Composition, form of production and packaging
Spray nasal dosed 1 dose
Levocabastin 50 mcg
100 doses - polyethylene bottles with a sprayer (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Levocabastin is a selective blocker of H 1 -gistamine receptors with a prolonged action. The local effect occurs after 5 minutes, and the effect lasts for up to 12 hours. After intranasal administration, Reaktin eliminates the symptoms of allergic rhinitis: nasal discharge, sneezing, itching in the nasal cavity.
PHARMACOKINETICS
With each intranasal administration, approximately 30-40 Ојg of levocabastine is absorbed at a rate of 50 Ојg / dose, left-cobastin C max in blood plasma is reached approximately 3 hours after nasal administration, excreted unchanged by kidneys with urine.
Levocabastin binds to plasma proteins approximately 55%.
The main metabolite of levocabastin, acylglucuronide, is formed when glucuronization, which is the main way of metabolite formation.
The half-life of Levokabastin is about 35-40 hours.
INDICATIONS
- symptomatic therapy of seasonal and all-year-round allergic rhinitis.
DOSING MODE
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 the case of severity of symptoms can be used 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 EFFECT
Undesirable phenomena that have been observed in y? 1% of patients in clinical trials:
From the side of the digestive system: nausea.
From the nervous system: headache, drowsiness, dizziness.
On the part of the respiratory system: pain in the pharynx and larynx, nosebleeds, cough.
Other: fatigue, pain at the injection site.
Adverse events that occurred in <1% of patients during clinical trials:
From the respiratory system: short-term local irritation at the injection site.
Other: irritation, pain, dryness, burning and discomfort at the injection site.
Postmarketing data:
Very often (> 1/10), often (> 1/100) and infrequently (> 1/1000, <1/100), rarely (> 1/10000, <1/1000) and very rarely (<1/10000 , including individual cases).
From the cardiovascular system: tachycardia (rarely).
From the immune system: allergic reactions (infrequently).
On the part of the respiratory system: bronchospasm (the frequency is unknown), dyspnea (infrequently), edema of the nasal mucosa (rarely).
Other: malaise (infrequently), edema of the eyelids (frequency unknown).
CONTRAINDICATIONS
- patients with impaired renal function and elderly people.
PREGNANCY AND LACTATION
There are no reliable data on the use of nasal spray Reaktin in pregnant women. Therefore, nasal spray Reactin should not be used during pregnancy, except when the intended use for the mother justifies the potential risk to the fetus.
Based on the determination of the concentration of levocabastine in saliva and breast milk of lactating women who once orally received 0.5 mg of levocabastine, it is expected that approximately 0.6% of the total intranasal dose of levocabastin can be transmitted to the infant during breastfeeding. Due to the limited number of clinical and experimental data, caution should be exercised when applying Reaktin nasal spray to lactating women. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.
APPLICATION FOR FUNCTIONS OF THE LIVER
It is forbidden to use the drug for patients with impaired renal function.
APPLICATION IN ELDERLY PATIENTS
Contraindicated in old age.
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.
Impact on the ability to drive and use machinery
Nasal Spray Reactin at the recommended dose usually does not have a clinically pronounced sedative effect and does not reduce the reaction rate compared to placebo. In case of drowsiness, do not engage in potentially dangerous activities that require increased attention and speed of psychomotor reactions.
OVERDOSE
Symptoms: There have been no reports of an overdose of levocabastine. With the occasional ingestion, it is possible to reduce blood pressure, tachycardia, and small sedation.
Treatment: In case of ingestion, a patient should drink a large amount of fluid to accelerate the release of Levocabastin through the kidneys.
DRUG INTERACTION
Interactions with alcohol in clinical studies were not noted. Also, there was no increase in the effect of alcohol or diazepam when using conventional Reaktin dosages.
Simultaneous use of inhibitors of CYP3A4 isoenzymes 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.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored at a temperature of no higher than 25 В° 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.
