No

Selective 5-HT₃ Receptor Antagonist

May be prescribed for patients who are refractory to or have severe adverse reactions to standard antiemetic therapy. Ondansetron may be prescribed for young patients (ie, <45 years of age who are more likely to develop extrapyramidal reactions to high-dose metoclopramide) who are to receive highly emetogenic chemotherapeutic agents as listed:

B

Clinical effects on the fetus: No data available on crossing the placenta; no effects on the fetus from 2 case reports

Breast-feeding/lactation: No data available. American Academy of Pediatrics has NO RECOMMENDATION.

Hypersensitivity to ondansetron or any component

Ondansetron should be used on a scheduled basis, not as an "as needed" (PRN) basis, since data supports the use of this drug in the prevention of nausea and vomiting and not in the rescue of nausea and vomiting. Ondansetron should only be used in the first 24-48 hours of receiving chemotherapy. Data does not support any increased efficacy of ondansetron in delayed nausea and vomiting.

>10%:

Central nervous system: Headache, fever

Gastrointestinal: Constipation, diarrhea

1% to 10%:

Central nervous system: Dizziness

Gastrointestinal: Abdominal cramps, xerostomia

Hepatic: AST/ALT elevations (5%)

Neuromuscular & skeletal: Weakness

<1%: Tachycardia, lightheadedness, seizures, rash, hypokalemia, transient elevations in serum levels of aminotransferases and bilirubin, bronchospasm, shortness of breath, wheezing, angina

CYP1A2, 2D6, 2E1, and 3A3/4 enzyme substrate

Increased toxicity: Inhibitors (eg, cimetidine, allopurinol, and disulfiram)

Injection may be stored between 36°F and 86°F; stable when mixed in 5% dextrose or 0.9% sodium chloride for 48 hours at room temperature; does not need protection from light

Selective 5-HT₃-receptor antagonist, blocking serotonin, both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone

Onset of effect: Within 30 minutes

Plasma protein binding: 70% to 76%

Metabolism: Extensively by hydroxylation, followed by glucuronide or sulfate conjugation

Half-life: Children <15 years: 2-3 hours; Adults: 4 hours

Elimination: In urine and feces; <10% of parent drug recovered unchanged in urine

Chemotherapy-induced emesis: Oral:

Children 4-11 years: 4 mg 30 minutes before chemotherapy; repeat 4 and 8 hours after initial dose, then 4 mg every 8 hours for 1-2 days after chemotherapy completed

Children >11 years and Adults: 8 mg every 8 hours for 2 doses beginning 30 minutes before chemotherapy, then 8 mg every 12 hours for 1-2 days after chemotherapy completed

Total body irradiation: Adults: 8 mg 1-2 hours before each fraction of radiotherapy administered each day

Single high-dose fraction radiotherapy to abdomen: 8 mg 1-2 hours before irradiation, then 8 mg every 8 hours after first dose for 1-2 days after completion of radiotherapy

Daily fractionated radiotherapy to abdomen: 8 mg 1-2 hours before irradiation, then 8 mg every 8 hours after first dose for each day of radiotherapy

Prophylaxis with moderate-emetogenic chemotherapy (not FDA-approved): 8 mg twice daily has been shown to be as effective as doses given 3 times/day

I.V.: Administer either three 0.15 mg/kg doses or a single 32 mg dose; with the 3-dose regimen, the initial dose is given 30 minutes prior to chemotherapy with subsequent doses administered 4 and 8 hours after the first dose. With the single-dose regimen 32 mg is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Dosage should be calculated based on weight:

Children: Pediatric dosing should follow the manufacturer's guidelines for 0.15 mg/kg/dose administered 30 minutes prior to chemotherapy, 4 and 8 hours after the first dose. While not as yet FDA-approved, literature supports the day's total dose administered as a single dose 30 minutes prior to chemotherapy.

Adults:

>80 kg: 12 mg IVPB

45-80 kg: 8 mg IVPB

<45 kg: 0.15 mg/kg/dose IVPB

Postoperative emesis: I.V.:

Children >2 years: 0.1 mg/kg I.V. slow push; if over 40 kg weight, administer 4 mg IVP over 2-5 minutes (no faster than 30 seconds); give I.V. as s single dose immediately before induction of anesthesia or shortly following procedure if vomiting occurs

Adults (infuse in not less than 30 seconds, preferably over 2-5 minutes, as undiluted drug): 4 mg as a single dose immediately before induction of anesthesia; or shortly following procedure if vomiting occurs

Dosing in hepatic impairment: Maximum daily dose: 8 mg in cirrhotic patients with severe liver disease

Food: Increases the extent of absorption. The C_max and T_max does not change much; take without regard to meals

Potassium: Hypokalemia; monitor potassium serum concentration

May cause dizziness

Barbiturates and carbamazepine may increase the metabolism of ondansetron; monitor for diminished effects

No information available to require special precautions

No effects or complications reported

This drug may cause drowsiness; use caution when driving or engaging in tasks that require alertness until response to drug is known. You may experience constipation and headache (request appropriate treatment from prescriber). Do not change position rapidly (rise slowly). Good mouth care and sucking on lozenges may help relieve nausea. Report persistent headache, excessive drowsiness, fever, numbness or tingling, or severe changes in elimination patterns (constipation or diarrhea), chest pain, or palpitations. Breast-feeding precautions: Consult prescriber if breast-feeding.

First dose should be given 30 minutes prior to beginning chemotherapy

Injection, as hydrochloride: 2 mg/mL (2 mL, 20 mL); 32 mg (single-dose vials)

Solution, as hydrochloride: 4 mg/5 mL

Tablet, as hydrochloride: 4 mg, 8 mg, 24 mg

Tablet, as hydrochloride, orally disintegrating: 4 mg, 8 mg

A 0.8 mg/mL syrup may be made by crushing ten 8 mg tablets; flaking of the tablet coating occurs. Mix thoroughly with 50 mL of the suspending vehicle, Ora-Plus® (Paddock), in 5 mL increments. Add sufficient volume of any of the following syrups: Cherry syrup USP, Syrpalta® (Humco), Ora-Sweet® (Paddock), or Ora-Sweet® Sugar-Free (Paddock) to make a final volume of 100 mL. Stability is 42 days refrigerated.

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