Tizin Alergi - instructions for use, dose, side effects, contraindications

Active substanceLevocabastineLevocabastine

Similar drugsTo uncover

Vizin® Alerji

drops d / eye

Johnson & Johnson, LLC Russia

Tizin® Allegi

spray nazal.

Johnson & Johnson, LLC Russia

Dosage form: & nbspFROMnasal dosing.

Composition:

1 ml of the preparation contains:

active substance: Levocabastin hydrochloride (0.54 mg) in terms of levocabastine 0.5 mg;

Excipients: propylene glycol 48.26 uL, 8.66 mg sodium phosphate, sodium hydrogen phosphate monohydrate, 5.38 mg of hypromellose (5 mPa.s 2910) 2.50 mg Polysorbate 80 1.00 mg Benzalkonium chloride 0.15 mg (as 50% solution 0.03 mL) disodium edetate 0.15 mg water for injection to 1.0 ml.

Description:Bhomogeneous suspension.

Pharmacotherapeutic group:antiallergic agent - H1-histamine receptor blocker

ATX: & nbsp

R.01.A.C Antiallergic drugs (excluding corticosteroids)

R.01.A.C.02 Levocabastine

Pharmacodynamics:

Levokabastin - selective blocker H₁-gistamine receptors with prolonged action. The local effect comes in 5 minutes, and the action lasts for 12 hours. After intranasal administration, nasal spray "Tizin® Alerdzhi" eliminates allergic rhinitis symptoms: runny nose, sneezing, itching of the nasal cavity.

Pharmacokinetics:

Each intranasal administration rate of 50 mg / dose absorbed about 30-40 micrograms levocabastine,the maximum concentration of levocabastin in the blood plasma is reached approximately 3 hours after nasal administration. Levocabastine binds to blood plasma proteins by approximately 55%.

The major metabolite levocabastine, atsilglyukuronid is formed by glucuronidation, which is a main metabolic pathway.

Levocabastine excreted predominantly in the urine in unchanged form (about 70% of the absorbed amount).

The half-life of Levokabastin is about 35-40 hours.

Indications:

Symptomatic therapy of seasonal and year-round allergic rhinitis.

Contraindications:

Hypersensitivity to any of the components of the drug.

Children under 6 years.

Carefully:

Patients with impaired renal function and elderly people.

Pregnancy and lactation:

There are no reliable data on the use of Tizin® Alzergi nasal spray in pregnant women. Therefore, nasal spray Tizin® Alerdzhi should not be used during pregnancy except in cases where the anticipated benefits to the mother justifies the potential risk to the fetus.

Based on the determination of the concentration of levocabastin in saliva and breast milk of lactating women who once received 0.5 mg of levocabastin, about 0.5% of the total intranasal dose of levocabastin is expected to be transmitted to the infant during breastfeeding. Due to the limited number of clinical and experimental data, caution should be exercised when applying Tizin® Alercei nasal spray to lactating women. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

Intranasal to adults and children over 6 years of age, 2 doses (100 mcg) in each nasal passage 2 times a day. The drug should be continued until symptoms are eliminated.

In case of symptoms, you can apply 3-4 times a day.

Patients should be warned about the need to empty the nasal passages before using the spray and inhale through the nose during the injection.

Before the first use, remove the protective cap and press the spray nozzle several times until the "mist" appears. The bottle is ready for further use.

Before each use, shake the bottle.The drug is inhaled through the nose.

Side effects:

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), the frequency is unknown (the incidence rate can not be estimated from the available data).

Undesirable effects observed in patients during clinical trials

Disorders from the gastrointestinal tract: nausea (often).

General disorders and disorders at the site of administration: fatigue, pain at the injection site (often), irritation at the injection site, pain at the injection site, dryness at the injection site, restlessness (infrequently), burning at the injection site, discomfort at the injection site (rarely).

Infectious and parasitic diseases: sinusitis (often).

Disturbances from the nervous system: headache (very often), drowsiness, dizziness (often).

Disturbances from the respiratory system, chest and mediastinal organs: pain in the pharynx and larynx, nasal bleeding (often), dyspnea, nasal congestion (infrequently), swelling of the nasal mucosa (rarely), bronchospasm, cough (frequency unknown).

Heart Disease: a feeling of palpitations (infrequently), tachycardia (rarely).

Disturbances on the part of the organ of sight: edema of the eyelids (frequency unknown).

Immune system disorders: hypersensitivity (infrequently), anaphylactic reactions (frequency unknown).

Post-registration data

Heart Disease: palpitation, tachycardia (very rarely).

Disturbances on the part of the organ of sight: swelling of the eyelids (very rarely).

General disorders and disorders at the site of administration: malaise (infrequently).

Immune system disorders: anaphylactic reactions, hypersensitivity (very rarely).

Disturbances from the respiratory system, chest and mediastinal organs: bronchospasm, shortness of breath, swelling of the nasal mucosa (very rarely).

Overdose:

Symptoms

There were no reports of an overdose of Levocabastine. At casual intake it is possible decrease in arterial pressure, a tachycardia, a small sedation.

Treatment

In case of oral administration, the patient should drink a large amount of fluid to accelerate the release of Levokabastin through the kidneys.

Interaction:

Interactions with alcohol in clinical studies were not noted. Also, there was no increase in the effect of alcohol or diazepam when using the usual dosages of the nasal spray "Tizin® Alergi".

Simultaneous application of inhibitors of isoenzymes CYP3A4 ketoconazole or erythromycin did not affect the pharmacokinetics of levocabastine in nasal administration.

Possible local interactions with other nasal drugs have not been adequately studied, with the exception of interaction with oxymetazoline, which can transiently reduce the absorption of levocabastine in nasal administration.

Special instructions:

If the medicine has become unusable or the expiration date has expired, do not throw it into sewage or 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:

The nasal spray "Tizin® Alergi" at the recommended dose is usually not has a clinically pronounced sedative effect and does not reduce the reaction rate compared to placebo. In case of drowsiness, do not engage in potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Spray nasal dosed, 50 mcg / dose.

Packaging:

10 ml (100 doses) of the preparation into a bottle of high-density polyethylene with a sprayer and a protective cap made of low-density polyethylene.

1 bottle with instructions for use in a cardboard box.

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.

Terms of leave from pharmacies:Without recipe

Registration number:П N014198 / 02

Date of registration:07.07.2010 / 24.10.2012

Expiration Date:Unlimited

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

Manufacturer: & nbsp

JANSSEN PHARMACEUTICA, N.V. Belgium

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

Information update date: & nbsp16.12.2016

Illustrated instructions

Instructions

Tizin® Allegi (Tyzine® Allergy)