Prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy and radiotherapy in adults
The choice of the dosage regimen is determined by the emetogenicity of the antitumor therapy and can differ depending on the combination of the regimens of chemotherapy and radiotherapy used.
Adults
The recommended dose is 8 mg, intravenously or intramuscularly immediately before chemotherapy or radiotherapy.
With highly emeticogenic chemotherapy, the maximum initial dose of ondansetron should be 16 mg in the form of a 15-minute infusion.A single intravenous dose should not exceed 16 mg.
The efficacy of ondansetron in high-emetogenic chemotherapy can be increased by a single intravenous injection of dexamethasone sodium phosphate at a dose of 20 mg before chemotherapy.
When administered intravenously in doses exceeding 8 mg but not more than a maximum of 16 mg, prior to treatment, the drug Ondansetron should be diluted in 50-100 mg solution of sodium chloride for injection, or 5% solution of glucose for injection, and then injected for at least 15 minutes. When ondansetron is administered in doses not exceeding 8 mg, no dilution is required; in this case, the drug can be administered slowly intramuscularly or intravenously for at least 30 seconds.
After the first dose of ondansetron is administered, two additional doses of intramuscular or intravenous 8 mg can be administered at intervals of 2-4 hours, or a continuous infusion of 1 mg / h for a maximum of 24 hours can be administered.
To treat delayed or protracted vomiting after the first 24 hours, ondansetron is recommended in medicinal forms for rectal or oral administration.
Special patient groups
Elderly patients
In the treatment of patients aged 65 years and older, all doses for intravenous administration should be diluted and administered as a 15-minute infusion, and if necessary, re-administered no earlier than 4 hours later.
In patients aged 65 to 74 years after the first dose of ondansetron 8 mg or 16 mg in the form of a 15-minute infusion, 2 additional doses (not earlier than 4 hours) of 8 mg can be administered as a 15-minute infusion.
In patients aged 75 years and older, the first intravenous 15-minute infusion should not exceed 8 mg. After the administration of the first dose of 8 mg, 2 additional doses may be administered as a 15-minute infusion (not earlier than 4 hours) at 8 mg.
Patients with impaired renal function
Correction of the daily dose, the frequency of dosing or the route of administration of ondansetron is not required.
Patients with impaired hepatic function
In patients with impaired liver function of moderate and severe severity, clearance of ondansetron is significantly reduced, the half-life is significantly increased.
In such patients, the daily dose of ondansetron should not exceed 8 mg.
Patients with a slow metabolism of sparteine-debrisoquine
In patients with a slow metabolism of sparteine-debrisoquine, the half-life of ondansetron is not changed.Consequently, with the repeated administration of such patients to ondansetron, its plasma concentration will not differ from that in the general population. Therefore, correction of the daily dose or ondansetron dosing frequency in this case is not required.
Prevention and treatment of nausea and vomiting, caused by cytotoxic chemotherapy in children
Nausea and vomiting during chemotherapy in children and adolescents (aged 6 months to 18 years)
Dose of the drug Ondansetron in children is calculated on the basis of surface area or body weight.
In pediatric clinical trials ondansetron was used as an intravenous infusion after dissolving the drug in 25-50 ml of a 0.9% solution of sodium chloride or another compatible infusion solution as a 15-minute infusion.
Calculation of the dose based on body surface area in children aged 6 months to 18 years for the prevention and treatment of nausea and vomiting caused by chemotherapy
Ondansetron should be given as a single intravenous injection at a dose of 5 mg / m2 (not more than 8 mg) immediately before the chemotherapy followed by oral intake after 12 hours. Ondansetron orally can be continued for another 5 days after the course of chemotherapy. When using the drug in this age group, do not exceed the dose used in adults.
Table of dose calculation based on body surface area in children aged 6 months to 18 years for the prevention and treatment of nausea and vomiting caused by chemotherapy.
| Body surface area | Day 1 | Day 2-6 |
| <0.6 m2 | 5 mg / m2 intravenously, followed by 2.5 ml syrup (2 mg ondansetron) after 12 h | 2.5 ml syrup (2 mg ondansetron) every 12 hours |
| ≥ 0,6 m2 ≤ 1.2 m2 | 5 mg / m2 intravenously, then 5 ml of syrup (4 mg ondansetron) after 12 h | 5 ml syrup (4 mg ondansetron) every 12 hours |
| > 1.2 m2 | 5 mg / m2 intravenously or 8 mg intravenously, followed by 10 ml of syrup (8 mg ondansetron) after 12 h | 10 ml of syrup (8 mg ondansetron) every 12 hours |
Calculation of dose based on body weight in children aged from 6 months to 18 years for the prevention and treatment of nausea and vomiting caused by chemotherapy
A drug Ondansetron, a solution for intravenous and intramuscular administration, should be administered once intravenously immediately before the start of chemotherapy at a dose of 0.15 mg / kg. The dose for intravenous administration should not exceed 8 mg.On the first day, 2 additional doses may be administered at an interval of 4 hours, followed by taking ondansetron drugs orally 12 hours later. Oral administration of ondansetron drugs can continue for 5 days after chemotherapy. When using the drug in patients of this age group, do not exceed the doses used in adults.
Dose calculation table based on body weight in children aged 6 months to 18 years for the prevention and treatment of nausea and vomiting caused by chemotherapy
| Body mass | Day 1 | Day 2-6 |
| ≤ 10 kg | Up to 3 doses of 0.15 mg / kg intravenously, every 4 hours | 2.5 ml syrup (2 g ondansetron) every 12 hours |
| > 10 kg | Up to 3 doses of 0.15 mg / kg intravenously, every 4 hours | 5 ml syrup (4 mg ondansetron) every 12 hours |
Preventive maintenance and treatment of postoperative nausea and vomiting in adults and children
Adults
To prevent nausea and vomiting in the postoperative period, a single intramuscular or slow intravenous injection of the drug is recommended Ondansetron in a dose of 4 mg during the initial anesthesia.
For the treatment of nausea and vomiting in the postoperative period, the drug Ondansetron is administered once in a dose of 4 mg intramuscularly or slowly intravenously.
Special patient groups
Children and adolescents (aged 1 month to 18 years)
For the prevention and treatment of nausea and vomiting in the postoperative period in children who underwent surgery under general anesthesia, the drug Ondansetron can be used at a dose of 0.1 mg / kg (maximum 4 mg) in the form of a slow intravenous injection (at least 30 seconds) before, during or after an initial anesthesia or after surgery.
Elderly patients
There is limited experience with ondansetron for the prevention and treatment of postoperative nausea and vomiting in elderly patients, although ondansetron well tolerated by patients aged 65 years and older who are receiving chemotherapy.
Patients with impaired renal function
Correction of the daily dose, the frequency of dosing or the route of administration of ondansetron is not required.
Patients with impaired hepatic function
In patients with moderate to severe hepatic impairment, the clearance of ondansetron is significantly reduced, and the half-life is significantly increased. The daily dose of ondansetron should not exceed 8 mg.
Patients with a slow metabolism of sparteine-debrisoquine
In patients with a slow metabolism of sparteine-debrisoquine, the half-life of ondansetron is not changed.Consequently, with the repeated administration of such patients to ondansetron, its plasma concentration will not differ from that in the general population. Therefore, correction of the daily dose or ondansetron dosing frequency in this case is not required.