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Arlevert instructions for use

Arlevert is a combination drug that acts on the nervous system. Dimenhydrinate, the chlortheophylline salt of diphenhydramine, acts as an antihistamine with anticholinergic (M-anticholinergic) activity, parasympatholytic effects and a central depressant effect. By acting on the chemoreceptor trigger zone in the 4th ventricle, dimenhydrinate suppresses the urge to vomit and dizziness. So, dimenhydrinate affects mainly the central vestibular system. Due to its ability to block calcium receptors, cinnarizine inhibits the entry of calcium into vestibular sensory cells, thereby acting as a vestibulolytic agent. Thus, cinnarizine affects mainly the peripheral vestibular system. Both cinnarizine and dimenhydrinate are known to treat dizziness. According to test results, the combined product is superior in its effectiveness to each of these drugs separately. This drug has not been studied as a remedy for motion sickness. Pharmacokinetics: Absorption and distribution. After dimenhydrinate is administered internally, diphenhydramine is rapidly released. Diphenhydramine and cinnarizine are rapidly absorbed from the gastrointestinal tract. In humans, maximum plasma concentrations of cinnarizine and diphenhydramine (Cmax) are achieved within 2-4 hours. The half-life of both substances from plasma is from 4 to 5:00 (despite whether they are used separately or as part of a combination drug). Metabolism. Cinnarizine and diphenhydramine are extensively metabolized in the liver. Cinnarizine is metabolized through cycle hydroxylation reactions, partially catalyzed by the cytochrome isoenzyme CYP2D6, and N-dealkylation reactions, for which cytochrome isoenzymes exhibit low selectivity. The main metabolic pathway of diphenhydramine is sequential N-demethylation of the tertiary amine. In vitro studies on microsomal fractions from human liver indicate that these reactions occur with the participation of various cytochrome isoenzymes, including the CYP2D6 enzyme. Since both active components of the drug Arlevert are intensively metabolized by hepatic enzymes of the cytochrome P450 system, in patients with severe liver dysfunction, plasma concentrations of the components (unchanged) and their half-life increase. Regarding diphenyldihydramine, this has been shown in patients with cirrhosis. Conclusion. Cinnarizine is excreted mainly in feces (40-60%) and partially in urine (mainly in the form of metabolites conjugated with glucuronic acid). Diphenhydramine is excreted in the urine and mainly in the form of metabolites; the main metabolite (40-60%) is a deaminated derivative - diphenylmethoxyoctic acid. Diphenhydramine is excreted exclusively through the kidneys, so Arlevert should not be used in patients with severe renal impairment (CrCl £ 25 ml/min). Indications for use: Arlevert is used in the symptomatic treatment of dizziness of various origins.

Directions for use: Adults take Arlevert 1 tablet 3 times a day. Take the tablets after meals, without chewing, with a small amount of liquid, for example ½ glass of water. Elderly patients. No dose adjustment is required. For kidney dysfunction. Arlevert should be used with caution in patients with mild to moderate renal impairment. For liver disease. Studies of the use of the drug in patients with impaired liver function have not been conducted. In general, the duration of use of the drug should not exceed 4 weeks. The decision about longer treatment should be made by the doctor. It is not recommended for children to use the drug due to the lack of data on its use.

Side effects: The side effects most commonly observed in clinical trials were confusion (including drowsiness, tiredness, fatigue, confusion), observed in 8% of patients, and dry mouth, which was observed in 5% of patients. Typically, these reactions are mild and disappear within a few days, even after prolonged use. Side effects that occurred during the use of the drug Arlevert, according to clinical trials and further spontaneous reports, are shown in the table: From the blood and lymphatic system: leukopenia, thrombocytopenia, aplastic anemia. From the immune system: allergic reactions (for example, skin reactions). From the nervous system: drowsiness, headache, paresthesia, amnesia, tinnitus, tremor, nervousness, convulsions. From the organs of vision: visual impairment. From the digestive system: dry mouth, abdominal pain, dyspepsia, nausea, diarrhea. From the skin and subcutaneous fat: sweating, rash, photosensitivity. From the kidneys and urinary tract: difficulty urinating. In addition, the following adverse reactions are associated with the use of dimenhydrinate and cinnarizine: Dimenhydrinate: paradoxical excitability, worsening of existing closed-angle glaucoma, reversible agranulocytosis, dizziness, possible blurred vision, diplopia, tinnitus, tachycardia, arrhythmia, angina attacks, arterial hypotension, constipation, increased appetite, rash, urticaria, angioedema, arthralgia, decreased sweating, dry mucous membranes. Cinnarizine: constipation, weight gain, chest tightness, cholestatic jaundice, extrapyramidal disorders, skin reactions resembling systemic lupus erythematosus, lichen planus, hypersomnia, lethargy, dyskinesia, parkinsonism, gastric discomfort, vomiting, muscle rigidity. The medical literature mentions a special case of obstructive jaundice. In elderly patients, during long-term treatment, cases of intensification or appearance of extrapyramidal symptoms, sometimes in combination with depressive states, have been observed. In such cases, the use of this remedy should be discontinued.

Contraindications: Contraindications to the use of the drug Arlevert are: allergic reactions to the active ingredients, diphenhydramine or other antihistamines of a similar structure, or to any excipient; severe renal impairment (creatinine clearance £ 25 ml/min); severe liver dysfunction; glaucoma; convulsions; suspicion of increased intracranial pressure; alcoholism; urinary retention caused by disorders of the urethra and prostate gland; convulsions (eg eclampsia, epilepsy), acute asthma attack, pheochromocytoma, porphyria.

