Ditadrin^® (Drops) Instructions for Use

Marketing Authorization Holder

Warsaw Pharmaceutical Work Polfa, S.A. (Poland)

ATC Code

S01GA51 (Naphazoline in combination with other drugs)

Active Substances

Diphenhydramine (Rec.INN registered by WHO)

Naphazoline (Rec.INN registered by WHO)

Dosage Form

Ditadrin®

Ophthalmic drops 1 mg+0.33 mg/1 ml: bottle 5 ml 2 pcs.

Dosage Form, Packaging, and Composition

Ophthalmic drops transparent, colorless.

Excipients : boric acid – 19 mg, disodium edetate – 0.5 mg, benzalkonium chloride (solution) – 0.2 mg, sodium hydroxide 10% – to pH 4.4-5.6, purified water – to 1 ml.

5 ml – polyethylene bottles (2) with a dropper – cardboard packs.

Clinical-Pharmacological Group

Drug with antiallergic and vasoconstrictive action for topical use in ophthalmology

Pharmacotherapeutic Group

Combined antiallergic agent (H₁-histamine receptor blocker + alpha-adrenomimetic)

Pharmacological Action

Combined drug for topical use in ophthalmology.

Diphenhydramine is a first-generation histamine H₁-receptor antagonist.

It reduces allergy symptoms caused by histamine release (including increased capillary permeability).

Naphazoline is an alpha-adrenomimetic; when applied topically, it has a vasoconstrictive effect.

The therapeutic effect develops 5 minutes after instillation of the drug and lasts up to 8 hours; with frequent use of the drug, the duration of action may be reduced to 6 hours.

Pharmacokinetics

When applied topically, Naphazoline can be absorbed into the systemic circulation and exert a systemic effect.

The development of systemic effects is most likely in children under 6 years of age and in elderly persons.

The systemic effect of diphenhydramine is unlikely.

Indications

• Exacerbation of seasonal allergic conjunctivitis;
• Exacerbation of perennial allergic conjunctivitis;
• Conjunctival irritation when using contact lenses;
• Conjunctival irritation under the influence of external factors (including sunlight, cigarette smoke, swimming pool water).

ICD codes

Dosage Regimen

Instill 1-2 drops into the lower conjunctival sac of the affected eye(s).

Administer drops no more frequently than every 6-8 hours.

Apply for a maximum duration of 3-5 days unless otherwise directed by a physician.

Determine the need for longer treatment on an individual basis.

Use with extreme caution in elderly patients and those with cardiovascular conditions due to potential systemic absorption.

Avoid use for more than 5 days or at intervals of less than 3 hours without medical supervision.

Discontinue use immediately if symptoms of irritation or eye pain persist for more than 72 hours.

Remove hard contact lenses before instillation; reinsert no sooner than 15-20 minutes after application.

Avoid touching the dropper tip to any surface to prevent contamination.

Do not drive or operate machinery immediately after instillation if visual clarity is impaired.

Adverse Reactions

From the organ of vision frequently – burning, itching, eye pain, visual impairment, conjunctival redness; mydriasis, increased intraocular pressure are possible.

A case of corneal clouding was described when using Ditadrin^® for 7 days at least 10 times/day (after drug withdrawal, the clouding disappeared).

Systemic reactions rarely – drowsiness, tachycardia, increased blood pressure, headaches, dizziness, nausea.

Contraindications

• Angle-closure glaucoma;
• Hyperthyroidism;
• Children under 2 years of age;
• Pregnancy;
• Lactation;
• Hypersensitivity to the drug components.

Use in Pregnancy and Lactation

Ditadrin^® is contraindicated for use during pregnancy.

It is unknown whether Diphenhydramine and Naphazoline are excreted in breast milk, so if it is necessary to use the drug during lactation, the issue of discontinuing breastfeeding should be decided.

Pediatric Use

Children over 2 years of age are prescribed 1-2 drops into the lower conjunctival sac, no more frequently than every 6-8 hours.

The duration of use is 3-5 days.

Contraindication: children under 2 years of age.

Special Precautions

The drug should be prescribed with caution to patients with arterial hypertension, atherosclerosis, cardiac rhythm disorders, chronic rhinitis, bronchial asthma, as well as to elderly persons.

If persistent symptoms of local irritation or development of systemic reactions are observed during treatment, the drug should be discontinued.

The patient should be warned that without a doctor’s prescription, the drug should not be used for more than 5 days or at intervals of less than 3 hours.

The patient should be warned about the need to discontinue the drug if symptoms of irritation or ophthalmalgia persist during therapy for more than 72 hours.

The systemic effect of Ditadrin^® components is unlikely, however, the drug should be used with caution in patients with arterial hypertension, cardiac rhythm disorders, hypersensitivity to sympathomimetics (including in hyperthyroidism, prostatic hypertrophy), as well as in elderly patients.

Patients should be warned that if any symptoms indicating a systemic effect of the drug appear, it is necessary to stop using Ditadrin^® and consult a doctor.

When using the drug, wearing soft contact lenses is not recommended.

Before instillation of the eye drops, hard contact lenses should be removed; they can be reinserted no less than 15-20 minutes after application of the drug.

It is not recommended to touch the dropper tip, as this may cause contamination of the eye drops.

Influence on the ability to drive vehicles and mechanisms

Patients who experience temporary loss of visual clarity after using the drug should not drive vehicles or work with mechanisms immediately after instillation of the eye drops.

Overdose

Symptoms data on overdose from instilling eye drops into the conjunctival sac are absent.

With prolonged or too frequent use of the drug in children under 6 years of age, depression of CNS functions, prolonged pupil dilation, hypothermia, and increased blood pressure are possible.

Treatment symptomatic therapy.

Drug Interactions

When using drugs containing Naphazoline during treatment with tricyclic antidepressants, an enhancement of the vasoconstrictive action of naphazoline is possible.

With simultaneous use of naphazoline with MAO inhibitors and for up to 10 days after its discontinuation, the development of a hypertensive crisis is possible.

Storage Conditions

List B. The drug should be stored in a light-protected place, out of reach of children, at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 3 years.
After opening the bottle, the storage period is 4 weeks.

Dispensing Status

The drug is dispensed by prescription.

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.