Instructions for use Vizin Comfort eye drops 0.05% bottle 15 ml
Composition
active ingredient: tetrahydrozoline hydrochloride;
1 ml of solution contains 0.5 mg of tetrahydrozoline hydrochloride;
excipients: glycerin (99.5%); hypromellose 2910; macrogol 400; boric acid; sodium hydrogen phosphate; sodium citrate; potassium chloride; magnesium chloride, hexahydrate; sodium lactate solution (50%); glycine; ascorbic acid; glucose, monohydrate; polyxetonium chloride (polyquaternium 42) (33% solution); purified water.
Dosage form
Eye drops, solution.
Main physicochemical properties: clear solution from colorless to slightly yellow.
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.
Mechanism of action
Tetryzoline 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.
Pharmacodynamic effects
As a sympathomimetic amine, tetrizoline has vasoconstrictor and anti-edema properties. When applied topically to the conjunctival mucosa, the drug has a temporary vasoconstrictor effect on small blood vessels, thereby reducing vasodilation and conjunctival edema.
Clinical efficacy and safety
A double-blind, controlled, randomized trial demonstrated symptom relief within 30–60 seconds of instillation of tetryzoline 0.05%. Improvement was sustained
6 hours after drug application, but after 8 hours, the efficacy of tetrizoline and placebo in reducing erythema was similar. Overall, the duration of anti-edematous effect of tetrizoline was between 6 and 8 hours.
A single-day, double-blind, randomized study involving
In 120 patients, 0.05% tetryzoline eye drops were shown to reduce eye redness compared to baseline 30 seconds after application and improve ocular comfort for 12 hours when used as directed. A participant questionnaire assessed sensory benefits to the user as secondary endpoints and demonstrated significant improvements (p < 0.001) in eye moisturization compared to baseline 60 seconds, 10, and 12 hours after the first application of the eye drops.
Pharmacokinetics.
Absorption
In a study in 10 healthy volunteers, systemic absorption varied between individuals, with peak serum concentrations ranging from 0.068 to 0.380 ng/mL.
When used topically as directed, systemic absorption is not expected to be clinically significant. After topical administration, especially in patients with damaged mucosa and epithelium, systemic absorption cannot be excluded.
Distribution
Data is missing.
Metabolism
Data is missing.
Breeding
In a study of 10 healthy volunteers, serum and urine concentrations of tetrahydrozoline were detectable after therapeutic ophthalmic administration. The mean serum half-life of tetrahydrozoline was approximately 6 hours. After 24 hours, all patients had detectable urinary concentrations of tetrahydrozoline.
Linearity/nonlinearity
Data is missing.
Preclinical safety data
Local toxicity
Application of a buffered (pH 5.5) solution of tetrizoline (0.25% and 0.50%) twice daily for 5 consecutive days did not demonstrate any eye irritation in rabbits.
Acute toxicity
Animal studies have not shown any specific sensitivity to tetrizoline hyrochloride. The acute oral LD50 is 420 mg/kg in mice and 785 mg/kg in rats.
Chronic toxicity
In rats, no toxicity related to the active substance was observed after oral administration of 10 to 30 mg tetryzoline hydrochloride per kilogram of body weight over several weeks. In rhesus monkeys, long-lasting sedation and hypnotic states were demonstrated after intravenous administration of 5 to 10 mg/kg body weight for 120 days and after oral administration of 5 to 50 mg/kg body weight for 32 weeks. However, when used as eye drops as directed, little systemic toxicity is expected.
There are no preclinical data on genotoxicity, carcinogenicity or reproductive toxicity of tetryzoline.
Indication
Temporary relief of ocular hyperemia secondary to irritants from non-infectious factors such as smoke, dust, wind, chlorinated water, light or due to allergic conjunctivitis.
Contraindication
Hypersensitivity to the active substance or to any of the excipients.
Angle-closure glaucoma.
Children under 2 years old.
Interaction with other medicinal products and other types of interactions
Concomitant use of monoamine oxidase (MAO) inhibitors of the tranylcypromine type or tricyclic antidepressants with other drugs with the potential to increase blood pressure (such as tetryzoline hydrochloride) may potentiate their vasoconstrictor effect and increase blood pressure. Therefore, such a combination should be avoided.
Before using simultaneously with other ophthalmic drugs, it is necessary to consult a doctor.
Application features
Vizin® Comfort should not be used in the presence of:
- serious cardiovascular diseases (e.g. coronary heart disease, arterial hypertension, pheochromocytoma);
- prostatic hyperplasia;
- metabolic disorders (e.g. hyperthyroidism, diabetes, porphyria);
- dry rhinitis;
- keratoconjunctivitis sicca;
- glaucoma (detailed information is provided below).
Excessive or prolonged use of this drug (more than 3–5 days) may cause tachyphylaxis, lead to increased redness of the eyes (ricochet hyperemia) or nasal mucosa (rhinitis medicamentosa), and should therefore be avoided.
This medicine can be used in children aged 2 to 6 years only after consulting a doctor.
Prolonged and excessive use of the drug should be avoided, especially in children. Use in children and use of higher doses should only be carried out under the supervision of a physician.
Use in narrow-angle glaucoma is contraindicated. Use in other types of glaucoma should be carried out with the help and under the supervision of a physician.
Even the recommended doses for topical use should be used with caution in cases of hyperthyroidism, heart disease, high blood pressure, and diabetes.
Patients using Vizin® Comfort should be warned that eye irritation or redness are common symptoms of serious eye disease, and advised to seek advice from an ophthalmologist.
Vizin® Comfort should only be used for mild eye irritation. If no improvement is observed after 48 hours of use or if eye irritation or redness persists or worsens, discontinue use and consult a doctor.
Irritation or redness of the eyes due to infection, foreign particles, or chemical damage to the cornea also requires medical treatment. If eye pain, headache, vision loss, visual disturbances (such as floating "spots" or double vision), severe acute or unilateral eye redness, or pain when exposed to light occur, discontinue use and consult a doctor immediately.
When using this drug, the pupils may temporarily dilate.
Contact lenses should not usually be worn if you have an eye condition. If you wear contact lenses, they should be removed before instillation and can be reinserted at least 15 minutes after instillation.
Do not use the medicine if the solution is discoloured or cloudy. Any unused medicine or waste material should be disposed of in accordance with local requirements.
Use during pregnancy or breastfeeding
Pregnancy
There are no adequate and well-controlled studies of tetrizoline in pregnant women. This drug should not be used during pregnancy unless, in the opinion of the physician, the potential benefit to the mother outweighs the potential risk to the fetus.
Breast-feeding
There are no adequate and well-controlled studies of the use of tetrizoline in women during breastfeeding. There are no data on the excretion of tetrizoline or its metabolites in human breast milk. This drug should not be used during breastfeeding unless, in the opinion of the physician, the potential benefit of treatment for the mother outweighs the potential risk to the breastfed infant.
Fertility
Data is missing.
Ability to influence reaction speed when driving vehicles or other mechanisms
Ophthalmic drugs may cause temporary visual disturbances (blurred vision and mydriasis) which may affect the ability to drive or use machines. Patients should be advised to wait until visual disturbances have resolved before driving or using machines.
Method of administration and doses
Dosage
Adults and children aged 6 years and over
Instill 1–2 drops of the solution into the affected eye(s) 2–3 times daily.
This medicine should be used for the shortest time necessary to relieve symptoms. See section "Special warnings and precautions for use" regarding the risk of rebound effects with prolonged use.
Children under 12 years of age are recommended to use the drug under adult supervision.
Children aged 2 to 6 years
The drug can be used in children aged 2 to 6 years only after consulting a doctor (see section "Special instructions for use"). The recommended dose is 1 drop of solution in the affected eye(s) 2–3 times a day.
The drug is contraindicated in children under 2 years of age (see section "Contraindications").
