Лазолван® Rino

General characteristics. Structure:

Active ingredient: 82 mkg of a tramazolin a hydrochloride (in the form of a tramazolin of a hydrochloride of monohydrate) in 1 spray dose.

Excipients: citric acid monohydrate, sodium hydroxide, a benzalkoniya chloride, a gipromelloz (gidroksipropilmetiltsellyuloz), povidone, глицерол 85%, sulfate magnesium heptahydrate, chloride magnesium hexahydrate, Calcii chloridum a dihydrate, Natrii hydrocarbonas, sodium chloride, cineol (eucalyptole), left menthol (L-menthol), camphor racemic, the water purified.

Pharmacological properties:

Pharmacodynamics. Active agent of the drug Lazolvan® of Rino - a tramazolin a hydrochloride, alfa2-adrenomimetik, causes vasoconstriction. When drawing owing to vasoconstrictive action drug reduces puffiness by mucous membranes of a nose. As a result, passability of the nasal courses is quickly recovered, nasal breath is for a long time facilitated.

Effect of drug begins within the first 5 min. and continues 8-10 h.

Pharmacokinetics. Pharmakinetichesky researches at the person were not conducted. The pharmacokinetics of a tramazolin is studied on rats, rabbits and monkeys. It is shown that after drug use inside or intranazalno 50-80% of the entered dose are soaked up. Tramazolin and his metabolites are distributed in all internals, Cmax is noted in a liver.

After oral or topical administration the main metabolites are defined in urine. Terminal T1/2 makes from 5 to 7 h.

Indications to use:

— a rhinedema, the nose congestion caused by acute respiratory diseases and/or a pollinosis (rhinitis, hay fever);

— at sinusitis and average otitis (eustachitis) for simplification of outflow of contents of adnexal bosoms of a nose (according to the recommendation of the doctor).

Route of administration and doses:

To adults and children 6 years are more senior appoint on one injection in each nasal course (up to 4 injections in each nasal course in day).

It is not necessary to use drug more than 5-7 days without appointment of the doctor.

The instruction for use of a bottle with the portioning device. Before injection it is necessary to clear 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 cloud of an aerosol. After that the portioning device is ready to use.

3. To enter a tip into the nasal course and to make one injection.

To repeat the procedure for other nasal course. After extraction of a tip to make a usual breath through a nose.

4. To put on a protective cap.

It is recommended to clear a tip after each use.

Features of use:

Use at pregnancy and feeding by a breast. Long experience of use shows that Rino's Lazolvan® does not exert a negative impact on pregnancy. Safety of use of drug in the period of a lactation is not confirmed. Лазолван® Rino should not be applied in the I trimester of pregnancy. On later durations of gestation and during feeding by a breast use of drug is allowed only after consultation of the doctor.

Use for children. It is contraindicated at children's age up to 6 years.

If after 7 days of administration of drug of positive dynamics of symptoms it is not noted, it is necessary to resolve an issue of the termination of administration of drug or of treatment continuation. Prolonged use of nasal vasoconstrictive drugs can lead to development of a chronic inflammation and congestion of a nose, and also to a nose mucosal atrophy.

It is necessary to avoid hit of drug in eyes.

Influence on ability to driving of motor transport and to control of mechanisms. Researches on influence of drug on ability to drive the car and the machine equipment were not conducted. However at administration of drug such undesirable effects as a hallucination, drowsiness, sedation, dizziness and fatigue are possible. Therefore it is necessary to be careful when driving and the machine equipment.

At emergence of above-mentioned side effects it is necessary to avoid performance of such potentially dangerous tasks as driving and the machine equipment.

Side effects:

From a nervous system: seldom (≥0.01% and <0.1%) - dizziness, disturbances of flavoring feelings; infrequently (≥0.1% and <1%) - a headache; frequency is not established * - drowsiness, sedation.

From mentality: infrequently (≥0.1% and <1%) - concern; frequency is not established * - hallucinations, sleeplessness.

From cardiovascular system: infrequently (≥0.1% and <1%) - heartbeat; frequency is not established * - arrhythmia, tachycardia, increase in the ABP.

From respiratory system: often (≥1% and <10%) - nasal discomfort; infrequently (≥0.1% and <1%) - nose hypostasis, dryness in a nose, a rhinorrhea, sneezing; seldom (≥0.01% and <0.1%) - nasal bleeding.

From a GIT: infrequently (≥0.1% and <1%) - nausea.

From immune system: frequency is not established * - hypersensitivity.

From skin and hypodermic fabrics **: frequency is not established * - rash, an itch, a cutaneous dropsy.

Others: frequency is not established * - hypostasis of a mucous membrane **, fatigue.

* The undesirable phenomena which communication with drug was regarded as possible, registered at broad use of drug. It is difficult to estimate the frequency of these unusual occurrences.

** As hypersensitivity symptoms.

Interaction with other medicines:

Some antidepressants (MAO inhibitors and tricyclic antidepressants) and vasoconstrictive drugs at co-administration can cause increase in the ABP.

The combined reception with tricyclic antidepressants can lead to development of arrhythmia.

The concomitant use with anti-hypertensive means (especially with those which influence a sympathetic nervous system) can result in various cardiovascular effects.

Contraindications:

— closed-angle glaucoma;

— atrophic rhinitis;

— the skull operations which are carried out through a nasal cavity (in the anamnesis);

— children's age up to 6 years;

— hypersensitivity to a tramazolin to a hydrochloride or a benzalkoniya to a hydrochloride, and also to other components of drug.

With care. Patients with arterial hypertension, heart diseases, a hyper thyroidism, a prostate hyperplasia, a pheochromocytoma, a porphyria should use drug only according to the recommendation of the doctor in connection with existence of potential risk of system absorption of drug.

It is necessary to be careful at reception of MAO inhibitors, tricyclic antidepressants, angiotonic drugs and anti-hypertensive drugs.

Overdose:

Symptoms: after increase in the ABP and tachycardia perhaps (especially at children) falling of the ABP, 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 stimulation and a depression of TsNS and cardiovascular system can replace each other.

Especially at children intoxication leads to impacts on TsNS with development of spasms and a coma, bradycardia, respiratory depression. Symptoms of stimulation of TsNS are uneasiness, excitement, hallucinations and spasms. Refer decrease in body temperature, slackness, drowsiness and a coma to symptoms of oppression of TsNS.

Besides, development of the following symptoms is possible: a mydriasis, a miosis, the increased sweating, fever, pallor, cyanosis of lips, disturbances of functions of cardiovascular system (including a cardiac standstill); breath disturbance (including respiratory insufficiency, an apnoea); psychological disturbances.

Treatment: in case of nasal overdose immediately wash out or clear a nose. The symptomatic treatment can be required.

Storage conditions:

Drug should be stored in the place, unavailable to children, at a temperature not above 25 °C. A period of validity - 3 years.

Issue conditions:

Without recipe

Packaging:

On 10 ml in bottles from dark glass with the portioning device and the nasal adapter, on 1 bottle in packs cardboard.