Optiwell (Drops) Instructions for Use

Marketing Authorization Holder

Micro Labs Limited (India)

ATC Code

S01GX01 (Cromoglicic acid)

Active Substance

Cromoglicic acid (Rec.INN registered by WHO)

Dosage Form

Optiwell

Eye drops 2%: dropper bottle 5 ml or 10 ml 1 pc.

Dosage Form, Packaging, and Composition

Eye drops 2% in the form of a transparent solution from colorless to pale yellow.

Excipients: benzalkonium chloride solution 50% – 0.2 mg (in terms of benzalkonium chloride – 0.1 mg), water for injections – up to 1 ml, disodium edetate dihydrate – 0.1 mg.

5 ml – dropper bottles made of low-density polyethylene (1) – cardboard boxes.
10 ml – dropper bottles made of low-density polyethylene (1) – 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 mucous membrane of the eye 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 intestine 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 domestic animals).

ICD codes

Dosage Regimen

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

For severe or acute allergic conditions, increase the frequency to every 2-3 hours during initial therapy.

Use at regular intervals to ensure continuous therapeutic effect.

Begin treatment before anticipated allergen exposure for optimal prophylactic results.

Continue use for the entire duration of allergen exposure.

Do not discontinue therapy abruptly; taper frequency gradually as symptoms resolve.

Do not touch the dropper tip to any surface to avoid contamination.

If using other ophthalmic products, maintain a minimum 5-minute interval between instillations.

Apply eye drops before ophthalmic ointments.

Close eyes gently after instillation; do not blink excessively.

Press a finger to the inner corner of the eye for one minute to minimize systemic absorption.

Wipe away any excess solution from the skin around the eyes with a clean tissue.

If you wear soft contact lenses, remove them before application and wait at least 15 minutes before reinsertion.

The duration of treatment is determined by the prescribing physician based on clinical response.

Adverse Reactions

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

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 hepatic impairment

Use in Renal Impairment

The drug is approved for use in renal impairment

Pediatric Use

Contraindicated in children under 2 years of age. In children over 2 years of age, use in 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 preparations 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.