Rhinostop Double Help, spray 0.1 mg+5 mg/dose 15 ml

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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.

Pharmacological effect

Anticongestant

ATC: 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 constriction of the blood vessels of the nasal mucosa, reduces hyperemia and swelling of the mucous membrane, restores the patency of the nasal passages, facilitates nasal breathing and thereby reduces the symptoms of rhinitis. 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 regeneration 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 hydrochloride is practically not absorbed when applied topically; plasma concentrations are so low that they cannot be determined by modern analytical methods.

When applied topically, dexpanthenol is quickly absorbed by the skin and converted into pantothenic acid and 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 μg/l. Pantothenic acid is not metabolized in the body (except for inclusion in Co-A) and is excreted unchanged.

Special instructions

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

Avoid getting the drug into your 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 long QT syndrome using xylometazoline may be at increased risk of developing serious ventricular arrhythmias.

Do not exceed the maximum duration and recommended doses when using the drug independently. If there is no improvement or if the symptoms of the disease worsen, you should consult a doctor.

Impact on the ability to drive vehicles. Wed and fur.:

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

For 1 dose:

Active ingredients:

xylometazoline hydrochloride – 0.1 mg,

dexpanthenol – 5 mg.

Excipients: 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.

Pregnancy

The drug should not be used during pregnancy.

The drug is contraindicated during breastfeeding.

Before use, if you are pregnant, think you might be pregnant, or are planning a pregnancy, 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 history), simultaneous use with monoamine oxidase inhibitors (MAO) and tricyclic antidepressants, pregnancy, breastfeeding, childhood up to 6 years old.

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.

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

Side Effects

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

The frequency of occurrence is defined as follows: very common (with a frequency of more than 1/10), common (with a frequency of at least 1/100 but less than 1/10), uncommon (with a frequency of at least 1/1000 but less than 1/100), rare (with a frequency of at least 1/10,000 but less than 1/1000), very rare (with a frequency of less than 1/10,000), unknown (frequency based available data is unknown).

Nervous system disorders:

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

Cardiovascular system disorders:

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.

Disorders of the musculoskeletal system:

Very rare: convulsions (especially in children).

Immune system disorders:

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

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

With the simultaneous use of MAO inhibitors and tricyclic antidepressants, the systemic effect may be enhanced.

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

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

The 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.

In case of overdose, consult a doctor.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life

25 months.

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

Manufacturer

Pharmstandard-Leksredstva, Russia