Ksimelin extra spray Nazal. scrapper. 84mkg 70mkg + / dose vials with 10ml dozir.ustr.

Description

Composition
Active substance:
1 dose comprising: ipratropium bromide monohydrate, 84 mg, xylometazoline hydrochloride-70 mg.
Excipients:
Disodium edetate dihydrate 70 g glycerol (85%) 3.91 mg, a concentrated hydrochloric acid to pH 4.5 with sodium hydroxide to pH 4.5 Purified water to 140 microliters.
Description:
Clear, colorless or slightly colored liquid.
Product form:
Nasal spray dosage 84 .mu.g / dose + 70 .mu.g / dose. 10 ml of the product (at least 60 doses) in a plastic bottle fitted with a dosing pump action device with a tip and a protective cap made of polyethylene. 1 bottle together with instructions for use placed in a cardboard box.
Contraindications
Increased sensitivity to the drug, hypertension, tachycardia, expressed atherosclerosis, hypersensitivity to atropine or similar compounds (hyoscyamine, scopolamine), glaucoma, atrophic rhinitis, hyperthyroidism, post transsphenoidal hypophysectomy, surgical operations on the brain membranes (history), pregnancy and during breast-feeding, age up to 18 years. Do not use the drug in the therapy or monoamine oxidase inhibitors tricyclic antidepressants, including the period of 14 days after their withdrawal.
Carefully
Diabetes; hyperthyroidism; pheochromocytoma; diseases of the cardiovascular system, including Coronary artery disease, angina III – IV functional class; bladder neck obstruction; stenosis of the bar of bladder; prostatic hyperplasia, porphyria. We recommend caution in treating patients susceptible to nosebleeds, sensitivity to adrenergic agents, which can lead to symptoms such as sleep disturbance, dizziness, tremor of skeletal muscles, arrhythmia, increased blood pressure, paralytic ileus, and in patients with cystic fibrosis . Caution is recommended when using the drug in patients who have a history of hypersensitivity reactions of immediate type, including urticaria, angioedema, skin rashes, bronchospasm, laryngeal edema and anaphylactic reactions. If you have one of these diseases, before taking this medication, you should consult with your doctor.
Dosage
84 .mu.g + 70 pg / dose
Indications
Symptomatic treatment of edema and hyperemia of the nasal cavity; acute respiratory illness with symptoms of rhinitis (common cold), acute allergic rhinitis, hay fever, sinusitis.
Interaction with other drugs
The drug is incompatible with the simultaneous reception of monoamine oxidase inhibitors (MAO), tri- and tetracyclic antidepressants, as well as in the case of reception of these drugs within the preceding two weeks. Simultaneous use or use during the previous 2 weeks tri- and tetracyclic antidepressants and sympathomimetic drugs can enhance the sympathomimetic effect of xylometazoline and is therefore not recommended. Sympathomimetic drugs cause the release of catecholamines, including norepinephrine, having a vasoconstrictor effect, thereby increasing blood pressure. With a significant increase in blood pressure medication treatment Xymelin Extra should be canceled and hold symptomatic treatment. When concomitant administration of other drugs with anticholinergic activity, may increase the anticholinergic effects of ipratropium bromide. The above interactions have been studied individually for both of the active substances belonging to the Extra Xymelin drug. In the above combination has not been studied for interaction of both active substances.
Overdose
Following intranasal application of the preparation Xymelin Extra acute overdose is unlikely because absorption of the drug is extremely small. In case of overdose ksilometazolina clinical picture is characterized by dizziness, nausea, sweating, low body temperature, headache, bradycardia, disturbance of accommodation, hypertension, respiratory depression, coma, convulsions. Hypertension may be replaced by hypotension. Symptomatic treatment should be carried out under the supervision of a physician. Excessive use of ipratropium bromide overdose is unlikely due to the negligible absorption of substances in the blood, but can develop dry mouth, difficulty of accommodation, tachycardia. Treatment is symptomatic. A considerable overdose can cause symptoms associated with anticholinergic activity of the drug from the CNS, including hallucinations, to eliminate assigning cholinesterase inhibitors. Appropriate supportive measures should be taken in any suspected overdose. If necessary, show the immediate symptomatic treatment under the supervision of a physician. These measures should include observation of the patient within six hours. In case of severe poisoning with cardiac arrest CPR should be continued for at least 1 hour.
pharmachologic effect
Pharmacological group:
Decongestant agent.
Pharmacodynamics:
Xylometazoline refers to a group of local vasoconstrictive agents (decongestants) with alpha-adrenomimeticheskim action causes vasoconstriction of nasal mucosa, thereby eliminating, mucosal swelling and nasal congestion. Relieves nasal breathing in rhinitis. Ipratropium bromide possesses anticholinergic effect. At intranasal application reduces the secretion of glands nasal mucosa. At therapeutic concentrations does not irritate, does not cause flushing. Effect of the drug occurs within 5 – 10 minutes and lasts for 6 – 8 hours.
Pharmacokinetics:
Intranasal application of Ipratropium bromide and Xylometazoline hydrochloride is little absorbed and are present in blood plasma in minor amounts.
Pregnancy and breast-feeding
Use of the drug during pregnancy and breast-feeding period is contraindicated.
Conditions of supply of pharmacies
Without recipe.
side effects
The classification of the frequency of occurrence of adverse reactions: very often (> 1/10); common (> 1/100,
special instructions
Before use, clean the nasal passages. It should not be used for a long time, for example, in chronic rhinitis. Patients should be cautioned against spray formulation Xymelin Extra eyes or around the eyes. Eye drug wash with cold water. If symptoms worsen or the patient’s condition does not improve within 3 days of ksimelin Extra should consult a physician.
Effects on ability to drive vehicles and use machinery
Use of the drug at therapeutic doses does not affect the ability to drive vehicles and use machinery. Overdose or penetration of the drug into the eye may affect the ability to drive vehicles and use machinery.
Storage conditions
Store at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Intranasally. For individuals and patients older than 18 years: 1 injection in each nostril, 3 times a day. Between injections must be at least 6 hours. The drug is administered not more than 7 days without consulting a doctor. Prior to starting the spray click on a pump dispensing device several times before the full dose. During further use additional activation of the metering device is not required. If there is an uneven dosing spray or a break in the use of the drug was more than 9 days it is necessary to press a few times on a pump dispensing device to activate it before the full dose. It is recommended to discontinue treatment immediately after the relief of symptoms, even if it occurred earlier than 7 days (maximum duration of therapy) in order to minimize the risk of adverse events. Prolonged use of Xylometazoline can cause swelling of the nasal mucosa and increase secretions, which is due to the development of hypersensitivity of cells to the active ingredients of the preparation, the effect of the so-called “rebound”. Use in the elderly: the experience of the drug in people older than 70 years is limited. Single-spraying drug Xymelin Extra contains about 70 micrograms xylometazoline hydrochloride and 84 mg of ipratropium bromide.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist