Nazo drops maluyk

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NAZО Drops MALYUK

Composition:

Active substance: oxymetazoline;

1 ml of the preparation contains 0.1 mg of oxymetazoline hydrochloride;

Excipients: citric acid monohydrate; sodium citrate; glycerin; benzalkonium chloride; purified water.

Pharmaceutical form. Nasal drops, solution.

Main physicochemical properties: clear or almost clear solution, colorless to slightly yellowish.

Pharmacotherapeutic group. Decongestants and other drugs for local use in nasal cavity disorders. Sympathomimetics, simple agents.

ATC code R01A A05.

Pharmacological Properties.

Pharmacodynamics.

The medicinal product belongs to the group of local vasoconstrictor agents. Oxymetazoline exerts sympathomimetic and vasoconstrictive effects, reducing nasal mucosal edema. It constricts blood vessels at the site of application, decreases swelling of the nasal mucosa and upper respiratory tract, and reduces nasal discharge. It restores nasal breathing. Relief of nasal mucosal edema promotes restoration of aeration in the paranasal sinuses and the middle ear cavity, thus preventing the development of bacterial complications.

Oxymetazoline exerts antiviral, anti-inflammatory, immunomodulatory, and antioxidant effects. Due to this combined mechanism of action, clinical studies have demonstrated faster and more effective relief of acute rhinitis symptoms (nasal congestion, rhinorrhea, sneezing, and general malaise).

Pharmacokinetics.

When the medicinal product is applied, the effects of oxymetazoline manifest within several minutes after instillation.

With local nasal application at therapeutic concentrations, it does not irritate the nasal mucosa or cause hyperemia. The elimination half-life is approximately 35 hours after administration. 2.1% of the drug is excreted by the kidneys, and approximately 1.1% is excreted in feces.

The duration of action lasts several hours (on average 6–8 hours), up to a maximum of 12 hours.

Indications.

• Acute respiratory diseases accompanied by nasal congestion.
• Allergic rhinitis.
• Vasomotor rhinitis.
• To restore drainage and nasal breathing in diseases of the nasal paranasal sinuses, eustachian tube inflammation (eustachitis).
• To reduce swelling prior to diagnostic procedures in the nasal passages.

Contraindications.

Hypersensitivity to the components of the drug.

Dry rhinitis.

Do not use after transsphenoidal hypophysectomy or other surgical procedures exposing the meninges.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of oxymetazoline with tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) such as tranylcypromine, and hypertensive agents may lead to increased arterial pressure. These drugs should not be combined if possible.

In cases of oxymetazoline overdose, if swallowed, or when used simultaneously or immediately after tricyclic antidepressants and/or MAO inhibitors, increased arterial pressure may occur.

Special precautions for use

The drug should be used only after careful assessment of the benefit-risk ratio in the following cases:

• elevated intraocular pressure, especially in angle-closure glaucoma;
• severe cardiovascular diseases (e.g. ischemic heart disease) and arterial hypertension;
• pheochromocytoma;
• metabolic disorders (e.g. hyperthyroidism, diabetes mellitus, porphyria);
• benign prostatic hyperplasia;
• concomitant use of MAO inhibitors and other medicinal products that may potentially increase blood pressure.

Prolonged use and exceeding the recommended dose should be avoided. Doses higher than recommended should be used only under medical supervision.

The preservative (benzalkonium chloride) contained in the drug may cause swelling of the nasal mucosa, especially with prolonged use.

Medical monitoring is recommended for premature newborns or infants with low body weight to avoid the risk of overdose.

Prolonged use and overdose of nasal decongestants may lead to reduced drug efficacy and may produce clinical manifestations similar to vasomotor rhinitis. Misuse of this medicinal product may cause drug-induced rhinitis, mucosal atrophy, and reactive hyperemia of the nasal mucosa (rebound effect).

Use during pregnancy or breastfeeding

The drug is used in infants.

Pregnancy

Oxymetazoline should be used during pregnancy with particular caution, based on a well-considered benefit-risk assessment. Exceeding the recommended dosage is not recommended.

