Hay-Crom (Drops) Instructions for Use

Marketing Authorization Holder

NORTON HEALTHCARE, Limited (United Kingdom)

ATC Code

S01GX01 (Cromoglicic acid)

Active Substance

Cromoglicic acid

Dosage Form

Hay-Crom

Eye drops 2%: bottle 10 ml or 13.5 ml with dropper

Dosage Form, Packaging, and Composition

Eye drops as a clear, light straw-colored solution.

Excipients: benzalkonium chloride, disodium edetate, purified water.

10 ml – low-density polyethylene bottles (1) with a dropper – cardboard boxes.
13.5 ml – low-density polyethylene bottles (1) with a dropper – cardboard boxes.

Clinical-Pharmacological Group

An antiallergic drug for topical use in ophthalmology

Pharmacotherapeutic Group

Antiallergic agent – mast cell membrane stabilizer

Pharmacological Action

Antiallergic agent, mast cell membrane stabilizer. Inhibits the release of histamine, leukotrienes, and other biologically active substances from mast cells.

It is believed that the delay in the release of mediators occurs as a result of an indirect blockade of calcium ion entry into the cells.

It has been established that Cromoglicic acid suppresses the migration of neutrophils, eosinophils, and monocytes.

Pharmacokinetics

Absorption through the ocular mucosa is insignificant. Systemic bioavailability is less than 0.03%.

The half-life (T_1/2) is 5-10 minutes. Plasma protein binding is 65%.

It is not metabolized. It is excreted unchanged in urine and through the intestines in approximately equal amounts.

Indications

Prevention and treatment: allergic conjunctivitis, allergic keratitis, keratoconjunctivitis, irritation of the ocular mucosa caused by allergic reactions (environmental factors, occupational hazards, household chemicals, cosmetics, ophthalmic dosage forms, plants, and pets).

ICD codes

Dosage Regimen

Instill one drop into each affected eye four times daily at regular intervals.

Increase the frequency of administration to up to six times daily for severe, acute allergic conditions as directed by a physician.

Maintain a consistent dosing schedule for optimal prophylactic effect.

Use the drops at regular intervals while exposed to the known allergen.

Continue treatment for the entire duration of allergen exposure.

Administer the drops into the conjunctival sac. Avoid contact between the dropper tip and the eye or any other surface to prevent contamination.

If you wear soft contact lenses, remove them before instillation. Wait at least 15 minutes before reinserting the lenses.

Do not use the solution if it becomes discolored or contains particulate matter.

Discard the bottle four weeks after first opening to prevent microbial contamination.

Adverse Reactions

From the organ of vision: temporary impairment of visual clarity, sensation of warmth in the eye, conjunctival edema, sensation of a foreign body in the eye, dry eyes, lacrimation, meibomitis, superficial corneal epithelial damage.

Contraindications

Hypersensitivity to cromoglicic acid, children under 2 years of age.

With caution

Children under 4 years of age, pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Use with caution during pregnancy and breastfeeding.

Use in Hepatic Impairment

The drug is approved for use in patients with impaired liver function.

Use in Renal Impairment

The drug is approved for use in patients with impaired renal function.

Pediatric Use

Contraindicated for use in children under 2 years of age. In children over 2 years of age, use dosage forms intended for this category of patients.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

For some time after instillation into the eyes, one should refrain from performing work requiring increased attention and good vision.

Drug Interactions

When used topically in ophthalmic practice, Cromoglicic acid reduces the need for the use of ophthalmic drugs containing corticosteroids.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.