Nasic^® (Spray) Instructions for Use

ATC Code

R01AB06 (Xylometazoline in combination with other drugs)

Active Substances

Dexpanthenol (Rec.INN registered by WHO)

Xylometazoline (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Decongestant

Pharmacological Action

Xylometazoline belongs to the group of topical vasoconstrictors (decongestants) with alpha-adrenomimetic activity. It causes constriction of the blood vessels of the nasal mucosa, restores the patency of the nasal passages, and facilitates nasal breathing. The drug’s effect usually begins within a few minutes after application and lasts up to 10 hours.

Dexpanthenol is a B vitamin, a derivative of pantothenic acid. Dexpanthenol is converted in the body into pantothenic acid, which is a component of coenzyme A and is involved in acetylation processes, carbohydrate and fat metabolism, and in the synthesis of acetylcholine, corticosteroids, and porphyrins. It stimulates the regeneration of the skin and mucous membranes, normalizes cellular metabolism, accelerates mitosis, and increases the strength of collagen fibers. It has a regenerating, metabolic, and weak anti-inflammatory effect.

Pharmacokinetics

Xylometazoline, when applied topically, is practically not absorbed; plasma concentrations are so low that they cannot be determined by modern analytical methods.

Dexpanthenol, when applied topically, is rapidly absorbed by the skin and converted into pantothenic acid, which binds to plasma proteins (mainly beta-globulin and albumin). Its concentration in the blood is 0.5-1 mg/L, and in the blood serum is 100 µg/L. Pantothenic acid is not metabolized in the body (except for incorporation into CoA) and is excreted unchanged.

Indications

• Acute respiratory diseases with symptoms of rhinitis;
• Acute allergic rhinitis;
• Vasomotor rhinitis;
• Sinusitis;
• Otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa);
• To facilitate rhinoscopy;
• To restore impaired nasal breathing after surgical interventions in the nasal cavity.

ICD codes

Dosage Regimen

Spray

Intranasally. For adults and children over 6 years old.

Remove the pump dosing device from the packaging. Uncap the bottle with the drug, screw the dosing device onto the neck of the bottle, and remove the protective cap.

Before the first use of the spray, press the pump dosing device several times until a uniform spray appears.

When using the nasal spray, the bottle must be held in an upright position. During spraying, you should inhale lightly through the nose. One spray into each nostril 3-4 times a day.

The duration of therapy is 3-5 days.

Adverse Reactions

With frequent and/or prolonged use – irritation and/or dryness of the nasopharyngeal mucosa, burning, tingling, sneezing, hypersecretion, allergic reactions, swelling of the nasal mucosa, vomiting, headache, dry rhinitis, palpitations, increased blood pressure, insomnia, visual disturbances, depression (with long-term use of high doses).

Contraindications

• Hypersensitivity to the components of the drug;
• Arterial hypertension;
• Tachycardia;
• Severe atherosclerosis;
• Atrophic rhinitis;
• Hyperthyroidism;
• Porphyria;
• Prostatic hyperplasia;
• Glaucoma;
• Surgical interventions on the meninges (in history);
• Children under 6 years of age;
• Concomitant therapy with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants.

With caution : diabetes mellitus, pheochromocytoma.

Use in Pregnancy and Lactation

Given that there are no data on the reproductive toxicity of the drug, its use during pregnancy and lactation is not recommended.

Pediatric Use

Contraindicated in children under 6 years of age.

Special Precautions

Before use, it is necessary to clean the nasal passages.

Should not be used for more than 5 days.

Effect on the ability to drive vehicles and mechanisms

During the period of drug use, precautions should be taken, or driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions should be avoided.

Overdose

In cases of overdose or accidental oral application, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, heart rhythm disturbances, vascular insufficiency, cardiac arrest, hypertension, pulmonary edema, respiratory dysfunction, hallucinations. Patients may also develop symptoms of CNS depression, accompanied by drowsiness, decreased body temperature, bradycardia, shock, respiratory arrest, and coma.

Treatment. Use of activated charcoal, gastric lavage, oxygen ventilation of the lungs. To reduce blood pressure, 5 mg of phentolamine in 0.9% sodium chloride solution is administered by slow intravenous injection or 100 mg of phentolamine orally. Vasoconstrictor drugs are contraindicated. If necessary, antipyretic and anticonvulsant agents are used.

Drug Interactions

With simultaneous use of MAO inhibitors and tricyclic antidepressants, an enhancement of the systemic effect is possible.

Storage Conditions

At a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

Over-the-counter.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.