Ocu-Ocu^® (Drops) Instructions for Use

Marketing Authorization Holder

Norton, LLC (Russia)

Manufactured By

Firm VIPS-MED, LLC (Russia)

ATC Code

S01GA51 (Naphazoline in combination with other drugs)

Active Substances

Diphenhydramine (Rec.INN registered by WHO)

Zinc sulfate (BP British Pharmacopoeia)

Naphazoline (Rec.INN registered by WHO)

Dosage Form

Ocu-Ocu®

Eye drops 10 mg+10 mg+10 mg/10 ml: bottle 5 ml or 10 ml with dropper caps

Dosage Form, Packaging, and Composition

Eye drops in the form of a transparent, blue liquid.

Excipients: sodium citrate – 140 mg, citric acid – 6 mg, benzalkonium chloride – 2 mg, methylthioninium chloride (methylene blue dye) – 0.3 mg, sodium chloride – 32 mg, hypromellose 4000 – 2.5 mg, sodium hydroxide – 3 mg, water for injection – up to 10 ml.

5 ml – polyethylene bottles (1) with dropper caps – cardboard packs.
10 ml – polyethylene bottles (1) with dropper caps – cardboard packs.

Clinical-Pharmacological Group

Drug with antiallergic and vasoconstrictive action for topical use in ophthalmology

Pharmacotherapeutic Group

Agents used in ophthalmology; decongestants and antiallergic agents; sympathomimetics used as decongestants

Pharmacological Action

A combined medicinal product for topical use. It has antiallergic, vasoconstrictive, antimicrobial, and anti-inflammatory effects.

Diphenhydramine is an H₁-histamine receptor blocker. It reduces capillary permeability and prevents tissue edema.

Naphazoline is a sympathomimetic. It has a rapid, pronounced, and prolonged vasoconstrictive effect. It reduces swelling and hyperemia of the mucous membranes.

Zinc sulfate has an astringent, drying, anti-inflammatory, and antiseptic effect.

Pharmacokinetics

When applied topically, it undergoes systemic absorption.

Indications

Chronic nonspecific, allergic conjunctivitis and blepharoconjunctivitis; angular conjunctivitis; symptoms of eye tissue irritation (redness, itching, foreign body sensation).

ICD codes

Dosage Regimen

Instill one drop into the conjunctival sac of the affected eye.

Apply two to three times daily, or as directed by a physician.

Ensure the dropper tip does not contact the eye, eyelids, or any other surface to prevent contamination of the solution.

Wash hands thoroughly before and after administration.

Tilt the head back, pull down the lower eyelid to form a pouch, and instill the drop.

Close the eye gently for one to two minutes after instillation; avoid blinking.

Apply gentle pressure to the tear duct (inner corner of the eye) for approximately one minute to reduce systemic absorption.

Do not exceed the recommended dosage or frequency of administration.

Discontinue use and consult a physician if no symptomatic improvement is observed within 72 hours.

If using other ophthalmic products, administer them at least 15 minutes apart from Ocu-Ocu^® drops.

Exercise caution when driving or operating machinery immediately after application, as transient blurred vision may occur.

Adverse Reactions

Local reactions: mild burning, allergic reactions; reactive hyperemia and edema of the eye mucosa; paresis of accommodation.

Systemic reactions: tachycardia, increased blood pressure, nausea, headache, photosensitization, dryness and numbness of the mucous membranes, drowsiness, weakness, decreased speed of psychomotor reactions, impaired coordination of movements, dizziness.

Contraindications

Angle-closure glaucoma; dry eye syndrome; pheochromocytoma; diabetes mellitus; prostatic hyperplasia, stenosing gastric and duodenal ulcer, stenosis of the bladder neck, bronchial asthma, epilepsy, arterial hypertension, severe atherosclerosis, hyperthyroidism; pregnancy; lactation period; children’s age (under 2 years); hypersensitivity to the components of the combination.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindication — children’s age (under 2 years).

Special Precautions

To avoid contamination of the solution, keep the bottle tightly closed and avoid contact of the pipette tip with any surface.

Effect on the ability to drive vehicles and machinery

During treatment, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions (within 10-15 minutes after instillation, a decrease in visual acuity is possible).

If no reduction in symptoms is observed within 72 hours after application, the use of the medicinal product should be discontinued.

Drug Interactions

Concomitant use with medicinal products that stimulate the CNS – mutual reduction of effects.

Naphazoline slows down the absorption of local anesthetics.

Zinc sulfate is pharmaceutically incompatible with salts of gold, zinc, quinine, ichthammol, citral, protargol, alkali-reacting substances.

Should not be used simultaneously with MAO inhibitors and within 10 days after their discontinuation.

As a result of concomitant use of beta-blockers, MAO inhibitors with adrenomimetics, the effect of the latter is enhanced.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.