Drops, for children 0.05%, 10 ml

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with a-adrenomimetic action, causes narrowing of blood vessels of nasal mucosa, eliminating edema and hyperemia of nasopharyngeal mucosa.

Xylometazoline also decreases accompanying mucus hypersecretion and facilitates drainage of nasal passages blocked with nasal discharge and thus improves nasal breathing in case of nasal congestion.

In therapeutic concentrations the drug does not irritate the nasal mucosa and does not cause hyperemia.

Indications

– Acute respiratory diseases with symptoms of rhinitis (runny nose);

– acute allergic rhinitis;

– hay fever;

– sinusitis;

– eustachitis;

– otitis media (to reduce swelling of the nasopharyngeal mucosa);

– preparing the patient for diagnostic manipulations in the nasal passages.

Pharmacological effect

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with an α-adrenomimetic effect, causing constriction of the blood vessels of the nasal mucosa, eliminating swelling and hyperemia of the nasopharyngeal mucosa.

Xylometazoline also reduces the accompanying hypersecretion of mucus and facilitates the drainage of nasal passages blocked by secretions, and thus improves nasal breathing during nasal congestion.

In therapeutic concentrations, the drug does not irritate the mucous membrane and does not cause hyperemia.

Special instructions

It is not recommended to use continuously for more than 10 days. Do not exceed recommended doses, especially in children and the elderly. Long-term (more than 10 days) or excessive use of the drug can cause a “ricochet” effect (medicinal rhinitis).

Effect on the ability to drive a vehicle or equipment

Xylometazoline, in dosages higher than recommended, may affect the ability to operate a vehicle or operate equipment.

Active ingredient

Xylometazoline

Composition

1 ml contains

xylometazoline hydrochloride 0.5 mg.

Pregnancy

The drug should not be used during pregnancy.

During lactation the drug should be used with caution.

The drug should be used only after a careful assessment of the risk-benefit ratio for the mother and fetus.

Do not exceed the recommended dosage.

Contraindications

– Arterial hypertension; tachycardia;

– severe atherosclerosis;

– glaucoma;

– atrophic rhinitis;

– hyperthyroidism;

– conditions after transsphenoidal hypophysectomy;

– surgical interventions on the meninges (history);

– pregnancy;

– children under 2 years of age;

– hypersensitivity to xylometazoline and other components of the drug.

Side Effects

Classification of the frequency of side effects (WHO): very often >1/10; often >1/100 to 1/1000 to 1/10000 to <1/1000; very rare from <1/10000, including isolated reports.From the immune system: very rarely – hypersensitivity reactions (angioedema, rash, itching).From the nervous system: often – headache; rarely – insomnia, depression (with long-term use in high doses).From the senses: very rarely – impaired clarity of visual perception.From the cardiovascular system: rarely – palpitations, increased blood pressure; very rarely – arrhythmia, tachycardia.From the respiratory system: often – irritation or dryness of the mucous membrane of the nasopharynx, burning, tingling, sneezing, hypersecretion of the mucous membrane of the nasopharynx.From the digestive system: often – nausea; rarely – vomiting.Local reactions: often – burning sensation at the site of application.If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Xylometazoline is contraindicated in patients currently receiving monoamine oxidase inhibitors or who have received them within the previous 2 weeks.

The simultaneous use of tri- or tetracyclic antidepressants and sympathomimetic drugs can lead to an increase in the sympathomimetic effect of xylometazoline, so this combination is recommended to be avoided.

Overdose

Xylometazoline, when administered locally in excess or accidentally ingested, can cause severe dizziness, increased sweating, a sharp decrease in body temperature, headache, bradycardia, increased blood pressure, respiratory depression, coma and convulsions.

Clinical pharmacology

When applied topically, it is practically not absorbed, plasma concentrations are below the detection limit.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C.

Shelf life

3 years.

Manufacturer

Sandoz Private Limited, India