Tizin Expert nasal spray doser 0.05% 10ml bottle PE with dosage. device
Registration Certificate Holder
JOHNSON & JOHNSON (Russia)
Dosage form
Medicinal product - Tyzine® Expert
Description
Nasal spray dosed 0.05%
in the form of a clear or slightly opalescent solution, colorless or slightly yellowish.
1 dose
1 ml
xylometazoline hydrochloride 0.035 mg 0.5 mg
Excipients
: glycerol - 8.5 mg, sorbitol - 5 mg, sodium dihydrogen phosphate dihydrate - 4 mg, sodium chloride - 3 mg, sodium phosphate dihydrate - 0.628 mg, sodium hyaluronate - 0.2 mg, water for injection - up to 1 ml.
10 ml (140 doses) - high-density polyethylene bottles (1) with a dosing device and a polyethylene cap - cardboard packs.
Indications
- reduction of swelling of the nasal mucosa during rhinitis, incl. allergic rhinitis, acute respiratory infections with symptoms of rhinitis, hay fever;
- relief of nasal discharge with paranasal sinusitis and inflammation of the middle ear caused by a cold;
- preparing patients for diagnostic manipulations in the nasal passages.
Nasal spray dosed 0.05% is intended for children aged 2 to 6 years.
Dosed nasal spray 0.1% is intended for adults and children over 6 years of age.
Contraindications for use
- hypersensitivity to any of the components of the drug;
- atrophic rhinitis;
- thyrotoxicosis;
- severe cardiovascular diseases (for example, ischemic heart disease, angina pectoris, tachycardia, arterial hypertension, severe atherosclerosis);
- increased intraocular pressure, especially angle-closure glaucoma;
- condition after transsphenoidal hypophysectomy;
- history of surgical interventions on the meninges;
- patients receiving MAO inhibitors or other drugs that can cause an increase in blood pressure;
- newborns and children under 2 years of age (for nasal spray dosed 0.05%);
- children under 6 years of age (for nasal spray dosed 0.1%).
Carefully
In the following cases, Tizin® Expert can be used only after carefully weighing the benefits and risks of treatment:
- increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure;
- pheochromocytoma;
- endocrine diseases (for example, hyperthyroidism, diabetes mellitus);
- prostatic hyperplasia;
- porphyria.
pharmachologic effect
Xylometazoline (imidazole derivative) is an alpha-adrenergic agonist that constricts the blood vessels of the nasal mucosa, eliminating swelling and hyperemia of the mucous membrane. Facilitates nasal breathing during rhinitis.
Hyaluronic acid, which is part of the drug, has a moisturizing effect when used in nasal medications due to its ability to maintain mucous membranes in a hydrated state and creates optimal conditions for regenerative processes.
The action usually develops within 5-10 minutes.
Drug interactions
Concomitant use of MAO inhibitors such as tranylcypromine or tricyclic antidepressants may lead to an increase in blood pressure due to the cardiovascular effects of these substances.
Dosage regimen
Adults and children over 6 years old
Prescribe a nasal spray dosed 0.1%, 1 dose in each nasal passage up to 3 times a day. The dose depends on the individual sensitivity of the patient and the clinical effect.
Children aged 2-6 years
Prescribe a nasal spray dosed 0.05%, 1 dose in each nasal passage 1-2 times a day.
You should not use the drug for more than 5-7 days, unless your doctor recommends a different duration of treatment. After completion of therapy, the drug can be re-administered only after a few days.
The duration of use of the drug in children is determined by the doctor.
For chronic rhinitis, the drug can only be used under the supervision of a doctor, taking into account the risk of developing atrophy of the nasal mucosa.
Method of use of the drug
Remove the protective cap. Before first use, press the spray nozzle several times until a uniform cloud of “fog” appears. The bottle is ready for further use.