Method of application
After removing the cap, the bottle should be turned upside down, then squeezed slightly to release one or two drops from the tip into the eye without touching the eye. The tip of the bottle should not come into contact with any surface other than the cap to prevent contamination of the solution.
Children.
The drug should be used in children according to the dosage specified in the section “Method of administration and doses”. Vizin® Comfort is contraindicated in children under 2 years of age.
Overdose
A review of the available safety data has not identified adverse drug reactions associated with overdose. Symptoms of overdose are unlikely in the case of ophthalmic use; however, tetryzoline may cause serious adverse effects if swallowed.
The clinical picture of intoxication with imidazole derivatives may be unclear, as periods of stimulation and periods of depression of the central nervous and cardiovascular systems may alternate.
Symptoms of central nervous system stimulation include anxiety, agitation, hallucinations, and seizures.
Symptoms of central nervous system depression include decreased body temperature, lethargy, drowsiness, and coma.
Additional symptoms may include: miosis, mydriasis, sweating, fever, pallor, cyanosis, nausea, vomiting, tachycardia, bradycardia, cardiac arrhythmia, palpitations, cardiac arrest, hypertension, shock-like hypotension, pulmonary edema, respiratory distress, drooling, and apnea. Especially in children, overdose by ingestion may lead to a dominant effect on the central nervous system with spasms, coma, bradycardia, apnea, and hypertension, which may progress to hypotension.
Even a dose of 0.01 mg of tetrizoline hydrochloride per kilogram of body weight must be considered a toxic dose.
Use of activated charcoal, gastric lavage, oxygen therapy, reduction of hyperthermia, and anticonvulsant therapy. Vasopressors are contraindicated in patients with hypotension.
If anticholinergic symptoms develop, an antidote, such as physostigmine, should be administered.
Adverse reactions
Adverse drug reactions identified during clinical trials of tetryzoline 0.05% and during the post-marketing period are presented in the table below according to system organ classes.
The frequency is given accordingly using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency unknown (cannot be estimated from the available data).
Adverse drug reactions are presented by frequency category, taking into account:
1) frequencies in appropriately designed clinical or epidemiological studies, if they have been conducted, or
2) if it is not possible to calculate the frequency, it is indicated as “frequency unknown”.
| Organ system class | Frequency | Adverse drug reaction (preferred term) |
| Vision disorders | Often | Eye irritation (pain, stinging, burning), vision impairment |
| Rarely | Mydriasis |
| Very rare | Epithelial keratinization (xerosis) of the conjunctiva with punctal occlusion and epiphora (excessive tearing) after long-term use of tetryzoline |
| Frequency unknown | Increased tearing |
| Systemic disorders and administration site conditions | Often | Reactive hyperemia, mucosal burn, dryness of mucous membranes |
| Frequency unknown | Application site reactions (including burning sensation in the eyes and periocular area, erythema, irritation, swelling, pain and itching) |
Adverse effects associated with excipients
In some patients with significant corneal damage, cases of corneal calcification have been very rarely reported with the use of eye drops containing phosphates.
Reporting of suspected adverse reactions
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua/.
Expiration date
36 months. After first opening the package – 6 weeks.
Storage conditions
Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.
Packaging
15 ml of solution in a bottle with a dosing tip and a child-resistant cap. 1 bottle together with instructions for medical use in a cardboard box.
Vacation category
Without a prescription.
Producer
Janssen Pharmaceutica NV/Janssen Pharmaceutica NV.
Location of the manufacturer and address of its place of business.
Turnhoutseweg 30, Beerse, 2340, Belgium.
Applicant.
McNeil Products Limited.
Location of the applicant.
50-100 Holmes Farm Way, High Wakeham, HP12 4EG, England/
Applicant's representative.
Johnson & Johnson Ukraine LLC
Location of the applicant's representative.
01010, Kyiv, 32/2 Ostrozkyh Knyaziv St., Ukraine.
+38 (044) 498 0888
+38 (044) 498 7392
