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Ondansetron Dosage

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Usual Adult Dose for Nausea/Vomiting - Chemotherapy Induced

Recommended dose: Three 0.15 mg/kg doses (up to a maximum of 16 mg per dose). The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose.

Alternative therapies:
Oral soluble film dosage form:
Highly emetogenic cancer chemotherapy: 24 mg given successively as three 8 mg films administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin greater than or equal to 50 mg/m2.
Moderately emetogenic cancer chemotherapy: One 8 mg soluble film given 2 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose.

Usual Adult Dose for Nausea/Vomiting

Recommended dose: Three 0.15 mg/kg doses (up to a maximum of 16 mg per dose). The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose.

Alternative therapies:
Oral soluble film dosage form:
Highly emetogenic cancer chemotherapy: 24 mg given successively as three 8 mg films administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin greater than or equal to 50 mg/m2.
Moderately emetogenic cancer chemotherapy: One 8 mg soluble film given 2 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose.

Usual Adult Dose for Nausea/Vomiting - Postoperative

4 mg IV (undiluted) over 2 to 5 minutes, or IM, immediately before induction of anesthesia or postoperatively if nausea or vomiting occurs within 2 hours after surgery. Alternatively, 4 mg (undiluted) may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. Patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

16 mg orally 1 hour before induction of anesthesia.

Oral soluble film dosage form: 16 mg given as successively as two 8 mg oral soluble films 1 hour before induction of anesthesia.

Usual Adult Dose for Nausea/Vomiting-Radiation Induced

8 mg orally every 8 hours, give the first dose 1 to 2 hours prior to radiotherapy.

Oral soluble film dosage form:
One 8 mg soluble film given 3 times a day.
For total body irradiation: One 8 mg soluble film given 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen: One 8 mg oral soluble film given 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen: One 8 mg oral soluble film given 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

Usual Adult Dose for Pruritus

Study (n=150) - Induced by Intrathecal Fentanyl
8 mg IV before spinal anesthesia.

Usual Adult Dose for Alcohol Dependence

Study (n=321) - Early onset alcoholism
4 mcg/kg two times daily.

Usual Adult Dose for Postanesthetic Shivering

Study (n=82)
8 mg IV, 3 to 5 minutes before the induction of anesthesia.

Usual Pediatric Dose for Nausea/Vomiting - Postoperative

Child 1 month to 12 years:
40 kg or less: 0.1 mg/kg single dose IV, administered over 2 to 5 minutes, immediately prior to or following anesthesia induction, or postoperatively if nausea and/or vomiting present shortly after surgery.

40 kg or more: 4 mg single dose IV, administered over 2 to 5 minutes, immediately prior to or following anesthesia induction, or postoperatively if nausea and/or vomiting present shortly after surgery.

Usual Pediatric Dose for Nausea/Vomiting - Chemotherapy Induced

Child 6 months to 18 years: 0.15 mg/kg (maximum of 16 mg per dose) as an IV infusion (over 15 minutes) administered 30 minutes before the start of emetogenic therapy, then at 4 and 8 hours after the first dose, respectively.

4 to 11 years: 4 mg orally given 30 minutes before the start of emetogenic therapy, then 4 mg orally 4 and 8 hours after the first dose. Thereafter, 4 mg orally every 8 hours for 1 to 2 days after emetogenic therapy is complete.

11 years or older:: 8 mg orally 3 times daily, or 24 mg orally once daily.

Oral soluble film dosage form: Use of ondansetron oral soluble films is not indicated for treatment of nausea and vomiting associated with highly emetogenic cancer chemotherapy in pediatric patients.
For prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy: For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg oral soluble film given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg oral soluble film should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

Usual Pediatric Dose for Gastroenteritis

Study (n=145) - Control of emesis during the ED phase of oral rehydration:
6 months to 12 months: 1.6 mg orally every 8 hours
1 year to 3 years: 3.2 mg orally every 8 hours
4 years or older: 4 mg orally every 8 hours

Dosage was administered 15 minutes before the start of oral rehydration.

Renal Dose Adjustments

No adjustments recommended

Liver Dose Adjustments

A total daily dose of 8 mg should not be exceeded in patients with severe hepatic impairment (Child-Pugh score of 10 or greater). Infuse the 8 mg IV dose over 15 minutes, 30 minutes before the start of emetogenic chemotherapy.

Oral soluble film dosage form: In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

Precautions

The use of a single 32 mg intravenous dose of ondansetron should be avoided. Information indicates that QT prolongation occurs in a dose-dependent manner, and specifically at a single intravenous dose of 32 mg.

The manufacturer recommends that pediatric patients 1 month to 4 months of age who are receiving this drug be closely monitored because the clearance in this age group is slower and the half-life is longer (approximately 2.5-fold longer) than in patients who are 4 to 24 months of age.

Patients diagnosed with phenylketonuria should be informed that ondansetron orally disintegrating tablets (Zofran ODT) contain phenylalanine (less than 0.03 mg).

The concurrent administration of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness.

Safety and effectiveness of ondansetron oral soluble films for highly emetogenic cancer chemotherapy, prevention of nausea and vomiting associated with radiotherapy, and prevention of postoperative nausea and vomiting have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Ondansetron injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.

All injectable preparation should be inspected visually for discoloration and particulate matter.

All infusions should be given over 15 minutes. The necessity of continuing ondansetron therapy should be assessed frequently.

The injectable preparation is intended for IV or IM use only. Give the IV dose undiluted over 2 to 5 minutes (never faster than 30 seconds).

The manufacturer recommends shaking the vial if a precipitate is observed; potency and safety are not affected. The precipitate is occasionally found at the stopper/vial interface in vials stored upright.

Ondansetron oral soluble films should be placed on the top of the tongue, where it will dissolve in 4 to 20 seconds. Each film should be allowed to dissolve completely before administering the next film. Once the oral soluble film is dissolved, it may be swallowed with or without liquid.

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