Vizokko^® Tetryzoline (Drops) Instructions for Use

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Contact Information

SEVERNAYA ZVEZDA NAO (Russia)

ATC Code

S01GA02 (Tetryzoline)

Active Substance

Tetryzoline (Rec.INN registered by WHO)

Dosage Form

Vizokko® Tetryzoline

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: boric acid, sodium chloride, disodium edetate dihydrate, benzalkonium chloride – 0.1 mg/ml, disodium tetraborate decahydrate, water for injections.

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

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 is a sympathomimetic, an imidazole derivative, which stimulates α-adrenergic receptors of the sympathetic nervous system but has no or weak effect on β-adrenergic receptors.

Being a sympathomimetic, Tetryzoline has a vasoconstrictive effect and reduces tissue swelling. The drug’s action begins within 60 seconds after instillation and lasts for 4-8 hours.

Pharmacokinetics

When applied topically, it is practically not absorbed. However, systemic absorption in patients with damaged mucosa and epithelium cannot be ruled out with topical application.

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 recommended dose for adults and children over 2 years is 1 drop into the affected eye 2-3 times/day.

Use of the drug for more than 4 days should only be carried out under medical supervision.

Special patient groups

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.

Children

The dosage regimen for children from 2 to 18 years does not differ from the dosage regimen for adults.

Method of administration

Topically, as instillations into the conjunctival sac.

After removing the cap, if the snap-on tamper-evident ring is not flush with the neck, it must be removed before using the drug.

Do not touch the tip of the dropper bottle to the eyelids or any other surface to avoid contamination of the dropper bottle and its contents. The bottle should be closed after each use.

Adverse Reactions

Adverse reactions are classified according to the following frequency gradation: very common (≥1/10), common (≥1/100 but <1/10), uncommon (≥1/1000 but <1/100), rare (≥1/10000 but <1/1000), very rare (<1/10000), frequency not known (cannot be estimated from the available data).

Children

The frequency, type and severity of adverse reactions in children are assumed to be similar to those observed in adults.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after drug registration to ensure continuous monitoring of the benefit-risk balance of the drug.

Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting system of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to tetryzoline or to any of the excipients of the drug;
• Angle-closure glaucoma.

Use with caution in elderly patients, in patients with aneurysms, hypertension and/or coronary artery disease, type I diabetes mellitus, hyperthyroidism.

Use in Pregnancy and Lactation

Pregnancy

Data on the use of tetryzoline hydrochloride in pregnant women are absent or limited. No reproductive toxicity studies have been conducted.

The use of Vizokko^® Tetryzoline during pregnancy is not recommended.

Breastfeeding

Data on the penetration of tetryzoline hydrochloride into breast milk are not available. The use of the drug during lactation is not recommended.

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.

Geriatric Use

Use with caution in elderly patients, dose adjustment is not required.

Special Precautions

Failure to follow the instructions for use may lead to the development of reactive hyperemia of the conjunctiva and nasal mucosa (medicinal rhinitis).

Should be used with caution in patients with dry rhinitis and dry keratoconjunctivitis.

If the condition does not improve within 72 hours of using the drug, or if irritation and redness persist or worsen, 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.

Prolonged use of the drug may increase hyperemia or lead to its recurrence.

If irritation and/or redness are caused by eye diseases (infection, foreign body, or mechanical, chemical, thermal exposure), a doctor’s consultation is required before use to determine the need for further therapeutic measures.

The use of the drug may cause temporary pupil dilation.

Avoid prolonged use and overdose of the drug.

Do not use the drug if its color has changed or the contents of the bottle have become cloudy.

The drug should be used with caution in cases of prostate hyperplasia.

Excipients

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

Contact lenses must be removed before instilling the drug and reinserted no earlier than 15 minutes after instillation. With frequent or prolonged use of the drug by patients with corneal diseases, punctate/ulcerative keratopathy may develop. Monitoring of the corneal condition of such patients during treatment with the drug is required.

Effect on ability to drive vehicles and operate machinery

Vizokko^® Tetryzoline has a moderate influence on the ability to drive vehicles and operate machinery, because in rare cases after using Vizokko^® Tetryzoline eye drops, pupil dilation and blurred vision may occur, which may affect the ability to drive a car and other machinery.

Overdose

Symptoms

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: mydriasis, nausea, cyanosis, fever, convulsions, tachycardia, arrhythmia, cardiac arrest, arterial hypotension, pulmonary edema, respiratory depression including apnea, hypothermia, CNS depression including 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

A specific antidote is unknown.

In case of overdose, activated charcoal, gastric lavage, oxygen inhalation, antipyretics and anticonvulsants are prescribed.

To reduce blood pressure, phentolamine is used at 5 mg in saline slowly IV or 100 mg orally. Vasopressor agents are contraindicated in patients with low blood pressure. In case of accidental ingestion or the appearance of any of the overdose symptoms described above, a doctor should be consulted immediately.

Drug Interactions

Concomitant use of this drug with MAO inhibitors, e.g., tranylcypromine, tricyclic antidepressants, as well as with drugs that increase blood pressure, may enhance vasoconstriction and increase blood pressure. Therefore, the simultaneous use of these drugs should be avoided.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

The shelf life is 3 years. Do not use the drug after the expiration date printed on the packaging.

The shelf life after opening the dropper bottle is 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.