Optinol^® Tetryzoline (Drops) Instructions for Use

Marketing Authorization Holder

Jadran-Galenski Laboratorij, D.D. (Croatia)

Contact Information

JADRAN-GALENSKI LABORATORIJ a.o. (Croatia)

ATC Code

S01GA02 (Tetryzoline)

Active Substance

Tetryzoline (Rec.INN registered by WHO)

Dosage Form

Optinol® Tetryzoline

Eye drops 0.5 ml/1 ml: 10 ml bottle with dropper device

Dosage Form, Packaging, and Composition

Eye drops as a clear, colorless solution.

Excipients: boric acid, sodium chloride, sodium tetraborate (borax), purified water.

Does not contain preservatives.

10 ml – polyethylene bottles (1) with a 3K system dropper device – cardboard packs with a first-opening control sticker.

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 has a vasoconstrictive effect and reduces tissue swelling. Tetryzoline is a sympathomimetic that stimulates α-adrenergic receptors of the sympathetic nervous system but has no or weak effect on β-adrenergic receptors. Topical application of the tetryzoline solution to the conjunctiva leads to constriction of the eye’s blood vessels within 60 seconds and lasts for 4-8 hours.

Pharmacokinetics

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

Indications

For adults and children aged 2 years and older:

• To relieve hyperemia (redness of the eyes) and conjunctival edema caused by exposure to chemical and physical factors (smoke, dust, wind, chlorinated water, light, cosmetics, contact lenses), as well as those occurring during allergic reactions.

ICD codes

Dosage Regimen

The drug is intended for topical use only.

For adults and children over 2 years old, 1 or 2 drops 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.

For elderly patients, dose adjustment is not required.

For patients with impaired liver and kidney function, dose adjustment is not required.

Method of administration

1. Remove the protective cap from the bottle, being careful not to touch the open tip of the bottle dropper.
2. Place the index and middle fingers on the bottom of the bottle, and the thumb on the round plate at the top of the bottle.
3. Before the first use of the drug after the first drop appears, it is necessary to discard at least 5 more drops. Before each subsequent use, it is necessary to discard 1-2 drops. If the drug is not used for more than 15 days, before use, it is necessary to discard 5 drops.

Before first use of the bottle, turn it tip down and press the bottom of the bottle with the index and middle fingers 2-3 times until the first drop appears. Tilt your head back, gently pull the lower eyelid down with your index finger, and look up. If possible, hold the bottle vertically.

1. To instill the drug Optinol^® Tetryzoline into the conjunctival sac, press the bottle once. Thanks to the specially designed bottle mechanism, exactly 1 drop is released with each press. Close your eyes and slowly move your eyes in all directions so that the solution is evenly distributed over the surface of the eye.
2. Repeat the procedure for the second eye.

To prevent contamination of the bottle, do not allow the tip of the bottle dropper to touch the eye or lenses and do not touch it with your fingers.

After each use of the bottle, the dropper tip should be dried and closed with the protective cap.

Information for contact lens users

Before using the drug, contact lenses must be removed. Lenses can be put back on 15 minutes after application.

In case of concomitant use with ophthalmic drugs, it is recommended to observe a pause of at least 15 minutes between instillation of the drug Optinol^® Tetryzoline and other eye drops.

The drug Optinol^® Tetryzoline does not contain preservatives that may cause eye irritation or discolor soft contact lenses.

Adverse Reactions

The adverse events listed below are presented according to the affected organs and organ systems and frequency of occurrence. Frequency is defined as follows: very common (≥1/10); common (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100); rare (from ≥1/10000 to <1/1000); very rare (<1/10000); frequency not known (cannot be estimated from the available data).

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

Contraindications

• Hypersensitivity to the components of the drug;
• Angle-closure glaucoma;
• Pregnancy;
• Breastfeeding period;
• Children under 2 years of age.

Use in Pregnancy and Lactation

Pregnancy

Data on the use of tetryzoline hydrochloride in pregnant women are absent or limited. Reproductive toxicity studies have not been conducted. The use of the drug Optinol^® Tetryzoline during pregnancy is not recommended.

Breastfeeding period

Data on the penetration of the drug into breast milk are not available. The use of the drug Optinol^® Tetryzoline during breastfeeding is not recommended.

Use in Hepatic Impairment

For patients with impaired liver function, dose adjustment is not required.

Use in Renal Impairment

For patients with impaired kidney function, dose adjustment is not required.

Pediatric Use

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

Geriatric Use

For elderly patients, dose adjustment is not required.

Special Precautions

Patients are advised to use the drug Optinol^® Tetryzoline with caution and consult their doctor before use if they have concomitant eye or nose diseases accompanied by dryness of the mucous membranes.

The drug Optinol^® Tetryzoline should be used only for minor eye irritation. If no improvement occurs within 72 hours, or if irritation and redness persist or progress, the drug should be discontinued and a doctor should be consulted.

Irritation or redness caused by serious eye conditions, such as infection, a foreign body in the eye, or chemical damage to the cornea, also requires immediate medical consultation.

In case of severe eye pain, headache, loss of vision, spots in the visual field, severe, acute, or unilateral redness of the eyes, pain sensation when exposed to light, or double vision, it is necessary to consult a doctor immediately.

As a result of long-term and improper use of the drug in higher doses than recommended, reactive hyperemia (redness) of the conjunctiva and nasal mucosa (medicinal rhinitis) may occur. The use of the drug may cause temporary pupil dilation.

The drug Optinol^® Tetryzoline should be used with caution in elderly patients, in patients with vascular aneurysm, hypertension and/or coronary artery disease, in patients with pheochromocytoma, in patients with prostatic hyperplasia, in patients with dry rhinitis and dry keratoconjunctivitis, as well as in patients with type I diabetes mellitus or hyperthyroidism.

Use in children, as well as use in higher doses, is allowed only under medical supervision.

Thanks to the specially designed bottle mechanism, the solution remains sterile for 180 days (6 months) after first use, while containing no preservatives. The bottle multidispenser ensures dosing accuracy and convenience of using the drug Optinol^® Tetryzoline. The bottle contains more than 200 drops.

Effect on ability to drive vehicles and operate machinery

In rare cases, blurred vision may occur after using the drug, which may affect the ability to drive vehicles and operate machinery.

Overdose

Symptoms

When used in accordance with the drug characteristics, the risk of overdose is minimal. However, in case of accidental ingestion into the gastrointestinal tract (swallowing), the following overdose symptoms are possible: pupil dilation, nausea, cyanosis, fever, convulsions, tachycardia, arrhythmia, cardiac arrest, arterial hypertension, pulmonary edema, respiratory depression (including respiratory arrest), CNS depression (including the development of drowsiness and coma). The risk of developing overdose symptoms due to systemic effects is high in young children, especially if swallowed.

Treatment

A specific antidote is unknown. Treatment of overdose upon ingestion: activated charcoal, gastric lavage, oxygen inhalation, antipyretic and anticonvulsant drugs. 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.

If any of the overdose symptoms described above occur, you should consult a doctor immediately.

Drug Interactions

Concomitant use of the drug Optinol^® Tetryzoline with MAO inhibitors, for example, tranylcypromine or tricyclic antidepressants, as well as drugs that increase blood pressure, may lead to an enhancement of the vasoconstrictive effect and increase blood pressure. Thus, simultaneous treatment with these drugs should be avoided.

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 after the expiration date stated on the packaging.

The shelf life of the drug after opening the packaging is 180 days.

Dispensing Status

The drug is dispensed 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.