Generic Name and Formulations:
Ondansetron (as base) 4mg, 8mg; oral soluble film; peppermint flavor.
Midatech Pharma US Inc.
Indications for ZUPLENZ:
Prevention of nausea and vomiting associated with highly emetogenic chemotherapy, including cisplatin ≥50mg/m2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy. Prevention of nausea and vomiting associated with 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/or vomiting.
Allow each soluble film to dissolve completely before administering the next film. Dissolve on tongue for 4–20 secs before swallowing. Highly emetogenic chemotherapy: 24mg (given successively as three 8mg films) 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 (given successively as two 8mg films) 1hr before induction of anesthesia. For all: severe hepatic dysfunction (Child-Pugh score >10): max 8mg/day.
Highly emetogenic chemotherapy, radiotherapy, post-op prophylaxis or <4yrs of age: not established. Allow each soluble film to dissolve completely before administering the next film. Dissolve on tongue for 4–20 secs before swallowing. 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.
Avoid in congenital long QT syndrome. Electrolyte abnormalities (eg, hypokalemia, hypomagnesemia), CHF, bradyarrhythmias, concomitant drugs that prolong QT: monitor ECG. May mask progressive ileus and/or gastric distention (esp. after abdominal surgery or patients with chemotherapy-induced nausea/vomiting). Do not use as alternative to nasogastric suction. Hepatic dysfunction. Pregnancy (Cat.B). Nursing mothers.
See Contraindications. Profound hypotension, loss of consciousness with apomorphine. Serotonin syndrome possible esp. with concomitant serotonergic drugs. Potent CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin) may increase clearance of ondansetron. May reduce analgesic activity of tramadol.
Selective 5-HT3 receptor antagonist.
Headache, malaise/fatigue, constipation, diarrhea; serotonin syndrome (discontinue if occurs); rare: bronchospasm, anaphylaxis, transient ECG changes including QT prolongation (esp. IV form).