Cromicil-Solofarm, eye drops 2% 10 ml

Anti-allergic agent – stabilizer of mast cell membranes< br> < br> ATC: < section>

S.01.G.X.01 Cromoglycic acid

R.03.B.C.01 Cromoglycic acid

< section> Pharmacodynamics:< br> < br> < br> Antiallergic agent, prevents mast cell degranulation and the release from them of mediators of allergic reactions – 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 mediator release. Cromoglycic acid blocks both early and late allergic reactions.

The drug has no antihistamine and vasoconstrictor action.

< section>Pharmacokinetics:< br>

Absorption through the ocular mucosa is negligible. Systemic bioavailability is less than 0.03%. The elimination half-life is 5-10 minutes. Binding with plasma proteins is 65%. It is not metabolized, excreted by the kidneys and through the intestine unchanged (approximately equal amounts within 24 hours after application).

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Indications

Seasonal and year-round allergic conjunctivitis.

Pharmacological effect

Antiallergic agent – mast cell membrane stabilizer

ATX:

S.01.G.X.01 Cromoglycic acid

R.03.B.C.01 Cromoglycic acid

Pharmacodynamics:

An antiallergic agent that prevents the degranulation of mast cells and the release from them of mediators of allergic reactions – histamine and leukotrienes (especially SRS-A). The mechanism of action is probably based on stabilization of mast cell membranes and blocking calcium channels, which causes inhibition of the release of mediators. Cromoglicic 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. Communication with plasma proteins – 65%. Not metabolized, excreted by the kidneys and through the intestines unchanged (in approximately equal quantities within 24 hours after use).

Special instructions

The preservative contained in the drug may irritate the eyes when wearing contact lenses, so any contact lenses should be removed before instillation of the drug and installed no earlier than 15 minutes after instillation.

Impact on the ability to drive vehicles and machinery

Patients who experience short-term blurred vision after using the drug should not drive vehicles or machinery immediately after using eye drops.

Active ingredient

Cromoglicic acid

Composition

1 ml of the drug contains:

Active substance:
sodium cromoglycate – 20.0 mg

Excipients:
glycerol anhydrous – 21 mg,
disodium edetate dihydrate (trilon B) – 0.1 mg,
benzalkonium chloride – 0.05 mg,
water for d/i – up to 1 ml.

Pregnancy

The safety of the drug during pregnancy and breastfeeding has not been established, therefore during this period the drug should be used with caution and only if the expected 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 decided.

Contraindications

– Hypersensitivity to the components of the drug;

– children up to 4 years of age.

With caution:

Childhood.

Side Effects

The following undesirable effects are listed in accordance with the following gradations of frequency and severity:

Very common: >1/10

Often: >1/100, <1/10

Uncommon: >1/1000, <1/100

Rare: >1/10000, <1/1000

Very rare: < 1/10000

Frequency unknown: cannot be estimated from available data.

Adverse drug reactions are presented in descending order of severity.

On the part of the organ of vision: very rarely – a quickly passing disturbance in the clarity of visual perception, a short-term sensation of burning, a foreign body, dryness in the eye, swelling of the conjunctiva, lacrimation, meibomitis.

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

Recommendations for use

The drug is most effective when used prophylactically. 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.

For 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

Before using the drug, you must wash your hands thoroughly. If the drop does not enter the conjunctival sac, 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.

Procedure for working with a dropper tube:

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

2. Open the dropper tube (making sure that the solution is at the bottom of the dropper tube, turn with a rotating motion and separate the valve).

3. Drop 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 one use, the dropper tube should be thrown away, even if the contents remain.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiration date.

Manufacturer

Grotex LLC, Russia