Lasolvan Rhino, spray 1.18mg/ml, 10ml

Composition

1 dose contains:

Active ingredient:

tramazoline hydrochloride (in the form of tramazoline hydrochloride monohydrate) 82 mcg;

Auxiliary substances:

citric acid monohydrate – 270 mcg,

sodium hydroxide 154 µg

benzalkonium chloride – 14 mcg,

hypromellose (hydroxypropyl methylcellulose) – 35 mcg,

povidone – 2101 mcg,

glycerol 85% – 700 mcg,

magnesium sulfate heptahydrate – 49 mcg,

magnesium chloride hexahydrate – 35 mcg,

calcium chloride dihydrate – 11 µg

of sodium bicarbonate – 1 g,

sodium chloride – 183 µg

cineole (the evkaliptola) – 7 µg,

levomenthol (L-menthol) – 14 mcg,

camphor racemic – 14 mcg,

purified water – up to 66358 mcg.

Pharmacological action

Active ingredient of the preparation Lasolvan Rhino-tramazoline hydrochloride, an alpha-2-adrenomimetic, causes vasoconstriction. When applied to the nasal mucosa due to the vasoconstrictor effect, the drug reduces puffiness. As a result, the patency of the nasal passages is quickly restored, nasal breathing is relieved for a long time.

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

No pharmacinetic studies have been performed in humans. The pharmacokinetics of tramazoline have been studied in rats, rabbits, and monkeys. It is shown that after oral or intranasal use of the drug,50-80% of the administered dose is absorbed. Tramazoline and its metabolites are distributed in all internal organs, Cmax is noted in the liver.

After oral or topical use, the main metabolites are detected in the urine. The terminal T1 / 2 is 5 to 7 hours.

Indications

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

Sinusitis and otitis media (eustacheitis), to facilitate the outflow of the contents of the paranasal sinuses, as recommended by a doctor.

Contraindications

• Hypersensitivity to tramazoline hydrochloride or benzalkonium hydrochloride, as well as other components of the drug;
• angle-closure glaucoma;
• atrophic rhinitis;
• a history of cranial surgery performed through the nasal cavity;
• children under 6 years of age.

With caution:  concomitant use of MAO inhibitors, tricyclic antidepressants, vasopressors and antihypertensive drugs; patients with arterial hypertension, heart disease, hyperthyroidism, prostatic hypertrophy, pheochromocytoma, porphyria should use Lasolvan ® Reno only on the recommendation of a doctor due to the potential risk of systemic absorption of the drug.

Side effects

Nervous system disorders:  rarely — dizziness, taste disturbances; infrequently-headache; frequency not established-drowsiness, sedation.

Mental disorders:  infrequently-anxiety; frequency not established-hallucinations, insomnia.

From the CCC side:  infrequently — palpitations; frequency not established-arrhythmia, tachycardia, increased blood pressure.

Respiratory, thoracic and mediastinal disorders:  often-nasal discomfort; infrequently-nasal edema, dry nose, rhinorrhea, sneezing; rarely-nosebleeds.

From the gastrointestinal tract:  infrequently — nausea.

From the immune system:  frequency not established — hypersensitivity.

Skin and subcutaneous tissue disorders:  the frequency is not established-rash, itching, swelling of the skin.

General and local violations:  the frequency is not established — edema of the mucous membranes, fatigue.

Interaction

Some antidepressants (MAO inhibitors and tricyclic antidepressants) and vasoconstrictors may cause an increase in blood pressure when administered concomitantly.

Combined use with tricyclic antidepressants can lead to the development of arrhythmia.

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

How to take, course of use and dosage

Intranasally.

• Adults and children over 6 years of age:  1 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.

Overdose

Symptoms:  following an increase in blood pressure and tachycardia, it is possible (especially in children) to fall Blood pressure, development of shock, reflex bradycardia, lowering of body temperature. By analogy with other alpha-adrenomimetics, the clinical picture of intoxication may be indistinct, since the phases of stimulation and depression of the central nervous system and CVS can replace each other. Especially in children, intoxication leads to effects on the central nervous system: 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, disorders of the cardiovascular system (including bradycardia and cardiac arrest); respiratory disorders (including respiratory failure, respiratory arrest); mental disorders.

Treatment:  in case of nasal overdose, immediately flush or clean the nose. Symptomatic therapy may be required.

Special instructions

If after 7 days of taking the drug there is no positive dynamics of symptoms, you should consult a doctor to decide whether to stop taking the drug or continue treatment.

Long-term use of nasal vasoconstrictors can lead to the development of chronic inflammation and nasal congestion, as well as atrophy of the nasal mucosa.

Avoid contact with the eyes.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

Studies on the effect of the drug on the ability to drive a car and machinery have not been conducted. However, when taking the drug, undesirable effects such as hallucinations, drowsiness, sedation, dizziness and fatigue may occur. Therefore, care must be taken when driving the vehicle and machinery. If the above side effects occur, avoid performing potentially dangerous tasks such as driving a car or operating machinery.

Form of production

Spray

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Tramazolin

Dosage form

nasal spray

Description

Vasoconstrictor