Tysin - instructions for use, dose, side effects, contraindications

Excipients: benzalkonium chloride solution 50% - 0,4 mg, sorbitol, liquid 70% - 20,0 mg, sodium chloride - 4,16 mg, sodium dihydrogen phosphate dihydrate - 3,38 mg, sodium hydrogen phosphate dihydrate - 2,08 mg, disodium edetate dihydrate 1.0 mg, purified water sufficient to 1 ml.

Description:

A clear, colorless solution, odorless or with a weak characteristic odor.

Pharmacotherapeutic group:Antitussive medication - alpha-adrenomimetic

ATX: & nbsp

R.01.A.A.07 Xylometazoline

Pharmacodynamics:

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic activity, causes narrowing of the blood vessels of the mucous membrane of the nasal cavity, eliminating

thus, swelling and flushing of the mucous membrane of the nasal cavity, restores the patency of the nasal passages, facilitates nasal breathing. The effect of the drug comes in 5-10 minutes after its application.

Pharmacokinetics:

With topical application, the drug is practically not absorbed, so its concentration in the blood plasma is very small.

Indications:

- Reduction of edema of the nasal mucosa in rhinitis, including allergic rhinitis, acute respiratory disease with phenomena of rhinitis, pollinosis.

- Relief of discharge of discharge from the nose with paranasal sinusitis and inflammation of the middle ear caused by a cold.

- Preparation of patients for diagnostic manipulations in the nasal passages.

Contraindications:

- Hypersensitivity to any of the components of the drug;

- atrophic rhinitis, thyrotoxicosis;

- inflammatory diseases of the skin or mucous membrane of the vestibule of the nose;

- condition after transsphenoidal hypophysectomy;

- Children's age (up to 6 years - for a dosage of 0.1%, up to 2 years - for a dosage of 0.05%);

- patients with severe cardiovascular diseases (eg, coronary heart disease, angina pectoris, tachycardia, arterial hypertension, severe atherosclerosis);

- patients with surgical interventions on the meninges in the anamnesis;

- patients receiving monoamine oxidase (MAO) inhibitors or other drugs that can cause an increase in arterial pressure;

- patients with increased intraocular pressure, especially with an angle-closure glaucoma;

- with the therapy of tricyclic and tetracyclic antidepressants, other local vasoconstrictors (decongestants);

- pregnancy.

Carefully:

In the following cases, "Tysin^®", nasal drops 0.05% and 0.1%, can be applied only after carefully weighing the benefit and risk of treatment:

- patients with hypersensitivity to adrenomimetics, accompanied by symptoms of insomnia, dizziness, arrhythmia, tremor, increased blood pressure;

- patients with pheochromocytoma;

- patients with endocrine diseases (eg, hyperthyroidism, diabetes mellitus);

- patients with prostatic hyperplasia;

- in the period of breastfeeding

Pregnancy and lactation:

During pregnancy, the use of the drug is contraindicated.

During lactation, the drug should only be used as directed by the doctor, after a thorough assessment of the risk-benefit relationship for the mother and child. Do not exceed the recommended dosage.

Dosing and Administration:

Intranasally.

0.05% nasal drops

Children aged 2 to 6 years: 1-2 drops in each nasal passage up to 3 times a day.

0.1% nasal drops

Adults and children over 6 years of age: 1-2 drops in each nasal passage up to 3 times a day.

Do not use the drug more than 3 times a day.

It is not recommended to use the drug for more than 5-7 days if the doctor did not recommend a different duration of treatment.

After completion of therapy, the drug can be re-administered only after a few days.

In regard to the duration of use in children should consult with a doctor. In the case of chronic rhinitis, the drug "Tizin®", nasal drops 0.05% and 0.1% can be used only under the supervision of a doctor, given the risk of atrophy of the nasal mucosa.

Side effects:

The frequency of adverse reactions is given in the form of the following gradation: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000), including separate messages of the unspecified frequency (the frequency can not be calculated on the basis of available data).

