the International unlicensed
name Tramazolin Lekarstvennaya a form
Spray the nasal
of 1 ml of solution dosed 1.18mg/ml, 10 ml contain
active agent – a tramazolin a hydrochloride of monohydrate of 1.265 mg (1.18 mg of a tramazolin of a hydrochloride are equivalent),
excipients: citric acid monohydrate, sodium hydroxide, a benzalkoniya chloride, a gipromelloza, K25 povidone, glycerin of 85%, magnesium sulfate, magnesium chloride, Calcii chloridum, Natrii hydrocarbonas, sodium chloride, cineole, left menthol, camphor racemic, the water purified.
Transparent, light yellow solution with an eucalyptus smell
Nasal drugs. Antikongestanta and other nasal drugs for topical administration. Sympathomimetics. Tramazolin
ATX R01AA09 Code
Pharmacokinetics Absorption properties and distribution. Pharmacokinetic researches on the person were not conducted. Preclinical trials showed that after intranasal use from 50 to 80% of the entered dose are soaked up.
Metabolism and removal. Tramazolin and his metabolites are distributed in all internals, the highest concentration is found in a liver. After use of a tramazolin three of its of the main a metabolite were found in urine. Terminal elimination half-life makes 5–7 hours. It is removed mainly through kidneys.
Tramazolin’s pharmacodynamics a hydrochloride – alpha 2 – adrenomimetik, causes vasoconstriction. Thanks to vasoconstrictive action, drug when drawing reduces puffiness by mucous membranes of a nose. As a result, the passability of the nasal courses is restored, nasal breath is facilitated. Effect of drug begins within the first 5 minutes and 8-10 hours proceed.
– the rhinedema, congestion of a nose caused by acute respiratory diseases and/or a pollinosis (rhinitis, hay fever)
– in sinusitis and average otitis (eustachitis) for simplification of outflow of contents of adnexal bosoms of a nose (according to the recommendation of the doctor)
the Route of administration and
Adults and children are more senior than 6 years: on 1 injection in each nasal course, up to 4 injections a day as required.
It is not necessary to use administration of drug more than 5-7 days without medical prescription.
Operation manuals of a bottle with the portioning device:
Before injection of drug it is necessary to clean the nasal courses.
1. To remove a protective cap.
2. Before the first use it is necessary to make several injections in air before emergence of a steady uniform cloud of aerosol (fig. 1). After that the portioning device is ready to use.
fig. 1 3. Holding the head directly, to enter a tip into the nasal course and to make one injection (fig. 2). To repeat the procedure for other nasal course. After extraction of a tip to make a usual breath through a nose.
fig. 2 4. To put on a protective cap after use. It is recommended to clean a tip after each use.
– nasal bleeding, hypostasis of a nasal cavity, dryness and discomfort in a nasal cavity, a rhinorrhea, sneezing
– nausea, disturbance of flavoring feelings, drowsiness, insomnia, concern, fatigue, sedation, a headache, hallucinations, dizziness
– arrhythmia, tachycardia, heartbeat, increase in arterial blood pressure
– hypersensitivity, allergic reactions (hypostasis of integuments and a mucous membrane, rash, an itching)
of the Contraindication
– hypersensitivity to a tramazolin to a hydrochloride, a benzalkoniya to chloride or to any other component of drug
– closed-angle glaucoma
– atrophic rhinitis
– the surgical interventions on a skull performed through a nasal cavity (in the anamnesis)
– І a trimester of pregnancy and the period of a lactation
– children’s age up to 6 years
Some antidepressants (MAO inhibitors and tricyclic antidepressants) and vasoconstrictive drugs at co-administration can cause increase in arterial blood pressure. The combined reception with tricyclic antidepressants can lead ment of arrhythmia also.
The concomitant use with antihypertensive drugs (especially those which influence sympathetic nervous system) can result in various cardiovascular effects.
With care: patients with arterial hypertension, heart diseases, a hyperthyroidism, a prostate hypertrophy, a pheochromocytoma and a porphyria should use drug only according to the recommendation of the doctor in connection with presence of potential risk of system absorption of drug.
It is necessary to be careful at intake of MAO inhibitors, tricyclic antidepressants, angiotonic drugs and antihypertensive drugs.
If after 5-7 days of administration of drug positive dynamics of symptoms is not observed, it is necessary to see a doctor for the solution of a question of the termination of administration of drug or on need of continuation of treatment.
Prolonged use of nasal vasoconstrictive drugs can lead ment of chronic inflammation and congestion of a nose and also to a nose mucosal atrophy.
After reduction of therapeutic effect the inflammation mucous a nose (hypostasis mucous a nose) as sign of resuming of symptoms of a disease can be noted.
It is necessary to avoid hit of drug on a mucous membrane of eyes in avoidance of irritations.
Drug contains preservative a benzalkoniya the chloride causing irritation mucous a nose.
Pregnancy and the period of a lactation
Long experience of use shows that LAZORIN has no negative impact on pregnancy. Safety of use of drug in the period of a lactation is not confirmed. Drug should not be used during the first trimester of pregnancy. In more late stages of pregnancy the use of drug is allowed only after consultation of the doctor.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
of Researches about influence on ability to drive the car and potentially dangerous mechanisms it was not carried out. Nevertheless, at administration of drug some patients can test undesirable side effects as a hallucination, drowsiness, sedation, dizziness or fatigue. At emergence of above-mentioned side effects it is necessary to avoid potentially dangerous actions, such as driving of the car or control of mechanisms.
Symptoms: after increase in arterial blood pressure and tachycardia perhaps (especially at children) falling of arterial blood pressure, development of shock, reflex bradycardia, fall of temperature of a body.
By analogy with other alpha sympathomimetics the clinical picture of intoxication can be vague as phases of excitement and oppression of central nervous system and a cardiovascular system can alternate.
Especially at children intoxication leads to impacts on central nervous system with development of spasms and a coma, bradycardia, respiratory depression.
Besides, development of the following symptoms is possible: cardiovascular dysfunction (including cardiac arrest), breath disturbance (including respiratory insufficiency, an apnoea), expansion or narrowing of pupils, sweating, temperature, pallor, cyanosis of lips, psychological changes.
Treatment: in case of nasal overdose it is necessary to wash out or clean a nasal cavity immediately carefully. Symptomatic treatment.
The form of release and packing
On 10 ml of drug spill in glass bottles of amber color like І, supplied with the portioning device and the nasal adapter from polypropylene with a polyethylene protective cap.
On a bottle paste paper label.
On 1 bottle together with the instruction for medical use in the state and Russian languages place
Storage conditions in a cardboard box
to Store at a temperature not above 25ºС.
To store out of children’s reach!
not to use a period of storage after expiry date.
of Proizvoditel Institut de Angueli of S.R. L., Italy