Name:
Nixar tablets 20mg in a blister. in pack. No. 10х3
Description:
Tablets of white color, oval, biconvex, with one-sided risk for division. The main active ingredient Bilastin Release form 10 tablets are placed in a blisters made of aluminum. 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 renal insufficiency (GFR 30-50 ml / min / 1.73 m2) and severe severity (GFR < 30 ml / min / 1.73 m2), simultaneous use with P-glycoprotein inhibitors may lead to an increase in concentration bilastine in plasma, which increases the risk of side effects. In this regard, in patients with moderate to severe renal insufficiency, care must be taken while using bilastine with P-glycoprotein inhibitors (ketoconazole, erythromycin, cyclosporine, ritonavir, diltiazem, etc.). Influence on the ability to drive transport. cf. and fur.: In a study conducted to assess the effect of bilastine at a dose of 20 mg on the ability to drive vehicles, no negative effect of the drug was found. However, patients should be warned that in very rare cases, dizziness, drowsiness may occur, which in turn may affect the ability to drive vehicles or perform other activities that require increased concentration. If the described adverse events occur, you should refrain from performing these activities. Pharmacological action Antiallergic agent - H1-histamine receptor blocker Pharmacodynamics Bilastine - long-acting antihistamine, selectively blocks peripheral H1 receptors. A significant therapeutic effect is observed one hour after taking the drug, the antihistamine effect persists for 24 hours. Bilastine may slightly penetrate the blood-brain barrier, but bilastine does not have a significant effect on the central nervous system and does not cause a sedative effect. It has no anticholinergic effect. There is no prolongation of the QT interval on the ECG. Pharmacokinetics Absorption. After oral administration, bilastine is rapidly absorbed from the gastrointestinal tract. The time to reach the maximum plasma concentration (TCmax) is 1.3 hours. The bioavailability of bilastine when taken orally is 61%. Simultaneous food intake reduces the bioavailability of bilastine by 30%. Cumulation of the drug is not observed. Communication with blood plasma proteins - 84-90%. Metabolism and excretion. Bilastine is metabolized slightly, after a single application, up to 95% of bilastine from the dose taken is excreted unchanged by the kidneys (28.3%) and bile (66.5%). The half-life (T1 / 2) averages 14.5 hours. With moderate renal failure (glomerular filtration rate (GFR) 30-50 ml / min / 1.73 m2) and severe severity (GFR < 30 ml / min / 1.73 m2), the rate of elimination of bilastine slows down, which can lead to an increase in the concentration of bilastine in the blood plasma. Changes in pharmacokinetic parameters do not affect the safety profile of bilastine, since the plasma concentration of bilastine in patients with renal insufficiency remains within acceptable limits. In liver failure, there are no clinically significant changes in the pharmacokinetic parameters of bilastine, since bilastine is slightly metabolized in the liver. The pharmacokinetic parameters of bilastine in elderly patients are similar to those in young patients. 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 Inside. Unless otherwise prescribed by a doctor, the following doses of Nixar are recommended for the relief of symptoms of allergic rhinoconjunctivitis and urticaria: Adults and children over 12 years old: 1 tablet of Nixar, which corresponds to 20 mg of bilastine, once a day. The maximum daily dose of bilastine is 20 mg, since increasing the dose does not lead to an increase in the therapeutic effect. The tablet is taken one hour before a meal or 2 hours after a meal (or fruit juice). In allergic rhinoconjunctivitis, the drug is used during the entire period of contact with allergens. With urticaria, treatment is continued until the symptoms disappear or alleviate. In patients with impaired liver and kidney function, dose adjustment is not required. In elderly patients, dose adjustment is not required. Experience with the use of Nixar® in people over 65 years of age is negligible. Use during pregnancy and lactation The drug is contraindicated during pregnancy and lactation. Interaction with other drugs With the simultaneous use of bilastine with ketoconazole or erythromycin, the area under the concentration-time curve (AUC) of bilastine increased by 2 times, and the maximum concentration (Cmax) - by 2-3 times. With the simultaneous use of bilastine at a dose of 20 mg and diltiazem at a dose of 60 mg, the Cmax of bilastine increased by 50%. Such effects can be explained by the interaction at the level of carrier proteins (including P-glycoprotein) responsible for the excretion of drugs from intestinal cells, the substrate of which is bilastine. With the simultaneous use of bilastine and other drugs that are substrates or inhibitors of P-glycoprotein (for example, cyclosporine), the concentration of bilastine in the blood plasma may increase. Grapefruit and other fruit juices reduce the bioavailability of bilastine by 30%. This interaction is due to the ability of fruits to suppress the activity of the OATP1A2 organic anion carrier protein, for which bilastine is a substrate. Drugs that are substrates or inhibitors of OATP1A2 (for example, ritonavir or rifampicin) may reduce the plasma concentration of bilastine. Bilastine does not enhance the effect of ethanol on the central nervous system. With the simultaneous use of bilastine and lorazepam, no suppressive effect of lorazepam on the central nervous system was revealed. Contraindications Hypersensitivity to bilastine or auxiliary components of the drug; - age up to 12 years (efficacy and safety have not been established); - pregnancy and breastfeeding period. Composition Active substance: 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. OverdoseSymptoms: when using bilastine at a dose exceeding the recommended one by 10-11 times, side effects occurred 2 times more often than when using placebo. The following symptoms were most often noted: dizziness, headache, nausea. No serious side effects, including significant prolongation of the QT interval, were noted. Treatment: symptomatic and supportive therapy. There is no specific antidote. 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). C. Buy Nixar tablets 20mg №10x3 Price for Nixar tablets 20mg №10x3Instruction for use for Nixar tablets 20mg №10x3
INN | BILASTIN |
---|---|
The code | 80 734 |
Barcode | 4 013 054 022 894 |
Active substance | Bilastin |
Manufacturer | A. Menarini Manufactch. Logistics and Serv. S.r.l., Italy |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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