Visine^® Alergy (Drops) Instructions for Use

Marketing Authorization Holder

J&JTL, LLC (Russia)

Manufactured By

Famar, A.V.E. (Greece)

Contact Information

J&JTL LLC (Russia)

ATC Code

S01GX02 (Levocabastine)

Active Substance

Levocabastine

Dosage Form

Visine® Alergy

Eye drops 0.05%: 4 ml bottle with dropper device

Dosage Form, Packaging, and Composition

Eye drops as a white suspension.

Excipients: propylene glycol, sodium hydrogen phosphate, sodium phosphate monohydrate, hypromellose (2910 3000 mPa.s), polysorbate 80, benzalkonium chloride (as a 50% solution), disodium edetate, water for injection.

4 ml – low-density polyethylene bottles (1) with a dropper device and a high-density polyethylene screw cap with first-opening control – cardboard packs.

Clinical-Pharmacological Group

An antiallergic drug – a histamine H₁-receptor blocker

Pharmacotherapeutic Group

Agents used in ophthalmology; decongestants and antiallergic agents; other antiallergic agents

Pharmacological Action

Levocabastine is a selective blocker of histamine H₁-receptors with a prolonged action.

The local effect occurs within 5 minutes. Visine^® Alergy relieves typical symptoms of allergic conjunctivitis (itching, redness, swelling of the conjunctiva and eyelids, lacrimation).

The effect lasts up to 12 hours.

Pharmacokinetics

Absorption

After instillation into the eyes at a dose of 15 µg/drop, about 6 µg of levocabastine is absorbed. C_max in blood plasma is reached in approximately 6 hours.

Distribution

The binding of levocabastine to plasma proteins is approximately 55%.

Metabolism

The main metabolite of levocabastine, acylglucuronide, is formed by glucuronidation, which is the main pathway of metabolite formation.

Elimination

T_1/2 of levocabastine is 39-70 hours. Levocabastine is excreted mainly by the kidneys unchanged (about 70% of the absorbed amount).

Indications

For adults and children aged 12 years and older

• Allergic conjunctivitis.

ICD codes

Dosage Regimen

Topically.

For adults and children over 12 years, 1 drop into each eye 2 times/day, if necessary – 3-4 times/day. Treatment should be continued until symptoms disappear.

The safety and efficacy of Visine^® Alergy in children aged 0 to 12 years have not been established to date. Data are not available.

Since Visine^® Alergy eye drops are a suspension, the bottle must be shaken before each use.

Using the dropper bottle

Remove the cap from the dropper bottle and turn the bottle upside down.

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

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

Adverse Reactions

Definition of adverse reaction frequency: 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 (cannot be estimated from the available data).

Adverse reactions observed in patients during clinical and post-marketing studies

Immune system disorders: very rare – anaphylactic shock, angioedema, hypersensitivity.

Nervous system disorders very rare – headache.

Eye disorders common – eye pain, blurred vision; uncommon – eyelid edema; very rare – conjunctivitis, blepharitis, conjunctival edema, conjunctival hyperemia, lacrimation.

Cardiac disorders very rare – palpitations.

Skin and subcutaneous tissue disorders very rare – contact dermatitis, urticaria.

General disorders and administration site conditions common – burning sensation in the eyes, eye irritation; very rare – conjunctival hyperemia, eye pain, conjunctival edema, eye itching, lacrimation, blurred vision.

Reports of severe corneal injury, extremely rare cases of corneal decalcification when using the drug in combination with ophthalmic solutions containing phosphates have been received.

Contraindications

• Hypersensitivity to levocabastine or to any of the excipients included in the drug;
• Wearing contact lenses;
• Children under 12 years of age;
• Breastfeeding period.

With caution elderly patients, impaired renal function.

Use in Pregnancy and Lactation

Pregnancy

There are no data on the use of levocabastine in pregnant women. Therefore, it is not recommended to use Visine^® Alergy eye drops during pregnancy, except in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

In preclinical studies in animals, Levocabastine, when administered systemically at doses up to 2500 times (in mg/kg) higher than the recommended maximum dose for topical use in humans, did not cause embryotoxic or teratogenic effects. In animals, with systemic use of levocabastine at doses more than 5000 times (in mg/kg) higher than the recommended maximum dose for topical use in humans, teratogenic properties and/or increased embryo lethality were noted.

Breastfeeding period

The drug passes into breast milk, so breastfeeding should be discontinued during treatment.

Use in Renal Impairment

With caution impaired renal function.

Pediatric Use

Contraindicated for use in children under 12 years of age.

Geriatric Use

With caution elderly patients.

Special Precautions

During treatment, it is not recommended to use soft (hydrophilic) contact lenses – interaction with benzalkonium chloride contained in the drug is possible.

To prevent microbial contamination, avoid touching the eyelids with the dropper and close the bottle tightly.

The patient should be informed that if the medicine is unusable or the expiration date has passed, it should not be poured out. It is necessary to place the medicine in a bag and put it in a trash container. These measures will help protect the environment.

Excipients

The drug contains benzalkonium chloride and propylene glycol. Benzalkonium chloride may irritate the eyes.

Contact with soft contact lenses should be avoided. Contact lenses should be removed before use and put back in no earlier than 15 minutes later. May change the color of soft contact lenses.

Propylene glycol may irritate the skin.

Effect on ability to drive vehicles and operate machinery

Visine^® Alergy eye drops do not have a sedative effect and do not affect the speed of psychomotor reactions. Adverse reactions that may lead to visual impairment have been reported – for example, eye irritation, pain, swelling, itching, redness, burning sensation, lacrimation and blurred vision. Therefore, caution should be exercised when driving vehicles and operating machinery while using the drug.

Overdose

Symptoms: in case of accidental ingestion, decreased blood pressure, tachycardia, pronounced sedative effect are possible.

Treatment: forced diuresis.

Drug Interactions

Interaction studies have not been conducted.

Storage Conditions

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

Shelf Life

Shelf life – 2 years. Do not use the drug after the expiration date.

Visine^® Alergy eye drops should be used within 1 month after opening.

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.