Description
Description
Nasal drops for children 0.05% in the form of a clear, colorless solution, odorless.
Release form
Drops.
10 ml in dark glass vials with a screw-on aluminum lid equipped with a first opening control system complete with a screw-on polypropylene / polystyrene / rubber pipette lid.
Lid – pipette packed in a sealed bag of low density polyethylene.
Pharmacological action
Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with a-adrenomimetic action, causes narrowing of the blood vessels of the nasal mucosa, eliminating edema and hyperemia of the nasopharynx.
Xylometazoline also reduces concomitant hypersecretion of mucus and facilitates drainage of nasal passages blocked by secretions, and thus improves nasal breathing with nasal congestion.
In therapeutic concentrations, the drug does not irritate the mucous membrane, does not cause hyperemia. The action occurs 2 minutes after application and lasts for 12 hours.
In vitro studies have shown that xylometazoline inhibits the infectious activity of the human rhinovirus that causes the common cold.
Indications
– Acute respiratory diseases with rhinitis (runny nose)
– acute allergic rhinitis
– hay fever
– sinusitis
– eustachyitis
– otitis media (to reduce swelling of the nasal mucosa)
Contraindications
– Arterial hypertension
– tachycardia
– severe atherosclerosis
– glaucoma
– atrophic rhinitis
– hyperthyroidism
years
– hypersensitivity to xylometazoline and other components of the drug.
Use during pregnancy and lactation
The drug should not be used during pregnancy.
During lactation, use the drug with caution.
The drug should be used only after a thorough assessment of the risk-benefit ratio for the mother and the fetus.
Do not exceed recommended dosage.
Special instructions
Not recommended for continuous use for more than 10 days. Do not exceed recommended doses, especially in children and the elderly. Prolonged (more than 10 days) or excessive use of the drug can cause a rebound effect (drug rhinitis).
Influence on the ability to drive a vehicle or equipment
Xylometazoline, in dosages exceeding the recommended ones, may affect the ability to drive a vehicle or equipment.
Composition
1 ml contains
xylometazoline hydrochloride 0.5 mg.
Dosage and Administration
Intranasally.
Nasal drops 0.05% are prescribed for children from 2 to 5 years: 1-2 drops in each nasal passage 1-3 times / day, should not be used more than 3 times / day.
Children from 6 to 11 years old – 2-4 drops in each nasal passage 2-3 times / day, should not be used more than 3 times / day. The drug in children should be used under the supervision of adults.
Side effects
Classification of the incidence of side effects (WHO): very often> 1/10 often from> 1/100 to <1/10 rarely from> 1/1000 to <1/100 rarely from> 1/10000 to < 1/1000 is very rare from <1/10000, including single messages. On the part of the immune system: very rarely – hypersensitivity reactions (angioedema, rash, itching). From the nervous system: often – headache rarely – insomnia, depression (with prolonged use in high doses). On the part of the sensory organs: very rarely – a violation of the clarity of visual perception. From the cardiovascular system: rarely – palpitations, increased blood pressure is very rare – 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 a burning sensation at the site of use. If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor. Drug Interactions Xylometazoline is contraindicated in patients receiving monoamine oxidase inhibitors at this time or receiving them for the previous 2 weeks. The simultaneous use of three – or tetracyclic antidepressants and sympathomimetic drugs can increase the sympathomimetic effect of xylometazoline, so this combination is recommended to be avoided. Overdose Xylometazoline may cause severe dizziness, excessive sweating, sharp decrease in body temperature, headache, bradycardia, increase in blood pressure, and depression. Following an increase in blood pressure, a sharp decrease can be observed. Appropriate supportive measures should be taken with any suspected overdose, in some cases showing immediate symptomatic treatment under the supervision of a physician. These measures should include monitoring the patient for several hours. In case of severe poisoning with cardiac arrest, resuscitation should last at least 1 hour. Storage Conditions The product should be stored out of the reach of children at a temperature not exceeding 30 ° C. Shelf life 3 years. Deystvuyushtee substance Xylometazoline Terms and conditions without prescription drops nasal Appointment Appointment Children form Novartis Farm Stein AG, Switzerland
