Sanorin-Xylo - instructions for use, dose, side effects, contraindications

1 ml of the preparation contains: active substance: xylometazoline hydrochloride 1.00 mg; Excipients: citric acid monohydrate 0.50 mg, sodium citrate dihydrate 2,60 mg, glycerol 85 % 24.00 mg, water for injection 976,90 mg.

Description:

transparent, almost colorless solution.

Pharmacotherapeutic group:anticonvulsant - alpha-adrenomimetic

ATX: & nbsp

R.01.A.A.07 Xylometazoline

Pharmacodynamics:

Xylometazoline belongs to the group of local vasoconstrictors (zecongestants) with alpha2-adrenomimetic action, has a rapid and prolonged vasoconstrictive effect on the vessels of the mucous membrane of the nasal cavity, eliminating the edema and hyperemia of the mucosa. Relieves nasal breathing in rhinitis. The action comes in a few minutes and lasts for several hours (up to 6-8 hours), manifesting itself in restoring the patency of the nasal passages, sinus holes and Eustachian tubes. Restoration of air passableness of a nasopharynx improves state of health of patients and reduces danger of the possible complications caused by stagnation of a mucous secret.

Pharmacokinetics:

With topical application xylometazoline practically not absorbed, so the concentration in the blood plasma is very small (not analytically determined).

Indications:

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 edema of the mucosa of the Eustachian tube).

Contraindications:

Hypersensitivity to xylometazoline or other components of the drug; dry rhinitis; application after hypophysectomy or other surgical interventions performed through the dura mater; children's age until 6 years.

Carefully:

Pregnancy; the period of breastfeeding; arterial hypertension; cardiovascular diseases; metabolic disorders (including hyperthyroidism, diabetes mellitus); increased intraocular pressure (especially with closed-angle glaucoma); pheochromocytoma; porphyria; hyperplasia of the prostate; reception of monoamine oxide (MAO) inhibitors and tricyclic antidepressants.

Pregnancy and lactation:

The drug Sanorin-Xylo can be taken during pregnancy only after a thorough assessment of the relationship between benefit and risk. Since an overdose can disrupt the fetal blood supply, the recommended dose should not be exceeded during pregnancy.

During the period of breastfeeding, Sanorin-Xylon should be taken with caution.Due to a possible reduction in milk production, the recommended dose should not be exceeded.

Dosing and Administration:

Intranasally.

Adults and children over 6 years of age: 1-2 drops at most 3 times a day in each nasal passage. The duration of continuous use of the drug should not exceed 6 days.

The use of the drug can be resumed only a few days after the break.

In connection with the danger of atrophy of the nasal mucosa, the use of drops for chronic rhinitis is carried out only under medical supervision.

Before use, the vial should be turned down by the metering device. Before use, remove the protective cap, lie on your back or tilt your head back, insert the top of the dispenser into the nasal passage and press 1-2 times. Repeat the procedure in the other nasal passage. After use, wipe the top of the dispenser with a clean paper towel and put a protective cap on it.

Before the first application, several times, press the bottle until the first drop appears. At subsequent use the preparation is ready for use immediately after removing the protective cap.Before instillation of the drug is recommended to release the nasal passage from the secret. The last administration of the drug is desirable at the end of each day before going to bed.

For hygienic reasons and to avoid infection of drops, the drug should always be used by the same patient.

Side effects:

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%.

Immune system disorders: infrequently - hypersensitivity reaction, vascular edema, skin rash, itching.

Disorders from the central nervous system (CNS): very rarely - anxiety, insomnia, fatigue, lethargy, apathy, headache, dizziness, nausea, hallucinations (mainly in children).

Disorders from the cardiovascular system: rarely - sensation "palpitations", tachycardia, increased blood pressure; very rarely - arrhythmia. Disturbances from the respiratory system, chest and mediastinal organs: often - burning, dryness of the nasal mucosa, sneezing; infrequently - after weakening the therapeutic effect of increased swelling of the nasal mucosa, nosebleeds.

Disturbances from the musculoskeletal and connective tissue: very rarely - convulsions (mainly in children).

Overdose:

Symptoms: feelings of fear, anxiety, hallucinations, convulsions, lowering of body temperature, apathy, drowsiness, coma, miosis, mydriasis, increased sweating, fever, pallor, cyanosis, nausea, tachycardia, bradycardia, cardiac arrhythmia, violation breathing and apnea, a sharp decrease in blood pressure, pulmonary edema, increased blood pressure, cardiac arrest.

Treatment: symptomatic therapy, with the occasional taking the drug inside - the introduction of activated carbon, sodium sulfate (laxative), gastric lavage. In serious cases, nonselective alpha-blockers can be used to lower blood pressure, as well as intubation and artificial ventilation of the lungs. Vasoconstrictors are contraindicated.

Interaction:

Simultaneous administration of tri- or tetracyclic antidepressants may increase systemic exposurexylometazoline. With the simultaneous administration of xylometazoline with MAO inhibitors, there is a risk of increased blood pressure.

Special instructions:

With prolonged use of the drug Sanorin-Xylol, the therapeutic effect may be weakened, and the risk of reactive hyperemia and atrophy of the nasal mucosa (medicamentous rhinitis) increases.

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

Effects on the ability to manage transport and work with technology is not revealed. With the development of unwanted reactions from the central nervous system, care should be taken when performing actions requiring increased concentration and speed of psychomotor reactions.

Form release / dosage:

Nasal drops 0.1%.

For 10 ml in a bottle of dark glass with a dispensing device, nosepiece and protective cap. 1 bottle with instructions for use in a cardboard box.

Packaging:vial of dark glass (1) / 10 ml in a bottle of dark glass with a dispensing device, nosepiece and protective cap. 1 bottle with instructions for use in a cardboard pack ./- A pack of cardboard

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Shelf life:

Shelf life 3 years.

Shelf life of the opened bottle is 6 months.

Do not use after the expiration date!

Terms of leave from pharmacies:Without recipe

Registration number:LP-001934

Date of registration:18.12.2012

The owner of the registration certificate:Teva Pharmaceutical Vox Company Ltd.Teva Pharmaceutical Vox Company Ltd. Hungary

Manufacturer: & nbsp

MERCKLE, GmbH Germany

Representation: & nbspTeva Teva Israel

Information update date: & nbsp18.12.2012

Illustrated instructions

Instructions

Sanorin-Xylo (Sanorin-Xylo)