Instructions Nosolin plus spray nasal canister 30 g
Composition
active ingredients: oxymetazoline hydrochloride; racemic camphor; levomenthol; cineole (eucalyptol);
1 g of the drug contains: oxymetazoline hydrochloride (calculated as 100% substance) 0.5 mg; racemic camphor 1.7 mg; levomenthol 1.7 mg; cineole (eucalyptol) 1.7 mg;
Excipients: benzalkonium chloride, disodium edetate, propylene glycol, polysorbate 20, poloxamer 407, potassium dihydrogen phosphate, disodium phosphate dodecahydrate, purified water.
Dosage form
Nasal spray.
Main physicochemical properties: transparent colorless or pale yellow liquid with a specific odor; when pressing the valve, the drug is sprayed in the form of an aerosol jet.
Pharmacotherapeutic group
Anti-edematous and other drugs for local use in diseases of the nasal cavity. Sympathomimetics in combination with other agents. Oxymetazoline.
ATX code R01A B07.
Pharmacological properties
Pharmacodynamics
Vasoconstrictor, decongestant. Oxymetazoline hydrochloride stimulates a1-adrenoreceptors of the sympathetic nervous system. Narrows blood vessels at the site of application, which reduces swelling of the mucous membrane of the upper respiratory tract, facilitates nasal breathing, and reduces blood flow to the venous sinuses. The effect manifests itself 5-10 minutes after injection of the drug into the nasal cavity. Duration of action - up to 12 hours.
Levomenthol, racemic camphor, cineole (eucalyptol) have a weak local anti-inflammatory, anti-edematous and antiseptic effect, and facilitate the removal of mucus.
Propylene glycol, which is part of the drug, prevents excessive drying of the mucous membrane.
Pharmacokinetics
The half-life of oxymetazoline hydrochloride is 5-8 hours. It is excreted mainly unchanged in urine and feces. Camphor, menthol, eucalyptol gradually evaporate from the mucous membrane of the respiratory tract. A small amount of these substances, which has entered the general bloodstream, easily penetrates the alveolar-capillary membrane and quickly evaporates from the surface of the lungs.
Indication
Symptomatic treatment of colds, flu and acute respiratory viral infections accompanied by acute rhinitis, sinusitis, other sinusitis (frontitis, ethmoiditis).
Contraindication
Hypersensitivity to oxymetazoline, other adrenomimetics or any of the components of the drug, severe forms of cardiovascular diseases (e.g., ischemic heart disease, arterial hypertension), severe atherosclerosis, acute cardiovascular diseases or cardiac asthma, tachysystolic heart rhythm disorders, angina pectoris, renal failure, severe prostatic hypertrophy, pheochromocytoma, metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria), atrophic rhinitis, increased intraocular pressure, especially in angle-closure glaucoma, after transsphenoidal hypophysectomy or other surgical intervention with opening the dura mater, inflammation or damage to the skin around the nasal passages or nasal mucosa, use of drugs that contribute to an increase in blood pressure; simultaneous use with monoamine oxidase inhibitors (MAO) and use within 2 weeks after discontinuation of treatment with MAO inhibitors. Tendency to bronchospasm or convulsions.
Interaction with other medicinal products and other types of interactions
When using other medications, it is recommended to consult a doctor before starting treatment with this drug. Use of the drug together with other vasoconstrictors (by any route of administration) or with other nasal decongestants, as well as with tricyclic antidepressants, maprotiline, should be done after consulting a doctor, as an increase in blood pressure is possible.
Concomitant use of MAO inhibitors and oxymetazoline may increase blood pressure. Therefore, this drug should not be used simultaneously with or within two weeks of stopping treatment with MAO inhibitors.
With simultaneous use of oxymetazoline with tricyclic antidepressants, there may be an increased risk of increased blood pressure and arrhythmia.
Oxymetazoline may reduce the effectiveness of β-blockers, methyldopa, or other antihypertensive drugs.
With the simultaneous use of sympathomimetics and antiparkinsonian agents, an additive toxic effect on the cardiovascular system is possible.
Application features
When injecting into the nasal cavity, do not tilt your head or turn the canister over. It is not recommended to use one canister for several people to avoid spreading the infection.
You should consult a doctor before using this medication in the following cases: high blood pressure, cardiovascular disease, liver or kidney disorders, porphyria.
