Composition, form of production and packaging
? Spray nasal in the form of a transparent, colorless or slightly colored liquid.
1 ml
xylometazoline hydrochloride 500 Ојg
ipratropium bromide monohydrate 600 Ојg
Excipients: disodium edetate dihydrate, glycerol 85%, hydrochloric acid concentrated (to pH 4.5), sodium hydroxide (to pH 4.5), purified water.
10 ml - plastic bottles with pump dispenser (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Combination drug for topical application in ENT-practice.
Xylometazoline is an alpha-adrenomimetic. Causes constriction of the blood vessels of the nasal mucosa, thus eliminating the edema and hyperemia of the nasopharyngeal mucosa. Relieves nasal breathing in rhinitis.
Ipratropium bromide has an anticholinergic effect. With intranasal application reduces the secretion of the glands of the mucous membrane of the nasal cavity.
In therapeutic doses, Ximelin Extra does not irritate the mucous membrane, does not cause hyperemia. The effect of the drug comes in 5-10 minutes and lasts for 6-8 hours.
PHARMACOKINETICS
With intranasal application of xylometazoline hydrochloride and ipratropium bromide and little absorbed and present in blood plasma in small amounts.
INDICATIONS
- symptomatic treatment of edema and hyperemia of the nasal cavity;
- acute respiratory diseases with phenomena of rhinitis (common cold);
acute allergic rhinitis;
- Pollinosis;
- Sinusitis.
DOSING MODE
The drug is administered intranasally.
Adults over 18 years - 1 injection in each nasal passage 3 times / day.
The drug is applied no more than 10 days without consulting a doctor.
One Xymulin Extra injection contains about 70 Ојg of xylometazoline hydrochloride and 84 Ојg of ipratropium bromide
SIDE EFFECT
With frequent and / or prolonged use: irritation and / or dryness of the nasopharyngeal mucosa, burning and tingling in the nose and throat, edema of the nasal mucosa, sneezing, hypersecretion of the glands of the nasal mucosa, nosebleeds, headache.
Rarely: systemic allergic reactions, visual impairment, palpitation, tachycardia, arrhythmia, headache, dizziness, increased blood pressure, insomnia.
CONTRAINDICATIONS
- arterial hypertension;
- tachycardia;
- severe atherosclerosis;
- glaucoma;
- Atrophic rhinitis;
- thyrotoxicosis;
- surgical interventions on the meninges (in the anamnesis);
- I trimester of pregnancy;
- age up to 18 years;
- Hypersensitivity to the components of the drug.
With caution should be used in patients with diabetes mellitus, angina pectoris III-IV functional class, obstruction of the neck of the bladder, prostatic hyperplasia, in patients with cystic fibrosis; in patients predisposed to epistaxis, paralytic intestinal obstruction, dizziness, tremor of skeletal muscles, sleep disorders, arrhythmias, increased blood pressure.
PREGNANCY AND LACTATION
Contraindicated use of the drug in the I trimester of pregnancy.
In the II and III trimesters of pregnancy and lactation (breastfeeding), the drug should be used only after a thorough evaluation of the expected benefit of therapy for the mother and the possible risk to the fetus. Do not exceed the recommended dose.
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under 18 years.
SPECIAL INSTRUCTIONS
Before applying the drug, it is necessary to clean the nasal passages.
Do not use the drug for a long time, for example, with chronic rhinitis.
Patients should be warned about the inadmissibility of spraying Xymelyn Extra in the eyes or around the eyes. If the product gets into the eyes, rinse them with cold water.
If the symptoms worsen or the patient's condition does not improve within 3 days of taking Ximelin Extra, you should consult your doctor.
Impact on the ability to drive vehicles and manage mechanisms
The use of the drug in therapeutic doses does not affect the ability to drive vehicles and work with mechanisms. Overdose or ingestion of the drug in the eye can affect the ability to drive vehicles and other potentially hazardous activities.
OVERDOSE
After intranasal application of Ximelin Extra, an acute overdose is unlikely, because absorption of the drug is very low.
Symptoms: dry mouth, accommodation disorders, tachycardia, headache, arterial hypertension.
Treatment: withdrawal of the drug, symptomatic therapy.
DRUG INTERACTION
With simultaneous use with MAO inhibitors, it is possible to increase blood pressure.
When used simultaneously with tri- and tetracyclic antidepressants, the sympathomimetic effect of xylometazoline may be enhanced.
With the concomitant administration of other anticholinergic drugs, the anticholinergic effect of ipratropium bromide may be enhanced.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
