Xymelin Extra, nasal spray 84 mcg/dose +70 mcg/dose, 10 ml

Xymelin Extra (spray 84mcg/dose+70mcg 10ml)

A country

Germany
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Active substance

Ipratropium bromide + Xylometazoline

Compound

Ipratropium bromide monohydrate, xylometazoline hydrochloride.

pharmachologic effect

When applied topically, the drug is poorly absorbed; ipratropium bromide and xylometazoline are present in plasma in small quantities. Moreover, there is a slight decrease in the level of exposure to ipratropium, while the maximum concentrations of xylometazoline slightly increase. Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with an alpha-adrenomimetic effect; it causes constriction of the blood vessels of the nasal mucosa, thus eliminating swelling and hyperemia of the nasopharyngeal mucosa. Facilitates nasal breathing during rhinitis. Ipratropium bromide is a quaternary ammonium compound that has an anticholinergic effect. When administered intranasally, it reduces nasal secretion through competitive inhibition of cholinergic receptors localized in the nasal epithelium. The drug in therapeutic concentrations does not irritate the mucous membrane and does not cause hyperemia. The effect occurs within 5 - 10 minutes and lasts for 6 - 8 hours.

Indications for use

Acute respiratory diseases with symptoms of rhinitis (runny nose), acute allergic rhinitis, hay fever, sinusitis (to reduce swelling of the nasopharyngeal mucosa).

Mode of application

Before use, it is necessary to clean the nasal passages. For adults: 1 spray into each nasal passage; should not be used more than 3 times a day. The drug is used for no more than 10 days. Missed dose: use immediately within 1 hour, do not use after 1 hour; Do not double the dose.

Interaction

Concomitant use with monoamine oxidase inhibitors can lead to a significant increase in blood pressure. Sympathomimetic drugs cause the release of catecholamines, which leads to an intense release of norepinephrine, which, in turn, has a vasoconstrictor effect, resulting in an increase in blood pressure. If there is a critical increase in blood pressure, treatment with the drug should be discontinued and symptomatic treatment prescribed. Concomitant use with tri- and tetracyclic antidepressants can enhance the sympathomimetic effect of xylometazoline. With concomitant administration of other anticholinergic drugs, the anticholinergic effect may be enhanced.

Side effect

Irritation and/or dryness of the mucous membrane of the nasopharynx, burning, sneezing, hypersecretion, headache, systemic allergic reactions (anaphylactic reaction, angioedema of the tongue, lips and face, laryngospasm, swelling of the nasal mucosa, rash, urticaria), blurred vision, palpitations, tachycardia, arrhythmias, increased blood pressure, headache, insomnia, fatigue, anxiety (with prolonged use of high doses).

Contraindications

Hypersensitivity to the components of the drug, glaucoma, atrophic rhinitis, after surgical interventions on the dura mater (with its penetration), children under 18 years of age. Pregnancy and lactation: The drug should be used only after a thorough assessment of the benefit-risk ratio for the mother, fetus, child.

Overdose

An overdose of the drug with excessive intranasal use of xylometazoline hydrochloride can lead to severe dizziness, sweating, a sharp decrease in body temperature, headache, bradycardia, arterial hypertension, respiratory depression and coma. After hypertension, hypotension may develop. Symptomatic treatment should be carried out by a physician. After excessive intranasal use, an overdose of ipratropium bromide is unlikely due to extremely low absorption into the blood, but symptoms such as dry mouth, difficulty in accommodation and tachycardia may develop. Treatment is symptomatic. A significant overdose can cause anticholinergic symptoms from the central nervous system, including hallucinations, for the elimination of which cholinesterase inhibitors (galantamine, proserine) are prescribed.

special instructions

Long-term treatment with xylometazoline can cause swelling of the nasal mucosa and increased secretion due to increased sensitivity of cells - a “reverse effect” (medicinal rhinitis). With caution in patients with hyperthyroidism, diabetes mellitus, arterial hypertension, angina pectoris III - IV functional class, prostatic hyperplasia, stenosis of the interureteric fold on the bladder mucosa, pheochromocytoma. Caution should be exercised when prescribing the drug to patients sensitive to adrenergic drugs, which may cause sleep disturbances, dizziness, tremor, cardiac arrhythmias or increased blood pressure. Patients should be warned not to spray the drug into or around the eyes. If the drug gets into the eyes, the following reactions are observed: temporary blurred vision, irritation, pain, redness of the eyes. An exacerbation of angle-closure glaucoma may develop. Patients should be warned to rinse their eyes with cold water if the drug gets into their eyes and to consult a doctor if they experience eye pain or blurred vision. It is recommended to exercise caution in the treatment of patients predisposed to nosebleeds, atonic intestinal obstruction and patients with cystic fibrosis. There are no data on the use of the drug in children and adolescents under 18 years of age. Do not exceed the recommended dosage. The drug does not affect the ability to drive vehicles or use machinery.

Xymelin Extra, nasal spray 84 mcg/dose +70 mcg/dose, 10 ml

Classification of the frequency of occurrence of adverse reactions: very often (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000), including isolated reports and reactions with unknown frequency (cannot be calculated from available data).

