Montevizin (Drops) Instructions for Use

Marketing Authorization Holder

Hemofarm, A.D. (Serbia)

Manufactured By

Hemomont, LLC (Montenegro)

Quality Control Release

HEMOFARM, A.D. (Serbia)

Contact Information

NIZHPhARM group of companies (Russia)

ATC Code

S01GA02 (Tetryzoline)

Active Substance

Tetryzoline (Rec.INN registered by WHO)

Dosage Form

Montevizin

Eye drops 0.05%: bottle 10 ml with a dosing nozzle

Dosage Form, Packaging, and Composition

Eye drops transparent, colorless.

Excipients : benzalkonium chloride – 100 mcg, disodium edetate dihydrate – 1 mg, sodium chloride – 1.8 mg, boric acid – 12 mg, sodium tetraborate decahydrate – 570 mcg, water for injections – up to 1 ml.

10 ml – bottles of colorless glass (1) in a set with a dosing nozzle – carton packs.

Clinical-Pharmacological Group

Drug with vasoconstrictive action for topical use in ophthalmology

Pharmacotherapeutic Group

Alpha-adrenomimetic

Pharmacological Action

A drug with a vasoconstrictive action for topical use in ophthalmology. Alpha-adrenomimetic. It has a vasoconstrictive and anti-edema effect.

The vasoconstrictive effect without secondary reactive hyperemia develops within a few minutes and lasts for 4-8 hours.

Pharmacokinetics

With topical application, systemic absorption is low.

Indications

• Conjunctival edema, secondary hyperemia in allergic eye diseases, conjunctival irritation;
• Conjunctival hyperemia and/or edema caused by various nonspecific causes (condition after tonometry, dust, cigarette smoke, smog, swimming, reading, driving).

ICD codes

Dosage Regimen

Instill 1-2 drops into the conjunctival sac of both eyes.

Apply the drops 2-3 times per day as needed for symptom relief.

Limit the duration of use to a few days. Avoid long-term continuous application.

Discontinue use and consult a physician if improvement does not occur within 48 hours.

Remove soft contact lenses before instillation. Wait at least 15 minutes after administration before reinserting lenses to avoid binding the preservative.

Do not exceed the recommended dosage. Systemic absorption can occur, leading to adverse effects.

Seek immediate medical attention if severe eye pain, vision disturbances, persistent redness, or intense headache occurs after use.

Adverse Reactions

Local reactions: mydriasis, increased intraocular pressure, reactive hyperemia, lacrimation, burning sensation in the eye.

Systemic reactions (possible when instilling a large amount of the drug): headache, nausea, drowsiness, weakness, tremor, dizziness, insomnia, palpitations, tachycardia, hyperglycemia, increased blood pressure, cardiac activity disorders, allergic reactions.

Contraindications

• Glaucoma;
• Children under 6 years of age;
• Endothelial-epithelial dystrophy of the cornea;
• Pregnancy;
• Lactation period (breastfeeding);
• Hypersensitivity to the components of the drug.

Use with caution in arterial hypertension, arrhythmia, aneurysm, thyrotoxicosis, pheochromocytoma, diabetes mellitus, severe organic diseases of the heart and blood vessels (including coronary artery disease), during treatment with MAO inhibitors and other drugs that increase blood pressure.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindication: children under 6 years of age.

Special Precautions

Long-term use and overdose should be avoided, especially in children.

If the eye condition is not an obstacle to wearing contact lenses, they should be removed before instilling the drug and reinserted after approximately 15 minutes. Direct contact of the eye drops with soft contact lenses should be avoided, considering the risk of impairing their transparency.

If the condition does not improve within 48 hours or if eye irritation and hyperemia persist or increase, the drug should be discontinued and a doctor should be consulted. If intense eye pain, headache, vision loss, sudden appearance of “floating” spots before the eyes, eye redness, pain upon exposure to light, or double vision occurs, a doctor should be consulted immediately.

Effect on the ability to drive vehicles and operate machinery

During treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (due to the possibility of developing visual impairment).

Overdose

Symptoms mydriasis, cyanosis, fever, convulsions, arrhythmias, increased blood pressure, pulmonary edema, dyspnea, cardiac arrest. Excessive systemic absorption of imidazole derivatives can lead to CNS depression, accompanied by drowsiness, hypothermia, bradycardia, collapse, apnea, and coma. The risk of overdose symptoms associated with drug absorption is high in young children, especially if swallowed.

Treatment antidote is unknown. Administer activated charcoal, gastric lavage, oxygen inhalation, antipyretics and anticonvulsants. To reduce blood pressure – phentolamine 5 mg in physiological solution slowly IV or 100 mg orally.

Drug Interactions

With simultaneous use with MAO inhibitors, tricyclic antidepressants, maprotiline, the risk of hypertensive crisis increases.

With simultaneous use with inhalation anesthetics (cyclopropane, halothane and other halogenated anesthetics), the risk of ventricular fibrillation increases.

Storage Conditions

The drug should be stored out of the 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 drug should be used within 30 days.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.