Rhinonorm Comfort, spray 0.1 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 quickly 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

Used for 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, restoration of impaired nasal breathing after surgical interventions in the nasal cavity.

Pharmacological effect

Pharmacotherapeutic group: anticongestive agent

ATX code: R01AB06

Pharmacological properties

Pharmacodynamics

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

Dexpanthenol is a B vitamin and is a derivative of pantothenic acid. Dexpanthenol is converted in the body into pantothenic acid, which is an integral part of coenzyme A and is involved in the processes of acetylation, carbohydrate and fat metabolism, in the synthesis of acetylcholine, corticosteroids, porphyrins; stimulates the restoration of skin and 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 their determination by modern analytical methods is impossible.

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

Special instructions

Before use, it is necessary to clean the nasal passages.
The duration of use of the drug in children is determined after consultation with a doctor.
Patients with long QT syndrome using xylometazoline may be at increased risk of developing serious ventricular arrhythmias.

Impact on the ability to drive vehicles and machinery
When using the drug in accordance with these instructions for use, the drug does not affect the ability to drive vehicles or machines, however, if adverse events occur, you should refrain from performing these types of activities.

Active ingredient

Xylometazoline, [Dexpanthenol]

Composition

1 dose of the drug contains: active ingredients:

xylometazoline hydrochloride 0.100/0.050 mg, dexpanthenol 5.000 mg;

excipients: sodium hydrogen phosphate heptahydrate (disodium phosphate heptahydrate) 0.0225 mg, potassium dihydrogen phosphate 0.855 mg, water for injection 95.322/95.372 mg.

Pregnancy

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

Contraindications

Hypersensitivity to the components of the drug, arterial hypertension, tachycardia, severe atherosclerosis, atrophic rhinitis, dry rhinitis, hyperthyroidism, porphyria, prostatic hyperplasia, glaucoma, surgical interventions on the meninges (in history), simultaneous use with monoamine oxidase inhibitors (MAO) and tricyclic antidepressants, pregnancy, breastfeeding.

For dosage 0.1 mg + 5 mg/dose

Children under 6 years old

For dosage 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), increased sensitivity to the action of adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

Side Effects

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

From the immune system: very rarely – allergic reactions (skin rash, itching, angioedema).

From the nervous system: very rarely – headache, anxiety, insomnia, fatigue (drowsiness), hallucinations (mainly in children).

From the cardiovascular system: rarely – palpitations, tachycardia, increased blood pressure; very rarely – arrhythmia.

From the respiratory system, chest and mediastinal organs: very rarely – swelling of the nasal mucosa, hypersecretion, nosebleeds.

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

From the musculoskeletal system: very rarely – convulsions (mainly in children).

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

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

Overdose

In cases of overdose or accidental oral use, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, cardiac arrhythmias, vascular insufficiency, cardiac arrest, hypertension, pulmonary edema, respiratory dysfunction, hallucinations. Patients may also experience symptoms of central nervous system depression, including drowsiness, decreased body temperature, bradycardia, shock, respiratory arrest, and coma.

Treatment: use of activated carbon, gastric lavage, oxygen ventilation. To lower blood pressure, 5 mg of phentolamine in 0.9% sodium chloride solution is prescribed by slow intravenous administration or 100 mg of phentolamine orally. Vasoconstrictor drugs are contraindicated. If necessary, antipyretic and anticonvulsants are used.

Storage conditions

At a temperature not exceeding 25 °C in the original packaging (bottle in a pack).
Keep out of the reach of children!

Shelf life

3 years.
After opening the bottle, the drug is suitable for use for 6 months.
Do not use after expiration date.

Manufacturer

Merkle GmbH, Germany