Nixar tablets 20mg №10×1

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Nixar tablets 20mg in a blister. in pack. No. 10×1
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Oval-shaped tablets, with a biconvex surface, white, with a notch for division, without cracks or defects. 1, 2, 3, 4 or 5 contour packs, together with instructions for medical use in the state and Russian languages, are put into a pack of cardboard. Special instructions In patients with moderate or severe impaired renal function, the use of bilastine simultaneously with inhibitors of P-glycoprotein (ketoconazole, erythromycin, cyclosporine, ritonavir, diltiazem, etc.) can lead to an increase in the plasma concentration of bilastine and thereby increase the risk of its side effects. For this reason, bilastine should not be used concomitantly with P-glycoprotein inhibitors in patients with moderate to severe renal dysfunction. Fertility: Clinical data are limited or absent. Pregnancy and lactation Pregnancy: there are limited or no data on the use of bilastine in pregnant women. Lactation: there are no data on whether bilastine passes into breast milk in women. The excretion of bilastine in milk has not been studied in animals. The decision to continue or stop breastfeeding, as well as to continue or stop Nixar® therapy, should be made taking into account the benefits of breastfeeding for the child, on the one hand, and the mother’s need for bilastine therapy, on the other. Pediatric Use The safety and efficacy of bilastine in children under 12 years of age have not been established. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms According to a study that studied the effect of bilastine on the ability to drive a car, the use of bilastine at a dose of 20 mg does not affect the ability to drive vehicles. However, patients should be informed that in very rare cases the drug may cause drowsiness and thus affect the ability to drive vehicles and operate machinery and does not bind to M-cholinergic receptors. In clinical studies, it has been proven that in the case of a single application of bilastine for 24 hours, it suppresses histamine-induced skin reactions with wheals and erythema. Bilastine relieves the symptoms of allergic rhinoconjunctivitis (sneezing, nasal discharge, nasal itching, nasal congestion, itchy eyes, tearing and redness of the eyes). Patients experienced an improvement in well-being. Neither clinically significant prolongation of the QTc interval, nor other disorders of the cardiovascular system have been identified in clinical studies of bilastine. In controlled clinical trials in which bilastine was used at the recommended dose of 20 mg once daily, the CNS safety profiles of bilastine and placebo were similar. In clinical studies, bilastine, used in doses up to 40 mg 1 time per day, did not affect psychomotor functions and the ability to drive a car (in a standard driving test). In elderly patients (≥65 years of age), who were included in phase II and III studies, the efficacy and safety of the drug did not differ from those in younger patients. Pharmacokinetics Absorption After oral administration, Nixar is rapidly absorbed, and its maximum plasma concentration is reached approximately 1.3 hours after ingestion. Accumulation of the drug in the body was not detected. The average bioavailability of Nixar® when administered orally is 61%. Distribution When used in therapeutic doses, Nixar binds to plasma proteins by 84-90%. Biotransformation In in vitro studies, Nixar® did not show the ability to induce or inhibit the activity of cytochrome P450 isoenzymes. Elimination According to a study conducted in healthy volunteers, after a single dose of Nixar® at a dose of 20 mg, almost 95% of the administered dose was found in urine and feces (28.3% and 66.5%, respectively) as unchanged Nixar®, from which it follows that Nixar® is metabolized insignificantly in the human body. On average, the elimination half-life of Nixar® in healthy volunteers is 14.5 hours. Patients with impaired renal function The mean AUC and half-life of Nixar are increased in severe renal insufficiency. In almost all patients, 48-72 hours after taking Nixar® in the urine was not detected. Such changes in pharmacokinetics should not be of clinical significance and affect the safety of Nixar, since its plasma concentrations in patients with impaired renal function remain within safe limits. Patients with hepatic impairment No pharmacokinetic data are available for patients with hepatic impairment. Nixar® is not metabolized in the human body. A clinically significant effect of impaired liver function on the pharmacokinetics of Nixar seems unlikely. Elderly patients Data on the use of the drug in patients over 65 years of age are limited. The pharmacokinetic parameters of Nixar® in elderly patients and in young patients are not statistically significantly different. Indications for use Allergic (seasonal and year-round) rhinoconjunctivitis: elimination or relief of symptoms (sneezing, feeling of nasal congestion, itching of the nasal mucosa, rhinorrhea, burning sensation and itching in the eyes, redness of the eyes, lacrimation); urticaria: elimination or reduction of skin itching, rash. Dosage and Administration For oral administration Adults and adolescents (12 years of age and older) The recommended dose is 20 mg (1 tablet) once daily to relieve the symptoms of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria. The tablet should be taken orally 1 hour before or 2 hours after a meal or fruit juice. The daily dose is recommended to be taken at one time. Elderly patients Elderly patients do not need to adjust the