Visine^® Comfort (Drops) Instructions for Use

Marketing Authorization Holder

J&JTL, LLC (Russia)

Manufactured By

Janssen Pharmaceutica, NV (Belgium)

Contact Information

J&JTL LLC (Russia)

ATC Code

S01GA02 (Tetryzoline)

Active Substance

Tetryzoline (Rec.INN registered by WHO)

Dosage Form

Visine® Comfort

Eye drops 0.05%: 15 ml bottle with dropper device

Dosage Form, Packaging, and Composition

Eye drops as a transparent, colorless or slightly yellowish liquid.

Excipients: glycerol 99.5%, hypromellose-2910, macrogol-400, boric acid, sodium hydrogen phosphate, sodium citrate, potassium chloride, magnesium chloride hexahydrate, sodium (S)-lactate solution (50% solution), glycine, ascorbic acid, dextrose monohydrate, polyquaternium-42 chloride (polyquaternium 42) (33% solution), purified water.

15 ml – low-density polyethylene bottles with a dropper device and a screw cap with a child-resistant opening system and a polyethylene first-opening control tape (1) – cardboard packs.

Clinical-Pharmacological Group

Topical alpha-adrenergic agonist for use in ophthalmology

Pharmacotherapeutic Group

Alpha-adrenomimetic

Pharmacological Action

Tetryzoline is a sympathomimetic drug that stimulates α-adrenergic receptors of the sympathetic nervous system but has no or weak effect on β-adrenergic receptors.

Being a sympathomimetic amine, Tetryzoline has a vasoconstrictive effect and reduces tissue edema.

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

Pharmacokinetics

Absorption

In a study involving 10 healthy volunteers, systemic absorption varied among patients with maximum serum concentrations ranging from 0.068 to 0.380 ng/ml.

When applied topically according to the instructions for medical use, systemic absorption is very limited and is not considered clinically significant.

However, the possibility of systemic absorption after topical application cannot be excluded, especially in patients with damage to the mucous membrane and epithelium.

Distribution

No data available.

Metabolism

No data available.

Excretion

In a study involving 10 healthy volunteers, tetryzoline concentrations were determined in both serum and urine after therapeutic ophthalmic administration.

The mean T_1/2 of tetryzoline from serum was approximately 6 hours. After 24 hours, tetryzoline concentration was detected in the urine of all patients.

Indications

• For the relief of conjunctival edema and hyperemia (redness of the eyes) caused by exposure to chemical and physical factors such as smoke, dust, chlorinated water, light, cosmetics, contact lenses.

ICD codes

Dosage Regimen

The drug is applied topically.

Adults and children over 6 years – 1 or 2 drops into the affected eye 2-3 times/day.

Children from 2 to 6 years – use of the drug is possible after consultation with a healthcare professional.

Continuous use of the drug for more than 4 days is not recommended.

Instructions for using the dropper bottle

The medicinal product is supplied in child-resistant packaging.

When using the bottle for the first time, it is necessary to remove the first-opening control tape from the cap.

Press down on the bottle cap while turning it counterclockwise. Remove the cap from the dropper bottle and turn the bottle over.

Do not touch the tip of the bottle to any surfaces.

After use, screw the cap back onto the dropper bottle.

Adverse Reactions

Post-marketing data

Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10000, <1/1000), very rare (<1/10000, including isolated reports), frequency unknown (frequency cannot be estimated from available data).

Eye disorders frequency unknown – increased lacrimation, pupil dilation.

General disorders and administration site conditions frequency unknown – reactions at the administration site (including burning sensation in the eye area, redness, irritation, swelling, pain, itching).

If the side effects listed in the instructions occur, or they worsen, or any other side effects not listed in the instructions occur, the patient should inform the doctor.

Contraindications

• Hypersensitivity to the components of the drug;
• Angle-closure glaucoma;
• Corneal endothelial-epithelial dystrophy;
• Children under 2 years of age.

With caution

In patients with severe cardiovascular diseases (coronary artery disease, arterial hypertension, arrhythmias, aneurysm), hyperthyroidism, pheochromocytoma, diabetes mellitus, and in patients receiving MAO inhibitors or other agents that can increase blood pressure.

Use in Pregnancy and Lactation

The drug should not be used during pregnancy and breastfeeding, as well-controlled studies on the effect of tetryzoline hydrochloride on the fetus have not been conducted.

Data on the penetration of the drug through the placenta and into breast milk are not available.

Pediatric Use

The use of the drug is contraindicated in children under 2 years of age.

Special Precautions

Tetryzoline should be used with caution in elderly patients, in patients with aneurysms, hypertension and/or coronary artery disease, as well as in patients with type 1 diabetes mellitus or hyperthyroidism.

Safety studies of the drug in children and adolescents have not been conducted.

Contact lenses should be removed before instilling the drug and reinserted after 15 minutes. Direct contact of the drug with soft contact lenses should be avoided due to the possible impairment of their transparency.

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

If the condition does not improve within 72 hours 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, it is necessary to consult a doctor immediately. Long-term use of the drug may increase hyperemia or lead to its recurrence.

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

The use of the drug may cause temporary pupil dilation.

Visine^® Comfort moisturizing drops contain 7.5 µg of phosphates in each drop. If a patient has serious damage to the transparent layer of the cornea, phosphates can, in very rare cases, cause the appearance of cloudy spots on the cornea due to calcium accumulation during treatment.

Long-term use and overdose of the drug should be avoided.

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

If the medicinal product is no longer usable or the expiration date has passed, it should not be poured into drains or thrown onto the street. It is recommended to place the medicinal product in a bag and put it in a trash container. These measures will help protect the environment.

Effect on the ability to drive vehicles and operate machinery

In rare cases, after using Visine^® Comfort eye drops, temporary pupil dilation and blurred vision may occur, which may affect the ability to drive a car and operate machinery.

Overdose

When used according to the instructions, the risk of overdose is minimal. However, if the drug accidentally enters the gastrointestinal tract (swallowing), the following symptoms of overdose are possible: pupil dilation, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, bradycardia, arrhythmia, cardiac arrest, arterial hypotension, pulmonary edema, respiratory depression including apnea (respiratory arrest), hypothermia, CNS depression, sedative effect, lethargy, stupor, salivation, development of drowsiness, 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 specific antidote is unknown. If it enters the gastrointestinal tract, activated charcoal, gastric lavage, oxygen inhalation, antipyretics and anticonvulsants are prescribed. To reduce blood pressure, phentolamine is used at 5 mg in physiological saline slowly intravenously or 100 mg orally. Vasopressor agents are contraindicated in patients with low blood pressure.

The drug should be stored out of the reach of children. In case of accidental ingestion or the appearance of any overdose symptoms described above, a doctor should be consulted immediately.

Drug Interactions

Significant interactions with other medicinal products are unknown. The patient should consult a doctor before using it concomitantly with other ophthalmic drugs.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

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

After opening the bottle, the drug should be used within 3 months.

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.