Instructions for use Rinazal nasal spray dosed 0.5 mg/ml bottle 10 ml
Composition
active ingredient: xylometazoline hydrochloride;
1 ml of solution contains xylometazoline hydrochloride 0.5 mg or 1.0 mg;
Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, disodium edetate, benzalkonium chloride, non-crystallizing liquid sorbitol, hypromellose, sodium chloride, purified water.
Dosage form
Nasal spray, metered.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
Drugs used in diseases of the nasal cavity. Anti-edematous and other drugs for local use in diseases of the nasal cavity. Sympathomimetics, simple drugs.
ATX code R01A A07.
Pharmacological properties
Pharmacodynamics.
Xylometazoline is a sympathomimetic agent that acts on α-adrenergic receptors.
Xylometazoline, when applied nasally, causes constriction of the blood vessels of the nasal mucosa and paranasal sinuses, thus eliminating edema and hyperemia of the nasal mucosa and nasopharynx, and also reduces the associated increased mucus secretion and facilitates the removal of blocked secretions from the nose, which leads to cleansing of the nasal passages and facilitating nasal breathing.
The effect of the drug begins within 2 minutes after application and lasts up to 12 hours.
The drug is well tolerated, even by patients with sensitive mucous membranes, and does not reduce mucociliary function. According to the results of laboratory tests, xylometazoline reduces the infectious activity of human rhinovirus, which is associated with the common cold.
Thanks to moisturizing components (sorbitol, hypromellose), the drug Rinazal®, a nasal spray, dosed, helps with dryness and irritation of the mucous membrane of the nasal passages.
The drug has a balanced pH value within the limits inherent in the nasal cavity.
Pharmacokinetics.
When applied topically, the drug is almost not absorbed, and the concentrations of xylometazoline in blood plasma are so low that they are almost undetectable (the concentration in blood plasma is close to the detection limit).
Xylometazoline does not have mutagenic properties. Also, in animal studies, no teratogenic effects of xylometazoline were detected.
Indication
Symptomatic treatment of nasal congestion due to colds, hay fever, other allergic rhinitis, and sinusitis.
To facilitate the outflow of secretions in diseases of the paranasal sinuses.
Adjunctive therapy in cases of otitis media (to eliminate swelling of the mucous membrane).
To facilitate rhinoscopy.
Contraindication
- Hypersensitivity to xylometazoline, any other component of the drug or to other sympathomimetic amines;
- closed-angle glaucoma;
- simultaneous use with monoamine oxidase inhibitors (MAO) and within 2 weeks after discontinuation of their use;
- history of transsphenoidal hypophysectomy and surgical interventions with exposure of the meninges;
- dry rhinitis (rhinitis sicca) or atrophic rhinitis.
Interaction with other medicinal products and other types of interactions
Monoamine oxidase inhibitors (MAO inhibitors): xylometazoline may potentiate the effects of MAO inhibitors and induce hypertensive crisis.
Do not use xylometazoline in patients who are taking or have taken MAO inhibitors within the last two weeks.
Tri- and tetracyclic antidepressants: with simultaneous use of tri- or tetracyclic antidepressants and sympathomimetic drugs, the sympathomimetic effect of xylometazoline may be enhanced, particularly in case of overdose, therefore the simultaneous use of such drugs is not recommended.
When used together with β-blockers, it may cause bronchial spasm or a decrease in blood pressure.
Application features
The medicine should not be used for longer than 5 days without a break.
Long-term treatment with xylometazoline may cause secondary swelling of the nasal mucosa with the risk of chronic rhinitis and/or atrophy of the nasal mucosa.
The drug, like other sympathomimetics, should be prescribed with caution to patients who have strong reactions to adrenergic agents, manifested as insomnia, dizziness, tremor, cardiac arrhythmia or increased blood pressure.
The recommended dose of the drug should not be exceeded, especially when treating children and the elderly.
The drug should be prescribed with caution to patients with cardiovascular diseases, arterial hypertension, diabetes mellitus, hyperthyroidism, pheochromocytoma, prostatic hypertrophy, and should not be used in patients receiving concomitant treatment with MAO inhibitors and within 2 weeks after discontinuation of their use.
Patients with long QT syndrome who use xylometazoline are at increased risk of serious ventricular arrhythmias.
Isolated cases of posterior reversible encephalopathy syndrome (PRES)/reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of sympathomimetic drugs. The reported symptoms included sudden severe headache, nausea, vomiting and visual disturbances. In most cases, symptoms improved or resolved within a few days after appropriate treatment. The drug should be discontinued immediately and a doctor consulted if signs/symptoms of PRES/RCVS develop.
Use during pregnancy or breastfeeding
The drug should not be used during pregnancy due to its potential vasoconstrictor effect.
