Index of drugs

Adults. Prevention and treatment of nausea and vomiting caused by cytotoxic chemotherapy and radiotherapy. Prevention and treatment of post-operative nausea and vomiting (PONV).Children and youth. Treatment of nausea and vomiting induced by chemotherapy (CINV) in children ≥6 months and prevention and treatment of post-operative nausea and vomiting (PONV) in children ≥1 months.

1 ml of solution contains 2 mg ondansetron as dihydrochloride hydrochloride. 1 ml of solution contains 3.34 mg of sodium in the form of citrate and chloride.

A strong, highly selective antagonist of 5-HT serotonin receptors₃ neurons located in both peripheral and o.u.n. Chemotherapy and radiotherapy can cause the release of 5HT in the small intestine, triggering the gag reflex by stimulating the central nerve fibers through the 5-HT receptors₃. Ondansetron blocks the initiation of this reflex. Stimulation of centrifugal vagal fiber may also cause the release of 5-HT in the area located in the bottom of the fourth chamber of the brain, which can also cause vomiting of central origin. The mechanism of action of ondansetron in vomiting of the perioperative period is unknown, but it seems to be similar to that described in the case of nausea and vomiting induced by cytotoxic drugs. Ondansetron does not affect the concentration of prolactin in the blood. After intravenous infusion over 5 min C_max in the blood is about 65 ng / ml. Ondansetron is 70-76% bound to plasma proteins. It is metabolized in the liver. Less than 5% of the absorbed dose is excreted in the urine in unchanged form. T_0,5 is 3 hours. In patients with severe hepatic impairment, clearance of ondansetron is significantly reduced and the half-life extended to 15-32 hours.

Hypersensitivity to the active substance or to any of the excipients. Concomitant use with apomorphine (risk of deep hypotension and unconsciousness).

Hypersensitivity reactions have been reported in patients who have been hypersensitive to other selective 5-HT receptor antagonists₃. In case of respiratory distress, symptomatic treatment should be used and caution should be exercised because these disorders may be harbors of hypersensitivity reactions. The use of ondansetron in patients with congenital long QT syndrome should be avoided. Caution should be exercised in patients with risk factors for QT prolongation or arrhythmias: electrolyte disturbances, congestive heart failure, bradyarhythmias, use of other QT prolonging agents (including cytotoxic agents) or drugs that may lead to electrolyte imbalance and the use of drugs that reduce the rate of heart rhythm. The hypokalemia and hypomagnesaemia should be corrected prior to administration of ondansetron. Ondansetron increases intestinal transit time - patients with symptoms of subacute intestinal obstruction should be observed after administration of ondansetron. In patients undergoing tonsillectomy, the use of ondansetron to prevent nausea and vomiting may mask latent bleeding - these patients should be carefully observed. Children receiving ondansetron with chemotherapeutic agents with hepatic toxicity should be closely monitored for liver dysfunction. In patients with reduced renal function and patients on a sodium-containing diet, the sodium in the formulation should be included (2.3 mmol, i.e., 53.5 mg sodium / dose).

Pregnancy is not recommended. In animals, it has been shown that ondansetron is excreted in milk, therefore it is recommended that mothers receiving ondansetron do not breastfeed.

Very common: headache. Common: feeling hot, flushing, constipation, hypersensitivity reaction around the injection site. Uncommon: convulsions, disorders with involuntary movements (such as extrapyramidal reactions, e.g.dystonic reactions, forcible eyes and eye rotation and dyskinesia), arrhythmia, chest pain with or without ST depression, bradycardia, hypotension, hiccups, asymptomatic increases in liver function (often in patients receiving cisplatin). Rare: immediate type hypersensitivity reactions (sometimes severe, including anaphylactic reactions), dizziness during rapid intravenous administration, transient visual disturbances (e.g. blurred vision, mainly during rapid administrationLv.), prolongation of the QTc interval (including ventricular tachycardiatorsade de pointes). Very rare: temporary blindness (mainly during administrationLv.; most of the incidents resolved within 20 min, most of the patients who had this symptom were taking chemotherapy, including cisplatin; some cases of transient blindness were of cortical origin). The types and frequency of side effects in children and adolescents were comparable to those in adults.

