Rhinonorm Comfort, spray 0.05 mg+5 mg/dose 10 ml

Pharmacotherapeutic group: antincongestive

ATX code: R01AB06

Pharmacological properties

Pharmacodynamics

Csilometazoline refers to a group of local vasoconstrictors (decongestants) with alpha-adrenomimetic activity, causes narrowing of the blood vessels of the nasal mucosa, restores nasal passageway, facilitates nasal breathing. The action of the drug usually comes within a few minutes after application and lasts up to 10 hours.

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

Pharmacokinetics

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

Dexpanthenol when applied topically is rapidly absorbed by the mucous membrane, converted to pantothenic acid, binds to plasma proteins (mainly beta-globulin and albumin). Its concentration in blood is 0.5-1 mg/l, in serum 100 µg/l. Pantothenic acid is not metabolized (except for inclusion in Co-A) and is excreted unchanged.

Indications

It is used for acute respiratory diseases with rhinitis, acute allergic rhinitis, vasomotor rhinitis, sinusitis, otitis media (as part of combined therapy to reduce nasopharyngeal mucosa edema), to facilitate rhinoscopy, restoration of impaired nasal breathing after surgical interventions in the nasal cavity.

Active ingredient

Xylometazoline, [Dexpanthenol]

Composition

One dose of the drug contains: active ingredients: xylometazoline hydrochloride 0.100/ 0.050 mg, dexpanthenol 5.000 mg; excipients: sodium hydrophosphate heptahydrate (dinatrium phosphate heptahydrate) 0.0225 mg, potassium dihydrophosphate 0.855 mg, water for injection 95.322/ 95.372 mg.

How to take, the dosage

Intranasally.

For doses of 0.1 mg + 5 mg/dose – adults and children from 6 years of age one injection into each nasal passage 3-4 times a day. The duration of therapy is 5-7 days.

For doses of 0.05 mg + 5 mg/dose – children from 2 to 6 years old one injection into each nasal passage 3-4 times a day. The duration of therapy is 5-7 days.

Do not use for more than 7 days. The duration of use of the drug in children is determined after consultation with a physician.

Repeated use is possible only after a break of several days.

If after 5 days of treatment there is no improvement or if symptoms worsen or new symptoms develop, you should talk to your doctor. Use only with the directions, route of administration, and dosage listed.

To use

• Remove the protective cap;
• .Before first use, press the pump dispenser several times until evenly atomized;
• Hold the bottle upright, insert the dispense tip into the nasal passage and press once. Inhale lightly through the nose while injecting;
• After use, wipe the dispensing tip thoroughly with a clean cloth and close the protective cap.

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Interaction

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

Special Instructions

Nasal passages should be cleaned before use.
The duration of use of the drug in children is determined after consultation with the doctor.
Patients with prolonged QT interval syndrome using xylometazoline may be at increased risk of serious ventricular arrhythmias.

Impact on the ability to drive, operate machinery
When the drug is used in accordance with these instructions for use, the drug does not affect the ability to operate vehicles, machinery, but if adverse events occur, you should refrain from performing the specified activities.

Synopsis

Transparent almost colorless solution.

Contraindications

Hypersensitivity to the drug components, arterial hypertension, tachycardia, marked atherosclerosis, atrophic rhinitis, dry rhinitis, hyperthyroidism, porphyria, prostatic hyperplasia, glaucoma, brain surgery (in anamnesis), simultaneous use with monoamine oxidase inhibitors (MAO) and tricyclic antidepressants, pregnancy, breastfeeding period.

For doses of 0.1 mg + 5 mg/dose

Children under 6 years of age <./p>

For doses of 0.05 mg + 5 mg/dose

Children under 2 years of age.

With caution

. Diabetes mellitus, pheochromocytoma, diseases of the cardiovascular system (including coronary heart disease), hypersensitivity to the action of adrenergic drugs, accompanied by insomnia, dizziness, arrhythmias, tremors, increased blood pressure.

Side effects

The adverse events listed below are systematized according to the World Health Organization (WHO) Classification: very common (≥1/10), common (≥1/100 and < 1/10), infrequent (≥1/1000 and < 1/100), rare (≥1/10000 and < 1/1000), very rare (< 1/10000); unknown (cannot be determined based on available data).

Immune system involvement: very rarely, allergic reactions (skin rash, pruritus, angioedema).

Nervous system disorders: very rarely – headache, anxiety, insomnia, fatigue (drowsiness), hallucinations (mainly in children).

Cardiovascular system disorders: rarely – sensation of palpitations, tachycardia, increased blood pressure; very rarely – arrhythmia.

In the respiratory system, thoracic and mediastinal organs:very rarely – nasal mucous membrane edema, hypersecretion, nasal bleeding.

frequency unknown – burning and dryness of the nasal mucosa, sneezing.

Muscular system disorders: very rarely – seizures (mainly in children).

If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

In cases of overdose or accidental oral administration the following symptoms may occur: Mydriasis, nausea, vomiting, cyanosis, fever, seizures, tachycardia, heart rhythm disturbance, vascular failure, cardiac arrest, hypertension, pulmonary edema, respiratory depression, hallucinations. Patients may also experience symptoms of central nervous system depression accompanied by drowsiness, decreased body temperature, bradycardia, shock, respiratory arrest and coma.

Treatment: use of activated charcoal, gastric lavage, oxygen ventilation. To decrease blood pressure, 5 mg of phentolamine in 0.9% sodium chloride solution by slow intravenous injection, or 100 mg of phentolamine by oral administration is prescribed. Vasoconstrictors are contraindicated. If necessary, antipyretics and anticonvulsants are used.

Pregnancy use

The drug should not be used during pregnancy. Use of the drug during breastfeeding should be avoided.

Similarities

Tizin, Rhinostop, Xylong