Pregnancy: The safety of Arlevert for pregnant women has not been established. Dimenhydrinate may have a stimulating effect on the uterine musculature and shorten the duration of labor, so Arlevert should not be used during pregnancy. Breastfeeding period. Dimenhydrinate and cinnarizine pass into mother's breast milk, so Arlevert should not be used by breastfeeding women.

Interaction with other drugs: The anticholinergic and sedative effectiveness of Arlevert may be enhanced by the use of MAO inhibitors. The effect of the drug can be enhanced by procarbazine. Like other antihistamines, Arlevert can enhance the sedative effect of drugs that depress the central nervous system, in particular alcohol, barbiturates, narcotic analgesics and tranquilizers. Patients should be warned not to drink alcoholic beverages. Arlevert can also enhance the effect of antihypertensive drugs, ephedrine and anticholinergic drugs, in particular atropine and tricyclic antidepressants. Arlevert can mask the manifestations of the ototoxic effect of aminoglycoside antibiotics and the skin reaction to skin allergy tests. Considering that Arlevert can mask positive reactions regarding skin reactivity factors during a skin test, its use should therefore be discontinued 4 days before the test after consultation with a doctor. The simultaneous use of drugs that prolong the QT interval on the ECG (for example, class IA and III antiarrhythmic drugs) should be avoided. There is not enough information on the possible pharmacokinetic interaction of cinnarizine and diphenhydramine with other drugs. Diphenhydramine suppresses metabolic processes mediated by the cytochrome CYP2D6 isoenzyme, therefore, caution is recommended when using Arlevert in combination with substrates of this enzyme (especially those with a narrow therapeutic range).

Overdose: Symptoms of Arlevert overdose include drowsiness, dizziness and ataxia in combination with such manifestations of anticholinergic action as dry mouth, facial flushing, dilated pupils, tachycardia, fever, headache and urinary retention. Complications such as convulsions, hallucinations, agitation, respiratory depression, arterial hypertension, tremors and coma (especially in cases of severe overdose) may also occur. Treatment. In case of respiratory depression or acute circulatory failure, the patient should be given supportive therapy. It is recommended to rinse the stomach with saline sodium chloride solution. Body temperature should be closely monitored, as antihistamine intoxication can lead to fever (especially in children). For cramping pain, short-acting barbiturates can be prescribed, but they should be used with caution. In case of pronounced anticholinergic effects on the central nervous system, a test with physostigmine should be carried out, and then physostigmine should be administered by slow infusion (or, if necessary, by injection) at a dose of 0.03 mg / kg body weight (maximum dose for adults - 2 mg, the maximum dose for children is 0.5 mg). Dimenhydrinate can be removed from the blood using hemodialysis, but this method of treatment in case of overdose is considered unacceptable. The required amount of the drug can be removed from the blood using hemoperfusion using activated charcoal. There are no data on the removal of cinnarizine by hemodialysis. Symptoms of cinnarizine overdose. In rare cases of acute overdose (from 90 to 2250 mg), the following manifestations were observed: changes in consciousness from drowsiness to stupor and coma, vomiting, extrapyramidal symptoms, arterial hypotension. A small number of children experienced seizures. In most cases, the clinical outcome was not severe, but deaths have been reported after overdose when used concomitantly with other drugs, including cinnarizine. Treatment for overdose of cinnarizine. There is no specific antidote. During the first hour after ingestion, gastric lavage is necessary. According to indications, activated carbon can be prescribed. Symptoms of an overdose of Dimenhydrinate: dry nose, throat, rash, arrhythmia, a sharp decrease in blood pressure with possible loss of consciousness, depression of the central nervous system or agitation with hallucinations, convulsions. Rarely, the following may occur: blurred vision, tinnitus, difficulty urinating, stomach pain, increased or decreased appetite.

Storage conditions: Special storage conditions are not required. Keep out of the reach of children.

Release form: Arlevert - tablets of 20; 40 mg. Packaging: 15 or 20 or 25 tablets in a blister, 1 blister of 20 tablets or 2 blisters of 15 tablets or 2 or 4 blisters of 25 tablets in a cardboard box.

Composition: 1 tablet Arlevert contains cinnarizine 20 mg and dimenhydrinate 40 mg. Excipients: microcrystalline cellulose, corn starch, talc, hypromellose, colloidal silicon dioxide, magnesium stearate, croscarmellose sodium.

Additionally: Arlevert does not cause a significant reduction in blood pressure, however, it should be used with caution in patients with low blood pressure. To minimize stomach irritation, Arlevert should be taken after meals. Arlevert should be used with caution in patients with diseases or conditions that may be aggravated by the use of anticholinergic drugs, for example in patients with increased intraocular pressure, obstruction of the pylorus of the stomach and duodenum, prostatic hypertrophy, arterial hypertension, thyrotoxicosis or severe coronary heart disease . Arlevert should be used with caution in patients with Parkinson's disease. Since Arlevert may cause drowsiness, especially at the beginning of treatment, concomitant use of alcohol, CNS antidepressants or tricyclic antidepressants should be avoided. Arlevert should be avoided if you have porphyria. Arlevert should be used with caution in patients with hepatic or renal impairment. The ability to influence the reaction rate when driving a vehicle or working with other mechanisms. Arlevert may cause drowsiness, loss of coordination, dizziness, and increased reaction time, especially at the initial stage of treatment. In such cases, patients should not drive vehicles or operate machinery.