Vizokko^® (Drops) Instructions for Use

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Manufactured By

Diafarm, JSC (Russia)

Packaging and Quality Control Release

SEVERNAYA ZVEZDA, NAO (Russia)

ATC Code

S01GA02 (Tetryzoline)

Active Substance

Tetryzoline (Rec.INN registered by WHO)

Dosage Form

Vizokko®

Eye drops 0.5 mg/1 ml: 5 ml or 10 ml dropper bottles

Dosage Form, Packaging, and Composition

Eye drops as a transparent, colorless solution.

Excipients: benzalkonium chloride, boric acid, sodium chloride, disodium edetate dihydrate, disodium tetraborate decahydrate, purified water.

5 ml – dropper bottles (1) – cardboard boxes.
10 ml – dropper bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Vasoconstrictor for topical use in ophthalmology (alpha-adrenergic agonist)

Pharmacotherapeutic Group

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

Pharmacological Action

Tetryzoline, the active substance of Vizokko^®, is an agent from the group of imidazole derivatives, has a vasoconstrictive effect and reduces tissue swelling.

When applied topically, it relieves redness and swelling of the eye by constricting the blood vessels in the eye.

The effect of the drug begins 60 seconds after instillation and lasts 4-8 hours.

Indications

Adults and children aged 2 years and older

• To relieve eye swelling and redness caused by exposure to chemical and physical factors such as smoke, wind, dust, chlorinated water, light, cosmetics, contact lenses.

ICD codes

Dosage Regimen

The drug Vizokko^® is intended for instillation into the eyes, regardless of food intake.

Recommended dose: 1 or 2 drops 2-3 times/day into the affected eye.

When using Vizokko^® with other ophthalmic agents, the drops should be instilled at least 10 minutes apart. Eye ointments are applied last.

Elderly patients dose adjustment is not required.

Patients with hepatic impairment dose adjustment is not required.

Patients with renal impairment dose adjustment is not required.

Method of administration

1. Wash your hands.
2. Open the bottle. Pay special attention that the tip of the dropper bottle does not touch the eye, the skin around the eye, or your fingers. This will avoid contamination of the eye drops with microorganisms.
3. Tilt your head back and hold the bottle upside down over the eye.
4. Pull the lower eyelid down and look up. Holding and gently squeezing the bottle from both sides, instill one drop into the space between the eye and the lower eyelid.
5. Press your finger against the corner of the eye, near the nose, or close your eyes for 2 minutes. This will help prevent the drug from entering the bloodstream.
6. If necessary, repeat steps 3 to 5.
7. Tightly screw the cap onto the bottle.

If the patient did not apply Vizokko^® at the scheduled time, it should be instilled in the recommended dose as soon as possible.

If the missed dose is about 12 hours, the drug should be applied at the next scheduled time, without doubling the dose to compensate for the missed dose.

Adverse Reactions

From the organ of vision frequency unknown (cannot be estimated from the available data) – lacrimation, pupil dilation, burning in the eye area, redness, irritation, swelling, pain, itching.

Contraindications

• Hypersensitivity to tetryzoline or any other component of the drug;
• Angle-closure glaucoma;
• Children under 2 years of age.

With caution

Aneurysms, increased blood pressure and/or coronary artery disease, type 1 diabetes mellitus, hyperthyroidism, benign prostatic hyperplasia, chronic inflammatory diseases of the mucous membranes of the eyes or nose, accompanied by dryness.

Use in Pregnancy and Lactation

In case of planned, suspected, or confirmed pregnancy, as well as during breastfeeding, the patient should consult her doctor before starting to use the drug.

Pregnancy

Data on use during pregnancy are absent or limited. The drug should not be used during pregnancy.

Breastfeeding

Data on penetration into breast milk are absent. The drug should not be used during breastfeeding. If use during lactation is necessary, breastfeeding should be discontinued.

Fertility

Data on fertility are absent.

Use in Hepatic Impairment

In case of hepatic impairment, dose adjustment is not required.

Use in Renal Impairment

In case of renal impairment, dose adjustment is not required.

Pediatric Use

Contraindicated for use in children under 2 years of age.

Special Precautions

If the condition does not improve within 72 hours of using the drug, or if irritation and redness persist or increase, the use of the drug should be discontinued and a doctor should be consulted.

If intense eye pain, severe acute or unilateral eye redness, headache, visual impairment, spots before the eyes, or double vision occur, a doctor should be consulted immediately.

With frequent or prolonged use of the drug by patients with corneal diseases, the development of punctate/ulcerative toxic keratopathy is possible. Monitoring of the corneal condition of such patients during treatment with the drug is required.

Long-term use of the drug may increase hyperemia (swelling) or lead to its recurrence.

If there is a possibility that irritation and/or redness are caused by any diseases of the visual organs (e.g., infection, foreign body, or mechanical, chemical, or thermal exposure), a doctor should be consulted before using the drug. Further treatment may be required.

Sometimes, when using the drug, temporary pupil dilation may occur, which resolves after discontinuation of the drug.

Prolonged use and overdose of the drug should be avoided.

Do not use the drug if the solution has changed color or become cloudy.

Use of contact lenses

In general, wearing contact lenses while using the drug is not recommended. Avoid contact of the drug with soft contact lenses, as this may cause them to discolor. Remove contact lenses before using the drug and put them on 15 minutes after application.

Use in pediatrics

The drug should not be used in children under 2 years of age, because the expected benefit for this category of patients does not exceed the potential risk of use.

Excipients

The drug Vizokko^® contains the preservative benzalkonium chloride, which may cause eye irritation or discolor soft contact lenses.

Effect on ability to drive vehicles and operate machinery

If adverse reactions such as pupil dilation and blurred vision occur during the use of the drug, one should refrain from driving vehicles and operating machinery. Children receiving the drug who experience these adverse reactions are not allowed to ride bicycles and scooters.

Overdose

Symptoms with topical use in high doses for a long time, dry keratoconjunctivitis may develop, manifested by itching, burning, lacrimation, and swelling of the nasal mucosa (medicinal rhinitis).

When used in accordance with the instructions for use, the risk of overdose is minimal. However, if the drug accidentally enters the gastrointestinal tract (swallowing), the following overdose symptoms are possible: pupil dilation, nausea, cyanosis, fever, convulsions, tachycardia, arrhythmia, cardiac arrest, arterial hypotension, pulmonary edema, respiratory depression, apnea, decreased body temperature, depression of CNS function, including the development of drowsiness and coma.

The risk of developing overdose symptoms due to the systemic effects of the drug is high in newborns and young children, especially if swallowed.

Treatment of overdose in case of swallowing: administer activated charcoal, gastric lavage, oxygen inhalation, antipyretics and anticonvulsants. A specific antidote is unknown.

Drug Interactions

The patient should inform the attending physician about the planned, recent, or current use of any other drugs, including over-the-counter ones. This is especially true for the following medications

• MAO inhibitor antidepressants;
• Tricyclic antidepressants (e.g., amitriptyline or clomipramine);
• Drugs that increase blood pressure.

The above should not be taken simultaneously with the use of Vizokko^®, as this may lead to an increase in blood pressure.

Storage Conditions

The drug should be stored out of the reach of children at a temperature below 30°C (86°F).

Do not use the drug after the expiration date (shelf life) indicated on the packaging. The expiration date is the last day of the specified month.

After opening the dropper bottle, the drug should be used within 28 days.

Dispensing Status

The drug is available without a 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.