Universal reference book for medicines
Product name: LAZOLVAN® RINO (LASOLVAN® RHINO)

Active substance: tramazoline

Type: Vasoconstrictive drug for topical application in ENT practice

Manufacturer: BOEHRINGER INGELHEIM INTERNATIONAL (Germany) manufactured by ISTITUTO de ANGELI (Italy)
Composition, form of production and packaging
?
Spray nasal dosed pale yellow, transparent, with the smell of eucalyptus.
1 dose

tramazoline hydrochloride monohydrate in terms of tramazoline hydrochloride 82 μg

Excipients: citric acid monohydrate 270 μg, sodium hydroxide 154 μg, benzalkonium chloride 14 μg, hypromellose hydroxypropyl methylcellulose 35 μg, povidone 2101 μg, glycerol 85% 700 μg, magnesium sulfate heptahydrate 49 μg, magnesium chloride hexahydrate 35 μg, calcium chloride dihydrate 11 μg, sodium hydrogencarbonate 1 μg, sodium chloride 183 μg, cineole (eucalyptol) 7 μg, L-menthol (levomentol) 14 μg, racemic camphor 14 μg, water purified - 66358 mcg.

10 ml - bottles of brown glass (1) with a dosing device and a nasal adapter - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

The active substance of the preparation Lazolvan ® Rino - tramazolin hydrochloride, alpha 2 -adrenomimetic, causes vasoconstriction.
When applied to the mucous membranes of the nose due to vasoconstrictive action, the drug reduces puffiness. As a result, the passability of the nasal passages is quickly restored, nasal breathing is facilitated for a long time.
The effect of the drug begins within the first 5 minutes and lasts 8-10 hours.

PHARMACOKINETICS

Pharmacokinetic studies in humans have not been conducted.
The pharmacokinetics of tramazolin have been studied in rats, rabbits and monkeys. It is shown that after application of the preparation, 50-80% of the administered dose is absorbed or intranasally absorbed. Tramazoline and its metabolites are distributed in all internal organs, C max is noted in the liver.
After oral or topical administration, the main metabolites are determined in the urine.
The terminal T 1/2 is between 5 and 7 hours.
INDICATIONS

- edema of the nasal mucosa, nasal congestion caused by acute respiratory diseases and / or pollinosis (rhinitis, hay fever);

- with sinusitis and otitis media (eustachyte) to facilitate the outflow of the paranasal sinuses (at the doctor's recommendation).

DOSING MODE

Adults and children over 6 years of age are prescribed one injection in each nasal passage (up to 4 injections in each nasal passage per day).

Do not use the drug for more than 5-7 days without prescribing a doctor.

Instructions for using a vial with a dosing device

Before injection, the nasal passages should be cleared.

1. Remove the protective cap.

2. Before the first use, several injections into the air must be made before a stable aerosol cloud appears.
After that, the dosing device is ready for use.
3. Insert the tip into the nasal passage and make one injection.

Repeat the procedure for another nasal passage.
After removing the tip, draw a normal breath through the nose.
4. Put the protective cap on.

It is recommended that the tip be cleaned after each use.

SIDE EFFECT

From the side of the nervous system: rarely (? 0.01% and <0.1%) - dizziness, flawed sensations;
infrequently (? 0.1% and <1%) - headache; frequency not established * - drowsiness, sedation.
From the side of the psyche: infrequently (? 0.1% and <1%) - anxiety;
frequency not established * - hallucinations, insomnia.
From the side of the cardiovascular system: infrequently (? 0.1% and <1%) - palpitation;
frequency not established * - arrhythmia, tachycardia, increased blood pressure.
On the part of the respiratory system: often (? 1% and <10%) - nasal discomfort;
infrequently (? 0.1% and <1%) - swelling of the nose, dry nose, rhinorrhea, sneezing;rarely (? 0.01% and <0.1%) - epistaxis.
From the digestive tract: infrequently (? 0.1% and <1%) - nausea.

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

From the skin and subcutaneous tissues **: frequency is not established * - rash, itching, swelling of the skin.

Other: frequency not established * - mucosal edema **, fatigue.

* Adverse events, the relationship of which with the drug was regarded as possible, recorded with a wide application of the drug.
The frequency of these rare phenomena is difficult to assess.
** How are the symptoms of hypersensitivity.

CONTRAINDICATIONS

- an angle-closure glaucoma;

- Atrophic rhinitis;

- operations on the skull, carried out through the nasal cavity (in the anamnesis);

- children's age till 6 years;

- Hypersensitivity to tramazolin hydrochloride or benzalkonium hydrochloride, as well as to other components of the drug.

With caution

Patients with hypertension, heart disease, hyperthyroidism, prostatic hyperplasia, pheochromocytoma, porphyria should be used only on the advice of a doctor because of the potential risk of systemic absorption of the drug.

Caution should be exercised when taking MAO inhibitors, tricyclic antidepressants, vasopressor drugs and antihypertensive drugs.

PREGNANCY AND LACTATION

Long-term experience shows that Lazolvan® Reno does not adversely affect pregnancy.
The safety of the drug during lactation is not confirmed. Lazolvan® Reno should not be used in the first trimester of pregnancy. At later gestational age and during breastfeeding, the drug is only allowed after a doctor's consultation.
APPLICATION FOR CHILDREN

Contraindicated in children under 6 years.

SPECIAL INSTRUCTIONS

If after 7 days of taking the drug there is no positive symptom dynamics, you should decide whether to stop taking the drug or about continuing treatment.
Long-term use of nasal vasoconstrictive drugs can lead to the development of chronic inflammation and nasal congestion, as well as atrophy of the nasal mucosa.
Avoid contact with the eyes.

Impact on the ability to drive vehicles and manage mechanisms

Studies on the effect of the drug on the ability to drive and machine equipment were not conducted.
However, when taking the drug, such undesirable effects as hallucination, drowsiness, sedation, dizziness and fatigue are possible. Therefore, care must be taken when driving and machinery.
When these side effects appear, it is necessary to avoid such potentially dangerous tasks as driving and machinery.

OVERDOSE

Symptoms: after the increase in blood pressure and tachycardia, it is possible (especially in children) to have a drop in blood pressure, development of shock, reflex bradycardia, and lowering of body temperature.

By analogy with other alpha-sympathomimetics, the clinical picture of intoxication can be indistinct, since the phases of stimulation and depression of the central nervous system and the cardiovascular system can change each other.

Especially in children, intoxication leads to effects on the central nervous system with the development of convulsions and coma, bradycardia, respiratory depression.Symptoms of CNS stimulation are anxiety, agitation, hallucinations and convulsions.
Symptoms of CNS depression include a decrease in body temperature, lethargy, drowsiness and coma.
In addition, the following symptoms may develop: mydriasis, miosis, increased sweating, fever, pallor, cyanosis of the lips, dysfunction of the cardiovascular system (including cardiac arrest);
respiratory failure (including respiratory failure, respiratory arrest); psychological disorders.
Treatment: In case of nasal overdose, immediately flush or clean the nose.
Symptomatic treatment may be required.
DRUG INTERACTION

Some antidepressants (MAO inhibitors and tricyclic antidepressants) and vasoconstrictor drugs with simultaneous administration may cause an increase in blood pressure.

Combination with tricyclic antidepressants may lead to arrhythmia.

Simultaneous reception with antihypertensive drugs (especially those that affect the sympathetic nervous system) can lead to various cardiovascular effects.

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 out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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