Similar drugsTo uncover Dosage form: & nbspPills. Composition:Active substance: R (+) - Ondansetron hydrochloride dihydrate 2.25 mg or 4.50 mg, calculated as R (+) - Ondansetron 2.0 mg or 4.0 mg; auxiliary substances: starch 5.0 mg, lactose monohydrate 20.0 mg, cellulose microcrystalline 35.95 / 33.70 mg, silicon dioxide colloid 3.0 mg, carboxymethyl starch sodium 5.0 mg, magnesium stearate 0.8 mg. Description:Round biconvex tablets of white color with an engraving "2" for tablets of 2 mg or "4" for tablets of 4 mg. Pharmacotherapeutic group:Antiemetic means - serotonin receptor antagonist. Pharmacodynamics:Ondansetron is a selective antagonist of 5-HT3 receptors of serotonin. Clinical studies have shown that the isolated R (+) isomer has a more pronounced pharmacological effect than S (-) - Ondansetron. Drugs for cytostatic chemotherapy and radiotherapy can cause an increase in serotonin concentration, which, by activating the afferent fibers of the vagus nerve, containing 5-HT3 receptors, causes a vomiting reflex. R (+) - Ondansetron has a great affinity for the serotonin 5-HT3 receptors of central neurons (the vomiting center) and the peripheral (gastrointestinal tract) of the nervous system that regulate the gag reflex.Does not disrupt the coordination of movements, does not cause sedation and reduced efficiency. Does not change the concentration of prolactin in the plasma. Pharmacokinetics:After oral administration ondansetron completely absorbed in the gastrointestinal tract and subjected to the effect of "first passage" through the liver. Bioavailability is about 60%. The maximum concentration in the blood plasma is achieved through 1.31+0.53 hours and averages 22.87+4.05 ng / ml after taking the drug at a dose of 4 mg.Bioavailability of the drug is slightly increased with simultaneous intake with food, but does not change when taking antacids. The distribution of ondansetron when administered orally, intravenously or intramuscularly is the same. The volume of distribution when an equilibrium state is reached is about 140 liters. Ondansetron and its metabolites accumulate in breast milk. Binding to blood plasma proteins - 70-76%.Ondansetron is eliminated from the body, mainly as a result of liver metabolism involving several microsomal isozymes (CYP1A2, CYP2D6, CYP3A4). The absence of the CYP2D6 isoenzyme does not affect the pharmacokinetics of ondansetron.Less than 5% of the administered dose is excreted by the kidneys unchanged. The half-life is 3 hours. The pharmacokinetic parameters of ondansetron do not change when it is repeated.Pharmacokinetics in special clinical casesIn children, the values of clearance and volume of distribution depend on age. Correction of dose taking into account the patient's body weight (from 0.05 mg / kg to 2 mg maximum) compensates these changes and normalizes the system exposure of ondansetron in children.In patients with moderate renal insufficiency (creatinine clearance 15-60 ml / min) systemic clearance and volume of distribution are reduced, which leads to a small and clinically insignificant increase in the half-life (T1 / 2 - 5.4 hours).In patients with severe impairment of renal function on hemodialysis, the pharmacokinetics of ondansetron is virtually unchanged.In patients with severe hepatic insufficiency significantly decreases ondansetron clearance, resulting in a half-life increases (up to 15-32 hours), and oral bioavailability reaches 100% due to a decrease in the systemic metabolism.In elderly people there is a slight increase in bioavailability to 65% and a half-life of up to 5 hours.The distribution of ondansetron depends on sex, women have a higher intake absorption, as well as a lower systemic clearance and volume of distribution. Indications:- Prevention and management of nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy. - Prevention and relief of nausea and vomiting in the postoperative period (for adults). Contraindications:- Hypersensitivity to ondansetron or to any other component of the drug.- Children under 4 years of age (for a dosage of 2 mg).- Children under 12 years (for a dosage of 4 mg).- Pregnancy and the period of breastfeeding. Carefully:Patients with hereditary lactose intolerance, congenital lactase deficiency or glucose-galactose malabsorption. Pregnancy and lactation:contraindicated Dosing and Administration:The drug is intended for oral administration.The choice of the dosage regimen is determined by the severity of the emetogenic effect of the antitumor therapy.For adults and children from 12 years old The daily dose, as a rule, is 4-12 mg.For children from 4 to 12 years The daily dose is 2-6 mg.The following modes are recommended:With moderate expression of the emetogenic effect of chemo- or radiotherapy: - adults and children from 12 years old prescribe 4 mg of the drug Rondaset 1-2 hours before the start of the main therapy, followed by taking another 4 mg orally after 12 hours; children from 4 to 12 years old prescribe 