Lazolvan Rhino, 82 mcg/dose 10 ml

The active substance of Lazolvan Rhino is tramazoline hydrochloride, alpha2-adrenomimetic, causes vasoconstriction. When applied to the nasal mucosa, the drug reduces swelling due to its vasoconstrictor effect. As a result, the patency of the nasal passages is quickly restored, and nasal breathing is relieved for a long time.

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

Pharmacokinetic studies in humans have not been performed. The pharmacokinetics of tramazoline has been studied in rats, rabbits and monkeys. It has been shown that after administration of the drug orally or intranasally, 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 administration, the major metabolites are detected in the urine. The terminal T1/2 is 5 to 7 h.

Indications

Nasal mucous membrane swelling, nasal congestion caused by acute respiratory diseases and/or pollinosis (rhinitis, hay fever).

Sinusitis and otitis media (eustachitis), to facilitate the outflow of the contents of the sinus cavities, as recommended by the doctor.

Active ingredient

Composition

1 dose contains:

The active ingredient:

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

Auxiliary substances:

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 micrograms,

calcium chloride dihydrate – 11 micrograms,

sodium hydrocarbonate – 1 microgram,

sodium chloride – 183 microgram,

cineol (eucalyptol) – 7 micrograms,

levomenthol (L-menthol) – 14 micrograms,

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camphor racemic – 14 micrograms,

purified water – up to 66358 micrograms.

How to take, the dosage

Intranasally.

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

Interaction

Some antidepressants (MAO inhibitors and tricyclic antidepressants) and vasoconstrictors when administered simultaneously may cause an increase in BP.

Combination with tricyclic antidepressants may lead to arrhythmias.

The concomitant use with antihypertensive agents (especially those affecting the sympathetic nervous system) may lead to various cardiovascular effects.

Special Instructions

If after 7 days of taking the drug no positive dynamics of symptoms are observed, a physician should be consulted to decide whether to stop taking the drug or to continue treatment.

Long-term use of nasal vasoconstrictors may lead to chronic inflammation and nasal congestion, and atrophy of the nasal mucosa.

Contacting the drug in the eyes should be avoided.

Impact on the ability to drive vehicles and other mechanisms requiring increased attention

Studies on the effect of the drug on the ability to drive vehicles and machinery have not been conducted. However, adverse effects such as hallucinations, drowsiness, sedation, dizziness and fatigue are possible when taking the drug. Therefore, caution should be exercised when driving a car and operating machinery. If the above side effects occur, potentially hazardous tasks such as driving and operating machinery should be avoided.

Contraindications

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

Side effects

Nervous system disorders: rare – dizziness, taste disturbances; infrequent – headache; frequency is not established – somnolence, sedative effect.

Mental disorders: infrequent – anxiety; frequency is not established – hallucinations, insomnia.

Systemic disorders: infrequent – palpitations; frequency is not established – arrhythmia, tachycardia, increased blood pressure.

Respiratory, chest and mediastinum disorders: frequently – nasal discomfort; infrequently – nasal edema, dry nose, rhinorrhea, sneezing; rarely – nasal bleeding.

Gastrointestinal disorders: infrequent – nausea.

The immune system: frequency is not determined – hypersensitivity.

Skin and subcutaneous tissue disorders: frequency is not established – rash, itching, skin edema.

General and local disorders: frequency not established – swelling of mucous membranes, fatigue.

Overdose

Symptoms: after BP increase and tachycardia there may be (especially in children) BP drop, development of shock, reflex bradycardia, decrease in body temperature. Similar to other alpha-adrenomimetics, the clinical picture of intoxication may be vague, since the phases of CNS and SSS stimulation and depression may alternate. Especially in children, intoxication results in CNS effects: symptoms of CNS stimulation include anxiety, agitation, hallucinations and seizures; symptoms of CNS depression include decreased body temperature, lethargy, somnolence and coma.

In addition, the following symptoms may develop: mydriasis, miosis, increased sweating, fever, pallor, cyanosis of the lips, cardiac dysfunction (including bradycardia and cardiac arrest); respiratory disorders (including respiratory failure, respiratory arrest); psychiatric disorders.

Treatment: in case of nasal overdose, the nose should be immediately flushed or cleared. Symptomatic therapy may be required.