Ophthophenazole (Drops) Instructions for Use

Marketing Authorization Holder

Representative Office of Polfa Warsaw Pharmaceutical Works S.A. (Russia)

ATC Code

S01GA51 (Naphazoline in combination with other drugs)

Active Substances

Naphazoline (Rec.INN registered by WHO)

Antazoline (Rec.INN registered by WHO)

Dosage Form

Ophthophenazole

Nasal and eye drops 5 mg+0.25 mg/ml: 5 ml fl. 2 pcs.

Dosage Form, Packaging, and Composition

Eye drops as a transparent, colorless or light yellow liquid.

Excipients: boric acid 15 mg, disodium edetate dihydrate 0.5 mg, benzalkonium chloride 50% 0.2 mg, sodium hydroxide solution 10% to pH 4.0-5.5, purified water to 1 ml.

10 ml – polyethylene dropper bottles (1) – cardboard boxes.
15 ml – polyethylene dropper bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Drug with antiallergic and vasoconstrictive action for topical use in ophthalmology

Pharmacotherapeutic Group

Antiallergic agent (H1-histamine receptor blocker + alpha-adrenomimetic)

Pharmacological Action

The drug Ophthophenazole is a combined drug containing an antihistamine agent – Antazoline and an alpha-adrenomimetic agent – Naphazoline.

Antazoline is a first-generation H1-histamine receptor blocker. By competitively blocking H1-histamine receptors, the drug alleviates such allergic reactions as dilation and increased permeability of blood vessels, in particular, those associated with the release of histamine.

Naphazoline stimulates alpha-adrenergic receptors of blood vessels; when applied topically, it constricts dilated blood vessels of the conjunctiva and eliminates symptoms of inflammation (reduces swelling, hyperemia, and exudation phenomena).

Pharmacokinetics

The effect of naphazoline appears within 5 minutes after topical application. The duration of action is 6-8 hours.

Naphazoline can be absorbed through the mucous membranes, exerting a systemic effect, although such an effect in adults after administration of the drug into the conjunctival sac is unlikely. Systemic reactions mainly occur in elderly patients and young children. The occurrence of a systemic effect of antazoline is unlikely.

Indications

• Acute, seasonal or perennial allergic conjunctivitis.

ICD codes

Dosage Regimen

The drug is intended for topical use only as instillations into the conjunctival sac.

Adults and children over 6 years

1-2 drops into the conjunctival sac; if necessary, the dose can be repeated after 4-6 hours.

After instilling the drug, you should gently close your eye, do not blink and do not open it for about 2 minutes so that the drug is absorbed. After instillation, you should gently press with your finger on the inner corner of the lower eyelid for 1-2 minutes. This may prevent the drops from entering the nasal cavity through the nasolacrimal duct and the occurrence of systemic side effects. Then wash your hands to remove any residue of the drug and close the bottle.

It is not recommended to use the drug for longer than 3-5 days without a doctor’s recommendation.

The need to change the dose or duration of treatment is determined by the doctor individually in each specific case.

With caution

• In patients with chronic conjunctivitis, the drug should be used for a short time and only in case of exacerbation of symptoms;
• The recommended time of application of the drug should be observed and the prescribed dose should not be exceeded due to the danger of secondary increase in conjunctival edema and increased discharge, as well as the development of persistent changes in the epithelium.

Adverse Reactions

Usually temporary symptoms from the conjunctiva appear burning, itching in the eye, visual disturbance, redness of the conjunctiva.

Systemic reactions drowsiness, lethargy, increased blood pressure, headaches and dizziness, nausea, eye pain.

Persistence of symptoms or intensification of local changes is an indication for discontinuation of the drug.

Contraindications

• Hypersensitivity to the components of the drug;
• Closed-angle glaucoma;
• With increased sensitivity to adrenomimetic agents;
• Taking monoamine oxidase (MAO) inhibitors;
• Children under 6 years of age.

Use in Pregnancy and Lactation

During pregnancy, the use of the drug is contraindicated. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Pediatric Use

Contraindicated in children under 6 years of age. Used in children over 6 years of age.

Special Precautions

The medicinal product Ophthophenazole^® contains benzalkonium chloride as a preservative; patients who wear contact lenses should remove them before instillation of the eye drops and wait at least 15 minutes before reinserting them. Benzalkonium chloride can cause eye irritation and change the color of contact lenses.

When using the drug, avoid contact of the dropper tip with any surface to avoid microbial contamination.

Effect on the ability to drive vehicles and operate machinery

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

Overdose

There are no data concerning acute overdose of drops administered topically into the conjunctival sac.

Long-term or too frequent administration of the drug to children, or accidental ingestion may lead to depression of the central nervous system, drowsiness, hypothermia and even coma. Decreased blood pressure and tachycardia may occur. Symptomatic treatment should be prescribed.

Drug Interactions

Do not use the drug simultaneously with monoamine oxidase (MAO) inhibitors and tricyclic antidepressants.

Storage Conditions

Store the drug in a place inaccessible to children at a temperature not exceeding 25°C (77°F). Do not freeze.

Shelf Life

Shelf life – 3 years. Shelf life after opening – 4 weeks. Do not use after the expiration date stated on the packaging.

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.