When using, press 1 time. Inhale the drug through the nose. If possible, keep the spray bottle vertical. Do not spray horizontally or downwards. After use, close the bottle with a cap.
Overdose
Overdose or accidental ingestion of the drug can lead to the following symptoms:
dilated pupils, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, arrhythmia, collapse, cardiac arrest, hypertension, pulmonary edema, respiratory failure, mental disorders. In addition, the following symptoms may be observed: suppression of central nervous system function, accompanied by drowsiness, decreased body temperature, bradycardia, hypotension, apnea and coma.
Treatment:
the use of activated carbon, gastric lavage, artificial respiration with the introduction of oxygen. To lower blood pressure, use phentolamine 5 mg (in saline solution) slowly intravenously or 100 mg orally. Vasopressor drugs are contraindicated. If necessary, antipyretic and anticonvulsant drugs are used.
Side effect
Local reactions:
transient mild nasal irritation (burning) in susceptible people, sneezing.
Often (>1%, <10%) after discontinuation of the drug, increased swelling of the nasal mucosa (reactive hyperemia) may be observed. Prolonged or too frequent use of xylometazoline, or its use in high doses, can lead to a burning sensation in the nose or dry mucous membrane, as well as reactive nasal congestion, with the development of drug-induced rhinitis, paresthesia, sneezing, hypersecretion (this effect can be observed even after 5- 7 days after completion of treatment, and with prolonged use it can cause chronic inflammation of the mucous membrane with the formation of crusts (dry rhinitis)). From the nervous system:
rarely (>0.01%, <1%) - headache, insomnia, blurred vision, fatigue and depression (with long-term use in high doses).
From the cardiovascular system:
in isolated cases (0.1%, <1%), local intranasal use of sympathomimetics may be accompanied by systemic effects such as palpitations, tachycardia, arrhythmia and increased blood pressure.
special instructions
Long-term use (more than 7 days) and overdose of sympathomimetics that have a decongestive effect can lead to reactive hyperemia of the nasal mucosa. As a result, difficulty in nasal breathing occurs, which leads to the patient starting to use the drug repeatedly or even constantly. This can lead to chronic swelling (rhinitis medicamentosa), and sometimes even to atrophy of the nasal mucosa (ozena).
In milder cases, to improve the patient's condition, you can first stop administering the sympathomimetic in one nasal passage, and after the complaints have subsided, continue to administer it into the other nasal passage to partially ensure nasal breathing.
Recommended doses should not be exceeded, especially in children and elderly patients.
It is not recommended to use the drug continuously for more than 7 days.
If the medicine has become unusable or has expired, do not throw it into wastewater or onto the street.
It is necessary to place the medicine in a bag and place it in the trash container. These measures will help protect the environment. Effect on the ability to drive vehicles and machines
With long-term treatment or use of the drug in higher doses, the possibility of its systemic effect on the cardiovascular system cannot be excluded. In such cases, the ability to drive and control equipment may be impaired.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Best before date
Shelf life: 2 years. Do not use after the expiration date stated on the package.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.
Xylometazoline should not be used during pregnancy, because the effect on the fetus has not been studied in clinical studies.
The drug should not be used during breastfeeding, because It is unknown whether the active substance is excreted in breast milk.
Use in children
Restrictions for children - With caution. The use of the drug is contraindicated in newborns and children under 2 years of age (nasal spray dosed 0.05%), in children under 6 years of age (nasal spray dosed 0.1%).
Terms of sale
The drug is available without a prescription.
Contacts for inquiries
JOHNSON & JOHNSON LLC (Russia)
"JOHNSON & JOHNSON" LLC group of companies Johnson & Johnson
121614 Moscow st. Krylatskaya, 17, bldg. 2 Tel Fax
Tizin Expert
Release form, packaging and composition of the drug Tizin® Expert
Nasal spray dosed 0.05% in the form of a clear or slightly opalescent solution, colorless or slightly yellowish.
