NAPHTHYZINE®

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

Composition:

Active substance: naphazoline;

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

Excipients: boric acid, water for injections.

Pharmaceutical form. Nasal drops.

Main physicochemical properties: 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-adrenoreceptors. 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 after 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 Naftyzin® with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, mапротиліне, or within several days after their discontinuation may cause an increase in blood pressure.

Special precautions.

Use the drug with great caution in severe cardiovascular diseases (arterial hypertension, ischemic heart disease), diabetes mellitus, hyperthyroidism, pheochromocytoma, and concomitant use of MAO inhibitors or other drugs that may exert a hypertensive effect. Caution is required during general anesthesia using 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 such as palpitations, arterial hypertension, arrhythmia, headache, dizziness, drowsiness, or insomnia may occur.

Prolonged use and overdosing should be avoided, especially in children. Prolonged use of drugs intended for relief of 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 to be excreted in breast milk. Therefore, when considering prescribing the drug to women during pregnancy or breastfeeding, all potential risks and benefits of treatment should be carefully evaluated, and the drug should only be prescribed if absolutely necessary.

Ability to affect reaction speed when driving vehicles or operating machinery.

The use of Naftizin® at recommended doses does not affect the ability to drive vehicles or operate machinery. However, if recommended doses are exceeded, dizziness and drowsiness may occur.

Method of Administration and Dosage.

Naphthyzine® is administered by instilling drops into each nostril, tilting the head slightly backward and inclining it 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® must 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 laryngeal edema, spray 1–2 mL of the drug using a laryngeal syringe.

Children.

Naphthyzine® 0.05% can be used in children aged 3 to 15 years.
Naphthyzine® 0.1% can 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.

Central nervous system depression may manifest as decreased body temperature; bradycardia; increased sweating; drowsiness; hypotensive-like 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 the recommended doses, Naftyzin® is generally well tolerated. In patients with increased sensitivity, the drug may rarely cause burning and dryness of the nasal mucosa. In isolated cases, a sensation of severe nasal congestion may occur.

Systemic adverse effects occur only rarely (most often in cases of overdose):

Immune system: allergic reactions, including angioedema, burning;

Nervous system: nervousness, headache, tremor;

Cardiac system: tachycardia, palpitations;

Vascular system: arterial hypertension;

Skin and subcutaneous tissues: increased sweating.

Prolonged use (more than 5 days in adults and more than 3 days in children) or frequent administration may lead to drug dependence, accompanied by intense swelling of the nasal mucosa, which develops shortly after application. Long-term use of the drug may damage the mucosal epithelium, suppress 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 drug is 28 days.

Do not use the drug after the expiry date stated on the packaging.

Storage conditions.

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

Packaging.

10 mL in a polyethylene bottle or in a polyethylene bottle with a dispenser or in a polyethylene bottle with a dropper cap. One bottle per carton.

Availability. Over-the-counter.

Manufacturer. JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.