Instructions Lazorin nasal spray 1.18 mg/ml canister 10 ml
Composition
active ingredient: tramazoline;
1 ml of solution contains 1.265 mg of tramazoline hydrochloride monohydrate, which corresponds to 1.18 mg of tramazoline hydrochloride;
Excipients: citric acid monohydrate, sodium hydroxide, benzalkonium chloride, hydroxypropylmethylcellulose, povidone, glycerin (85%), magnesium sulfate heptahydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium bicarbonate, sodium chloride, eucalyptol, menthol, camphor, purified water.
Dosage form
Nasal spray.
Main physicochemical properties: transparent, slightly yellowish solution with a eucalyptus odor.
Pharmacotherapeutic group
Anti-edematous and other drugs for local use in diseases of the nasal cavity. Sympathomimetics, simple drugs.
ATX code R01A A09.
Pharmacological properties
Pharmacodynamics
Tramazoline is an imidazoline derivative. Tramazoline is an α-sympathomimetic that directly stimulates α-adrenergic receptors of the sympathetic nervous system, but has little or no effect on β-adrenergic receptors. Intranasal administration of tramazoline leads to narrowing of dilated arterioles, which in turn leads to reduced blood circulation in the mucous membrane, reduced edema, and improved nasal breathing.
After intranasal administration of the drug, vasoconstriction occurs after 5 minutes and lasts for 8-10 hours.
Pharmacokinetics
Pharmacokinetic studies in humans have not been conducted. The pharmacokinetic characteristics of tramazolin have been studied in rats, rabbits and primates. It was found that 50-80% of the dose is absorbed after oral and intranasal administration.
Tramazoline and its metabolites are distributed to all internal organs. The highest concentrations are always observed in the liver.
Three major metabolites were identified in urine after oral and topical administration.
The terminal half-life of tramazoline and its metabolites from the blood is 5-7 hours.
Tramazoline and its metabolites are excreted primarily by the kidneys.
After intranasal administration, the amount of drug absorbed may sometimes be sufficient to cause systemic effects, affecting in particular the central nervous and cardiovascular systems.
Indication
For the relief of nasal congestion associated with acute rhinitis, vasomotor rhinitis and allergic rhinitis.
To facilitate the discharge of secretions in sinusitis and otitis media associated with acute rhinitis.
Contraindication
Hypersensitivity to tramazoline hydrochloride or to any of the excipients of the drug. Angle-closure glaucoma. Dry rhinitis. Transnasal intracranial surgery. Children under 6 years of age.
Interaction with other medicinal products and other types of interactions
Concomitant use with monoamine oxidase inhibitors, tricyclic antidepressants or other potential vasopressor substances may affect the cardiovascular system and cause an increase in blood pressure.
Concomitant use with tricyclic antidepressants may cause arrhythmia.
Interactions with antihypertensive drugs, especially those that affect the sympathetic nervous system, can be complex and cause various cardiovascular effects.
Application features
Due to the potential risk of systemic absorption, Lazorin® should be used with caution and only after a careful benefit/risk assessment in patients with increased intraocular pressure, severe cardiovascular diseases (e.g., ischemic heart disease or arterial hypertension), prostatic hyperplasia, pheochromocytoma, metabolic disorders (e.g., hyperthyroidism or diabetes mellitus), and porphyria.
The drug should be used with caution and as prescribed by a doctor in patients taking monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, vasopressor and antihypertensive drugs (see section "Interaction with other medicinal products and other types of interactions").
If after using Lazorin® for 7 days the symptoms do not disappear, you should consult a doctor about the advisability of continuing treatment with this drug.
Long-term use of nasal vasoconstrictors can lead to chronic swelling of the nasal mucosa, nasal congestion, and atrophy of the nasal mucosa.
After the therapeutic effect of the drug has worn off, a rebound effect of symptoms is possible, characterized by severe swelling of the nasal mucosa (nasal edema).
Avoid getting Lazorin® in the eyes to prevent irritation.
Lazorin® contains benzalkonium chloride as an excipient, which may cause irritation of the nasal mucosa.
Ability to influence reaction speed when driving vehicles or other mechanisms
However, patients should be informed that when using Lazorin® they may experience side effects such as hallucinations, drowsiness, sedation, dizziness and fatigue. Therefore, the drug should be used with caution when driving or operating other mechanisms. If patients experience the above-mentioned side effects after using the drug, they should avoid potentially hazardous activities such as driving or operating other mechanisms.
