Octilia (Drops) Instructions for Use

Marketing Authorization Holder

SIFI, S.p.A. (Italy)

Contact Information

BAUSH HEALTH LLC (Russia)

ATC Code

S01GA02 (Tetryzoline)

Active Substance

Tetryzoline (Rec.INN registered by WHO)

Dosage Form

Octilia

Eye drops 0.05%: dropper bottle 8 ml 1 pc.

Dosage Form, Packaging, and Composition

Eye drops as a clear, colorless or slightly yellowish solution.

Excipients: chamomile water – 5 g, linden water – 5 g, sodium phosphate dibasic dodecahydrate – 2.45 g, potassium phosphate monobasic – 0.44 g, sodium chloride – 0.15 g, disodium edetate – 0.01 g, polysorbate 80 – 0.067 g, benzalkonium chloride – 0.005 g, purified water – up to 100 ml.

8 ml – low-density polyethylene dropper bottles (1) – cardboard packages.

Clinical-Pharmacological Group

Drug with vasoconstrictive action for topical use in ophthalmology

Pharmacotherapeutic Group

Alpha-adrenomimetic

Pharmacological Action

Adrenomimetic for topical use in ophthalmology. It stimulates the α-adrenergic receptors of the sympathetic nervous system and has no or weak effect on β-adrenergic receptors.

Tetryzoline has a vasoconstrictive effect and reduces tissue swelling.

Pharmacokinetics

With topical application, systemic absorption is low.

Systemic absorption is possible in patients with damage to the mucous membrane and epithelium.

Indications

For the relief of conjunctival edema and hyperemia caused by exposure to chemical and physical factors (smoke, wind, dust, chlorinated water, light, cosmetics, contact lenses), as well as those occurring in allergic reactions, such as hay fever.

ICD codes

Dosage Regimen

Instill one to two drops into the conjunctival sac of the affected eye or eyes.

Administer the drops up to three times daily, as needed for symptom relief.

Maintain an interval of at least six hours between consecutive applications.

Limit the total duration of treatment to a maximum of 72 hours (three days).

Do not use the medication continuously for more than four days.

Discontinue use and consult a physician if eye irritation, redness, or discomfort persists beyond 48 hours.

Remove contact lenses prior to instillation. Wait at least 15 minutes after administration before reinserting lenses.

Strictly adhere to the prescribed dosage and frequency. Do not exceed the recommended number of instillations per day.

Use the minimum effective dose for the shortest duration necessary to control symptoms.

Prolonged use may lead to rebound hyperemia and diminished therapeutic effect.

Adverse Reactions

From the organ of vision: frequency unknown – pupil dilation, burning sensation in the eye area, redness, irritation, swelling, pain, itching.

Contraindications

Hypersensitivity to tetryzoline; angle-closure glaucoma; children under 2 years of age.

With caution in patients with severe cardiovascular diseases (coronary artery disease, arterial hypertension), pheochromocytoma, prostatic hyperplasia, hyperthyroidism, diabetes mellitus, porphyria, dry rhinitis, dry keratoconjunctivitis, glaucoma; in patients receiving MAO inhibitors or other agents that can cause an increase in blood pressure. Use in angle-closure glaucoma is contraindicated; in other types of glaucoma, Tetryzoline should be used with extreme caution, under medical supervision.

Use in Pregnancy and Lactation

Given the possibility of systemic side effects, the use of tetryzoline during pregnancy and breastfeeding is possible in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

Contraindicated for use in children under 2 years of age.

Special Precautions

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

If signs of eye irritation persist for 48 hours, you should stop using tetryzoline and consult a doctor.

Contact lenses should be removed before using tetryzoline and reinserted no less than 15 minutes after instillation.

If intense eye pain, severe acute or one-sided eye redness, headache, visual impairment, spots before the eyes, or double vision occur, you should immediately consult a doctor.

Long-term use of tetryzoline may increase hyperemia or lead to its recurrence.

Effect on the ability to drive vehicles and machinery

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

Drug Interactions

With simultaneous use with MAO inhibitors, tricyclic antidepressants, as well as drugs that increase blood pressure, an enhancement of the vasoconstrictive effect of tetryzoline and an increase in blood pressure are possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.