Composition
1 ml | |
xylometazoline hydrochloride | 1 mg |
Auxiliary substances:
citric acid monohydrate,
sodium citrate dihydrate,
glycerol 85%,
water d / I.
Pharmacological action
Clinical and pharmacological group:
Vasoconstrictor drug for topical use in ENT practice
Pharmacotherapy group:
Anticonvulsant – vasoconstrictor (alpha-adrenomimetic)
Pharmacological action
of Alpha-adrenomimetic for topical use in ENT practice.
When applied topically, xylometazoline causes narrowing of the arterioles, leads to a decrease in hyperemia and edema of the nasopharyngeal mucosa and a decrease in secretions.
A clear local effect of the drug is detected in a few minutes and persists for several hours (up to 6-8 hours), manifesting itself in the restoration of patency of the nasal passages, sinus openings and Eustachian tubes. Restoration of nasopharyngeal air patency improves the patient’s well-being and reduces the risk of possible complications caused by stagnation of mucosal secretions.
Pharmacokinetics
When applied topically, xylometazoline is practically not absorbed, so plasma concentrations are very low (not analytically determined).
Indications
Rhinonorm is used as a symptomatic therapy for the following diseases and conditions:
— acute viral or bacterial rhinitis;
– acute allergic rhinitis—
– acute sinusitis or exacerbation of chronic sinusitis—
– acute otitis media (to reduce edema of the mucous membrane of the Eustachian tube)—
– preparation of the patient for diagnostic procedures in the nasal passages.
Contraindications
and atrophic (dry) rhinitis;
— closure glaucoma;
— condition after hypophysectomy;
— simultaneous reception of MAO inhibitors and tricyclic antidepressants;
— children’s age up to 2 years (to spray for children);
— children under the age of 10 years (to spray for adults);
— hypersensitivity to Xylometazoline or other components of the drug.
The drug should be used with caution in patients with arterial hypertension, severe heart disease, hyperthyroidism, diabetes mellitus, and patients taking bromocriptine.
Side effects
Local reactions: burning sensation and dryness of the nasal mucosa; rarely-irritation of the nasal mucosa, oral cavity and larynx.
From the central nervous system: rarely-headache; extremely rare (
From the cardiovascular system: extremely rare (<1/10 000) – arrhythmia, increased blood pressure.
Other: rarely – nausea; extremely rare (
Interaction
Concomitant use of tri-or tetracyclic antidepressants may increase systemic exposure to xylometazoline. If the drug is taken concomitantly with MAO inhibitors, there may be a risk of increased blood pressure.
How to take, course of use and dosage
Adults and children over 10 years of age are prescribed Rhinonorm nasal spray 0.1% in 1 dose (1 push on the piston device) in each nasal passage no more than 3 times / day.
Children aged 2 to 10 years are prescribed Rhinonorm nasal spray for children 0.05% for 1 dose (1 push on the piston device) in each nasal passage no more than 3 times / day.
As much as possible, the drug can be used no more than 7 times / day. The interval between drug use should not be less than 6 hours.
The amount of fluid entering the patient’s nasal passage (1 dose) is 0.14 ml of solution.
In order to avoid complications in the form of renewed symptoms of the disease, the duration of continuous use of the drug should not exceed 7 days.
Before using the drug, the nasal passages should be cleared of secretions. During the use of the drug, take a light breath through the nose.
Overdose
Symptoms: in rare cases of overdose, which occur mainly in children, there may be arrhythmia, increased blood pressure, in some cases – loss of consciousness.
Treatment: symptomatic therapy is indicated under supervision. In severe cases, non-selective alpha-blockers may be used to lower blood pressure, as well as intubation and mechanical ventilation.
Vasoconstrictor drugs are contraindicated. If you accidentally take a moderate or large amount of the drug inside, you should take activated charcoal and a laxative (for example, sodium sulfate), do gastric lavage.
Special instructions
Influence on the ability to drive motor vehicles and manage mechanisms
There was no effect on the ability to drive vehicles and control machines and mechanisms.
Form of production
Metered dose nasal spray
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Shelf
life is 3 years, after opening the bottle-1 year.
Active ingredient
Xylometazoline
Dosage Form
Spray nasal
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Side effects of Rhinonorm nasal spray 0.1%, 20ml
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