Instructions Optin 0.5mg/ml eye drops 10ml
Composition
active ingredient: tetrizoline hydrochloride;
1 ml of solution contains 0.5 mg of tetrizoline hydrochloride;
excipients: borax, sodium chloride, boric acid, purified water.
Dosage form
Eye drops, solution.
Main physicochemical properties: transparent colorless solution.
Pharmacotherapeutic group
Agents used in ophthalmology. Anti-edematous and anti-allergic agents. Sympathomimetics used as anti-edematous agents. ATX code S01G A02.
Pharmacological properties
Pharmacodynamics.
Tetrizoline is a sympathomimetic agent belonging to the group of imidazoline decongestants. It directly stimulates alpha-adrenoceptors of the sympathetic nervous system with little or no effect on beta-adrenoceptors. 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 serum half-life of tetrizoline was approximately 6 hours. Systemic absorption varied among patients, with peak serum concentrations ranging from 0.068 to 0.380 ng/mL. After 24 hours, tetrizoline was detected in the urine of all patients.
Indication
Symptomatic temporary relief of secondary ocular hyperemia due to moderate irritant effects and allergic conjunctivitis.
Contraindication
Hypersensitivity to the components of the drug, angle-closure glaucoma.
Interaction with other medicinal products and other types of interactions
There are no known significant interactions with other drugs. It is necessary to consult a doctor before use with other ophthalmic drugs.
Application features
The use of the drug may cause mydriasis. The drug should be discontinued and a doctor should be consulted if improvement is not observed within 72 hours or if irritation or hyperemia persists or worsens, or if eye pain or visual disturbances occur.
Optin eye drops are used only in case of minor eye irritation. The patient should know:
if the condition does not improve within 48 hours or irritation or redness persists or increases, the drug should be discontinued;
If irritation or redness is associated with serious eye diseases (such as infection, foreign body, or chemical injury to the cornea), it is recommended to consult a doctor;
If you experience intense eye pain, headache, rapid vision loss, sudden appearance of "floating" spots before your eyes, redness of the eyes, pain when exposed to light, or if your eyes begin to "double," you should consult a doctor immediately.
As a result of prolonged and improper use of doses higher than recommended (or overdose), reactive hyperemia (redness) of the conjunctiva and nasal mucosa (rhinitis medicamentosa) may occur. Optin eye drops should not be used in patients with epidermal epithelial corneal dystrophy.
Patients with severe cardiovascular diseases, such as coronary heart disease, arterial hypertension, pheochromocytoma and metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria), as well as patients receiving monoamine oxidase inhibitors (MAO inhibitors), tricyclic antidepressants, or other drugs that can increase blood pressure, should use Optin eye drops when the possible benefit outweighs the potential risk. Prolonged use and overdose should be avoided, especially in children. The use of drops in children aged 2 to 6 years should be carried out with caution.
Patients who have had contact hypersensitivity to silver should not use this product, as the dispensed drops may contain traces of silver. To avoid contamination, do not touch the top of the container to any surface. Do not use if the solution has changed color or become cloudy.
Contact lenses should be removed before using Optin. Lenses can be reinserted 15 minutes after using the medicine.
Use during pregnancy or breastfeeding
Adequate and well-controlled studies of the effects of tetrizoline hydrochloride on the fetus have not been conducted. There are no data on the excretion of the drug into breast milk.
Although the drug is not intended for systemic exposure, it is recommended that pregnant and breastfeeding women consult a doctor to assess the possible risk before using it.
Ability to influence reaction speed when driving vehicles or other mechanisms
The use of eye drops may cause temporary blurred vision.
Method of administration and doses
For topical use in ophthalmology only.
The solution can be used for more than 72 hours only under the supervision of a doctor.
Adults and children aged 6 years and over
Instill 1-2 drops of the solution into the affected eye(s) up to 4 times a day.
The solution can be used in children under 6 years of age only under the supervision of a doctor.
Instructions for use:
1. Wash your hands. Remove the protective cap from the bottle (Figure 1).
2. Turn the bottle over and activate the dispenser to release the first drop (Figures 2-3).
Before the first use of the product, after the first drop appears, it is necessary to make several presses to release 5 drops of solution. Before each subsequent use, it is necessary to remove 2 drops. If the product has not been used for more than 15 days, it is necessary to remove a few drops again before use.
3. Tilt your head back and gently pull back your lower eyelid and, holding the bottle upside down, instill one drop into each eye(s) by pressing the dispenser (Figure 4).
To avoid contamination, do not touch the tip of the dispenser to any surfaces.
4. Immediately after instillation, press your finger on the corner of your eye near your nose or close your eyelids for 1-2 minutes. Immediately after using the drops, close the bottle with the protective cap.
Children. Use in children aged 2 to 6 years as prescribed by a doctor. There is no experience in using the drug in children under 2 years of age.
Overdose
When using the drug according to recommendations, overdose is unlikely.
In case of an overdose of the drug, increased hyperemia or reactive hyperemia may occur.
Signs and symptoms
Symptoms that may occur in case of ingestion or excessive use of the drug: bradycardia, drowsiness, decreased blood pressure, apathy and decreased body temperature. Additional symptoms that may occur only in case of ingestion of the drug may be apnea, CNS depression, coma, respiratory depression, possible development of reactions from the cardiovascular system.
Treatment
If the drug is swallowed, treatment consists of taking activated charcoal and emptying the stomach. Further treatment should be symptomatic and supportive.
Side effects
Very rarely (<0.01%) adverse reactions associated with the use of tetrizoline hydrochloride were observed in the post-marketing period:
Application site reactions (including burning sensation in the eyes and periocular area, irritation of the mucous membrane of the eyes, eye pain, itching, erythema, stinging in the eyes, dilated pupils (mydriasis), reactive hyperemia of the eye ("ricochet" hyperemia of the eye).
Systemic sympathomimetic effects may occasionally occur.
Hypersensitivity reactions may occur in patients with hypersensitivity to the components of the drug.
Expiration date
3 years.
The shelf life after first opening the package is no more than 180 days.
Storage conditions
Store at a temperature not exceeding 25 ̊ C. Keep out of the reach of children.
Packaging
10 ml of solution in a bottle with a dosing device; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Jadran-Galensky Laboratories, Dr.
Address
Svilno 20, 51000 Rijeka, Croatia.
