RINONORM SPRAY NASAL 0.1% 20ML

International Nonproprietary Name (INN):

Xylometazoline

Dosage Form: 

spray nasal dosed

Composition

100 ml of the preparation contain: active substance: Xylometazoline hydrochloride 0.100 g; Excipients: benzalkonium chloride (in the form of a 50% solution) 0.040 g in terms of benzalkonium chloride 0.020 g, citric acid monohydrate 0.050 g, sodium citrate dihydrate 0.260 g, glycerol 85% 2.400 g, purified water to 100 ml.

Description

Transparent colorless solution.

Pharmacological group

anti-congestive agent - alpha adrenomimetic.

pharmachologic effect

Xylometazoline is an alpha adrenergic agonist used for topical use in ENT practice.

When applied topically, xylometazoline causes a narrowing of the arterioles, which leads to a decrease in hyperemia and edema of the mucous membranes of the nasopharynx and a decrease in secretion. A distinct local effect of the drug is detected within a few minutes and lasts for several hours (up to 6-8 hours), manifesting itself in the restoration of the patency of the nasal passages, openings of the sinuses and the Eustachian tubes. Restoration of air permeability of the nasopharynx improves the well-being of patients and reduces the risk of possible complications caused by stagnation of mucous secretions.

Pharmacokinetics:

With topical administration, xylometazoline is practically not absorbed, so plasma concentrations are very low (not analytically determined).

Indications for use

As a symptomatic treatment 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 swelling of the mucous membrane of the Eustachian tube);

- preparation of patients for diagnostic procedures in the nasal passages.

Contraindications

- Hypersensitivity to xylometazoline or other components of the drug;

- inflammation of the skin, nasal mucosa and the formation of a crust (dry rhinitis);

- use after hypophysectomy;

- use in children up to 10 years;

- angle-closure glaucoma;

- taking monoamine oxidase inhibitors (MAO) and tricyclic antidepressants.

Carefully

Use with caution in patients with arterial hypertension, severe heart disease, hyperthyroidism, diabetes mellitus and taking Bromocriptine.

Use during pregnancy and lactation

The drug should not be taken during pregnancy. Take care when breastfeeding.

Dosage and administration

Adults and children over 10 years old:

1 dose (one press on the piston unit) in each nasal passage no more than 3 times a day (the maximum dose should not exceed 7 times a day).The interval between the introduction of the drug should not be less than 6 hours.

1 dose = 0,14 ml of solution, 140 mkg.

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 Rinonorm-Teva It is recommended to release the nasal passage from the secret, and during the administration of the drug it is necessary to take a light breath through the nose.

For use in children from 2 to 10 years old, you should use the drug Rinonorm-Teva, nasal spray dosed [for children].

Side effect

Sensation of burning and dryness of the nasal mucosa;

in rare cases - irritation of the nasal mucosa, oral cavity and larynx, headache and nausea;

extremely rarely (<1/10000) - arrhythmia, increase in blood pressure, irritability, skin reactions.

Overdose

In rare cases of overdose, occurring predominantly in children, the following symptoms may occur: irregular pulse, increased blood pressure, in some cases - loss of consciousness. In case of overdose, symptomatic treatment is indicated under supervision.

In serious cases, non-selective alpha-blockers can 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 carbon (adsorbent) and sodium sulfate (a laxative), make a gastric lavage.

Interaction with other drugs

Simultaneous use of tri- or tetracyclic antidepressants may increase the systemic effects of xylometazoline. At the same time taking the drug with monoamine oxidase inhibitors (MAO), the risk of increased blood pressure is possible.

special instructions

Influences on ability of driving of transport and on control of cars and mechanisms are not noted.

Storage conditions

Store at a temperature not higher than 25 0WITH

Keep out of the reach of children!

Pharmacy sales terms

It is released without a prescription.