Nazivin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NASIVIN®

Composition:

Active substance: oxymetazoline;

1 ml of solution contains:

Nasivin® 0.01% oxymetazoline hydrochloride 0.1 mg;

Nasivin® 0.025% oxymetazoline hydrochloride 0.25 mg;

Nasivin® 0.05% oxymetazoline hydrochloride 0.5 mg;

Excipients: citric acid monohydrate; sodium citrate; glycerol (85%); benzalkonium chloride solution 50%; purified water.

Pharmaceutical form. Nasal drops.

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

Pharmacotherapeutic group. Anti-edematous and other preparations for local use in nasal cavity diseases. Simple sympathomimetics. ATC code R01A A05.

Pharmacological properties.

Pharmacodynamics.

Nazivin® belongs to the group of local vasoconstrictive agents. Oxymetazoline exerts sympathomimetic and vasoconstrictive effects, reducing nasal mucosal edema. It constricts blood vessels at the site of application, reduces swelling of the nasal mucosa and upper respiratory tract, and decreases nasal discharge. It restores nasal breathing. Relief of nasal mucosal swelling promotes re-establishment of ventilation 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 symptoms of acute rhinitis (nasal congestion, rhinorrhea, sneezing, malaise).

Nazivin® 0.05%, nasal drops

A double-blind, comparative study with parallel groups involving 247 patients demonstrated faster and greater improvement in typical symptoms of acute rhinitis (nasal congestion, rhinorrhea, sneezing, malaise) (p < 0.05), attributable to the combined vasoconstrictive, antiviral, anti-inflammatory, and antioxidant effects of oxymetazoline. Thus, treatment with 0.05% oxymetazoline nasal drops, compared to physiological saline, significantly reduced the duration of the common cold from an average of 6 days to 4 days (p < 0.001).

Pharmacokinetics.

When Nazivin® 0.01% and 0.025% nasal drops are used, the effects of oxymetazoline manifest within several minutes after instillation.

When applied locally to the nasal mucosa 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 the drug's effect lasts several hours (on average, 6–8 hours), and up to 12 hours at maximum.

Clinical characteristics.

Indications.

• Acute respiratory diseases accompanied by nasal congestion.
• Allergic rhinitis.
• Vasomotor rhinitis.
• For restoration of drainage and nasal breathing in diseases of the nasal sinus cavities, eustachitis.
• To eliminate swelling prior to diagnostic procedures in the nasal passages.

Contraindications.

Hypersensitivity to the components of the drug. Dry rhinitis.

Nasivin® 0.025%: children under 1 year of age.

Nasivin® 0.05%: children under 6 years of age.

Special precautions for use.

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

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

Prolonged use or exceeding the recommended dose should be avoided, especially when prescribing to children. Doses exceeding the recommended should be used only under medical supervision.

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

Medical monitoring is recommended for premature infants or low-birth-weight neonates to avoid the risk of overdose.

Prolonged use or overdose of nasal decongestants may lead to reduced drug efficacy and may present clinically similar to vasomotor rhinitis. Misuse of this product may cause drug-induced rhinitis, mucosal atrophy, and reactive nasal mucosal hyperemia (rebound effect).

Interaction with other medicinal products and other forms of interaction.

Concomitant use of oxymetazoline and:

• tricyclic antidepressants;
• monoamine oxidase inhibitors such as tranylcypromine;
• antihypertensive agents may lead to increased blood pressure. These drugs should not be combined if possible.

In cases of oxymetazoline overdose, ingestion of the drug, or concomitant use either simultaneously or immediately after tricyclic antidepressants and/or MAO inhibitors, an increase in blood pressure may occur.

Use during pregnancy or breastfeeding.

Pregnancy.

During pregnancy or breastfeeding, the drug should be used with particular caution, following a careful benefit-risk assessment. Exceeding the recommended dosage is not recommended.

Breastfeeding.

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

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

Method of Administration and Dosage

Nasivin® 0.01%, 0.025%, 0.05%, nasal drops, are intended for intranasal use.

Adults and children aged 6 years and older.

Apply Nasivin® 0.05% – 1–2 drops into each nostril 2–3 times daily.

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

The effect of the drug develops within 25 seconds after administration and lasts for several hours (on average 6–8 hours, up to a maximum of 12 hours).

Children aged 1 to 6 years.

Administer Nasivin® 0.025% – 1–2 drops into each nostril 2–3 times daily.

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

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

Infants.

For infants up to 4 weeks of age, administer 1 drop of Nasivin® 0.01% into each nostril 2–3 times daily. From the 5th week of life up to 1 year of age – 1–2 drops into each nostril 2–3 times daily.

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

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

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

Nasivin® nasal drops 0.01%, 0.025%, 0.05% should not be used for longer than 5–7 days.

Children. Nasivin® 0.025% is contraindicated in children under 1 year of age; Nasivin® 0.05% is contraindicated in children under 6 years of age.

Overdose.

Overdose may occur following intranasal or accidental oral ingestion. The clinical picture caused by intoxication with imidazole derivatives may be variable, as hyperreactive phases 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, seizures. Depression of the central nervous system may present as: hypothermia, lethargy, drowsiness, and coma.

Other possible symptoms include: arterial hypertension, tachycardia, bradycardia, miosis, mydriasis, seizures, hyperthermia, spasms, sweating, pallor, lethargy, hypothermia, 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 such as seizures and coma, bradycardia, apnea, and also arterial hypertension, which may follow an initial phase of hypotension.

Treatment measures: Indicated in cases of severe overdose. Immediate administration of activated charcoal (adsorbent), sodium sulfate (laxative), or gastric lavage (in case of ingestion of a large amount of the drug) is recommended, as oxymetazoline may 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, thoracic and mediastinal disorders.

Common: burning or dryness of the 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-muscular system.

Very rare: convulsions (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. 3 years.

After first opening of the bottle, do not store for more than 6 months.

Storage conditions. Store at a temperature not exceeding 25°C. Keep out of the reach of children!

Packaging. 10 ml of 0.025% and 0.05% solution; 5 ml of 0.01% solution in a bottle. One bottle per cardboard box.

Availability classification. Over-the-counter.

Manufacturers.

1. Sofarimex – Indústria Química e Farmacêutica, S.A./Sofarimex–Industria Quimica e Farmaceutica, S.A.
2. Procter & Gamble Manufacturing GmbH

Manufacturer's location and address of the place of business.

1. Av. das Indústrias - Alto do Colaride, Cacém, 2735-213, Portugal/Av. das Indústrias – Alto do Colaride, Cacém, 2735-213, Portugal.
2. Procter-&-Gamble-Strasse 1, 64521 Gross-Gerau, Hessen, Germany/Procter-&-Gamble-Strasse 1, 64521 Gross-Gerau, Hessen, Germany.