Long-term use and overdose of the drug should be avoided. Long-term use of an anti-edema agent may lead to a weakening of its effect. Abuse of this agent may cause atrophy of the mucous membrane and reactive hyperemia with rhinitis medicamentosa, as well as damage to the mucous epithelium and inhibition of epithelial activity. After using the drug, special observation of patients with chronic rhinitis and in cases of elimination of edema before diagnostic manipulations is necessary. Doses above the recommended ones should be used only under the supervision of a physician. The recommended dosage should not be exceeded.
Use during pregnancy or breastfeeding
Oxymetazoline has not been associated with adverse pregnancy outcomes. It should be used with caution in patients with hypertension or signs of reduced placental blood flow. Frequent or prolonged use of high doses may lead to reduced placental blood flow. The drug should be used in pregnant women only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the fetus/child.
It is not known whether oxymetazoline passes into breast milk. Due to the lack of data, oxymetazoline should not be used during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive vehicles and operate complex mechanisms, but after prolonged use of the drug in doses exceeding the recommended ones, a general effect on the cardiovascular system cannot be excluded. In such cases, the ability to drive may be reduced.
Method of administration and doses
Before using the drug on an aerosol can, it is necessary to put on the sprayer, remove the protective cap, shake the can several times, and then, by pressing the base of the sprayer all the way down, inject a dose of spray into each nostril.
Adults and children over 12 years of age should be given 2 sprays, children 6 to 12 years of age should be given 1 spray in each nostril. Repeat the spray no earlier than 12 hours later.
Duration of treatment – no more than 3 days. Long-term use is possible – up to 7-10 days, 2 injections per day under the supervision of a doctor.
Children
The drug should not be used in children under 6 years of age.
Overdose
With topical application, systemic adverse reactions usually do not occur.
In case of overdose or accidental ingestion of oxymetazoline, various symptoms may occur. Stages of hyperreactivity and inhibition are distinguished. Stimulation of the central nervous system is clinically manifested as a feeling of fear, excitement, hallucinations, and convulsions.
Symptoms of moderate or severe overdose include miosis (narrowing of the pupils), mydriasis (dilation of the pupils), nausea, vomiting, cyanosis, increased sweating, spasms, tachycardia, arrhythmia, cardiovascular failure, cardiac arrest, increased blood pressure, pulmonary edema, shortness of breath, convulsions, physical discomfort, fever, palpitations, pallor, hyposmia, and mental disorders.
Central nervous system depression is clinically manifested as drowsiness, decreased body temperature, bradycardia, hypotension, collapse, shock, respiratory distress and respiratory arrest, loss of consciousness, and coma.
Clinical manifestations of overdose in children include CNS symptoms: seizures and coma, hallucinations, bradycardia, apnea, hypertension progressing to hypotension.
Emergency care. In case of suspected overdose with oxymetazoline, urgent hospitalization in the intensive care unit is necessary. Activated charcoal and laxatives should be prescribed. Gastric lavage is necessary. In order to reduce high blood pressure, α-blockers (phentolamine) should be prescribed. Vasopressors should not be taken. If necessary, anticonvulsant therapy is indicated. In severe cases, intubation and artificial ventilation of the lungs may be necessary.
Side effects
With frequent and prolonged use, a burning sensation, tingling in the nose, nasal discomfort, flushing, sneezing, dryness of the nasal mucosa may occur. Rarely - after the effect of the drug wears off - a feeling of severe nasal congestion (reactive hyperemia), apnea in newborns and young children (especially in case of overdose).
Long-term continuous use of vasoconstrictors may lead to tachyphylaxis or the development of rhinitis medicamentosa. In general, no serious side effects are expected.
From the cardiovascular system: Very rarely, tachycardia, palpitations, increased blood pressure, heart pain are possible.
On the part of the organs of vision. Rarely, irritation, discomfort or redness of the eyes, blurred vision may occur.
On the part of the immune system: In rare cases, hypersensitivity reactions are possible, including rash, itching, angioedema.
Respiratory, thoracic and mediastinal disorders: Rarely, discomfort or irritation of the nose, mouth and throat, dry mouth, epistaxis may occur.
Nervous system: Restlessness, nervousness, anxiety, insomnia, drowsiness, tremor, hallucinations (especially in children), increased fatigue, headache, dizziness.
Skin and subcutaneous tissue disorders: Rash.
Musculoskeletal and connective tissue disorders: Convulsions (especially in children).
General disorders: Weakness.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
30 g in a bottle with a pump-type valve, sprayer and protective cap; 1 bottle in a pack.
Vacation category
Without a prescription.
Producer
JSC "STOMA".
Address
Ukraine, 61105, Kharkiv, Newton St., 3.
