Xymelin Extra spray 84 + 70mkg / dose, 10ml

• symptomatic treatment of edema and hyperemia of the nasal cavity;

• acute respiratory diseases with symptoms of rhinitis (rhinitis);

• acute allergic rhinitis;

• hay fever;

• sinusitis

The drug is administered intranasally.

One shot of Xymelin Extra contains about 70 mcg of Xylometazoline hydrochloride and 84 mcg of ipratropium bromide.

Adults over 18 years old - 1 injection in each nasal passage 3 times / day. At least 6 hours must elapse between two injections.

The drug is used for no more than 7 days without consulting a doctor. It is recommended to stop treatment immediately after relief of symptoms, even if it happened earlier than 7 days (maximum duration of therapy), in order to minimize the risk of adverse events. Long-term use of xylometazoline can cause swelling of the nasal mucosa and increased secretion, which is due to the development of increased cell sensitivity to the active substances of the drug, the so-called 'rebound' effect.

The experience of use in elderly patients (over 70 years old) is limited.

Mode of application

Before the first use of the spray, press the pump dispenser several times until the full dose is released. With further use, additional activation of the dosing device is not required. If there is an uneven dosing of the spray or the break in the use of the drug is more than 9 days, you must repeatedly press the pump device several times to activate it until the full dose is released.

Dosed nasal spray in the form of a clear, colorless or slightly colored liquid.

1 dose of ipratropium bromide monohydrate 84 mcg xylometazoline hydrochloride 70 mcg

Excipients: disodium edetate dihydrate - 70 ?g, glycerol 85% - 3.91 mg, concentrated hydrochloric acid - up to pH 4.5, sodium hydroxide - up to pH 4.5, purified water - up to 140 ?L.

• hypersensitivity to drug components;

• hypersensitivity to atropine or similar compounds (hyoscyamine, scopolamine);

• arterial hypertension;

• tachycardia;

• severe atherosclerosis;

• glaucoma;

• atrophic rhinitis;

• hyperthyroidism;

• condition after transsphenoidal hypophysectomy;

• condition after surgical interventions on the meninges (history);

• pregnancy;

• age under 18;

• therapy with MAO inhibitors or tricyclic antidepressants, including a period of 14 days after their withdrawal.

With care: diabetes mellitus; pheochromocytoma; diseases of the cardiovascular system, incl. Ischemic heart disease, angina pectoris III-IV functional class; obstruction of the bladder neck, stenosis of the ureteral fold, prostatic hyperplasia; porphyria.

It is recommended to be careful in the treatment of patients prone to nosebleeds; with sensitivity to adrenergic drugs, which can lead to the appearance of symptoms such as sleep disturbance, dizziness, tremor of skeletal muscles, arrhythmia, increased blood pressure; in patients with paralytic intestinal obstruction; patients with cystic fibrosis.

It is recommended to be careful when using the drug in patients with a history of immediate hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm, laryngeal edema and anaphylactic reactions.

pharmachologic effect

Combined preparation for topical use in ENT practice.

Xylometazoline is an alpha-adrenergic agonist. It causes narrowing of the blood vessels of the nasal mucosa, thus eliminating edema and hyperemia of the nasopharyngeal mucosa. Facilitates nasal breathing with rhinitis.

Ipratropium bromide has an anticholinergic effect. When used intranasally, it reduces the secretion of glands in the nasal mucosa.

In therapeutic doses, Xymelin Extra does not irritate the mucous membranes, does not cause hyperemia. The effect of the drug occurs in 5-10 minutes and lasts for 6-8 hours.

Pharmacokinetics

With intranasal use of xylometazoline hydrochloride and ipratropium bromide are both little absorbed and are present in blood plasma in small amounts.

