Rhinostop Dual Care nasal spray 0.1mg+5mg/dose bottle, 15ml

Composition

Per 1 dose:

Active ingredients:

xylometazoline hydrochloride-0.1 mg,

dexpanthenol-5 mg.

Auxiliary substances:  sodium citrate dihydrate-0.509 mg, sodium chloride-0.250 mg, hypromellose-0.100 mg, benzalkonium chloride-0.015 mg, citric acid monohydrate-0.350 mg, purified water up to 100 µl.

Pharmacological action

Anticonvulsant APX: R. 01. A. B Sympathomimetics in combination with other drugs (excluding corticosteroids)Pharmacodynamics :

Xylometazoline-belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic activity, causes narrowing of the blood vessels of the nasal mucosa, reduces hyperemia and swelling of the mucosa, restores patency of the nasal passages, facilitates nasal breathing and thereby reduces the symptoms of rhinitis. 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 and 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 hydrochloride 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 phenomena;

– 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

The drug should not be used during pregnancy.

The drug is contraindicated during breastfeeding.

Before using, if you are pregnant or think that you might be pregnant, or are planning to become pregnant, you should consult your doctor. ⁠

Contraindications

Hypersensitivity to the components of the drug, arterial hypertension, tachycardia, severe atherosclerosis, hyperthyroidism, glaucoma, atrophic rhinitis, dry rhinitis, porphyria, prostatic hyperplasia, surgical interventions on the meninges (in the anamnesis), simultaneous use with monoamine oxidase inhibitors (MAO) and tricyclic antidepressants, pregnancy, breastfeeding, children under 6 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, arrhythmia, tremor, increased blood pressure.

If you have one or more of the diseases and conditions listed above. then you should consult your doctor before starting the procedure.

Side effects

The adverse events presented below are listed according to the anatomical and physiological classification and frequency of occurrence.

The frequency of occurrence is determined as follows:  very often (with a frequency of more than 1/10), often (with a frequency of at least 1/100, but less than 1/10), infrequently (with a frequency of at least 1/1000, but less than 1/100), rarely (with a frequency of at least 1/10000. but less than 1/1000), very rare (with a frequency of less than 1/10000), unknown (frequency based on available data is unknown).

Nervous system disorders:

Very rare:  anxiety, insomnia, headache, fatigue (drowsiness), hallucinations (mainly in children).

Disorders of the cardiovascular system:

Rarely:  palpitations, tachycardia, increased blood pressure.

Very rare:  arrhythmia.

Respiratory system disorders:

Very rare:  swelling of the nasal mucosa, hypersecretion, nosebleeds.

Frequency unknown:  burning and dryness of the nasal mucosa, sneezing.

Musculoskeletal disorders:

Very rare:  convulsions (especially in children).

Immune system disorders:

Very rare:  allergic reactions (angioedema, skin rash, pruritus).

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

Interaction

With the simultaneous use of MAO inhibitors and tricyclic antidepressants, it is possible to increase the systemic effect.

If you are taking any other medications at the same time (including over-the-counter medications), please consult your doctor before using them.

How to take, course of use and dosage

Intranasally.

For adults and children over 6 years of age

When using nasal spray, the bottle should be kept in an upright position. Before use, it is necessary to clean the nasal passages.

During the injection, you need to easily inhale through your nose. One injection in each nasal passage up to 3-4 times a day.

The duration of therapy is 5-7 days.

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

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

If there is no improvement after 5 days of treatment, or if the symptoms worsen or new symptoms appear, you should consult your doctor. Use the drug only according to the indications, the method of use and in the doses indicated in the instructions.

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, 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 in 0.9% sodium chloride solution is prescribed by slow intravenous use or 100 mg of phentolamine orally. Vasoconstrictor drugs are contraindicated. If necessary, apply antipyretics and anticonvulsants.

In case of overdose, you should consult a doctor.

Special instructions

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

Avoid contact with eyes.

To avoid the spread of infection, it is necessary to use the drug individually. The duration of use of the drug in children is determined after consultation with a doctor.

Patients with extended QT syndrome who are taking xylometazoline may be at an increased risk of developing serious ventricular arrhythmias.

Do not exceed the maximum time and recommended doses for self-use of the drug. If there is no reduction or if the symptoms of the disease become more severe, you should consult a doctor.

Influence on the ability to drive vehicles and fur. :

When using the drug in accordance with these instructions for use, the drug does not affect the ability to drive vehicles, mechanisms, however, if adverse events occur, you should refrain from performing these activities.

Form of production

Dosed nasal spray,0.1 mg+5 mg / dose.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf

life is 25 months.

Do not use after the expiration date indicated on the package.

Active ingredient

Xylometazoline, [Dexpanthenol]

Dosage Form

Spray nasal