Tyzine Alergy nasal spray 50mcg/dose, 10ml

Product description

Helps to relieve allergy symptoms: rhinorrhea, sneezing, itching in the nasal cavity.

Composition

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1 ml of the drug contains:

Active ingredient:  

Levocabastine hydrochloride 540 mcg, acc. levocabastine content 500 mcg

Auxiliary substances:  

propylene glycol-48.26 µl,

sodium hydrophosphate-8.66 mg,

sodium hydrophosphate monohydrate-5.38 mg,

hypromellose (2910.5 MPa. c) – 2.5 mg,

polysorbate 80-1 mg,

benzalkonium chloride-150 mcg (in the form of a 50% solution-30 mcl),

disodium edetate-150 mcg,

water for injection-up to 1 ml.

Clinical Pharmacology

Pharmacodynamics : Levocabastine is a long-acting selective H1-histamine receptor blocker. The local effect occurs in 5 minutes, and the action lasts for 12 hours. After intranasal use, the nasal spray” Tizin® Alert ” eliminates the symptoms of allergic rhinitis: nasal discharge, sneezing, itching in the nasal cavity. Pharmacokinetics: With each intranasal use at the rate of 50 mcg/dose, approximately 30-40 mcg of levocabastine is absorbed, and the maximum concentration of levocabastine in blood plasma is reached approximately 3 hours after nasal use. Levocabastine binds to plasma proteins by approximately 55%. The main metabolite of levocabastine, acylglucuronide, is formed by glucuronidation, which is the main route of metabolism. Levocabastine is mainly excreted unchanged in the urine (about 70% of the absorbed amount). The half-life of levocabastine is about 35-40 hours.

Indications

Symptomatic treatment of seasonal and year-round allergic rhinitis.

Use during pregnancy and lactation

There are no reliable data on the use of Tizin® Alert nasal spray in pregnant women.

Therefore, the drug should not be used during pregnancy unless the intended benefit to the mother justifies the potential risk to the fetus.

Based on the determination of levocabastine concentrations in the saliva and breast milk of nursing women who received 0.5 mg of levocabastine once orally, it is expected that approximately 0.6% of the total intranasal dose of levocabastine can enter the child’s body during breastfeeding.

If it is necessary to prescribe the drug during lactation, stop breastfeeding.

Contraindications

Hypersensitivity to any of the components of the drug. Children under 6 years of age.

Side effects

Very often (>1/10), often (>>1/100, >><1/10), infrequently (>1/1000, <1/10), infrequently (><1/100), rarely (>1/10000, <1/100), rarely (><1/1000), very rarely (Adverse events that have been reported in patients in clinical studiesdisrubs from the gastrointestinal tract: nausea (often). General disorders and disorders at the injection site: fatigue, pain at the injection site (common), irritation at the injection site, pain at the injection site, dryness at the injection site, restlessness (infrequent), burning at the injection site, discomfort at the injection site (rare). Infectious and parasitic diseases: sinusitis (often). Nervous system disorders: headache (very common), drowsiness, dizziness (common). Respiratory, thoracic, and mediastinal disorders: pharyngeal and laryngeal pain, nosebleeds (common), shortness of breath, nasal congestion (uncommon), nasal mucosal edema (rare), bronchospasm, cough (unknown frequency). Cardiac disorders: palpitations (rare), tachycardia (rare). Visual disturbances: edema of the eyelids (frequency unknown). Immune system disorders: hypersensitivity (infrequent), anaphylactic reactions (frequency unknown). Post-registration datafrom the heart: palpitation, tachycardia (very rare). Visual disturbances: edema of the eyelids (very rare). General disorders and disorders at the injection site: malaise (infrequently). Immune system disorders: anaphylactic reactions, hypersensitivity (very rare). Respiratory, thoracic, and mediastinal disorders: bronchospasm, shortness of breath, and nasal mucosal edema (very rare).

Interaction

Interactions with alcohol were not observed in clinical studies. There was also no increase in the effect of alcohol or diazepam when using the usual dosages of Tizin® Alert nasal spray. Concomitant use of CYP3A4 inhibitors ketoconazole or erythromycin did not affect the pharmacokinetics of levocabastine when administered orally. Possible local interactions with other nasal medications are poorly understood, with the exception of interactions with oxymetazoline, which may transiently reduce levocabastine absorption during nasal use.

How to take, course of use and dosage

Intranasally, adults and children over 6 years of age receive 2 doses (100 mcg) in each nasal passage 2 times a day. The use of the drug should be continued until the symptoms are eliminated. In case of severe symptoms, it can be used 3-4 times a day. Patients should be warned to release the nasal passages before using the spray and inhale through the nose during use. Before the first application, remove the protective cap and press the spray nozzle several times until a cloud of “fog” appears. The bottle is ready for further use. Shake the bottle before each application. The drug should be inhaled through the nose.

Overdose

Symptoms: No levocabastine overdose has been reported. In case of accidental ingestion, a decrease in blood pressure, tachycardia, and slight sedation may occur. Treatment: If taken orally, the patient should drink a large amount of fluids to speed up the excretion of levocabastine through the kidneys.

Description

White homogeneous suspension

Special instructions

If the medicine has fallen into disrepair or the expiration date has expired, do not throw it into the sewer or on the street! Place the medicine in a plastic bag and put it in the trash can. These measures will help protect the environment!

Form of production

Metered dose nasal spray

Storage conditions

Store at a temperature not exceeding 25°C. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Levocabastine

Dosage form

nasal spray

Description

Children over 6 years of age, Pregnant women as prescribed by a doctor, For adults

Indications

Hay Fever, Allergies, Allergic rhinitis