Tizin alerdzhi Nazal Spray. 50mkg / 10ml dose 100doz

Description

Composition
Active substance:
1 ml of the preparation contains:
Levocabastine hydrochloride (0.54 mg) was converted to 0.5 mg levocabastine.
Excipients:
Propylene glycol, sodium phosphate, sodium hydrogen phosphate monohydrate, hypromellose, polysorbate, benzalkonium chloride, disodium edetate, water for injections.
Description:
White homogeneous suspension.
Product form:
Nasal spray dosage 50 .mu.g / dose.
10 ml (100 doses) of the drug vial with a spray of high density and the protective cap of low density polyethylene of polyethylene. 1 bottle with instructions for use in a cardboard box.
Contraindications
Hypersensitivity to any component of the drug.
Children up to age 6 years.
Patients with impaired renal function and the elderly.
Dosage
50 ug / dose
Indications
Symptomatic treatment of seasonal and perennial allergic rhinitis.
Interaction with other drugs
Interaction with alcohol in clinical studies were reported. Also, there were no amplification action of alcohol or diazepam using conventional dose nasal spray “Tizin® Alerdzhi”.
Simultaneous application isozymes CYP3A4 inhibitors ketoconazole or erythromycin did not affect the pharmacokinetics levocabastine when nasally administered.
Possible local interaction with other nasal preparations are not well understood, except interaction with oxymetazoline, which can transiently decrease the absorption of levocabastine nasal delivery.
Overdose
symptoms
Posts levocabastine has been reported about the overdose. In case of accidental ingestion may decrease blood pressure, tachycardia, slight sedation.
Treatment
In the case of oral administration to a patient should drink plenty of fluids to speed levocabastine excretion through the kidneys.
pharmachologic effect
Pharmacological group:
Antiallergic agent – H1-histamine receptor blocker.
Pharmacodynamics:
Levocabastine – selective blocker of H1-histamine receptor with long duration of action. A local effect after 5 minutes and the effect 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, levocabastine maximum concentration in plasma is reached after about 3 hours after nasal administration.
Levocabastine binds to plasma proteins, about 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). Levocabastine half-life of about 35-40 hours.
Pregnancy and breast-feeding
Reliable data on the use of the nasal spray “Tizin® Alerdzhi” in pregnant women are missing. 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 definition levocabastine concentration in saliva and breast milk of nursing women who received single oral 0.5 mg levocabastine, it is expected that approximately 0.6% of the total dose intranasal levocabastine may be transmitted to the baby during breastfeeding. Due to the limited number of clinical and experimental data, caution is recommended when using a nasal spray “Tizin® Alerdzhi” in lactating women. If necessary, the appointment during lactation should stop breastfeeding.
Conditions of supply of pharmacies
Without recipe.
side effects
Very common (> 1/10), common (> 1/100,
special instructions
If the drug has come into disrepair or expiration date – do not throw it in the sewer system or into the street! Place the drug in the bag and place in the trash. These measures will help protect the environment!
Nasal spray “Tizin® Alerdzhi” at the recommended dose generally does not have clinically significant sedative effect and reduces the reaction speed as compared to placebo. In case of drowsiness should not engage in potentially hazardous activities that require increased attention and psychomotor speed reactions.
Storage conditions
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Intranasal adults and children over 6 years: 2 doses (100 mcg) in each nostril 2 times a day. Use of the drug should be continued until symptoms resolve.
3-4 times a day can be used in case of symptoms.
Patients should be warned of the need to free up the nasal passages before using the spray and to breathe through the nose during insertion.
Before the first use to remove a protective cap and repeatedly press the spray nozzle until the cloud “fog”. The vial is ready for use.
Before each use, shake the bottle. The drug is inhaled through the nose.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist