active substance: tetrahydrozoline hydrochloride;
1 ml of solution contains 0.5 mg of tetrahydrozoline hydrochloride
Excipients: benzalkonium chloride, sodium chloride, boric acid, sodium tetraborate, disodium edetate, purified water.
Eye drops, solution (15 ml in a bottle, equipped with a dropper and a screw cap, with protection from children. 1 bottle in a cardboard box).
pharmachologic effect
Tetrizoline is a sympathomimetic agent that belongs to the group of imidazoline decongestants. It directly stimulates the alpha-adrenergic receptors of the sympathetic nervous system with little or no influence from the beta-adrenergic receptors. When applied topically on the conjunctival mucosa, the preparation has a temporary vasoconstrictor effect on small blood vessels, thereby reducing vasodilation and conjunctival edema.
In a study involving 10 healthy volunteers after therapeutic ocular administration, tetrizoline was shown in blood serum and urine. The serum half-life of tetrizoline was approximately 6:00. Systemic absorption in patients varied, with maximum serum concentrations ranging from 0.068 to 0.380 ng / ml. After 24 hours, all patients were found to have tetrizoline in the urine.
Symptomatic temporary relief of secondary ocular hyperemia due to moderate irritation and allergic conjunctivitis.
Hypersensitivity to preparation components
Glaucoma.
Method of administration and dosage
For topical use in ophthalmology only.
The solution can be used for more than 72 hours only under medical supervision.
Adults and children ≥ 6 years of age
Instill 1-2 drops of the solution into the affected eye (s) up to 4 times a day.
When using the preparation as recommended, overdose is unlikely.
If the preparation is swallowed, the treatment consists of taking activated charcoal and releasing the stomach. Further treatment should be symptomatic and supportive.
Very rarely (<0.01%), adverse reactions associated with the use of tetrahydrozoline hydrochloride were observed in the post-registration period:
Reactions at the site of application (including burning in the eyes and periocular area, irritation of the mucous membrane of the eyes, pain in the eyes, itching, erythema, pain in the eyes, dilated pupils (mydriasis), reactive hyperemia of the eye ("rebound" redness of the eye)).
Systemic sympathomimetic effects can sometimes occur.
Allergic reactions may occur in patients with hypersensitivity to the components of the preparation.
special instructions
Before using the preparation for pregnant and lactating women, it is recommended to consult a doctor to assess the possible risk.
Children
Use in children aged 2 to 6 years as directed by a doctor. There is no experience of using the preparation in children under 2 years of age.
The ability to influence the reaction rate when driving motor transport or other mechanisms
Eye drops can cause temporary blurred vision.
Interaction with other medicinal products and other forms of interaction
There are no known significant interactions with other preparations. Consult a doctor before using with other ophthalmic medications.
Store in its original packaging at a temperature not exceeding 30 ° C, out of the reach of children.
The shelf life is 3 years. An open bottle should be used for no more than 4 weeks.