dosage
nausea and vomiting induced by chemotherapy and radiotherapy (cinv and rinv)
adults
The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. selection of the dose regimen should be determined by the severity of the emetogenic challenge.
Emetogenic chemotherapy and radiotherapy: Zofran can be administered rectally, orally (tablets or syrup), intravenously or intramuscularly.
The recommended oral dose is 8 mg taken 1 to 2 hours before chemotherapy or radiation therapy, followed by 8 mg every 12 hours for up to 5 days to protect against delayed or prolonged emesis.
For highly emetogenic chemotherapy a single dose of up to 24 mg zofran taken with 12 mg dexamethasone sodium phosphate orally 1 to 2 hours before chemotherapy may be used.
To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with zofran may be continued for up to 5 days after a course of treatment.
The recommended dose for oral administration is 8 mg twice daily.
pediatric population
cinv in children and adolescents (from 6 months to 17 years)
cinv dose can be calculated based on body surface area (bsa) or weight; see below. In pediatric clinical studies, ondansetron was administered by IV infusion diluted in 25 to 50 mL of saline or other compatible infusion fluid and infused over no less than 15 minutes.
Weight-based dosing results in higher total daily doses compared to BSA-based dosing (see section 4.4).
There are no data from controlled clinical trials on the use of zofran in the prevention of delayed or prolonged cinv. There are no data from controlled clinical trials on the use of zofran for radiation therapy-induced nausea and vomiting in children.
dosage by bsa
Zofran should be administered immediately prior to chemotherapy as a single intravenous dose of 5 mg/m2. the single intravenous dose should not exceed 8 mg.
Oral dosing can begin 12 hours later and continue for up to 5 days (Table 1).
The total dose over 24 hours (given in divided doses) should not exceed the adult dose of 32 mg.
Table 1: Bsa-based dosing for cinv (ages ≥ 6 months to 17 years)
The intravenous dose should not exceed 8 mg.
b the total dose over 24 hours (given in divided doses) should not exceed the adult dose of 32 mg
dosage by body weight
Weight-based dosing results in higher total daily doses compared to BSA-based dosing (see sections 4.4 and 5.1).
Zofran should be administered immediately prior to chemotherapy as a single intravenous dose of 0.15 mg/kg. the single intravenous dose should not exceed 8 mg. two more intravenous doses may be given at 4-hour intervals.
Oral dosing can begin 12 hours later and continue for up to 5 days (Table 2).
The total dose over 24 hours (given in divided doses) should not exceed the adult dose of 32 mg.
table 2: weight-based dosing for cinv (6 months to 17 years)
The intravenous dose should not exceed 8 mg.
b the total dose over 24 hours (given in divided doses) should not exceed the adult dose of 32 mg.
elders
No change in oral dose or frequency of administration is required.
patients with kidney failure
No changes to daily dose, dosing frequency, or route of administration are required.
patients with liver failure
Zofran clearance is significantly reduced and serum half-life is significantly prolonged in subjects with moderate or severe hepatic impairment. in such patients a total daily dose of 8 mg should not be exceeded.
patients with poor metabolism of sparteine/debrisoquine
Ondansetron elimination half-life is not altered in subjects classified as poor metabolisers of sparteine and detritosquine. consequently, in such patients, repeat dosing will result in drug exposure levels that do not differ from those in the general population. no modification of daily dose or dose frequency is required.
postoperative nausea and vomiting (pnv):
adults
For the prevention of PVP, ondasetron can be administered orally or by intravenous or intramuscular injection.
The recommended oral dose is 16 mg taken one hour before anesthesia.
For the treatment of established PVP, intravenous or intramuscular administration is recommended.
pediatric population
ponv in children and adolescents (from 1 month to 17 years)
oral formulation:
There have been no studies of the use of orally administered ondansetron in the prevention or treatment of postoperative nausea and vomiting; slow intravenous injection (not less than 30 seconds) is recommended for this purpose.
injection:
For the prevention of nvp in pediatric patients undergoing surgery under general anesthesia, a single dose of ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum of 4 mg either before, during or after induction of anesthesia.
for the treatment of postoperative ponv in pediatric patients undergoing surgery under general anesthesia, a single dose of zofran may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1 mg /kg up to a maximum of 4 mg.
There are no data on the use of zofran in the treatment of ponv in children less than 2 years of age.
elders
There is limited experience with the use of zofran in the prevention and treatment of postoperative nausea and vomiting in the elderly; however, zofran is well tolerated in patients over 65 years of age receiving chemotherapy.
patients with kidney failure
No changes to daily dose, dosing frequency, or route of administration are required.
patients with liver failure
Zofran clearance is significantly reduced and serum half-life is significantly prolonged in subjects with moderate or severe hepatic impairment. in such patients a total daily dose of 8 mg should not be exceeded.
patients with poor metabolism of sparteine/debrisoquine
Ondansetron elimination half-life is not altered in subjects classified as poor metabolisers of sparteine and detritosquine. consequently, in such patients, repeat dosing will result in drug exposure levels that do not differ from those in the general population. no modification of daily dose or dose frequency is required.
method of administration
The tablets should be swallowed whole with liquid.
