Prevention and treatment of nausea and vomiting, caused by cytostatic chemotherapy and radiation therapy, in adults
The choice of the dosage regimen is determined by the emetogenicity of the antitumor therapy and can differ depending on the combinations 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 emetogenic chemotherapy, the maximum initial dose of ondansetron should be 16 mg in the form of intravenous infusion for 15 minutes. A single intravenous dose of ondansetron 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 at doses exceeding 8 mg but not exceeding the maximum dose of 16 mg, before administration ondansetron should be diluted in 50-100 ml of a 0.9% solution of sodium chloride or 5% solution of dextrose for injection, and then administered 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 8 mg can be administered intramuscularly or intravenously at intervals of 2-4 hours or a continuous infusion at a rate of 1 mg / h for a maximum of 24 hours.
For treatment of delayed or protracted vomiting after the first 24 hours, the drug is recommended to be taken Ondansetron in dosage forms for rectal or oral administration.
Special patient groups
Prevention and treatment of nausea and vomiting caused by cytostatic 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.
A drug Ondansetron can be used as an intravenous infusion after dissolution in 25-50 ml of 0.9% solution of sodium chloride or other compatible infusion solution for at least 15 minutes.
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 prior to chemotherapy followed by oral administration 12 hours after the chemotherapy session. Reception of the drug Ondansetron Inside 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 1. Calculation of ondansetron 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
| Body surface area | Day 1 | Days 26 |
| <0.6 m2 | 5 mg / m2 intravenously, followed by 2.5 ml syrup (2 mg ondansetron) 12 hours after the chemotherapy session | 2.5 ml syrup (2 mg ondansetron) every 12 hours |
| ≥0.6 and ≤1.2 m2 | 5 mg / m2 intravenously, then 5 ml of syrup or lyophilized tablets (4 mg ondansetron) after 12 hours | 5 ml syrup or lyophilized tablets (4 mg ondansetron) every 12 hours |
| > 1.2 m2 | 5 mg / m2 intravenously or 8 mg intravenously, followed by 10 ml of syrup or lyophilized tablets (8 mg ondansetron) after 12 hours | 10 ml syrup or lyophilized tablets (8 mg ondansetron) every 12 hours |
Calculation of the dose based on body weight in children aged 6 months to 18 years for the treatment of nausea and vomiting caused by chemotherapy
A drug Ondansetron should be administered as a solution for intravenous or intramuscular injection 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 should be administered at an interval of 4 hours, followed by ondansetron in the form of syrup inside after 12 hours. Ondansetron intake may last for 5 days after chemotherapy. When using the drug in patients of this age group, do not exceed the doses used in adults.
Table 2. Calculation of doses based on body weight in children aged 6 months to 18 years for the treatment of nausea and vomiting caused by chemotherapy
| Body weight, kg | Day 1 | Days 2-6 |
| ≤10 | Up to 3 doses of 0.15 mg / kg intravenously every 4 hours | 2.5 ml syrup (2 mg ondansetron) every 12 hours |
| >10 | Up to 3 doses of 0.15 mg / kg intravenously every 4 hours | 5 ml syrup or lyophilized tablets (4 mg ondansetron) every 12 hours |
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 dose of 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 severe and moderate degree of impaired liver function, clearance of ondansetron is significantly reduced, T1/2 significantly increased. In such patients, the daily dose of ondansetron should not exceed 8 mg.
Patients with slow metabolism of sparteine / debrisokwin
In patients with a slow metabolism of sparteine / debrisquine T1/2 ondansetron is not changed. Consequently, with repeated administration of the drug its concentration in the plasma will not differ from that in the general population, therefore correction of the daily dose or the frequency of dosing of ondansetron is not required.
Prevention 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 intravenously slowly.
Special patient groups
Children and adolescents (aged 1 month to 18 years)
To prevent 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 preventing and arresting 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 impaired liver function of moderate and severe degree, the clearance of ondansetron is significantly reduced, and T1/2 increased. The daily dose of ondansetron should not exceed 8 mg.
Patients with slow metabolism of sparteine / debrisokwin
In patients with a slow metabolism of sparteine / debrisokwin T1/2 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 frequency of administration of ondansetron in this case is notit takes.
Pharmaceutical compatibility with other solutions for intravenous administration
To dilute ondansetron, the following infusion solutions can be used:
- 0.9% solution of sodium chloride;
- 5% dextrose solution;
- Ringer's solution;
- 10% a solution of mannitol;
- 0,3% potassium chloride solution and 0.9% sodium chloride solution;
- 0.3% potassium chloride solution and 5% dextrose solution.
The infusion solution should be prepared immediately before use. During the infusion, protection against light is not required; The diluted injection solution remains stable for at least 24 hours under natural light or normal light.
Compatibility with other drugs
Ondansetron can be administered as an infusion at a rate of 1 mg / h from an infusion bag or syringe pump.
Ondansetron can be administered via Y-port in the concentration of ondansetron from 16 to 160 μg / ml (eg, 8 mg / 500 ml and 8 mg / 50 ml, respectively) concurrently with the preparations described below.
Cisplatinum
In a concentration of up to 0.48 mg / ml (e.g., 240 mg in 500 ml) upon administration for 1 to 8 hours.
Fluorouracil
At a concentration of up to 0.8 mg / ml (for example, 2.4 g in 3 L or 400 mg in 500 ml) when administered at a rate of at least 20 ml / h (500 ml / 24 hours).Higher concentrations of fluorouracil may cause ondansetron to precipitate. Fluorouracil for infusion can contain up to 0.045% Magnesium chloride in addition to other excipients for which compatibility is established.
Carboplatin
Concentrations ranging from 0.18 mg / ml to 9.9 mg / ml (eg from 90 mg in 500 ml to 990 mg in 100 ml) with administration for 10 minutes to 1 hour.
Etoposide
Concentrations in the range from 0.144 mg / ml to 0.25 mg / ml (for example, from 72 mg in 500 ml to 250 mg in 1 L) upon administration for 30 minutes to 1 hour.
Ceftazidime
Doses in the range of 250 mg to 2 g reconstituted water for injection of the drug according to the manufacturer's instructions (for example, 2.5 ml per 250 mg and 10 ml per 2 g ceftazidime) and administered as an intravenous bolus injection for approximately 5 minutes.
Cyclophosphamide
Doses in the range of 100 mg to 1 g reconstituted with water for injection preparation in accordance with the manufacturer's instructions for use (5 ml per 100 mg cyclophosphamide) and administered as an intravenous bolus injection for approximately 5 minutes.
Doxorubicin
Doses in the range of 10 mg to 100 mg reconstituted with water for injection of the drug in accordance with the instructions for use of the manufacturer (5 ml per 10 mgdoxorubicin) and administered as an intravenous bolus injection for approximately 5 minutes.
Dexamethasone
It is possible to administer dexamethasone sodium phosphate at a dose of 20 mg as a slow intravenous injection for 2 to 5 minutes via Y-port with the administration of 8 to 16 mg of ondansetron diluted in 50-100 ml in a compatible infusion solution, for about 15 minutes. The compatibility of dexamethasone sodium phosphate and ondansetron was confirmed by the administration of these drugs through the same system for administration, which allowed the expected concentrations of 32 μg / ml to 2.5 mg / ml for dexamethasone sodium phosphate and 8 μg / ml to 1 mg / ml for ondansetron.