1 dose 1 ml
xylometazoline hydrochloride 0.035 mg 0.5 mg
Excipients: glycerol - 8.5 mg, sorbitol - 5 mg, sodium dihydrogen phosphate dihydrate - 4 mg, sodium chloride - 3 mg, sodium phosphate dihydrate - 0.628 mg, sodium hyaluronate - 0.2 mg, water for injection - up to 1 ml.
10 ml (140 doses) - high-density polyethylene bottles (1) with a dosing device and a polyethylene cap - cardboard packs.
Nasal spray dosed 0.1% in the form of a clear or slightly opalescent solution, colorless or slightly yellowish.
1 dose 1 ml
xylometazoline hydrochloride 0.14 mg 1.0 mg
Excipients: glycerol - 8.5 mg, sorbitol - 5 mg, sodium dihydrogen phosphate dihydrate - 4 mg, sodium chloride - 3 mg, sodium phosphate dihydrate - 0.628 mg, sodium hyaluronate - 0.2 mg, water for injection - up to 1 ml.
10 ml (70 doses) - high-density polyethylene bottles (1) with a dosing device and a polyethylene cap - cardboard packs.
pharmachologic effect
Xylometazoline (imidazole derivative) is an alpha-adrenergic agonist that constricts the blood vessels of the nasal mucosa, eliminating swelling and hyperemia of the mucous membrane. Facilitates nasal breathing during rhinitis.
Hyaluronic acid, which is part of the drug, has a moisturizing effect when used in nasal medications due to its ability to maintain mucous membranes in a hydrated state and creates optimal conditions for regenerative processes.
The action usually develops within 5-10 minutes.
Pharmacokinetics
When applied topically, it is practically not absorbed; plasma concentrations are so small that they cannot be determined by modern analytical methods.
Pharmacokinetic studies have not been conducted in humans.
Indications for the drug Tizin® Expert
reduction of swelling of the nasal mucosa during rhinitis, incl. allergic rhinitis, acute respiratory infections with symptoms of rhinitis, hay fever, relief of nasal discharge with paranasal sinusitis and inflammation of the middle ear caused by colds, preparing patients for diagnostic manipulations in the nasal passages.
Nasal spray dosed 0.05% is intended for children aged 2 to 6 years.
Dosed nasal spray 0.1% is intended for adults and children over 6 years of age.
Dosage regimen
Adults and children over 6 years of age are prescribed a 0.1% dosed nasal spray, 1 dose in each nasal passage up to 3 times a day. The dose depends on the individual sensitivity of the patient and the clinical effect.
Children aged 2-6 years are prescribed a nasal spray dosed at 0.05%, 1 dose in each nasal passage 1-2 times a day.
You should not use the drug for more than 5-7 days, unless your doctor recommends a different duration of treatment. After completion of therapy, the drug can be re-administered only after a few days.
The duration of use of the drug in children is determined by the doctor.
For chronic rhinitis, the drug can only be used under the supervision of a doctor, taking into account the risk of developing atrophy of the nasal mucosa.
Method of use of the drug
Remove the protective cap. Before first use, press the spray nozzle several times until a uniform cloud of “fog” appears. The bottle is ready for further use.
When using, press 1 time. Inhale the drug through the nose. If possible, keep the spray bottle vertical. Do not spray horizontally or downwards. After use, close the bottle with a cap.
Side effect
Local reactions: transient mild nasal irritation (burning) in susceptible people, sneezing. Often (>.1%, <.10%) after discontinuation of the drug, increased swelling of the nasal mucosa (reactive hyperemia) may be observed. Prolonged or too frequent use of xylometazoline, or its use in high doses, can lead to a burning sensation in the nose or dry mucous membrane, as well as reactive nasal congestion, with the development of drug-induced rhinitis, paresthesia, sneezing, hypersecretion (this effect can be observed even after 5- 7 days after completion of treatment, and with prolonged use it can cause chronic inflammation of the mucous membrane with the formation of crusts (dry rhinitis)).