Breastfeeding period

It is unknown whether oxymetazoline passes into breast milk. Therefore, the use of oxymetazoline is possible only after a well-considered benefit-risk assessment. Exceeding the recommended dosage is not recommended, as it may reduce breast milk production.

Ability to influence reaction speed while driving or operating machinery

The drug is used in infants.

When oxymetazoline is used at recommended doses, no effect on reaction speed during driving or operating machinery is expected. However, after prolonged use of oxymetazoline at doses exceeding the recommended levels, a systemic effect on the cardiovascular system cannot be excluded. In such cases, the ability to drive or operate machinery may be reduced.

Method of Administration and Dosage

The medicinal product is intended for nasal use.

Infants

For infants up to 4 weeks of age, administer 1 drop of the preparation into each nostril 2–3 times daily. From week 5 of life up to 1 year of age: 1–2 drops into each nostril 2–3 times daily.

The single dose should not be used more than 3 times per day.

The effect of the preparation develops within several minutes after administration and lasts for several hours (on average 6–8 hours, maximum up to 12 hours).

Doses higher than recommended should be used only under medical supervision.

The medicinal product should not be used for longer than 5–7 days.

Children. The preparation is used in children from birth up to 1 year of age.

Overdose

Overdose may occur following nasal administration or accidental ingestion. The clinical picture caused by intoxication with imidazole derivatives may be complex and variable, as phases of hyperactivity may alternate with phases of depression of the central nervous system, cardiovascular system, and respiratory system.

Stimulation of the central nervous system may manifest as anxiety, agitation, hallucinations, and seizures. Depression of the central nervous system may present as decreased body temperature, lethargy, drowsiness, and coma.

Other possible symptoms include: arterial hypertension, tachycardia, bradycardia, miosis, mydriasis, elevated body temperature, spasms, excessive sweating, pallor, cyanosis, palpitations, arrhythmia, cardiac arrest, shock hypotension, nausea and vomiting, respiratory depression, and apnea, as well as psychogenic disorders.

In children, overdose often leads to predominant central nervous system effects, including seizures and coma, bradycardia, apnea, and arterial hypertension, which may follow an initial phase of hypotension.

Therapeutic measures: indicated in cases of severe overdose. Administration of activated charcoal (adsorbent), sodium sulfate (laxative), or gastric lavage (in case of ingestion of a large amount of the medicinal product) should be performed immediately, as oxymetazoline can be rapidly absorbed. Vasopressor agents are contraindicated. Non-selective alpha-blockers may be used as an antidote. If necessary, initiate anticonvulsant therapy, lung ventilation, and measures to reduce fever.

Adverse reactions.

The frequency of occurrence is classified as follows: very common (≥ 10%), common (≥ 1% – < 10%), uncommon (≥ 0.1% – < 1%), rare (≥ 0.01% – < 0.1%), very rare or isolated cases (< 0.01%).

Respiratory system, thorax and mediastinum.

Common: burning or dryness of nasal mucosa, sneezing.

Uncommon: increased swelling of the mucous membrane, nasal bleeding after discontinuation of use.

Very rare: apnea in newborns and young children.

Skeletal muscle system.

Very rare: seizures (mainly in children).

Nervous system.

Very rare: restlessness, insomnia, fatigue (drowsiness, sedative effect), headache, hallucinations (especially in children).

Cardiovascular system.

Rare: palpitations, tachycardia, arterial hypertension.

Very rare: arrhythmia.

Immune system.

Uncommon: hypersensitivity reactions (rash, itching, angioneurotic edema).

Shelf life. 2 years.

The shelf life of the medicinal product after opening the bottle is no more than 6 months.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 8 ml in a bottle closed with a dropper cap under a screw neck with a glass pipette, in a box.

Classification of supply. Over-the-counter.

Manufacturer. Limited liability company "Pharmaceutical Company "Zdorovye".

Manufacturer's address and place of business.

22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.