Nasic, children’s spray 0.05+5mg/dose, 10ml

Composition

Active ingredients:

xylometazoline hydrochloride 0.05 mg,

dexpanthenol 5 mg;

Auxiliary substances:

Benzalkonium chloride (as a 50% solution) 0.04 mg,

potassium dihydrogen phosphate 0.853 mg,

sodium hydrophosphate dodecahydrate 0.027 mg,

purified water 94.03 mg

Pharmacological action

Nasik is a combined nasal preparation for topical use containing Xylometazoline and Dexpanthenol.

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic activity, causes narrowing of the blood vessels of the nasal mucosa, restores patency of the nasal passages, facilitates nasal breathing. The effect of the drug usually occurs a few minutes after its use and lasts up to 10 hours.

Dexpanthenol is a B vitamin derived from pantothenic acid. Dexpanthenol is converted in the body into pantothenic acid, which is a component of coenzyme A and participates in the processes of acetylation, carbohydrate and fat metabolism, in the synthesis of acetylcholine, corticosteroids, porphyrins; it stimulates the regeneration of the skin, mucous membranes, normalizes cellular metabolism, accelerates mitosis and increases the strength of collagen fibers.

It has regenerating, metabolic and weak anti-inflammatory effects.

PHARMACOKINETICS

Xylometazoline is practically not absorbed when applied topically, and 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 to pantothenic acid, binds to plasma proteins (mainly beta-globulin and albumin).

Its concentration in the blood is 0.5-1 mg/l, in the blood serum-100 mcg/l. Pantothenic acid is not metabolized in the body (except for inclusion in Co-A), it is excreted unchanged.

Indications

• acute respiratory diseases with rhinitis symptoms;
• 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 disturbed nasal breathing after surgical interventions in the nasal cavity.

Use during 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.

Contraindications

• hypersensitivity to the components of the drug;
• arterial hypertension;
• tachycardia;
• severe atherosclerosis;
• hypertheriosis; glaucoma;
• atrophic rhinitis;
• surgical interventions on the meninges (in the anamnesis);
• dry rhinitis;
• children under 2 years of age.

With caution: diabetes mellitus, pheochromocytoma.

Side effects

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, palpitation, increased blood pressure, insomnia, visual impairment, depression (with prolonged use of high doses).

Interaction

Concomitant use of MAO inhibitors and tricyclic antidepressants may lead to increased blood pressure due to the effects of these drugs on the cardiovascular system.

How to take, course of use and dosage

Intranasally. For children from 2 to 6 years old.

Remove the pump dispenser from its packaging. Open the bottle with the drug, screw the dosing device on the neck of the bottle, remove the protective cap.

Before applying the spray for the first time, press the pump dispenser several times until a uniform spray pattern appears.

When using nasal spray, the bottle should be kept in an upright position. During the injection, you need to easily inhale through your nose. One injection in each nasal passage 3-4 times a day.

The duration of therapy is 5-7 days.

Overdose

Symptoms:  mydriasis, nausea, vomiting, cyanosis, fever, convulsions, cardiac arrhythmia, cardiac arrest, hypertension, pulmonary edema, impaired respiratory function, hallucinations. Patients may also experience symptoms of CNS depression, including 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 is prescribed in 0.9% sodium chloride solution by slow intravenous use or 100 mg of phentolamine orally. Vasoconstrictor drugs are contraindicated. If necessary, apply antipyretics and anticonvulsants.

Special instructions

Before use, it is necessary to clean the nasal passages. Do not apply for more than 7 days. The duration of use of the drug in children is determined after consultation with a doctor.

Influence on the ability to drive motor vehicles and manage mechanisms

During the period of use of the drug, care should be taken when performing potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

spray

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Xylometazoline, [Dexpanthenol]

Dosage form

nasal spray

Description

Children over 2 years old

Indications

Hay Fever, Healing, Allergic Runny Nose, Cold, Runny Nose, Flu