separate the valve).

3. Drip the required amount of the drug into the eyes.

The dose contained in the dropper tube is sufficient for one instillation into both eyes.

After a single use, the dropper tube should be discarded, even if the contents remain.

Side effects

The undesirable effects listed below are listed according to the following gradations of frequency and severity:

Very often: >1/10

Often: >1/100, <1/10

Infrequently: >1/1000, <1/100

Rare: >1/10000, <1/1000

Very rare: <1/10000

Frequency unknown: cannot be estimated based on available data.

Undesirable drug reactions are presented in descending order of their severity.

From the side of the organ of vision: very rarely - a rapidly passing violation of visual clarity, short-term burning sensation, foreign body, dryness in the eye, conjunctival edema, lacrimation, meibomitis.

Other: very rarely - allergic reactions (itching, mild soreness of the conjunctiva, conjunctival injection), changes in taste sensations.

Overdose

There is no data available.

Drug interaction

There were no adverse interactions of cromoglycic acid with other drugs.

Special instructions

Kromicil-Solopharm eye drops do not contain preservatives, so they can be used when wearing contact lenses of any type.

Influence on the ability to drive vehicles and mechanisms

Patients who have a short-term visual impairment after using the drug should not drive vehicles and mechanisms immediately after applying eye drops.

Storage temperature

from 2℃ to 25℃