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Composition:


active ingredient: tetryzoline;


1 ml of the solution contains tetrisoline hydrochloride 0.5 mg;


excipients: boric acid, benzalkonium chloride, sodium tetraborate, disodium edetate, sodium chloride, purified water.


Dosage form. Eye drops, solution.


Basic physical and chemical properties: transparent, colorless solution.


Pharmacotherapeutic group. Products used in ophthalmology. Decongestants and anti-allergic agents. Sympathomimetics used as decongestants.


ATX code S01G A02.


Pharmacological properties.


Pharmacodynamics. The drug is a sympathomimetic that belongs to the group of imidazoline decongestants. It directly stimulates the α-adrenergic receptors of the sympathetic nervous system, without affecting or minimally affecting the β-adrenergic receptors. When applied topically to the conjunctival mucosa, the drug has a temporary vasoconstrictor effect on small blood vessels, thereby reducing vasodilation and conjunctival edema.


Pharmacokinetics. It is known that after therapeutic ocular administration of tetrisoline, it was detected in blood serum and urine. The average serum Half-Life of tetrisoline was approximately 6 hours. Systemic absorption in patients varied, with the maximum serum concentration ranging from 0.068 to 0.380 ng/mL. After 24 hours, tetrisoline was detected in the urine.


Clinical characteristics.


Indications. Symptomatic temporary relief of secondary eye hyperemia due to moderate irritating effects and allergic conjunctivitis.


Contraindications. Hypersensitivity to the components of the drug, angle-closure glaucoma.


Interactions with other drugs and other types of interactions. There are no known significant interactions with other drugs. You should consult your doctor before using other ophthalmic medications.


Application features. The use of the drug may cause mydriasis.


You should stop using the drug and consult a doctor if there is no improvement within 72 hours, or if irritation or hyperemia continues or worsens, or if there is eye pain or visual impairment.


To avoid contamination, do not touch the top of the package to any surfaces. Close the bottle with the lid after use. In case of discoloration or turbidity of the solution, the drug is not suitable for use.


The use of drops in children aged 2 to 6 years should be carried out with caution. Patients with severe cardiovascular diseases, such as coronary heart disease, hypertension, pheochromocytoma and metabolic disorders (hyperthyroidism, diabetes mellitus), as well as patients receiving monoamine oxidase inhibitors or other drugs that can increase blood pressure, should use eye drops only when, in the opinion of the doctor, the expected benefit outweighs the potential risk. Very frequent use can cause redness of the eyes.


It is advisable to use the drug only in case of mild eye irritation. The patient should know:


* if the condition does not improve within 48 hours or the irritation or redness continues or increases, the drug should be discontinued;


* if the irritation or redness is associated with serious diseases of the visual organs (such as an infection, foreign body, or chemical injury to the cornea), then it is recommended to consult a doctor;


· if there is intense eye pain, headache, rapid loss of vision, sudden appearance of floating spots in front of the eyes, redness of the eyes, pain when exposed to light, or the eyes begin to double, you should immediately consult a doctor.


Long-term use and overdose should be avoided, especially in children.


Do not use the drug in patients with epidermal-epithelial corneal dystrophy.


The drug contains benzalkonium chloride. Avoid contact with soft contact lenses (remove contact lenses before using the product and re-install them 15 minutes after use). Discolors soft contact lenses.


Use during pregnancy or lactation. Adequate and well-controlled studies of the effect of tetrisoline hydrochloride on the fetus have not been conducted. There are no data on the excretion of the drug in breast milk.


Although the drug is not intended for systemic exposure, before using it in pregnant and lactating women, it is recommended to consult a doctor to assess the possible risk.


Ability to influence the reaction rate when driving vehicles or other mechanisms. The use of eye drops may cause temporary visual impairment.


Dosage and administration. Only for topical use in ophthalmology.


Apply the solution for more than 72 hours only under the supervision of a doctor.


Adults and children ≥ 6 years of age. Instill 1-2 drops in the affected eye (s) up to 4 times a day.


Children aged 2 to 6 years. The drug can only be used under the supervision of a doctor.


Children. Use the drug in children aged 2 to 6 years can only be prescribed by a doctor. There is no experience of using the drug in children under 2 years of age.


Overdose. When using the drug according to the recommendations, overdose is unlikely. In case of overdose of the drug, an increase in hyperemia or reactive hyperemia may occur.


Symptoms that may occur if the drug is swallowed or used excessively: bradycardia, drowsiness, decreased blood pressure, apathy, and decreased body temperature. Additional symptoms that can only be observed if the drug is swallowed may include apnea, central nervous system depression and coma, respiratory depression, and possible reactions from the cardiovascular system.


Treatment. If the drug is swallowed, treatment consists of taking activated charcoal and releasing the stomach. Further treatment should be symptomatic and supportive.


Adverse reactions. Reactions at the site of application (including burning sensation in the eyes and periocular area, irritation of the eye mucosa, eye pain, itching, erythema, pain in the eyes, dilated pupils (mydriasis), reactive hyperemia of the eye ("ricochet" hyperemia of the eye)). Sometimes systemic sympathomimetic effects may occur.


Hypersensitivity reactions may occur in patients with hypersensitivity to the components of the drug.


Expiration date. 2 years. The shelf life of the drug after opening the bottle is not more than 4 weeks.


Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.


Keep out of reach of children.

Tags: Tetrizoline