Index of drugs

Adults. Treatment of nausea and vomiting caused by cytotoxic chemotherapy and radiotherapy as well as prevention of nausea and vomiting in the postoperative period.Children. Treatment of nausea and vomiting caused by chemotherapy in children ≥ 6 months. Prevention and treatment of nausea and vomiting in the postoperative period in children ≥1 month.

1 tabl disintegrating in the mouth contains 4 mg or 8 mg of ondansetron. The preparation contains aspartame, sorbitol, Glucose and sulfur dioxide.

A strong, selective antagonist of 5-HT serotonin receptors₃ in neurons located in both the peripheral and central nervous systems. Chemotherapeutic agents and radiotherapy can cause the release of serotonin in the small intestine, triggering a gag reflex following stimulation through 5-HT receptors₃ centric fibers of the vagus nerve. Ondansetron inhibits the formation of this reflex. 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 change the plasma concentrations of prolactin. After oral administration, the drug is rapidly absorbed, the maximum plasma concentration occurs within 1.5 hours after administration of the 8 mg dose. Absolute bioavailability after tabling powl. and syrup is 60%. T_0,5 in the serum is 3 hours. Ondansetron is not strongly bound to serum proteins (70-76%) and is removed from the systemic circulation by metabolism in the liver, involving many metabolic pathways. Less than 5% of the absorbed dose is excreted in the urine in unchanged form.

Hypersensitivity to ondansetron or to other selective 5-HT receptor antagonists₃ (e.g., granisetron, dolasetron) or any of the excipients.

Patients with symptoms of subacute intestinal obstruction should be closely monitored after administration of the preparation, because the drug extends the time of intestinal transit. Due to the risk of ECG changes (including QT prolongation), caution should be exercised in patients with arrhythmias or conduction abnormalities, in patients receiving anti-arrhythmic or β-blockers, and in patients with significant electrolyte disturbances. When using the drug in children, special attention should be paid to respiratory events, as they may be precursors of hypersensitivity reactions (these events should be treated symptomatically). Children receiving ondansetron together with hepatotoxic agents should be carefully monitored for liver dysfunction. The preparation contains aspartame, which is a source of phenylalanine - it may be harmful for patients with phenylketonuria. The preparation contains sorbitol, mannitol and glucose - it should not be used in patients with rare hereditary disorders associated with fructose intolerance or glucose-galactose malabsorption syndrome. The essence of the fragrance contains sulfur dioxide, which in rare cases may cause severe hypersensitivity reactions and bronchospasm.

Ondansetron is not recommended during pregnancy. The drug is excreted in milk - it is recommended that mothers taking the preparation do not breastfeed.

Very common: headache. Common: constipation, burning sensation or sudden redness of the skin. Uncommon: cardiac arrhythmias, chest pain with or without ST segment depression in the ECG, bradycardia, convulsions, movement disorders (including extrapyramidal system symptoms, such as dystonic reactions, forcible eyes and eye rotation disorders and dyskinesia without significant , sustained effect on the clinical condition of the patient), hiccups, hypotension, asymptomatic elevation of liver enzymes (mainly in patients receiving chemotherapy with cisplatin). Rare: immediate hypersensitivity reactions (sometimes severe reactions including anaphylactic reactions), dizziness during intravenous administration, transient visual disturbances (eg blurred vision) during intravenous administration.Very rare: transient ECG changes (including QT prolongation), transient loss of vision (mainly during intravenous administration, in most cases, the eye blinds within 20 min, most patients have taken chemotherapy, including Cisplatin, in some cases transient loss of vision her cortical origin was described).

Orally.Nausea and vomiting caused by chemotherapy and radiotherapy. The route of administration and the dose of ondansetron should be selected individually depending on the type of radiotherapy and chemotherapy.Adults.
Chemotherapy with emetic effects and radiotherapy. Ondansetron can be administered either orally and intravenously. In the majority of patients, the drug should be administered intravenously, immediately before the start of treatment, and then orally at a dose of 8 mg every 12 hours. Oral use: 8 mg for 1 to 2 hours before the start of treatment, followed by 8 mg for 12 hours. vomiting delayed or prolonged after the first 24 h, oral therapy should be continued up to 5 days after the end of therapy. The recommended oral dose is 8 mg 2 times a day.Chemotherapy with strong vomiting. Ondansetron can be administered intravenously. To prevent delayed or prolonged vomiting after the first 24 h, oral therapy should be continued up to 5 days after the end of therapy. The recommended oral dose is 8 mg 2 times a day.Children and adolescents - nausea and vomiting induced by cancer chemotherapy in children ≥6 months and adolescents. The dosage can be determined based on the body surface or body weight. Dosage adjusted for body weight requires the use of higher daily doses than in the case of a dosage adapted to the body surface. There are no data from controlled clinical trials on the use of ondansetron in the prevention of delayed or prolonged emesis induced by chemotherapy and in the prevention of vomiting induced by radiotherapy in children.Dosage adapted to the body surface. Ondansetron should be given as a single intravenous dose of 5 mg / m² pc. immediately before chemotherapy. Oral administration of the drug at a dose appropriate to pc. continue to 5 days after the end of the course of treatment. Children on pc <0.6 m²: day 1 - 5 mg / m² pc. intravenously plus 2 mg in the form of syrup after 12 h, days 2 - 6. - 2 mg in the form of a syrup every 12 hours. Children with pc. ≥ 0.6 m²: day 1 - 5 mg / m² pc. intravenously plus 4 mg in the form of syrup or tablets after 12 h, days 2 - 6. - 4 mg in the form of syrup or tablets every 12 hours. The intravenous dose should not exceed 8 mg. The total daily dose may not exceed 32 mg.Dosage adapted to body weight. Ondansetron should be given as a single intravenous dose of 0.15 mg / kg. immediately before chemotherapy. You can give 2 additional intravenous doses at 4-hour intervals. Oral administration may be started 12 h later and continue 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 the form of a syrup every 12 hours. Children of the month. > 10 kg: day 1 - up to 3 doses of 0.15 mg / kg every 4 hours, days 2 - 6. - 4 mg in the form of syrup or tablets every 12 hours. The intravenous dose should not exceed 8 mg. The total daily dose may not exceed 32 mg.Nausea and vomiting in the postoperative period. Adults. Prevention of nausea and vomiting in the postoperative period. Ondansetron can be administered orally or intravenously. Oral use: 16 mg for 1 hour before anesthesia. Alternatively: 8 mg for 1 hour before anesthesia followed by 2 further doses of 8 mg at intervals of 8 hours.Treatment of nausea and vomiting in the postoperative period. Intravenous administration is recommended.Children and adolescents - nausea and vomiting of the postoperative period in children ≥1 months and adolescents. There are no studies on oral administration; it is recommended to administer the drug by slow intravenous injection. In the prevention of nausea and vomiting in the postoperative period in children undergoing surgery under general anesthesia, ondansetron can be given by slow intravenous injection (not shorter than 30 s) in a single dose of 0.1 mg / kg. up to a maximum of 4 mg before or after induction of anesthesia. Lack of experience regarding the treatment of nausea and vomiting in the postoperative period in children under the age of 2 years.
In patients with moderate or severe hepatic impairment, the daily dose of 8 mg should not be exceeded. In patients with impaired renal function, patients with slow metabolism of sparteine ​​and debrisoquine and in elderly patients over 65 years do not need to change the dose, frequency of administration or route of administration.
The orodispersible tablet should be placed on the tongue, where it dissolves within a few seconds.