2 mg of the drug Rondaset 30 minutes before the start of the main therapy, followed by taking another 2 mg orally every 8 hours.Data on the use of radiotherapy in children under 12 years are absent.If the emetogenic effect of chemotherapy or radiotherapy is high Recommended dose for adults (data on use in children are absent) is 12 mg concomitantly with dexamethasone orally at a dose of 12 mg 1-2 hours before the start of chemotherapy.To prevent late or prolonged vomitingAdults should continue taking Rondaset inside at a dose of 4 mg 2 times a day for 5 days after the end of the main therapy.Children ondansetron is administered at a dose of 5 mg / m2 body surface intravenously for at least 15 minutes immediately before the start of chemotherapy, followed by oral administration of 2 mg of Rondaset in 12 hours; treatment is recommended to continue at a dose of 2 mg 2 times a day inside for 5 days.Prevention of postoperative nausea and vomiting:- Adults are prescribed 8 mg orally 1 hour before the start of general anesthesia;- children to prevent and stop postoperative nausea and vomiting ondansetron only applied parenterally.Patients of advanced age.A dose change is not required.Patients with impaired renal function Change the usual daily dose and the frequency of taking the drug is not required.Patients with impaired hepatic functionThe daily dose should not exceed 4 mg per day.Patients with a slow metabolism of sparteine / debrisoquineCorrection of a daily dose or frequency of ondansetron is not required. Side effects:From the immune system: urticaria, bronchospasm, laryngospasm, angioedema, immediate-type hypersensitivity reactions, sometimes severe, including anaphylaxis.From the nervous system: headache, dizziness, convulsions, spontaneous movement disorders, including extrapyramidal disorders (dystonic reactions, oculogic crisis, dyskinesia), which are reversible and do not lead to persistent clinical consequences.From the cardiovascular system: pain in the chest, in some cases with depression of the S-T segment, arrhythmias, bradycardia, lowering of blood pressure.From the digestive system: hiccough, dry mouth, diarrhea, constipation, asymptomatic transient increase in the activity of "liver" enzymes.Other: sensation of fever and redness of the skin of the face, hypokalemia, hypercreatininaemia; temporary reduction of visual acuity. Overdose:Symptoms: visual impairment, constipation, lowering of arterial pressure and vasovagal episode with transient atrioventricular blockade of the II degree. In all cases, the phenomena are completely reversible.Treatment: conduct symptomatic and supportive therapy, a specific antidote is not known. Interaction:As ondansetron is metabolized by the enzyme system (cytochrome P450) of the liver, caution is required when combined:- with inducers of cytochrome P450 (isozymes CYP2D6 and CYP3A) - barbiturates, carbamazepine, carisoprodol, glutetimide, griseofulvin, dinitrogen oxide, papaverine, phenylbutazone, phenytoin (probably other hydantoins), rifampicin, tolbutamide;- with inhibitors of cytochrome P450 (isozymes CYP2D6 and CYP3A) - allopurinol, macrolide antibiotics, antidepressants (monoamine oxidase inhibitors), chloramphenicol, cimetidine, estrogen-containing oral contraceptives, diltiazem, disulfiram, valproic acid and its salts, erythromycin, fluconazole, fluoroquinolones, isoniazid, ketoconazole, lovastatin, metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil.Special studies have shown that ondansetron does not interact with ethanol, temazepam, furosemide and propofol.Data from special studies indicate that ondansetron can reduce the anesthetic effect of tramadol. Special instructions:As ondansetron slows the bowel motility, patients with symptoms of subacute intestinal obstruction require regular monitoring of the doctor.In tableted form ondansetron It can not be used to prevent and treat postoperative nausea and vomiting in children after surgery. Effect on the ability to drive transp. cf. and fur:In case of adverse reactions from the nervous system, patients are advised to refrain from driving and other mechanisms, as well as activities that require concentration,tension of psychomotor functions. Form release / dosage:Tablets 2 mg and 4 mg. Packaging:For 10 tablets in a blister of PVC / PVDC / Aluminum foil. For 1, 3 or 15 blisters in a cardboard box with instructions for use. Storage conditions:In dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children! Shelf life:2 years. Do not use after the expiration date printed on the package. Terms of leave from pharmacies:On prescription Registration number:LP-000108 Date of registration:24.12.2010 The owner of the registration certificate:Actavis PTS ehf GroupActavis PTS ehf Group Iceland Manufacturer: & nbspEMCURE PHARMACEUTICALS Ltd India Representation: & nbspACTAVIS GROUP AO ACTAVIS GROUP AO Iceland Information update date: & nbsp04.06.2013 Illustrated instructions × Illustrated instructions Instructions