Intravenously. VACCINES OF CHEMOTHERAPY AND RADIOTHERAPY.aDULTi. The selection of the dosing schedule should depend on the degree of severity of vomiting.Chemotherapy and radiotherapy with emetic effects. For patients receiving chemotherapy and irradiation therapy, ondansetron can be administered intravenously or orally. When administered intravenously, the dose is 8 mg administered as an intravenous injection lasting at least 30 seconds immediately prior to treatment. To prevent nausea and delayed or prolonged vomiting after 24 hours, ondansetron should be continued orally or rectally.Chemotherapy with strong vomiting, e.g. high doses of cisplatin. Intravenously in a single dose of 8 mg immediately before chemotherapy. Doses higher than 8 mg up to a maximum of 16 mg may be given only as an infusion lasting not less than 15 minutes and diluted in 50-100 ml of 0.9% sodium chloride solution or other appropriate solution for injection. Do not administer single doses greater than 16 mg due to the risk of dose-dependent prolongation of the QT interval. Patients receiving high emetogenic chemotherapy, 8 mg may be given by slow intravenous injection of at least 30 s followed by 2 consecutive intravenous doses of 8 mg each, separated by 4 h or by continuous intravenous infusion at 1 mg / h to 24 h. The efficacy of ondansetron can be increased by adding a single intravenous dose of 20 mg Dexamethasone phosphate sodium before chemotherapy. To prevent delayed or prolonged vomiting after the first 24 h, ondansetron should be continued orally or rectally.Children ≥6 months and adolescents. Nausea and vomiting caused by cancer chemotherapy. The dose of ondansetron is calculated based on body surface area or body weight. The total daily doses calculated on the basis of body weight are usually greater than the doses calculated on the basis of the body surface area. Ondansetron can be diluted with 0.9% sodium chloride solution or other compatible solutions and administered as an intravenous infusion lasting at least 15 min (in clinical trials, diluted in 25-50 ml of 0.9% sodium chloride solution or other suitable solution). There are no data on the use of the preparation in children for the treatment of nausea and vomiting induced by radiotherapy and in the prevention of delayed or prolonged nausea and vomiting induced by chemotherapy.The dose calculated on the basis of the body surface area. The preparation should be administered intravenously, in a single dose of 5 mg / m² pc, immediately before the start of chemotherapy. The dose administered intravenously can not exceed 8 mg. After 12 hours, ondansetron may be started orally and continued for up to 5 days. The total daily dose can not be greater than the adult dose, i.e. 32 mg. Children on pc <0.6 m²: day 1 - 5 mg / m² pc.i.v. + 2 mg in syrup or tablet after 12 hours, days 2 - 6. - 2 mg in syrup or tablet every 12 hours. Children with pc. ≥ 0.6 m²: day 1 - 5 mg / m² pc.i.v. + 4 mg in syrup or tablet after 12 hours, days 2 - 6. - 4 mg in syrup or tablet every 12 hours.Dose calculated based on body weight. The preparation should be administered intravenously, in a single dose of 0.15 mg / kg, immediately before the start of chemotherapy. The dose administered intravenously can not exceed 8 mg. Two consecutive doses may be given intravenously at intervals of 4 hours. The total daily dose should not be greater than the adult dose, i.e. 32 mg.After 12 hours, ondansetron may be started orally and continued for up to 5 days. Children about the month of ≤10 kg: day 1 - up to 3 doses of 0.15 mg / kg every 4 hours, days 2 - 6. - 2 mg in syrup or tablet every 12 hours. Children at birth. > 10 kg: day 1 - up to 3 doses of 0.15 mg / kg every 4 hours, days 2 - 6. - 4 mg in syrup or tablet every 12 hours.Special groups of patients. In patients from 65 to 74 years old, dosages may be used as in other adult patients. In patients ≥75 years, the initial ondansetron dose of 8 mg should not be administered intravenously; then give intravenously at intervals of not less than 4 h two consecutive doses of 8 mg in the form of an infusion lasting not less than 15 minutes. In both age groups, all intravenous doses should be diluted in 50-100 ml of 0.9% sodium chloride intravenous infusion or other suitable infusion fluid and infused over an average of 15 min. In patients with impaired renal function and in patients with metabolic disorders spartein and debrisoquine no dosage adjustment is necessary. In patients with moderate or severe hepatic impairment, the maximum daily dose is 8 mg. NUDGES AND EVENTS OF THE POST-OPERATING PERIOD.Adults. Before entering the anesthesia, give a single dose of 4 mg by slow intravenous injection. In the postoperative period, a single dose of 4 mg given by slow intravenous injection is recommended for the treatment of nausea and vomiting.Children ≥1 months and adolescents. In order to prevent post-operative nausea and vomiting in children after surgery under general anesthesia, administer in a slow intravenous injection (lasting not less than 30 s) in a single dose of 0.1 mg / kg. (up to a maximum dose of 4 mg) before or after the introduction of anesthesia. In the postoperative period, administer in a slow intravenous injection (lasting not less than 30 s) in a single dose of 0.1 mg / kg. (up to a maximum dose of 4 mg). There are no data on the use of the drug in the treatment of post-operative nausea and vomiting in children under 2 years.Special groups of patients. Experience in elderly people is limited, but it is known that ondansetron is well tolerated by these patients. In patients with renal insufficiency and in patients with disturbed metabolism of sparteine ​​and debrisoquine, no dosage adjustment is necessary. In patients with moderate or severe hepatic impairment, the maximum daily dose is 8 mg.