Instructions for use Nazol nasal spray 0.05% bottle with sprayer 10 ml
Composition
active ingredient: oxymetazoline hydrochloride;
1 ml of solution contains oxymetazoline hydrochloride 0.5 mg (0.05% solution);
Excipients: benzalkonium chloride; disodium edetate, dihydrate; macrogol 400; povidone; propylene glycol; sodium dihydrogen phosphate, dihydrate; sodium hydrogen phosphate, dihydrate; purified water.
Dosage form
Nasal spray.
Main physicochemical properties: clear, colorless, odorless liquid.
Pharmacotherapeutic group
Anti-edematous and other drugs for local use in diseases of the nasal cavity. Sympathomimetics, simple preparations. ATX code R01A A05.
Pharmacological properties
Pharmacodynamics
Oxymetazoline hydrochloride is a synthetic adrenomimetic. Stimulating α-adrenoreceptors of blood vessels, it contributes to a pronounced and long-lasting vasoconstrictor effect. The vasoconstrictor effect is manifested by a decrease in blood flow, a decrease in swelling of the mucous membranes of the nose, paranasal sinuses and Eustachian tube, as a result of which nasal breathing, which was disturbed during influenza, colds and allergic diseases, is restored.
Local vasoconstriction of the nasal mucosa and paranasal sinuses occurs 5–10 minutes after injection of the drug into the nasal cavity. The anti-edema effect lasts up to 12 hours. The drug has a softening effect on the irritated nasal mucosa and protects it from excessive drying.
Pharmacokinetics
The half-life is 5–8 hours. It is excreted mainly unchanged in urine and feces.
Indication
Symptomatic treatment of colds, flu, allergic diseases (hay fever) accompanied by acute rhinitis, sinusitis, other sinusitis (frontitis, ethmoiditis), acute otitis media.
Contraindication
Increased individual sensitivity to oxymetazoline, other adrenomimetics or any components of the drug, severe forms of 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), 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.
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 2 weeks of stopping treatment with MAO inhibitors.
Concomitant use of oxymetazoline with tricyclic antidepressants may increase the 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 drugs, an additive toxic effect on the cardiovascular system is possible.
Application features
When spraying into the nasal cavity, do not tilt your head or turn the bottle over. It is not recommended to use one bottle for several people to avoid spreading the infection.
Persistent swelling of the nasal passages after the third day of use may indicate the presence of a deviated nasal septum, purulent sinusitis, adenoids, allergic rhinitis, persistent bacterial infection, or other unrecognized diseases that require a doctor's consultation and specialized complex therapy.
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 the decongestant may lead to a weakening of its effect. Abuse of this drug 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. Doses above the recommended ones should be used only under the supervision of a physician. The recommended dosage should not be exceeded.
Ability to influence reaction speed when driving vehicles or other mechanisms
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 impaired.
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.
Method of administration and doses
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. The bottle should be held vertically. Repeat the spray no earlier than 12 hours later.
Duration of treatment – no more than 3 days. Long-term use up to 7–10 days, 2 injections per day, is possible under the supervision of a doctor.
Children
Should not be used in children under 6 years of age.
Overdose
With topical application, systemic adverse reactions usually do not occur.
Symptoms of oxymetazoline overdose are different. There are stages of hyperreactivity and inhibition. Stimulation of the central nervous system is clinically manifested in the form of a feeling of fear, excitement, hallucinations, convulsions.
Symptoms of moderate or severe overdose include miosis (narrowing of the pupils), mydriasis (dilation of the pupils), nausea, vomiting, cyanosis, fever, sweating, cramps, tachycardia, arrhythmia, cardiac arrest, increased blood pressure, pulmonary edema, shortness of breath, physical discomfort.
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 central nervous system (CNS) symptoms: seizures and coma, hallucinations, bradycardia, apnea, hypertension alternating with hypotension.
Emergency care. In case of suspected overdose with oxymetazoline, urgent hospitalization in the intensive care unit is necessary. Activated charcoal and laxatives are 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.
Adverse reactions
With frequent and prolonged use, a burning sensation, tingling in the nose, flushing, sneezing, and dryness of the nasal mucosa may occur. Rarely, after the effect of the drug wears off, a feeling of severe nasal congestion (reactive hyperemia). Long-term continuous use of vasoconstrictor drugs 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, and heart pain are possible.
On the part of the organs of vision. Rarely, irritation, discomfort or redness of the eyes, blurred vision may occur.
Gastrointestinal: Nausea may occur rarely.
On the part of the immune system: In rare cases, hypersensitivity reactions are possible, including rash, itching, angioedema.
Respiratory, thoracic and mediastinal disorders: Discomfort or irritation of the nose, mouth and throat, as well as epistaxis, may occur rarely.
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
3 years.
After opening the bottle, the shelf life is 12 months. Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 30 °C.
Keep out of reach of children.
Packaging
10 ml plastic bottle with sprayer in a cardboard box.
Vacation category
Without a prescription.
Producer
Istituto De Angeli Srl
Location of the manufacturer and its business address
Località Prulli n. 103/c - 50066 Reggello (FI), Italy.