There is no evidence of any adverse effects on the infant. It is not known whether xylometazoline is excreted in breast milk, therefore caution is required, and during breastfeeding the drug should be used only as prescribed by a doctor. Prolonged use should be avoided during breastfeeding, due to the risk of adverse effects in the infant (tachycardia, agitation, increased blood pressure).
Fertility.
There are no adequate data on the effect of the drug on fertility.
Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is also very low.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug usually has no or negligible influence on the ability to drive or use machines. With long-term use of high doses of xylometazoline, systemic effects with cardiovascular effects cannot be excluded.
Method of administration and doses
Rinazal®, nasal spray, metered, 0.5 mg/ml:
Children aged 2 to 5 years (under adult supervision) are prescribed 1 spray into each nasal passage 1–2 times a day. Use no more than 3 times in each nasal passage per day.
Children aged 6 to 11 years (under adult supervision) are prescribed 1–2 sprays into each nasal passage 2–3 times a day. Use no more than 3 times in each nasal passage per day.
The duration of treatment depends on the course of the disease and should not exceed 5 consecutive days.
Rinazal®, nasal spray, metered, 1.0 mg/ml:
The drug should be used by adults and children over 12 years of age, 1 injection into each nasal passage up to 3 times a day. The interval between applications should be at least 8-10 hours. Use no more than 3 times in each nasal passage per day.
The duration of treatment depends on the course of the disease and should not exceed 5 consecutive days.
If symptoms of the disease worsen or new ones appear, you should consult a doctor.
The metered spray ensures accurate dosing and proper distribution of the solution over the surface of the nasal mucosa. Each injection delivers 0.14 ml of solution, which corresponds to 0.14 mg of xylometazoline.
Before use, the dosing device must be primed by pressing the spray several times until the spray begins to spray into the air. If the spray does not spray when the spray is pressed or the medicine has not been used for more than 7 days, the spray must be primed again by pressing the spray several times until the spray begins to spray into the air.
For subsequent use, the dosing device will be ready for immediate use.
The spray should be applied as follows:
- thoroughly clean the nose before using the medicine;
- hold the bottle vertically, supporting the bottom with your thumb and placing the tip between two fingers;
- tilt the bottle slightly and insert the tip into the nostril;
- inject and at the same time inhale easily through the nose;
- before closing the tip with the cap, after use, clean and dry the tip;
- to prevent infection, each vial of medicine can only be used by one person.
The last application is recommended immediately before bedtime.
Children
Rinazal®, nasal spray, dosed 0.5 mg/ml, should not be used in children under 2 years of age.
Use in children aged 2 years and over is recommended only under adult supervision.
Rinazal®, nasal spray, dosed 1 mg/ml, should not be used in children under 12 years of age.
Overdose
Excessive topical application of xylometazoline hydrochloride or accidental ingestion may result in sympatholytic effects, including central nervous system depression (e.g., drowsiness, coma), severe dizziness, increased sweating, a significant decrease in body temperature, pallor, headache, tachycardia, bradycardia, arterial hypertension, respiratory depression, miosis, convulsions, ataxia, anxiety. Increased blood pressure may change to decreased. Impaired consciousness may be a sign of severe overt intoxication. Gastrointestinal symptoms such as nausea and vomiting may also occur. Young children are more sensitive to toxicity than adults.
In case of severe intoxication, the patient should be hospitalized, and urgent symptomatic treatment should be carried out under medical supervision. Medical care should include observation of the patient for several hours. There is no specific antidote, atropine can be used for bradycardia. In case of severe overdose accompanied by cardiac arrest, resuscitation measures should last at least 1 hour. Activated charcoal can be taken at home as an emergency measure before hospitalization.
Adverse reactions
All adverse reactions are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 - < 1/10), uncommon (≥ 1/1,000 - < 1/100), rare (≥ 1/10,000 - < 1/1,000), rare (< 1/10,000), frequency unknown (cannot be estimated from the available data).
On the part of the organs of vision: rare - temporary visual impairment.
Respiratory, thoracic and mediastinal disorders: common: dryness or discomfort of the nasal mucosa, burning sensation, rhinitis medicamentosa; uncommon: nosebleeds.
Gastrointestinal: often - nausea; infrequently - vomiting.
From the nervous system: often - headache; infrequently - insomnia.
Cardiovascular system: rare - irregular or rapid heartbeat, arterial hypertension, arrhythmia.
Immune system disorders: rare - hypersensitivity reactions, including angioedema, rash, itching.
General disorders and administration site conditions: common: burning sensation at the application site.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and/or lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of reach of children.
Packaging
10 ml in a bottle, 1 bottle with a dosing pump in a pack.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and address of its place of business.
Ukraine, 02093, Kyiv, Boryspilska St., 13.
