Ropaxim spray 84mkg + 70mkg / dose, 15ml

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

• acute respiratory diseases with symptoms of rhinitis (rhinitis), accompanied by congestion;

• acute allergic rhinitis;

• hay fever;

• sinusitis.

Intranasally.

For adults over 18 years of age: 1 injection in each nasal passage 3 times / day.

At least 6 hours should elapse between two injections.

The drug is used for no more than 7 days without consulting a doctor.

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 an interruption in the use of the drug is more than 9 days, you must repeatedly press the pump dosing device several times to activate it until the full dose is released. It is recommended to discontinue 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 sensitivity of cells to the active substances of the drug, the so-called effect 'ricochet '.

Use in elderly patients: the experience of using the drug in people over 70 years of age is limited.

One injection of Ropaxime contains about 70 mcg of xylometazoline hydrochloride and 84 mcg of ipratropium bromide.

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

1 dose

ipratropium bromide monohydrate 84 mcg

xylometazoline hydrochloride 70 mcg

Excipients: anhydrous glycerol - 3.32 mg, disodium edetate dihydrate - 70 ?g, 1M hydrochloric acid solution or 1M sodium hydroxide solution - up to pH 3.7-4.7, water d / i - up to 140 ?l.

• Hypersensitivity to the components of the drug;

• arterial hypertension;

• tachycardia;

• severe atherosclerosis;

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

• glaucoma;

• atrophic rhinitis;

• thyrotoxicosis;

• condition after transsphenoidal hypophysectomy;

• surgical interventions on the membranes of the brain (in history);

• pregnancy;

• breastfeeding period;

• age up to 18 years.

  Do not use the drug during therapy with MAO inhibitors or tricyclic antidepressants, including a period of 14 days after their cancellation.

  Carefully

  Diabetes mellitus, hyperthyroidism, pheochromocytoma, diseases of the cardiovascular system, incl. Ischemic heart disease, angina pectoris III-IV functional class, obstruction of the bladder neck, stenosis of the inter-ureteric fold, prostatic hyperplasia, porphyria.

  Caution is advised when treating patients prone to nosebleeds, sensitive to adrenergic drugs, which can lead to symptoms such as sleep disturbance, dizziness, skeletal muscle tremors, arrhythmias, increased blood pressure, paralytic bowel obstruction, and 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. If the patient has one of the listed diseases, he should definitely consult a doctor before taking the drug.

pharmachologic effect

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic action, causes narrowing of the blood vessels of the nasal mucosa, thus eliminating edema and hyperemia of the nasopharyngeal mucosa. Relieves congestion by facilitating nasal breathing with rhinitis.

Ipratropium bromide has an anticholinergic effect. When administered intranasally, it reduces nasal secretion, stopping the flow from the nose by competitive inhibition of cholinergic receptors located in the epithelium of the nasal cavity. In therapeutic concentrations, it does not irritate the mucous membrane, does not cause its hyperemia.

The drug begins to act in 5-10 minutes and has a lasting effect for 6-8 hours.

Pharmacokinetics

With intranasal administration, ipratropium bromide and xylometazoline hydrochloride are poorly absorbed and are present in blood plasma in small amounts.

Side effect

From the immune system: the frequency is unknown - hypersensitivity reactions (anaphylactic reaction, angioedema, rash, pruritus, laryngospasm.

From the nervous system: often - taste disturbances, 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 heart: infrequently - 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 nasopharyngeal 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 nasal mucosa, pain in the pharynx, cough, dysphonia; the frequency is unknown - discomfort in the paranasal sinuses, spasm of the larynx, swelling of the pharynx.

From the gastrointestinal tract: 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.

On the part of the kidneys and urinary tract: the frequency is unknown - difficulty urinating.

General disorders: infrequently - discomfort, fatigue; frequency unknown - chest discomfort, thirst.

If any of the side effects indicated in the instructions are aggravated or the patient has noticed any other side effects, he should 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 for use in children and adolescents under the age of 18 years.

Use in elderly patients

The experience of using the drug in persons over 70 years of age is limited.

special instructions

Before use, you must clean the nasal passages.

Do not use the drug for a long time, for example, with chronic rhinitis. 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. It is recommended to stop treatment immediately after relief of symptoms in order to minimize the risk of adverse events.

Do not allow the drug to come into contact with or around the eyes. In case of contact, temporary blurred vision, irritation, pain, redness of the eyes may occur, and an exacerbation of angle-closure glaucoma may develop. If the drug gets into your eyes, rinse your eyes with copious amounts of cold water and consult a doctor if you have eye pain or blurred vision.

Influence on the ability to drive vehicles and mechanisms

Cases of visual impairment (including blurred vision and dilated pupils), dizziness and fatigue have been reported. Patients should be warned that when such symptoms appear, they should refrain from driving vehicles, operating mechanisms, and also from performing actions in which such symptoms may entail a risk to the patients themselves and to other people.

Overdose

After intranasal use of the drug Ropaxime, an acute overdose is unlikely, because absorption of the drug is extremely insignificant.

Symptoms: in 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.

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, difficulty in accommodation, and 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.

Treatment: Appropriate supportive measures should be taken for any suspected overdose. 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 drug is incompatible with the simultaneous administration of MAO inhibitors, tri- and tetracyclic antidepressants, as well as in the case of taking these drugs within the previous 2 weeks. Concomitant use or use within the previous 2 weeks of tri- and tetracyclic antidepressants and sympathomimetic drugs may enhance the sympathomimetic effect of xylometazoline, and therefore 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 Ropaxim 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 the drug Ropaxim. In combination for both active ingredients, the above interaction has not been studied.