Ximelin - instructions for use, dose, side effects, contraindications

Excipients: disodium edetate - 0.5 mg, sodium hydrogen phosphate dihydrate - 2 mg, sodium dihydrogen phosphate dihydrate - 2 mg, sodium chloride - 7.4 mg, benzalkonium chloride in the form of 10% benzalkonium solution - 0.1 mg, purified water - 991.5 mg.

1 ml of nasal spray 0L % contains:

active substance: Xylometazoline hydrochloride.............. 1.0 mg

Excipients: disodium edetat - 6,5 mg, sodium hydrogen phosphate dihydrate - 2 mg, sodium dichydrophosphate, 2 mg dihydrophosphate, 7.3 mg sodium chloride, benzalkonium chloride 10% benzalkonium solution 0.1 mg, purified water 991.1 mg.

Description:

Transparent colorless liquid.

Pharmacotherapeutic group:anticonvulsant - alpha-adrenomimetic

ATX: & nbsp

R.01.A.A.07 Xylometazoline

Pharmacodynamics:

Xylometazoline belongs to the group of local vasoconstrictors(decongestants) with alpha2-adrenomimetic action, causes narrowing of the blood vessels of the mucosa, the nasal membranes, thus eliminating the edema and hyperemia of the nasopharyngeal mucosa. Relieves nasal breathing in rhinitis.

In therapeutic concentrations, it does not irritate the nasal mucosa

causes flushing. The action comes in a few minutes and lasts for 10 to 12 hours.

Pharmacokinetics:

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

Indications:

Acute rhinitis (including on the background of acute respiratory diseases and allergic rhinitis), pollinosis, sinusitis, eustachitis, otitis media (to reduce edema of the nasopharyngeal mucosa).

Preparation of the patient for diagnostic manipulation in the nasal passages.

Contraindications:

Hypersensitivity. to the components of the drug, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, thyrotoxicosis, surgical interventions on the meninges (in the anamnesis), pregnancy, children under 2 years (for Ximelin 0.05%); children's age to 6 years (for Ximelin 0.1%).

Carefully:diabetes mellitus, angina pectoris III - IV functional class, prostatic hyperplasia.

Pregnancy and lactation:

During pregnancy use of the drug is contraindicated.

During breastfeeding The drug should be used only after a thorough evaluation, the ratio - benefits for the mother and, risk for the child, is not allowed to exceed the recommended dose.

Dosing and Administration:

Intranasally.

0.05% spray for children from 2 to 6 years of age: by 1 Injection into each nasal passage 1-2 times a day; Do not use more than 3 times a day.

0.1% spray for adults and children over 6 years of age: by 1 injecting into each nasal passage (if necessary, repeat); Do not use more than 3 times a day.

The drug is applied no more than 7 days, further under the instruction of the doctor.

One xymilin injection of 0.05% contains about 35 μg xylometazoline hydrochloride; one injection of Ximelin 0.1% contains about 140 μg xylometazoline hydrochloride.

Side effects:

With frequent and / or prolonged use - irritation and / or dryness of the mucous membrane of the nasopharynx, burning, paresthesia, sneezing, hypersecretion.

Rarely - edema of the nasal mucosa, palpitations, tachycardia, arrhythmias, increased blood pressure, headache, vomiting, insomnia, impaired vision; depression (with prolonged use of high doses).

Overdose:

Symptoms: increase in blood pressure

blood pressure; bradycardia, lower body temperature.

Treatment: symptomatic.

Interaction:

When combined with monoamine oxidase inhibitors and tricyclic antidepressants, it can lead to increased blood pressure.

Special instructions:

Do not exceed the recommended dosage alone and use the drug for more than 7 days. If symptoms persist after this time, you should consult your doctor.

Effect on the ability to drive transp. cf. and fur:The drug in recommended doses does not affect the ability to drive vehicles.

Form release / dosage:

For 10 ml, 15 ml of the drug in a bottle of dark glass, equipped with a multi-dose sprayer with a tip and a protective cap made of polyethylene.

One bottle together with the instruction for use is placed in a cardboard box.

Packaging:a bottle of dark glass, equipped with a multidose sprayer with a tip and a protective cap made of polyethylene (1) / 10 ml of the drug in a bottle of dark glass, equipped with a multi-dose sprayer with a tip and a protective cap made of polyethylene. One bottle together with the instruction for use is placed in a cardboard box ./- Cardboard tutu
a bottle of dark glass, equipped with a multi-dose sprayer with a tip and with a protective cap made of polyethylene (1) / 15 ml of the drug in a bottle of dark glass,equipped with a multi-dose sprayer with a tip and with a protective cap made of polyethylene. One bottle together with the instruction for use is placed in a cardboard box ./- Cardboard tutu

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

Shelf life 2 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N015643 / 02

Date of registration:23.03.2009

The owner of the registration certificate:Nycomed Denmark APSNycomed Denmark APS Denmark

Manufacturer: & nbsp

NYCOMED PHARMA, AS Norway

Representation: & nbspNycomed Distribution Ltd.Nycomed Distribution Ltd.

Information update date: & nbsp13.12.2011

Illustrated instructions

Instructions

Ximelin (Xymelin)