Vizin Classic - instructions for use, dose, side effects, contraindications

Active substanceTetrisolinTetrisolin

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Vizin® Classic

drops d / eye

Johnson & Johnson, LLC Russia

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Dosage form: & nbspeye drops

Composition:

Active substance: tetrisisoline hydrochloride 0.50 mg / ml;

Excipients: boric acid 12.30 mg / ml, sodium tetraborate (borax) 0.25 mg / ml, sodium chloride 2.23 mg / ml, water for injection up to 1 ml.

Description:A clear, colorless solution.

Pharmacotherapeutic group:Alpha-adrenomimetic

ATX: & nbsp

S.01.G.A.02 Tetrisolin

Pharmacodynamics:

Tetrizolin is an adrenomimetic drug that stimulates the alpha-adrenergic receptors of the sympathetic nervous system, but does not or has little effect on beta-adrenergic receptors. Being an adrenomimetic amine, tetrisolin has a vasoconstrictive effect and reduces edema of tissues.

The effect begins 60 seconds after instillation and continues 4-8 hours.

Pharmacokinetics:

With topical application, systemic absorption is possible in patients with mucosal lesions and epithelium. Detailed pharmacokinetic studies after topical application of eye drops were not performed.

Indications:

For removal of edema and congestion hyperemia (red eyes), due to the impact of chemical and physical factors (smoke, wind, dust, chlorinated water, light, cosmetics, contact lenses), as well as arising from allergic reactions, such as pollinosis.

Contraindications:

- Dhypersensitivity to the components of the drug;

- angle-closure glaucoma;

- children under 2 years old.

Carefully:

In patients with severe cardiovascular diseases (ischemic heart disease, arterial hypertension), pheochromocytoma, prostatic hyperplasia, hyperthyroidism, diabetes mellitus, porphyria, dry rhinitis, dry keratoconjunctivitis, glaucoma and in patients,receiving monoamine oxidase (MAO) inhibitors or other agents capable of increasing blood pressure.

The use of the drug in closed-angle glaucoma is contraindicated. For other types of glaucoma, the drug should be used with extreme caution and under the supervision of a doctor.

Pregnancy and lactation:

Data on the penetration of the drug through the placenta and into breast milk are absent.Given the possibility of developing systemic side effects, use the drug during pregnancy and during breastfeeding is possible only if, in the opinion of the doctor, the expected benefit for the mother exceeds the potential risk to the fetus and the baby.

Dosing and Administration:

Locally.

Adults and children over 2 years old 1 drop in the affected eye 2-3 times a day.

Use of the drug for more than 4 days should only be carried out under control of the doctor.

Instructions for the use of ampoules for single use Each ampoule of the drug "Vizin® Classic" is intended for single use only. The drug should be used immediately afterwards. opening of the ampoule. The amount of the drug in one ampoule is sufficient for a single injection into both eyes.

Side effects:

Post-marketing data

Very often (≥1 / 10),

often (≥1 / 100, <1/10),

infrequently (≥1 / 1000, <1/100),

rarely (≥1 / 10000, <1/1000),

very rarely (<1/10000, including individual messages),

frequency is unknown (frequency of occurrence can not be estimated on the basis of available data).

Vision disorders: frequency is unknown: dilated pupil.

General disorders and disorders at the site of administration: frequency unknown: reactions at the injection site (including a burning sensation in the eye area, redness, irritation, swelling, pain, itching).

It is assumed that the frequency, type and severity of adverse reactions in children are similar to the adverse reactions observed in adults.

Overdose:

When administered in accordance with the instructions for use, the risk of overdose is minimal. However, if the drug is accidentally ingested into the gastrointestinal tract (ingestion), the following overdose symptoms may occur: pupil dilating, nausea, cyanosis, fever, convulsions, tachycardia, arrhythmia, cardiac arrest, arterial hypotension, pulmonary edema, respiratory depression, including apnea respiration), oppression of the central nervous system, including the development of drowsiness and coma.

The risk of developing symptoms of overdose due to systemic effects of the drug is high in newborns and young children, especially if swallowed.

The specific antidote is unknown.

Treatment of an overdose if ingested: appoint Activated carbon, gastric lavage, inhalation with oxygen, antipyretic and anticonvulsants. To reduce blood pressure apply phentolamine 5 mg on physiological solution slowly intravenously or 100 mg orally. Patients with low arterial pressure vasopressor agents are contraindicated.

If any of the symptoms of an overdose described above are indicated, immediately consult a doctor!

Interaction:

The drug "Vizin® Classical" should not be used simultaneously with inhibitors of MAO such as tranylcypromine, tricyclic antidepressants, as well as drugs that increase arterial pressure. Combination therapy with these groups of drugs can lead to increased vasoconstrictive effects and increased blood pressure.

Special instructions:

"Vizin® Classical "should be used with caution in elderly patients, in patients with aneurysms, hypertension and / or ischemic heart disease, as well as in patients with type I diabetes or hyperthyroidism.

Studies of the safety of the drug in children and adolescents have not been conducted.

Contact lenses should be removed before instillation of the drug and set them in 15 minutes. It is necessary to avoid direct contact of the drug with soft contact lenses due to a possible violation of their transparency.

It is possible to develop reactive hyperemia of the conjunctiva and nasal mucosa (medicamentous rhinitis) if the instructions for use are not observed.

If the condition does not improve within 72 hours, or irritation and redness persist or build up, the drug should be discontinued and the doctor should be consulted.

If intense pain in the eyes, severe acute or unilateral redness of the eyes, headache, visual impairment, appearance of stains in front of eyes or double vision in the eyes, you should immediately consult a doctor.

Prolonged use of the drug may exacerbate hyperemia or lead to its reappearance.

If irritation or redness is caused by diseases of the organ of vision: infection, foreign body or chemical injury of the cornea, consult a doctor before use.

The use of the drug may cause a temporary dilatation of the pupil.

Avoid prolonged use and overdose of the drug, especially in children.

Do not use the drug if it changes color or turbidity.

Local application of sympathomimetic amines to the conjunctival sac, as a result of pupillary dilatation, can sometimes lead to intraocular pressure disruption in predisposed individuals.

If the medicine has become unusable or the expiration date has expired, do not throw it into the waste water and throw it out! Place the drug in a bag and put it in the trash. These measures will help protect the environment!

Effect on the ability to drive transp. cf. and fur:

In rare cases, after the application of eye drops "Vizin® Classic" there is blurred vision, which can affect the ability to drive and machinery.

Form release / dosage:

Eye drops, 0.5 mg / ml.

Packaging:

For 0.5 ml of the drug in transparent ampoules for single use of low-density polyethylene, 5 ampoules are welded together in a strip.

2 strips in a bag of paper / PE / aluminum / film.

1 package together with instructions for use in a cardboard bundle.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the product after the expiry date printed on the package.

After a single use of the drug "Vizin Classic" unused contents of the ampoule must be disposed of.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001570

Date of registration:06.03.2012 / 12.08.2016

Expiration Date:06.03.2017

The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia

Manufacturer: & nbsp

Laboratoire UNITHER France

Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia

Information update date: & nbsp10.03.2017

Illustrated instructions

Instructions

Vizin® Classic (Visine® classic)