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Ondansetron Orally Disintegrating Tabs Generic Name & Formulations
Legal Class
Rx
General Description
Ondansetron (as base) 4mg, 8mg; strawberry flavor; contains phenylalanine.
Pharmacological Class
Selective 5-HT3 receptor antagonist.
How Supplied
Tabs 4mg, 8mg—30; ODT, oral soln, vials—contact supplier
Manufacturer
Generic Availability
YES
Ondansetron Orally Disintegrating Tabs Indications
Indications
Prevention of nausea and vomiting associated with: highly emetogenic chemotherapy, including cisplatin ≥50mg/m2; initial and repeat courses of moderately emetogenic chemotherapy; and radiotherapy in patients receiving total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Prevention of post-op nausea and vomiting.
Ondansetron Orally Disintegrating Tabs Dosage and Administration
Adult
See full labeling. Highly emetogenic chemotherapy: 24mg once 30 mins before start of single-day chemotherapy (multi-day, single-dose not studied). Moderately emetogenic chemotherapy: 8mg every 8hrs for 2 doses beginning 30 mins before chemotherapy, then 8mg every 12hrs for 1–2 days after chemotherapy completed. Total body irradiation: 8mg 1–2hrs before each fraction of radiotherapy administered each day. Single high-dose fraction radiotherapy to abdomen: 8mg 1–2hrs before radiotherapy, then 8mg every 8hrs after 1st dose for 1–2 days after radiation completed. Daily fractionated radiotherapy to abdomen: 8mg 1–2hrs before radiotherapy, then 8mg every 8hrs after 1st dose for each day of radiotherapy. Post-op prophylaxis: 16mg 1hr before induction of anesthesia. For all: severe hepatic dysfunction: max 8mg/day.
Children
Highly emetogenic chemotherapy, radiotherapy, or <4yrs of age: not recommended (see IV form). 4–11yrs: moderately emetogenic chemotherapy: 4mg every 4hrs for 3 doses beginning 30 mins before chemotherapy, then 4mg every 8hrs for 1–2 days after chemotherapy completed. Post-op prophylaxis: see IV form.
Ondansetron Orally Disintegrating Tabs Contraindications
Contraindications
Concomitant apomorphine.
Ondansetron Orally Disintegrating Tabs Boxed Warnings
Not Applicable
Ondansetron Orally Disintegrating Tabs Warnings/Precautions
Warnings/Precautions
<4 months of age (monitor closely). Not a substitute for nasogastric suction in gastric or intestinal peristalsis. Congenital long QT syndrome: avoid. Electrolyte abnormalities, CHF, bradyarrhythmias, concomitant drugs that prolong QT: monitor ECG. May mask progressive ileus and/or gastric distention. GI obstruction risk: monitor for decreased bowel activity. Coronary artery spasm. Monitor for myocardial ischemia during and after administration (esp. IV use; do not exceed recommended infusion rate). Phenylketonuria (ODT form). Hepatic dysfunction. Pregnancy. Nursing mothers.
Ondansetron Orally Disintegrating Tabs Pharmacokinetics
See Literature
Ondansetron Orally Disintegrating Tabs Interactions
Interactions
See Contraindications. Profound hypotension, loss of consciousness with apomorphine. Serotonin syndrome possible esp. with concomitant serotonergic drugs (eg, SSRIs, SNRIs, MAOIs, mirtazapine, fentanyl, lithium, tramadol, IV methylene blue). May antagonize tramadol.
Ondansetron Orally Disintegrating Tabs Adverse Reactions
Adverse Reactions
Diarrhea, headache, fever, constipation, fatigue, transient blindness; serotonin syndrome (discontinue if occurs); rare: angina, bronchospasm, anaphylaxis, seizures, ECG changes (including QT prolongation).
Ondansetron Orally Disintegrating Tabs Clinical Trials
See Literature
Ondansetron Orally Disintegrating Tabs Note
Not Applicable
Ondansetron Orally Disintegrating Tabs Patient Counseling
See Literature