Use during pregnancy or breastfeeding
During preclinical studies, no evidence of harmful effects of the drug on the embryo was found. Clinical studies during pregnancy were not conducted. Lazorin® should not be used in the first trimester of pregnancy.
There are no data on the excretion of the active substance in breast milk. The safety of the drug during breastfeeding has not been evaluated.
In the II and III trimesters of pregnancy and during breastfeeding, the drug should be used only as prescribed by a doctor.
Method of administration and doses
Lazorin® should be used by adults and children over 6 years of age.
Spray 1 dose into each nostril up to 3 times daily as needed. Dosage is determined based on individual sensitivity and clinical response.
Lazorin® should be used for short-term treatment of acute symptoms for no more than 5-7 days. In all other cases, according to indications and for all indications for use in children, a physician's assessment of the benefit/risk ratio is required. A break of several days should be taken between individual periods of treatment.
Instructions for use
The following recommendations should be followed before each use.
Thoroughly clean your nose before using Lazorin®.
1. Remove the safety cap.
2. Before using the dosing device for the first time, press it several times until a jet of aerosol appears.
The dosing device functions immediately when used again. No complicated preparation of the dosing device is required.
3. Insert the tip into one nostril and press the dosing device once. When the spray is injected, gently inhale through your nose. Then repeat the procedure by inserting the tip into the other nostril.
4. It is recommended to rinse the dosing device with running water after use.
After use, close the can with the safety cap.
Children
Use for children aged 6 and over.
Overdose
Symptoms
Increased blood pressure and tachycardia may be followed by decreased blood pressure, shock, vascular collapse, reflex bradycardia, and decreased body temperature, especially in children.
Similar to other α-sympathomimetic agents, the clinical picture of intoxication with Lazorin® may be mixed, as phases of excitation and depression of the central nervous system (CNS) and cardiovascular system may alternate.
Overdose, especially in children, leads to CNS disorders, causing convulsions, coma, bradycardia, respiratory depression. Symptoms of CNS excitation are restlessness, agitation, hallucinations and convulsions. Symptoms of CNS depression are decreased body temperature, lethargy, drowsiness and coma.
In addition, the following symptoms may occur: mydriasis; miosis; increased sweating; fever; pallor; cyanosis of the lips; cardiovascular disorders, including cardiac arrest; respiratory system disorders, including respiratory failure and respiratory arrest; mental disorders.
In case of overdose, the manifestations of adverse reactions may be increased.
Treatment
In case of nasal overdose, nasal lavage and cleaning are recommended first. Symptomatic treatment may be necessary.
Adverse reactions
Adverse reactions are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 - <1/10), uncommon (≥ 1/1000 - <1/100), rare (≥ 1/10000 - <1/1000), very rare (<1/10,000), frequency unknown (frequency cannot be estimated from the available data).
On the part of the immune system:
uncommon - hypersensitivity reactions.
Mental disorders:
infrequently - anxiety;
frequency unknown - hallucinations, insomnia.
From the nervous system:
infrequently - headache;
rarely - dizziness, taste disturbance;
frequency unknown - drowsiness, sedative effect.
From the heart:
infrequently - rapid heartbeat;
frequency unknown - arrhythmia, tachycardia.
From the respiratory system, chest organs and mediastinum:
often – burning of the nasal mucosa;
infrequently - nasal edema, dryness of the nasal mucosa, rhinorrhea, sneezing;
rarely - nosebleeds.
From the gastrointestinal tract:
infrequently - nausea.
From the skin and subcutaneous tissue:
frequency unknown - rash, itching, angioedema*.
General disorders and administration site conditions:
frequency unknown - swelling of the nasal mucosa*, increased fatigue.
Research:
frequency unknown - increased blood pressure.
* - as a symptom of a hypersensitivity reaction.
Reporting of suspected adverse reactions after the approval of a medicinal product is an important procedure. It allows for continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report all suspected adverse reactions via the national pharmacovigilance system.
Expiration date
3 years.
Do not use the drug after the expiration date.
Shelf life after opening the package: 12 months.
Storage conditions
Store at a temperature not exceeding 25 ºС in a place inaccessible to children.
Packaging
10 ml in a glass bottle with a dosing device; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Istituto de Angeli S.r.l., Italy.
Location of the manufacturer and its business address
Localita Prulli 103/s - 50066 Regello (Florence), Italy.
