Tizin Alergy, 50 mcg/dose 10 ml spray

Nasal congestion, Allergic rhinitis, runny nose (rhinitis), Pollinosis, AllergySymptomatic therapy for seasonal and year-round allergic rhinitis.

Indications

Symptomatic treatment of seasonal and year-round allergic rhinitis.

Special instructions

If the medicine has become unusable or has expired, do not throw it into wastewater or onto the street! Place the medication in a bag and place it in the trash. These measures will help protect the environment!

Active ingredient

Levocabastine

Composition

1 ml of the drug contains:

active ingredient:

levocabastine hydrochloride 540 mcg, which is resp. content of levocabastine 500 mcg

Excipients:

propylene glycol – 48.26 µl,

sodium hydrogen phosphate – 8.66 mg,

sodium hydrogen phosphate monohydrate – 5.38 mg,

hypromellose (2910 5 mPa.s) – 2.5 mg,

polysorbate 80 – 1 mg,

benzalkonium chloride – 150 µg (in the form of a 50% solution – 30 µl),

disodium edetate – 150 mcg,

water for injection – up to 1 ml.

Pregnancy

There are no reliable data on the use of Tizin® Alergy 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 determinations of levocabastine concentrations in the saliva and breast milk of lactating women who received a single oral dose of 0.5 mg levocabastine, it is expected that approximately 0.6% of the total intranasal dose of levocabastine may be excreted during breastfeeding.

If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Contraindications

Hypersensitivity to any of the components of the drug.

Children’s age up to 6 years.

Side Effects

Very common (>1/10), common (>1/100, 1/1000, 1/10000, <1/1000), very rare (<1/10000, including isolated reports), frequency unknown (frequency cannot be estimated from available data).Adverse events observed in patients during clinical trialsGastrointestinal disorders: nausea (common).General and injection site disorders: fatigue, injection site pain (common), injection site irritation, injection site pain, injection site dryness, restlessness (uncommon), injection site burning, injection site discomfort (rare).Infectious and parasitic diseases: sinusitis (often).Nervous system disorders: headache (very common), drowsiness, dizziness (common).Respiratory, thoracic and mediastinal disorders: pain in the pharynx and larynx, epistaxis (common), shortness of breath, nasal congestion (uncommon), swelling of the nasal mucosa (rare), bronchospasm, cough (frequency unknown).Cardiac disorders: palpitations (infrequent), tachycardia (rare).Visual disturbances: swelling of the eyelids (frequency unknown).Immune system disorders: hypersensitivity (uncommon), anaphylactic reactions (frequency unknown).Post-registration dataCardiac disorders: palpitations, tachycardia (very rare).Visual disturbances: swelling of the eyelids (very rare).General disorders and administration site disorders: malaise (uncommon).Immune system disorders: anaphylactic reactions, hypersensitivity (very rare).Disorders of the respiratory system, chest and mediastinal organs: bronchospasm, shortness of breath, swelling of the nasal mucosa (very rare).

Interaction

No interaction with alcohol was observed in clinical studies. There was also no increase in the effects of alcohol or diazepam when using normal dosages of Tizin® Allergy nasal spray.

Concomitant use of CYP3A4 isoenzyme inhibitors ketoconazole or erythromycin did not affect the pharmacokinetics of levocabastine when administered nasally.

Possible local interactions with other nasal drugs have not been well studied, with the exception of interaction with oxymetazoline, which may transiently reduce the absorption of levocabastine when administered nasally.

Overdose

Symptoms: There have been no reports of levocabastine overdose. In case of accidental ingestion, a decrease in blood pressure, tachycardia, and slight sedation may occur.

Treatment: If taken orally, the patient should drink large amounts of fluid to speed up the excretion of levocabastine through the kidneys.

Clinical pharmacology

Pharmacodynamics:

Levocabastine is a selective H1-histamine receptor blocker with a long-lasting effect. The local effect occurs within 5 minutes, and the effect lasts for 12 hours. After intranasal administration, Tizin® Alergy nasal spray eliminates the symptoms of allergic rhinitis: nasal discharge, sneezing, itching in the nasal cavity.

Pharmacokinetics:

With each intranasal administration at a rate of 50 mcg/dose, approximately 30–40 mcg of levocabastine is absorbed, the maximum concentration of levocabastine in the blood plasma is achieved approximately 3 hours after nasal administration.

Levocabastine is approximately 55% bound to plasma proteins.

The main metabolite of levocabastine, acyl glucuronide, is formed by glucuronidation, which is the main route of metabolism.

Levocabastine is excreted primarily in the urine unchanged (about 70% of the absorbed amount). The half-life of levocabastine is approximately 35–40 hours.

Short product description

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

Storage conditions

Store at a temperature not exceeding 25°C.

Keep out of the reach of children.

Shelf life

2 years.

Manufacturer

Janssen Pharmaceuticals N.V., Belgium