From the nervous system: rarely (>.01%, <.1%) - headache, insomnia, blurred vision, fatigue and depression (with long-term use in high doses).
From the cardiovascular system: in isolated cases (0.1%, <.1%), local intranasal use of sympathomimetics may be accompanied by systemic effects such as palpitations, tachycardia, arrhythmia and increased blood pressure.
Contraindications for use
hypersensitivity to any of the components of the drug, atrophic rhinitis, thyrotoxicosis, severe cardiovascular diseases (for example, ischemic heart disease, angina, tachycardia, arterial hypertension, severe atherosclerosis), increased intraocular pressure, especially angle-closure glaucoma, condition after transsphenoidal hypophysectomy, surgical interventions on history of meninges, patients receiving MAO inhibitors or other drugs that can cause an increase in blood pressure, newborns and children under 2 years of age (for nasal spray dosed 0.05%), children under 6 years of age (for nasal spray dosed 0.1%) .
Carefully
In the following cases, Tizin® Expert can be used only after carefully weighing the benefits and risks of treatment:
increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure, pheochromocytoma, endocrine diseases (for example, hyperthyroidism, diabetes mellitus), prostatic hyperplasia, porphyria.
Use during pregnancy and breastfeeding
Xylometazoline should not be used during pregnancy, because the effect on the fetus has not been studied in clinical studies.
The drug should not be used during breastfeeding, because It is unknown whether the active substance is excreted in breast milk.
Use in children
The use of the drug is contraindicated in newborns and children under 2 years of age (nasal spray dosed 0.05%), in children under 6 years of age (nasal spray dosed 0.1%).
special instructions
Long-term use (more than 7 days) and overdose of sympathomimetics that have a decongestive effect can lead to reactive hyperemia of the nasal mucosa. As a result, difficulty in nasal breathing occurs, which leads to the patient starting to use the drug repeatedly or even constantly. This can lead to chronic swelling (rhinitis medicamentosa), and sometimes even to atrophy of the nasal mucosa (ozena).
In milder cases, to improve the patient's condition, you can first stop administering the sympathomimetic in one nasal passage, and after the complaints have subsided, continue to administer it into the other nasal passage to partially ensure nasal breathing.
Recommended doses should not be exceeded, especially in children and elderly patients.
It is not recommended to use the drug continuously for more than 7 days.
If the medicine has become unusable or has expired, do not throw it into wastewater or onto the street. It is necessary to place the medicine in a bag and place it in the trash container. These measures will help protect the environment.
Impact on the ability to drive vehicles and machinery
With long-term treatment or use of the drug in higher doses, the possibility of its systemic effect on the cardiovascular system cannot be excluded. In such cases, the ability to drive and control equipment may be impaired.
Overdose
An overdose or accidental ingestion of the drug can lead to the following symptoms: dilated pupils, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, arrhythmia, collapse, cardiac arrest, hypertension, pulmonary edema, respiratory failure, mental disorders. In addition, the following symptoms may be observed: suppression of central nervous system function, accompanied by drowsiness, decreased body temperature, bradycardia, hypotension, apnea and coma.
Treatment: the use of activated carbon, gastric lavage, artificial respiration with the introduction of oxygen. To lower blood pressure, use phentolamine 5 mg (in saline solution) slowly intravenously or 100 mg orally. Vasopressor drugs are contraindicated. If necessary, antipyretic and anticonvulsant drugs are used.
Drug interactions
Concomitant use of MAO inhibitors such as tranylcypromine or tricyclic antidepressants may lead to an increase in blood pressure due to the cardiovascular effects of these substances.
Storage conditions for the drug Tizin® Expert
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Shelf life of the drug Tizin® Expert Shelf life - 2 years. Do not use after the expiration date stated on the package.
Terms of sale The drug is available without a prescription. ,
