Dipolkrom^® (Drops) Instructions for Use

Marketing Authorization Holder

Polpharma Pharmaceutical Works, Sa (Poland)

ATC Code

S01GX01 (Cromoglicic acid)

Active Substance

Cromoglicic acid (Rec.INN registered by WHO)

Dosage Form

Dipolkrom®

Eye drops 20 mg/1 ml: bottle-dropper 5 ml

Dosage Form, Packaging, and Composition

Eye drops transparent, greenish in color.

Excipients: sorbitol – 16 mg, sodium phosphate dibasic dodecahydrate – 4.78 mg, sodium phosphate monobasic monohydrate – 2.61 mg, disodium edetate dihydrate – 0.1 mg, sodium chloride – 3 mg, benzalkonium chloride 50% solution – 0.2 mg (equivalent to 0.1 mg of 100% benzalkonium chloride), polysorbate 80 – 1 mg, purified water – up to 1 ml.

5 ml – polyethylene dropper bottles (2) – 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 penetration 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 elimination 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 allergic conditions, increase the frequency of administration to six to eight times daily.

Initiate treatment before anticipated allergen exposure for optimal prophylactic effect.

Continue therapy for the entire duration of allergen exposure.

Maintain a regular administration schedule for consistent therapeutic effect.

Do not wear soft contact lenses during treatment due to the presence of benzalkonium chloride.

Allow at least 15 minutes after instillation before inserting any other type of contact lens.

If using other topical ophthalmic agents, administer them at least five minutes apart.

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

If no improvement is observed after two weeks of treatment, re-evaluate the diagnosis.

Adverse Reactions

From the organ of vision: temporary impairment of visual acuity, sensation of warmth in the eye, conjunctival edema, sensation of a foreign body in the eye, dry eye, lacrimation, meibomitis, superficial damage to 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 patients with hepatic impairment.

Use in Renal Impairment

The drug is approved for use in patients with 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.