Lasolvan® [Tramazoline]

Brand Boehringer Ingelheim

In stock 1898 Items

Available since: 2019-09-19

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Clinical Pharmacology

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

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

Pharmacokinetics

Pharmacokinetic studies in humans have not been conducted. The pharmacokinetics of Tramazoline has been studied in rats, rabbits and monkeys. It has been shown that 50-80% of the injected dose is absorbed after the drug is applied orally or intranasally. Tramazoline and its metabolites are distributed in all internal organs, C_max noted in the liver.

After oral or topical administration, the major metabolites are detected in the urine. Terminal T_1/2 ranges from 5 to 7 h.

Indications

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

With sinusitis and otitis media (Eustachitis) to facilitate the outflow of the contents of the paranasal sinuses (as recommended by the doctor).

Composition

1 dose contains:

Active substance: Tramazoline hydrochloride (in the form of Tramazoline hydrochloride monohydrate) 82 μg;

Excipients: citric acid monohydrate - 270 mcg, sodium hydroxide - 154 mcg, benzalkonium chloride - 14 mcg, hypromellose (hydroxypropylmethylcellulose) - 35 mcg, povidone - 2101 mcg, glycerol 85% - 700 mcg, magnesium sulphate heptahydrate - 49 mcg, magnesium chloride hexahydrate 35 mcg, calcium chloride dihydrate - 11 mcg, sodium bicarbonate - 1 mcg, sodium chloride - 183 mcg, cineol (eucalyptol) - 7 mcg, levomenthol (L-menthol) - 14 mcg, racemic camphor - 14 mcg, purified water - up to 66358 mcg.

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Dosage and Administration

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

Instructions for use of the bottle with a metering device

Clean the nasal passages before injecting.

Remove protective cap.
Before first use, it is necessary to make several injections into the air before the appearance of a stable aerosol cloud. After that, the dosing 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 extracting the tip, make a normal inhale through the nose.
Wear protective cap. It is recommended to clean the tip after each use.

Adverse reactions

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

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

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

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

Skin and Subcutaneous Tissue **: frequency is not installed * - rash, itching, swelling of the skin.

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

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

** - as symptoms of hypersensitivity.

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

Contraindications

Care should be taken when taking MAO inhibitors, tricyclic antidepressants, vasopressor drugs and antihypertensive drugs.

Drug interactions

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

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

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

Pregnancy and Lactation

Long experience of use shows that Lasolvan® Rino does not have a negative effect on pregnancy. The safety of the drug during lactation is not confirmed. Lasolvan® Rino should not be used in the first trimester of pregnancy. In the later stages of pregnancy and during breastfeeding, the use of the drug is allowed only after consulting a doctor.

Special instructions

If after 7 days of taking the drug there are no positive signs of symptoms, you should decide whether to stop taking the drug or continue the treatment. Prolonged use of nasal vasoconstrictor drugs can lead to the development of chronic inflammation and nasal congestion, as well as atrophy of the nasal mucosa.

Avoid contact with eyes.

Impact on the ability to drive vehicles and other mechanisms that require high concentration of attention

Studies on the effect of the drug on the ability to drive and machinery have not been 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 operating machinery.

If the above side effects appear, you must avoid performing potentially dangerous tasks such as driving a car or machinery.

Overdosage

Symptoms: following an increase in blood pressure and tachycardia, it is possible (especially in children) a fall in blood pressure, development of shock, reflex bradycardia, a decrease in 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 replace each other.

Especially in children, intoxication leads to effects on the central nervous system with the development of seizures and coma, bradycardia, respiratory depression. Symptoms of CNS stimulation are anxiety, agitation, hallucinations and convulsions. Symptoms of depression of the central nervous system include a decrease in body temperature, lethargy, drowsiness, and coma.

In addition, the following symptoms may develop: mydriasis, miosis, increased sweating, fever, pallor, lip cyanosis, and cardiovascular dysfunction (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.