dose. The experience of using the drug in patients older than 65 years is negligible. Children under 12 years of age The safety and efficacy of bilastine in children under 12 years of age have not been established. Impaired renal function Patients with impaired renal function do not need to adjust the dose. Impaired liver function There is no experience of clinical use of the drug in patients with impaired liver function. Since bilastine is not metabolized and is primarily excreted via the kidneys, impaired liver function should not increase its systemic exposure to dangerous levels. Therefore, patients with impaired liver function do not require dose adjustment. The duration of treatment is determined individually by the attending physician. Patients with allergic rhinitis should only use the drug during contact with allergens. For patients with seasonal allergic rhinitis, treatment can be stopped after resolution of symptoms and resumed after their return. For patients with perennial allergic rhinitis, the drug can be used continuously during the period of contact with allergens. In patients with urticaria, the duration of treatment depends on the nature and duration of the symptoms, as well as their dynamics. Use during pregnancy and lactation The drug is contraindicated during pregnancy and lactation. Interaction with other drugs Interaction with food: food reduces the bioavailability of bilastine after oral administration by 30%. Interaction with grapefruit juice: in the case of the use of bilastine at a dose of 20 mg simultaneously with grapefruit juice, the bioavailability of bilastine was reduced by 30%. A similar effect can be observed in the case of other fruit juices. The degree of reduction in bioavailability may vary depending on the manufacturer of the juice and the fruit from which it is derived. This interaction is due to the ability of fruit components to suppress the activity of the organic anion carrier protein OATP1A2, for which bilastine is a substrate. Drugs that are substrates or inhibitors of OATP1A2, such as ritonavir or rifampicin, can also reduce the plasma concentration of bilastine. Interaction with ketoconazole or erythromycin: in the case of taking bilastine simultaneously with ketoconazole or erythromycin, bilastine PFC increased by 2 times, and Cmax – by 2-3 times. Such effects can be explained by the interaction at the level of carrier proteins responsible for the excretion of drugs from intestinal cells, since bilastine is a substrate of P-glycoprotein and is not metabolized. The safety profile of bilastine, on the one hand, and ketoconazole or erythromycin, on the other, does not appear to be affected by these effects. Other drugs that are substrates or inhibitors of P-glycoprotein, for example, cyclosporine, can also increase the concentration of bilastine in plasma. Interaction with diltiazem: in the case of taking bilastine at a dose of 20 mg simultaneously with diltiazem at a dose of 60 mg, Cmax of bilastine increased by 50%. This effect can be explained by the interaction at the level of carrier proteins responsible for the removal of drugs from intestinal cells; the safety profile of bilastine does not appear to be affected by this effect. Interaction with alcohol: after the simultaneous use of alcohol and bilastine at a dose of 20 mg, psychomotor functions were at the same level as after the simultaneous use of alcohol and placebo. Interaction with lorazepam: in the case of the use of bilastine at a dose of 20 mg simultaneously with lorazepam at a dose of 3 mg for 8 days, no increase in the inhibitory effect of lorazepam on the central nervous system was detected. Contraindications hypersensitivity to the active substance (bilastine) and to any of the excipients children under 12 years of age pregnancy and lactation Ingredients Active ingredient: bilastine – 20.00 mg; Excipients: microcrystalline cellulose – 103.00 mg, sodium carboxymethyl starch (type A) – 1.00 mg, colloidal silicon dioxide – 0.50 mg, magnesium stearate – 0.50 mg. Opisaniye:Oval, biconvex tablets of white color, with one-sided risk for division. Side effects Possible side effects are listed below in descending frequency of occurrence: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (? 1/10000, < 1/1000), very rare (< 1/10000), including isolated reports. Gastrointestinal disorders Uncommon: dryness of the oral mucosa, diarrhoea, dyspepsia, gastritis, abdominal pain, upper abdominal pain, stomach discomfort, nausea. Skin and subcutaneous tissue disorders Uncommon: pruritus. Nervous system disorders Common: drowsiness, headache; Uncommon: dizziness. Psychiatric disorders Uncommon: anxiety, insomnia. Metabolic disorders Uncommon: increased appetite, weight gain. Hearing disorders and labyrinth disorders Uncommon: tinnitus, vertigo. Respiratory, thoracic and mediastinal disorders Uncommon: shortness of breath, dryness of the nasal mucosa, nasal discomfort. Cardiovascular disorders Uncommon: right bundle branch block, sinus arrhythmia, prolongation of the QT interval on the electrocardiogram, other changes on the electrocardiogram. Infectious and parasitic diseases Infrequently: herpetic lesions of the oral cavity. Other: Infrequently: thirst, fatigue, asthenia, fever, an increase in the concentration of triglycerides in the blood plasma, an increase in the concentration of creatinine in the blood plasma, an increase in the activity of "liver" enzymes (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase). Storage conditionsStore at a temperature not exceeding 30°C. Keep out of the reach of children! Buy Nixar tablets 20mg No. 10x1 Price for Nixar tablets 20mg No. 10x1