Tramazolyn | Lazolvan Rino spray 1.18 mg / ml, 10 ml

Release form

Distribution nasal spray

Packing

10 ml in a vial.

Pharmacological action

Pharmacodynamics

The active substance of the drug Lazolvan® Rino - Tramazoline hydrochloride, alpha2-adrenergic agonist, causes vasoconstriction. When applied to the mucous membranes of the nose due to the vasoconstrictor effect, the drug reduces swelling. As a result, the patency of the nasal passages is quickly restored, nasal breathing is facilitated for a long time.

The drug begins within the first 5 minutes and lasts 8-10 hours.

Pharmacokinetics

No pharmacokinetic studies have been conducted in humans. The pharmacokinetics of tramazoline has been studied in rats, rabbits, and monkeys. It is shown that after using the drug, 50-80% of the administered dose is absorbed orally or intranasally. Tramazolin and its metabolites are distributed in all internal organs, Cmax is noted in the liver.

Following oral or topical administration, major metabolites are detected in the urine. Terminal T1 / 2 is 5 to 7 hours.

Indications

Swelling of the nasal mucosa, nasal congestion caused by acute respiratory infections and / or hay fever (rhinitis, hay fever).

For sinusitis and otitis media (eustachitis), to facilitate the outflow of the contents of the sinuses (on the recommendation of a doctor).

Contraindications

Hypersensitivity to tramazoline hydrochloride or benzalkonium hydrochloride, as well as other components of the

preparation, angle-closure glaucoma

atrophic rhinitis

skull operations performed through the nasal cavity (a history of

) children under 6 years of age.

Caution: in patients with arterial hypertension, heart disease, hyperthyroidism, prostatic hyperplasia, pheochromocytoma, porphyria, the drug should be used only on the recommendation of a doctor due to the potential risk of systemic absorption of the drug.

Caution is advised when taking MAO inhibitors, tricyclic antidepressants, vasopressor drugs, and antihypertensive drugs.

Pregnancy and lactation

Long-term experience shows that LazolvanВ® Reno does not adversely affect pregnancy. The safety of the drug during lactation is not confirmed. LazolvanВ® Rino should not be used in the first trimester of pregnancy. At later stages of pregnancy and during breastfeeding, the use of the drug is allowed only after consulting a doctor.

Dosage and administration

Adults and children 6 years of age and older: prescribe 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 a doctor's prescription.

Instructions for use with the

dispensing bottle The nasal passages should be cleaned before injection.

Remove the protective cap.

Before first use, several injections must be made into the air before a steady aerosol cloud appears. After that, the metering device is ready for use.

Insert the tip into the nasal passage and make one injection. Repeat the procedure for the other nasal passage. After removing the tip, draw a regular breath through the nose.

Put on the protective cap. It is recommended to clean the tip after each use.

Side effects of the

From the nervous system: rarely ( 0.01% and <0.1%) - dizziness, taste disturbances infrequently ( 0.1% and <1%) - headache frequency not found * - drowsiness, sedation.

From the psyche: infrequently ( 0.1% and <1%) - anxiety frequency is not established * - hallucinations, insomnia.

From the cardiovascular system: infrequently ( 0.1% and <1%) - heart rate not found * - arrhythmia, tachycardia, increased blood pressure.

From the respiratory system: often ( 1% and <10%) - nasal discomfort infrequently ( 0.1% and <1%) - nasal edema, dry nose, rhinorrhea, sneezing rarely ( 0.01% and <0.1%) - nosebleeds.

From the gastrointestinal tract: infrequently ( 0.1% and <1%) - nausea.

On the part of the immune system: frequency not found * - hypersensitivity.

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

Other: frequency not established * - swelling of the mucous membrane **, fatigue.

* - adverse events, the relationship with the drug was regarded as possible, registered with the widespread use of the drug. The frequency of these rare events is difficult to assess.

** - as symptoms of hypersensitivity.

Drug Interaction

Certain antidepressants (MAO inhibitors and tricyclic antidepressants) and vasoconstrictor drugs at the same time may cause an increase in blood pressure.

Combined administration with tricyclic antidepressants can lead to arrhythmia.

Concurrent administration with antihypertensive agents (especially those that affect the sympathetic nervous system) can lead to various cardiovascular effects.

Overdose

Symptoms: following a rise in blood pressure and tachycardia, it is possible (especially in children) to drop blood pressure, develop shock, reflex bradycardia, decrease body temperature.

Similar to other alpha sympathomimetics, the clinical picture of intoxication may be indistinguishable, as the stimulation and depression phases of the CNS and cardiovascular system may change each other.

Especially in children, intoxication leads to CNS effects 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 to whom.

In addition, the following symptoms may develop: mydriasis, miosis, sweating, fever, pallor, cyanosis of the lips, impaired function of the cardiovascular system (including cardiac arrest) respiratory disorders (including respiratory failure, respiratory arrest) psychological disorders.

Treatment: In case of a nasal overdose, rinse immediately or cleanse your nose. Symptomatic treatment may be required.

Storage conditions

Keep out of the reach of children at a temperature not exceeding 25 РC.

The Expiration of

is 3 years.

Deystvuyuschee substances

Tramazolyn

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Dosage form

Dosage

spray nasal ny