Nazol® baby

INSTRUCTIONS for medical use of the medicinal product NAZOL® BABY

Composition:

Active ingredient: phenylephrine hydrochloride;

1 ml of the preparation contains 1.25 mg (0.125% solution);

Excipients: benzalkonium chloride; glycerin; macrogol 1500; sodium hydrogen phosphate, dihydrate; potassium dihydrogen phosphate; disodium edetate, dihydrate; purified water.

Pharmaceutical form. Nasal drops.

Main physicochemical properties: clear, colorless or slightly yellow liquid.

Pharmacotherapeutic group. Decongestants and other agents for local use in nasal cavity disorders. Simple sympathomimetics.

ATC Code R01A A04.

Pharmacological properties.

Pharmacodynamics.

Phenylephrine hydrochloride is a synthetic adrenergic agent. By stimulating vascular α-adrenergic receptors, it produces a pronounced vasoconstrictive effect. The vasoconstriction reduces blood flow and decreases swelling of the nasal mucosa, paranasal sinuses, and Eustachian tube. This helps restore normal nasal breathing impaired during influenza, colds, and allergic conditions.

Local vasoconstriction of the nasal and paranasal mucosa begins within 3–5 minutes after administration of the drug into the nasal cavity. The anti-edema effect lasts for up to 4–6 hours. Glycerin, included in the formulation, soothes the irritated nasal mucosa and protects it from excessive drying.

Pharmacokinetics.

The drug is intended for local use. When absorbed from the gastrointestinal tract, it is metabolized by monoamine oxidase in the liver and intestine.

Clinical characteristics.

Indications.

Treatment of acute rhinitis, sinusitis, and acute otitis (as an adjunctive agent) in children aged 2 months to 6 years.

Contraindications.

Hypersensitivity to the components of the drug (allergic reactions), marked increase in arterial blood pressure, tachysystolic cardiac rhythm disorders, acute cardiovascular diseases, decompensated heart failure, conduction disorders of the heart, renal failure, severe thyrotoxicosis, acute pancreatitis, hepatitis, inflammation of the skin and mucous membrane of the anterior nasal cavity, and predisposition to nasal crust formation (atrophic rhinitis); conditions following transsphenoidal hypophysectomy; concomitant use with monoamine oxidase inhibitors (MAOIs), or use within 15 days after discontinuation of MAOI therapy.

Interaction with other medicinal products and other forms of interactions.

Should not be used concomitantly with other vasoconstrictors (regardless of the route of administration), or with antihypertensive medicinal products (ß-adrenoblockers).

Atropine sulfate blocks reflex bradycardia caused by phenylephrine and enhances the vasopressor response to phenylephrine. Concurrent use of phenylephrine with ß-adrenoblockers may lead to arterial hypertension and excessive bradycardia with possible heart block. Use with caution together with thyroid hormones and drugs affecting cardiac conduction (cardiac glycosides, antiarrhythmic agents). Concomitant use with drugs causing potassium excretion, such as certain diuretics like furosemide, may potentiate hypokalemia and reduce arterial sensitivity to vasopressor agents such as phenylephrine.

Concurrent administration of phenylephrine and other sympathomimetics may result in additive stimulation of the central nervous system to an extremely high degree, manifesting as nervousness, irritability, and insomnia. Seizure attacks are also possible. Furthermore, concomitant use of other sympathomimetics with phenylephrine may enhance the vasoconstrictive or cardiovascular effects of either agent.

Concomitant use should be avoided, or administration of this drug should be initiated no sooner than 15 days after discontinuation of MAOI therapy, as pressor effects may be potentiated (see section "Contraindications").

Concomitant use of phenylephrine with linezolid is not recommended.

Special precautions.

Before using the medication, the patient's head should be tilted backward, then the vial should be inverted over the nostril. In this position, the medication is dispensed drop by drop. It is not recommended to use the same vial for several individuals to avoid the spread of infection.

Persistence of nasal congestion after 3 days of treatment may indicate the presence of a deviated nasal septum, purulent sinusitis, adenoids, allergic rhinitis, persistent bacterial infection, or other conditions requiring consultation with a specialist and specialized comprehensive therapy.

This medicinal product should be used with caution in patients with arterial hypertension, cardiovascular diseases, thyroid disorders (except those specified in the section "Contraindications"), closed-angle glaucoma, or diabetes mellitus.

The medicinal product should be used under adult supervision.

If children under 12 years of age develop nervousness, dizziness, or insomnia, the use of the medication should be discontinued and medical advice should be sought.

Use during pregnancy or breastfeeding.

Not to be used.

Ability to influence reaction speed while driving or operating machinery.

It is not expected that this medicinal product affects the ability to drive or operate machinery.

Dosage and Administration.

Instill into each nostril: for children aged 2 months to 1 year — 1 drop; aged 1 to 2 years — 1–2 drops; aged 2 to 6 years — 2–3 drops. Repeat no sooner than every 4 hours, but no more than 4 times daily.

Children aged 6 years and older should use more concentrated solutions of phenylephrine (0.25%), for example, "Nasol Kids."

The duration of use usually does not exceed 3 days.

Children.

Should not be used in children under 2 months of age.

Overdose.

Although systemic adverse reactions are generally not observed with local application, overdose may enhance adverse effects, especially with prolonged use. Possible symptoms include cardiac arrhythmias, increased arterial blood pressure, arterial hypotension, chest pain and discomfort, palpitations, shortness of breath, non-cardiogenic pulmonary edema, excitation, seizures, headache, tremor, sleep disturbances, restlessness, anxiety, nervousness, irritability, inappropriate behavior, psychosis with hallucinations, insomnia, weakness, anorexia, nausea, vomiting, oliguria, urinary retention, painful or difficult urination, facial flushing, cold sensation in extremities, paresthesia, skin pallor, piloerection, increased sweating, hyperglycemia, hypokalemia, constriction of peripheral and internal organ blood vessels, reduced blood flow to vital organs, which may lead to impaired renal perfusion, metabolic acidosis, and increased cardiac workload due to elevated systemic vascular resistance. Severe consequences of vasoconstriction are more likely in patients with hypovolemia and severe bradycardia. There is no specific antidote for phenylephrine poisoning. Treatment is symptomatic.

Adverse Reactions.

In isolated cases, the following adverse effects are possible.

At the site of application: irritation at the site of application, sneezing, burning sensation, nasal tingling.

Cardiovascular system side effects: facial flushing, cardiac rhythm disturbances, bradycardia, increased blood pressure.

Nervous system side effects: dizziness, feeling of fear, headache.

Immune system side effects: allergic reactions, including cross-reactions in case of allergy to other sympathomimetics, which may manifest as rashes, itching, urticaria, angioneurotic edema (of hands, face or throat), chest tightness, dyspnea.

When the medicinal product is used at doses higher than recommended, effects listed in the section "Overdose" may occur.

Shelf life. 2 years.

After opening the bottle, shelf life is 12 months. Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 30 °C.

Keep out of reach of children.

Packaging.

Plastic bottle with a capacity of 10 ml, with a dropper, in a cardboard box.

Pharmaceutical category.

Over-the-counter (without prescription).

Manufacturer.

Istituto De Angeli S.r.l.

Manufacturer's address.

Località Prulli n. 103/c - 50066 Reggello (FI), Italy.