Naphthyzine

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NAPHTIZIN® (NAPHTİZIN®)

Composition:

Active substance: naphazoline;

1 ml of the preparation contains 0.5 mg or 1 mg of naphazoline nitrate;

Excipients: boric acid, purified water.

Pharmaceutical form. Nasal drops.

Main physicochemical characteristics: clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Anti-edematous and other preparations for local use in nasal cavity disorders. Sympathomimetics. ATC code R01A A08.

Pharmacological properties.

Pharmacodynamics.

Naphthyzine® exerts a pronounced vasoconstrictor effect on peripheral blood vessels due to its action on α-adrenergic receptors. When applied to mucous membranes, it reduces swelling, hyperemia, and exudation, thereby facilitating nasal breathing in rhinitis. Naphazoline promotes opening and dilation of the drainage pathways of the nasal sinuses and Eustachian tubes, improving secretion drainage and preventing bacterial accumulation.

Pharmacokinetics.

When applied locally, naphazoline is completely absorbed.

Therapeutic effect begins within 5 minutes and lasts for 4–6 hours following intranasal administration.

Clinical characteristics.

Indications.

Acute rhinitis. As an adjunctive agent in inflammation of the paranasal sinuses and the middle ear.

For reduction of mucosal swelling during diagnostic procedures.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Dry inflammation of the nasal mucosa.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of Naftizin® with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, mianserin, or within several days after their discontinuation may cause an increase in blood pressure.

Special precautions.

Use the medicinal product with great caution in severe cardiovascular disorders (arterial hypertension, ischemic heart disease), in diabetes mellitus, hyperthyroidism, pheochromocytoma, and during concomitant use of monoamine oxidase inhibitors (MAOIs) or other drugs that may exert a hypertensive effect. Caution is required during general anesthesia with anesthetics that increase myocardial sensitivity to sympathomimetics (e.g., halothane), as well as in bronchial asthma.

When high doses of the drug are used, adverse effects on the cardiovascular and nervous systems may occur, such as palpitations, arterial hypertension, arrhythmia, headache, dizziness, drowsiness, or insomnia.

Prolonged use and overdosage should be avoided, especially in children. Prolonged use of medications intended to relieve mucosal edema may lead to swelling and subsequent atrophy of the nasal mucosa.

Use during pregnancy or breastfeeding.

There are no data regarding the ability of naphazoline to cross the placental barrier or pass into breast milk. Therefore, when considering the use of the drug in pregnant or breastfeeding women, all potential risks and benefits of treatment should be carefully evaluated, and the medicinal product should be prescribed only if absolutely necessary.

Effect on the ability to drive or operate machinery.

The use of Naftizin® at recommended doses does not affect the ability to drive or operate machinery. However, exceeding the recommended doses may cause dizziness and drowsiness.

Method of Administration and Dosage.

Naphthyzine® is administered by instilling drops into each nostril, with the head tilted slightly backward and inclined to the right when administering into the right nostril, and to the left when administering into the left nostril.

For therapeutic purposes. Adults and children aged 15 years and older – 1–3 drops of 0.05%–0.1% solution into each nostril.

Children aged 3–6 years – instill 0.05% solution, 1–2 drops into each nostril;

children aged 6–15 years – 2 drops into each nostril.

Naphthyzine® should be used 3 times daily, but no more frequently than every 4 hours.

Naphthyzine® should not be used for longer than 5 days in adults and longer than 3 days in children.

Naphthyzine® may be re-administered only after several days.

In case of nasal bleeding, use tampons moistened with 0.05% solution.

For diagnostic purposes (e.g., for diagnosis and treatment of nasal polyps). After cleaning the nasal cavity, instill 3–4 drops of 0.05%–0.1% solution into each nostril, or insert a tampon moistened with 0.05%–0.1% solution for 2–3 minutes.

In case of vocal cord edema, spray 1–2 mL of the drug using a laryngeal syringe.

Children.

Naphthyzine® 0.05% may be used in children aged 3 to 15 years.

Naphthyzine® 0.1% may be used in children aged 15 years and older.

Overdose.

Overdose or accidental ingestion of the drug may cause systemic adverse effects: nervousness, increased sweating, headache, tremor, tachycardia, palpitations, arterial hypertension. Cyanosis, nausea, elevated body temperature, spasms, cardiac arrest, pulmonary edema, psychiatric disturbances, skin pallor, and myocardial infarction may occur.

Depressive effects on the central nervous system may manifest as symptoms including decreased body temperature; bradycardia; excessive sweating; drowsiness; shock resembling hypotensive shock; apnea; coma. The risk of overdose is higher in children, who are more vulnerable to adverse effects than adults.

Treatment is symptomatic.

Adverse Reactions.

When used at recommended doses, Naftyzin® is generally well tolerated. In patients with increased sensitivity, the medicinal product may rarely cause burning and dryness of the nasal mucosa. In isolated cases, a sensation of pronounced nasal congestion may occur.

Systemic adverse effects occur only in rare cases (most often due to overdose):

Immune system: allergic reactions, including Quincke's edema, burning sensation;

Nervous system: nervousness, headache, tremor;

Cardiac system: tachycardia, palpitations;

Vascular system: arterial hypertension;

Skin and subcutaneous tissues: increased sweating.

Prolonged use (longer than 5 days in adults and longer than 3 days in children) or frequent use of the medicinal product may lead to drug dependence, manifested by intense swelling of the nasal mucosa occurring after a relatively short time interval following administration. Long-term use of the drug may result in damage to the mucosal epithelium, suppression of ciliary activity, and cause irreversible mucosal damage and development of atrophic rhinitis.

Shelf life. 3 years.

After opening the bottle, the shelf life of the product is 28 days.

Do not use the medicinal product after the expiry date stated on the package.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

10 ml in a glass bottle. 1 bottle per carton.

Availability. Over-the-counter.

Manufacturer.

JSC "Farmak".

Manufacturer's location and address of business activity.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.