Undesirable drug reactions, first detected during post-marketing use:

According to clinical and epidemiological studies

General disorders and disorders at the site of administration:

Unknown: burning sensation of the mucosa, dry nose, withdrawal syndrome.

According to spontaneous reports

General disorders and disorders at the site of administration:

Rarely: burning sensation of the nasal mucosa, dry nose, irritation, tingling, sneezing, hypersecretion of the mucosa nasopharynx. After using the drug, there may be increased edema of the nasal mucosa (reactive hyperemia), nasal bleeding.

Disturbances from the skin and subcutaneous tissues:

Infrequently: hypersensitivity reactions (angioedema, skin rash, itchy skin).

Disorders from the cardiovascular system:

Rarely: palpitation, tachycardia, increased blood pressure.

Rarely: arrhythmia.

Disturbances from the nervous system:

Rarely: anxiety, insomnia, fatigue, paresthesia, hallucinations and convulsions (mainly in children).

Disturbances on the part of the organ of sight:

Rarely: impaired vision.

Disorders from the gastrointestinal tract:

Rarely: vomiting, nausea.

Drug "Tizin®", nasal drops 0.05% and 0.1% should not be used in case of hypersensitivity to benzalkonium chloride, which is a part of the preparation.

Overdose:

In case of an overdose or accidental ingestion, the drug may cause: pupil dilating, nausea, vomiting, cyanosis, fever, dyspnea, severe dizziness, increased sweating, headache, cardiac rhythm disturbance, increase or decrease in blood pressure, respiratory depression, collapse, coma and convulsions . In addition, there may be signs of suppression of the central nervous system.

Treatment: The use of activated carbon, gastric lavage, artificial respiration with the introduction of oxygen. To reduce blood pressure apply phentolamine 5 mg in physiological solution intravenously slowly or 100 mg orally.

Interaction:

It is possible to enhance the systemic effect with simultaneous use of monoamine oxidase inhibitors and tricyclic antidepressants, incompatible simultaneous use of xylometazoline with tetracyclic antidepressants, other local vasoconstrictors (decongestants), and other drugs that increase blood pressure.

Special instructions:

Long-term use (more than 7 days) and an overdose of sympathomimetics, which have a decongestive effect, can lead to reactive hyperemia of the nasal mucosa. As a result, there is difficulty in nasal breathing, which leads to the fact that the patient begins to use the drug repeatedly or even constantly. This can lead to chronic swelling (medicamentous rhinitis), and eventually even to the atrophy of the mucous membrane of the nose (the lake).

In more mild cases, in order to improve the patient's condition, one can first stop the introduction of sympathomimetic into one nostril, and after reducing complaints continue to inject it into another nostril to at least partially provide nasal breathing.

Do not exceed recommended doses, especially in children and the elderly.

It is not recommended to apply the drug in continuous mode for more than 7 days.

The preparation contains benzalkonium chloride, which can cause irritation and swelling of the nasal mucosa.

If the medicine has become unusable or the expiration date has expired, do not throw it into the waste water and into the street! 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:

With long-term treatment or the use of the drug "Tizin®," nasal drops 0.05% and 0.1%, higher doses can not exclude the possibility of its systemic action. In the case of development of systemic side effects, it is necessary to refrain from driving and other potentially dangerous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Nasal drops, 0.05% and 0.1%.

Packaging:

For 10 ml of the preparation in a bottle of brown glass (class III) with a screwed polypropylene lid equipped with a drip device.

1 bottle with instructions for use in a cardboard pack.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

1 year.

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

Terms of leave from pharmacies:Without recipe

Registration number:LP-004111

Date of registration:31.01.2017

Expiration Date:31.01.2022

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

Manufacturer: & nbsp

FAMAR ORLEANS France

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

Information update date: & nbsp24.02.2017

Illustrated instructions

Instructions

Tizin® (Tyzine®)