From the immune system:

frequency unknown - hypersensitivity reactions (anaphylactic reaction, angioedema, rash, itching, laryngospasm).

From the nervous system:

often - taste disturbance, headache; infrequently - impaired sense of smell, dizziness, tremor; very rarely - insomnia, convulsions, hallucinations.

From the side of the organ of vision:

uncommon - eye irritation, dry eyes; frequency unknown - increased intraocular pressure, mydriasis, eye pain, photopsia, worsening of angle-closure glaucoma, impaired clarity of visual perception, pupil dilation, halo effect (presence of rainbow circles in the field of view around the light source).

From the cardiovascular system:

rarely - rapid heartbeat, supraventricular tachycardia, arterial hypertension; very rarely - arrhythmic pulse; frequency unknown - atrial fibrillation.

From the respiratory system:

very often - nosebleeds, irritation and/or dryness of the nasal mucosa; often - burning sensation, tingling sensation, nasal hypersecretion, sneezing, nasal congestion (with frequent and/or prolonged use of the drug), dry throat, sore throat, rhinalgia, rhinorrhea; uncommon - ulcer of the nasal mucosa, sneezing, sore throat, cough, dysphonia; frequency unknown - discomfort in the paranasal sinuses, laryngeal spasm, swelling of the pharynx.

From the digestive system:

often - dry mouth; infrequently - dyspepsia, nausea; frequency unknown - difficulty swallowing.

For the skin and subcutaneous tissues:

frequency unknown - itching, skin rash, urticaria.

From the urinary system:

frequency unknown - difficulty urinating.

General disorders and disorders at the injection site:

infrequently - discomfort, fatigue; frequency unknown - chest discomfort, thirst.

If any of the side effects indicated in the instructions are aggravated or other side effects not listed in the instructions are noted, the patient should inform the doctor.

Xymelin extra

Xymelin extra combined two-component local vasoconstrictor for the symptomatic treatment of rhinitis (runny nose). A runny nose is the most common disease of the upper respiratory tract. The greatest discomfort for the patient is caused by such symptoms as nasal congestion and constant secretion of mucus from the nasal passages. The lack of adequate and timely treatment of a runny nose can lead to complications such as inflammation of the paranasal sinuses, mucous membrane of the larynx, bronchi, lungs, and middle ear. Swelling of the nasal mucosa causes obstruction of the nasal passages and disruption of the outflow of mucus from the paranasal sinuses. Under such conditions, representatives of opportunistic microflora are activated, resulting in the development of a bacterial infection. Xymelin extra contains the vasoconstrictor-decongestant xylometazoline and the acetylcholine antagonist ipratropium. This combination allows you to quickly and effectively eliminate rhinorrhea and facilitate nasal breathing. Xylometazoline reduces the lumen of blood vessels, preventing the development and progression of edema and abundant blood flow to the nasal mucosa. Ipratropium reduces mucus secretion by blocking acetylcholine receptors concentrated in the ciliated epithelium of the inner lining lining the nasopharynx. Due to their mutual complementarity and enhanced effects, the combination of xylometazoline and ipratropium reduces the need for other symptomatic drugs and reduces the pharmacological burden on the body. The drug is available in the form of a spray, which ensures dosing accuracy and prevents possible overdose. The medicine can be used as part of a medication course lasting up to ten days. The drug does not irritate the inner lining of the nose. It begins to act within minutes of application and maintains clinically significant activity for eight hours. In most cases, local vasoconstrictors for the treatment of rhinitis include preservatives, incl.

including benzalkonium chloride. This auxiliary substance prevents microbial contamination, but at the same time has a negative effect on the ciliated epithelium, suppressing the process of cleansing the mucosa from foreign agents and mucus. The pump dispenser, which is equipped with a bottle of Xymelin Extra, prevents bacterial contamination and allows you to do without the addition of preservatives, including benzalkonium chloride. In addition to the above, such a dispenser design provides a finely dispersed (mist-like) spray of the spray, which allows the active ingredients to be evenly distributed onto the inner lining of the nasal cavity. This feature of drug administration makes it possible to achieve a more pronounced therapeutic effect and prevent taking the drug in doses exceeding the recommended ones. Xymelin extra is used for rhinitis (including allergic origin), otitis media (as an adjunct to eliminate swelling of the inner lining of the nasal cavity), inflammation of the mucous membrane of the paranasal sinuses. A single dose is one spray into each nostril. Frequency of application – three times a day. The maximum duration of use for self-medication (without consulting a doctor) is ten days. Possible undesirable side reactions develop mainly when the dosage frequency of the drug is exceeded or when it is used for a long time. This includes dehydration of the nasal mucosa, irritating sensations of heat and tingling, nosebleeds, cephalalgia, and increased mucus production. In rare cases, systemic reactions are possible: allergic manifestations, transient visual disturbances, rapid heartbeat, heart rhythm disturbances, vertigo, arterial hypertension, painful lack of sleep. If there is no clinical improvement in the patient's condition when using the drug for three or more days, medical advice should be sought to adjust treatment.