Side effect

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

From the immune system: the frequency is unknown - hypersensitivity reactions (anaphylactic reaction, angioedema, rash, pruritus, 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: infrequently - eye irritation, dry eyes; the frequency is unknown - increased intraocular pressure, mydriasis, eye pain, photopsia, deterioration in closed-angle glaucoma, impaired clarity of visual perception, pupil dilation, halo effect (the presence of rainbow circles in the field of view around the light source).

From the side of the cardiovascular system: rarely - heart palpitations, 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 - a burning sensation, tingling sensation, nasal hypersecretion, sneezing, nasal congestion (with frequent and / or prolonged use of the drug), dry throat, sore throat, rhinalgia, rhinorrhea; infrequently - ulcer of the mucous membrane of the nasal cavity, sneezing, pain in the throat, cough, dysphonia; the frequency is unknown - discomfort in the paranasal sinuses, spasm of the larynx, swelling of the pharynx.

From the digestive system: often - dry mouth; infrequently - dyspepsia, nausea; frequency unknown - difficulty swallowing.

On the part of the skin and subcutaneous tissues: the frequency is unknown - itching, skin rash, urticaria.

From the urinary system: the frequency is 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 indicated in the instructions are noted, the patient must inform the doctor about it.

Application during pregnancy and lactation

The use of the drug during pregnancy and during breastfeeding is contraindicated.

Application in children

Contraindicated in children and adolescents under 18 years of age.

Use in elderly patients

The experience of use in elderly patients (over 70 years old) is limited.

special instructions

Before using the drug, you must 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 Xymelin Extra into the eyes or around the eyes. If the drug gets into the eyes, rinse them with cold water.

If the symptoms of the disease worsen or the patient's condition does not improve within 3 days of taking Xymelin Extra, you should consult your doctor.

Influence on the ability to drive vehicles and use mechanisms

The use of the drug in therapeutic doses does not affect the ability to drive vehicles and work with mechanisms. Overdose or eye contact may affect the ability to drive vehicles and other potentially hazardous activities.

Overdose

Symptoms: after intranasal administration of the drug, acute overdose is unlikely, because absorption of the drug is extremely insignificant. In the case of an overdose of xylometazoline, the clinical picture is characterized by: dizziness, nausea, sweating, a decrease in body temperature, headache, bradycardia, impaired accommodation, arterial hypertension, respiratory depression, coma, convulsions. Arterial hypertension can be replaced by arterial hypotension.

Treatment: symptomatic therapy must be carried out under the supervision of a physician. With excessive use of ipratropium bromide, an overdose is unlikely due to the extremely insignificant absorption of the substance into the blood, but dry mouth, impaired accommodation, tachycardia may develop. Treatment is symptomatic. A significant overdose can cause symptoms associated with the cholinolytic effect of the drug on the part of the central nervous system, including hallucinations, for the elimination of which cholinesterase inhibitors are prescribed. Appropriate supportive measures should be taken if an overdose is suspected. If necessary, immediate symptomatic treatment is indicated under the supervision of a physician. These measures should include monitoring the patient for 6 hours.In case of severe poisoning with cardiac arrest, resuscitation should be continued for at least 1 hour.

Drug interactions

The simultaneous use of the drug with MAO inhibitors, tri- and tetracyclic antidepressants, as well as in the case of taking these drugs within the previous 2 weeks, is contraindicated. The simultaneous use or use during the previous 2 weeks of tri- and tetracyclic antidepressants and sympathomimetic drugs can enhance the sympathomimetic effect of xylometazoline, therefore it is not recommended.

Sympathomimetic drugs cause the release of catecholamines, incl. norepinephrine, which has a vasoconstrictor effect, resulting in an increase in blood pressure. With a significant increase in blood pressure, treatment with Xymelin Extra should be canceled and symptomatic treatment should be carried out.

With the concomitant administration of other drugs with anticholinergic activity, it is possible to enhance the anticholinergic effect of ipratropium bromide.

The above interaction was studied individually for both active substances that make up Xymelin Extra. In combination for both active ingredients, the above interaction has not been studied.