Rhinorus - instructions for use, doses, side effects, contraindications

Active substance:
Xylometazoline hydrochloride	0.5 mg	1.0 mg
Auxiliary thingsctva:
Benzalkonium chloride	0.1 mg	0.1 mg
Sodium chloride	5.0 mg	5.0 mg
Disodium edetate dihydrate (disodium ethylenediamine-N, N, N ', N'-tetrakic acid salt, 2-water [Trilon B])	0.5 mg	0.5 mg
Sodium dihydrogen phosphate dihydrate (sodium phosphate monosubstituted two aqueous)	6.0 mg	6.0 mg
Disodium phosphate dodecahydrate (sodium phosphate disubstituted twelve aqueous)	3.5 mg	3.5 mg
Glycerol (glycerin distilled)	40.0 mg	40.0 mg
Sorbitol (sorbitol liquid)	20.0 mg	20.0 mg
Hyetellosis (hydroxyethylcellulose, natrosol)	20.0 mg	20.0 mg
Purified water	up to 1 g	up to 1 g

Description:

Transparent, colorless or slightly yellowish shade gel.

Pharmacotherapeutic group:anticonvulsant - alpha-adrenomimetic

ATX: & nbsp

R.01.A.A.07 Xylometazoline

Pharmacodynamics:

Xylometazoline is an imidazole derivative with an alpha-adrenergic effect. Directly stimulates the alpha-adrenergic receptors.

When applied to the mucous membrane of the nose causes narrowing of the blood vessels, reduces flushing and edema of the mucous membrane of the nasopharynx, reduces the amount of discharge from the nose, facilitates nasal breathing in rhinitis.

Pharmacokinetics:

The effect of xylometazoline begins in 5-10 minutes and is held for 10 hours.

With topical application is practically not absorbed, the concentrations in the blood plasma are so small that they can not be determined by modern analytical methods.

Indications:

Symptomatic treatment:

- acute rhinitis of viral or bacterial origin;

- acute sinusitis or chronic sinusitis in the phase of exacerbation;

- allergic rhinitis;

- acute otitis media - to restore the patency of the Eustachian tube.

Contraindications:

- Hypersensitivity to any of the components of the drug;

- surgical intervention on the meninges (in the anamnesis);

- atrophic rhinitis;

- children under 3 years old (for 0.05% gel), children under 12 years (for 0.1% gel);

- pregnancy;

- simultaneous administration of monoamine oxidase (MAO) inhibitors and tricyclic antidepressants, as well as other drugs that increase blood pressure;

- arterial hypertension;

- glaucoma;

- tachycardia;

- severe atherosclerosis;

- condition after transsphenoidal hypophysectomy;

- thyrotoxicosis.

Carefully:

- Angina pectoris;

- diabetes;

- hyperplasia of the prostate;

- the period of breastfeeding;

- hyperthyroidism;

- increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure;

- pheochromocytoma;

- porphyria.

Pregnancy and lactation:

Do not use the drug during pregnancy.

There is no data on the isolation of xylometazoline with breast milk. It is necessary to prescribe with caution the drug to women during breastfeeding.

Dosing and Administration:

Gel nasal, 0.05%

One dose is 0.1 g - a pea with a diameter of 10 mm (0.05 mg xylometazoline hydrochloride).

Children between the ages of 3 and 12: a single injection of one dose into each nasal passage every 8-10 hours.

Do not exceed the indicated dose.

Duration of the drug - no more than 3-5 days.

Nasal gel, 0.1%

One dose is 0.1 g - a pea with a diameter of 10 mm (0.1 mg xylometazoline hydrochloride).

Adults and children over 12 years of age: a single injection of one dose into each nasal passage every 8-10 hours.

Do not exceed the indicated dose.

Duration of the drug - no more than 3-5 days.

Side effects:

The incidence of adverse events is given in accordance with the WHO classification: very often more than 1/10. often more than 1/100 and less than 1/10, infrequently more than 1/1000 and less than 1/100, rarely more than 1/10000 and less than 1/1000, very rarely - less than 1/10000, frequency unknown - it is impossible to establish the frequency of occurrence by available data.

Local Reactions: often dry nasal mucosa, irritation of the nasal mucosa, burning sensation in the nose and throat, sneezing, hypersecretion; infrequently - reactive hyperemia, bleeding from the nose.

Are noted symptoms of systemic action: infrequently - allergic reactions (choking, angioedema, skin rash, urticaria); rarely - vomiting, visual disturbances, palpitations, tachycardia, increased blood pressure (especially in people with diseases of the circulatory system); very rarely - nausea, headache, weakness, fatigue, drowsiness, arrhythmia, spasms (especially in children), anxiety, paresthesia, hallucinations (mainly in children), depression (long-term use of high doses).

The use of the drug longer than recommended, and / or in doses exceeding the recommended, may lead to the development of drug rhinitis.

Overdose:

In case of an overdose or accidental ingestion of the drug, the following symptomsDizziness, sweating, sudden drop in body temperature, headache, bradycardia, arrhythmia, tachycardia, increased blood pressure, respiratory depression, coma and convulsions.Following the increase in blood pressure, there may be a sharp decrease in blood pressure. In young children with overdose, there are dominant central effects with convulsions, coma and bradycardia, apnea, as well as an increase in blood pressure, which follows the hypotension. Children may experience excessive sedation.

Treatment: symptomatic. Observe the patient for several hours. In case of severe poisoning with cardiac arrest, resuscitation should last at least 1 hour.

Interaction:

There have been cases of interaction of xylometazoline with tricyclic antidepressants and MAO inhibitors, do not use the drug during treatment with these drugs.

It should avoid the simultaneous use of xylometazoline with other adrenomimetic agents (eg, ephedrine, pseudoephedrine), given the potentiation of the actions.

Special instructions:

Preparation Renorus® gel nasal 0.05% should not be administered to children under 3 years of age, and Rhinorus^® Nasal gel 0.1% should not be administered to children under 12 years of age.

The drug, like other sympathomimetics,with special care should be given to patients with hypersensitivity to adrenomimetics, manifested by insomnia, dizziness, tremor, violation of the heart rhythm and increased blood pressure (BP).

Do not prescribe the drug to patients with chronic or vasomotor rhinitis, as they tend to use the drug for longer than 5 days. The use of the drug for longer than 5 days is not recommended, since it can lead to a secondary dilatation of the blood vessels and subsequently to secondary medicament rhinitis (rhinitis medicamentosa). The cause of this disease, most likely, is the suspension of the release of norepinephrine from the nerve endings by stimulation of presynaptic alpha-2 receptors.

Do not use doses above recommended, especially in children and elderly people.

The drug should not be prescribed during treatment with MAO inhibitors and tricyclic antidepressants.

The preparation contains benzalkonium chloride, therefore can cause irritation of the nasal mucosa.

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the ability to drive vehicles and mechanisms, if used at the recommended dose and for a short time. With prolonged use or use in high doses, undesirable effects from the circulatory system and the central nervous system may occur. In the case of side effects, the drug may affect the ability to drive vehicles and mechanisms.

Form release / dosage:Gel nasal, 0.05% and 0.1%.

Packaging:

5 grams, 10 grams, 15 grams in aluminum tubes with polymeric screw-on buds.

Each tube with instruction for use is placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003830

Date of registration:14.09.2016

Expiration Date:14.09.2021

The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia

Information update date: & nbsp29.09.2016

Illustrated instructions

Instructions

Rhinurus® (RHINORUS®)