Optin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT OPTIN (OPTIN)

Composition:

Active substance: tetrahydrozoline hydrochloride;

1 ml of solution contains 0.5 mg of tetrahydrozoline hydrochloride;

Excipients: borax, sodium chloride, boric acid, purified water.

Pharmaceutical form. Eye drops, solution.

Main physicochemical properties: clear, colorless solution.

Pharmacotherapeutic group. Agents used in ophthalmology. Anti-edematous and anti-allergic agents. Sympathomimetics used as anti-edematous agents. ATC code S01G A02.

Pharmacological properties.

Pharmacodynamics.

Tetrahydrozoline is a sympathomimetic agent belonging to the group of imidazoline decongestants. It directly stimulates alpha-adrenergic receptors of the sympathetic nervous system with minimal or no effect on beta-adrenergic receptors. When applied topically to the conjunctival mucosa, the drug exerts a temporary vasoconstrictive effect on small blood vessels, thereby reducing vasodilation and conjunctival edema.

Pharmacokinetics.

The mean elimination half-life of tetrahydrozoline from blood plasma was approximately 6 hours. Systemic absorption varied among patients, with maximum plasma concentrations ranging from 0.068 to 0.380 ng/mL. Twenty-four hours after administration, tetrahydrozoline was detected in the urine of all patients.

Clinical characteristics.

Indications.

Symptomatic temporary relief of secondary ocular hyperemia due to mild irritative influences and allergic conjunctivitis.

Contraindications.

Hypersensitivity to the components of the drug, closed-angle glaucoma.

Interaction with other medicinal products and other forms of interactions.

There are no known significant interactions with other medicinal products. Consult a physician before use with other ophthalmic medications.

Special precautions for use.

The use of the drug may cause mydriasis. The drug should be discontinued and medical advice sought if improvement is not observed within 72 hours, or if irritation or hyperemia persists or worsens, or if eye pain or visual disturbances occur.

Optine eye drops should be used only in cases of mild eye irritation. The patient should be aware:

• if there is no improvement within 48 hours, or if irritation or redness persists or increases, use of the drug should be discontinued;
• if irritation or redness is associated with serious eye conditions (such as infection, foreign body, or chemical corneal injury), medical advice is recommended;
• if severe eye pain, headache, rapid vision loss, sudden appearance of floating spots in front of the eyes, eye redness, pain upon exposure to light, or diplopia (double vision) occurs, immediate medical attention should be sought.

Prolonged and improper use of doses higher than recommended (or overdose) may result in reactive hyperemia (redness) of the conjunctiva and nasal mucosa (rhinitis medicamentosa). Optine eye drops should not be used in patients with epithelial-epidermal corneal dystrophy.

Optine eye drops should be used with caution in patients with severe cardiovascular disorders, such as ischemic heart disease, arterial hypertension, pheochromocytoma, and metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria), as well as in patients receiving monoamine oxidase inhibitors (MAO inhibitors), tricyclic antidepressants, or other medicinal products that may increase blood pressure, only when the potential benefit outweighs the potential risk. Prolonged use and overdosing should be avoided, especially in children. Use in children aged 2 to 6 years should be done with caution.

Patients with a history of contact hypersensitivity to silver should not use this drug, as the dropper container may contain trace amounts of silver. To avoid contamination, do not let the tip of the container touch any surface. Do not use the drug if the solution has changed color or become cloudy.

Contact lenses must be removed before applying Optine. Lenses may be reinserted 15 minutes after administration of the drug.

Use during pregnancy or breastfeeding.

Adequate and well-controlled studies on the effects of tetrahydrozoline hydrochloride on the fetus have not been conducted. There are no data on the excretion of the drug into breast milk.

Despite the fact that the drug is not intended for systemic exposure, consultation with a physician is recommended before use in pregnant women or women who are breastfeeding, in order to assess potential risks.

Effect on the ability to drive vehicles or operate machinery.

The use of eye drops may cause temporary blurred vision.

Method of Administration and Dosage

For topical ophthalmic use only.

The solution may be used for more than 72 hours only under medical supervision.

Adults and children aged 6 years and older

Instill 1–2 drops of the solution into the affected eye(s) up to 4 times daily.

Children aged 2 to 6 years

The use of the solution in children under 6 years of age is permitted only under medical supervision.

Instructions for Use:

1. Wash your hands. Remove the protective cap from the bottle (Figure 1).
2. Invert the bottle and activate the dispenser to release the first drop (Figures 2–3).

Before the first use, after the appearance of the first drop, press the dispenser several times to dispense 5 drops of the solution. Before each subsequent use, discard 2 drops. If the product has not been used for more than 15 days, several drops must be discarded again before use.

1. Tilt your head backward and gently pull down the lower eyelid. Holding the bottle upside down, instill one drop into the eye(s) by pressing the dispenser (Figure 4).

To avoid contamination, do not let the dispenser tip touch any surfaces.

1. Immediately after instillation, press a finger against the inner corner of the eye near the nose or close the eyelids for 1–2 minutes. Immediately after use, replace the protective cap on the bottle.

Children. Use in children aged 2 to 6 years only as prescribed by a physician. Experience with use in children under 2 years of age is lacking.

Overdose

Overdose is unlikely when the drug is used as directed.

With overdose, increasing hyperemia or reactive hyperemia may occur.

Signs and Symptoms

Symptoms that may occur following ingestion or excessive use of the drug: bradycardia, drowsiness, decreased blood pressure, apathy, and hypothermia. Additional symptoms that may occur only with ingestion of the drug include apnea, central nervous system (CNS) depression, coma, respiratory depression, and possible cardiovascular reactions.

Treatment

In case of drug ingestion, treatment includes administration of activated charcoal and gastric decontamination. Further treatment should be symptomatic and supportive.

Adverse reactions.

Very rare (<0.01%) adverse reactions associated with the use of tetriazole hydrochloride have been observed in the post-marketing period:

Application site reactions (including burning sensation in eyes and periorbital area, eye mucous membrane irritation, eye pain, itching, erythema, eye discomfort, mydriasis (pupil dilation), reactive ocular hyperemia ("rebound" ocular hyperemia).

Systemic sympathomimetic effects may occasionally occur.

Hypersensitivity reactions are possible in patients with increased sensitivity to the components of the medicinal product.

Shelf life. 3 years.

Shelf life after first opening of the packaging: not more than 180 days.

Storage conditions.

Store below 25°C. Keep out of reach and sight of children.

Packaging.

10 ml of solution in a bottle with a dosing device; 1 bottle in a cardboard box.

Classification. Over-the-counter (OTC).

Manufacturer.

Jadran-Galenski Laboratorij d.d.

Manufacturer's address and place of business.

Svilno 20, 51000 Rijeka, Croatia.