on.
Effect on Peristalsis
Zuplenz is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction.
Adverse Reactions
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The following adverse events have been reported in clinical trials of patients treated with ondansetron, the active ingredient of Zuplenz. A causal relationship to therapy with ondansetron was unclear in many cases.
Chemotherapy-Induced Nausea and Vomiting
Table 1: Adverse Events Reported in ≥5% of Adult Patients After Single Day Therapy Ondansetron HCl Tablets [Highly Emetogenic Chemotherapy (cisplatin dose ≥50 mg/m2)] Adverse Event Ondansetron 24 mg once daily N=300 Ondansetron 8 mg twice a day N=124 Ondansetron 32 mg once daily N=117
Headache 33 (11%) 16 (13%) 17 (15%)
Diarrhea 13 (4%) 9 (7%) 3 (3%)
Table 2:Adverse Events Reported in ≥5% of Adult Patients After Three Days of Therapy With Ondansetron HCl Tablets [Moderately Emetogenic Chemotherapy (primarily cyclophosphamide-based regimens)] Adverse Event Ondansetron 8 mg twice daily N=242 Ondansetron 8 mg three times day. N=415 Placebo N=262
Headache 58 (24%) 113 (27%) 34 (13%)
Malaise/fatigue 32 (13%) 37 (9%) 6 (2%)
Constipation 22 (9%) 26 (6%) 1 (<1%)
Diarrhea 15 (6%) 16 (4%) 10 (4%)
Central Nervous System: There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ondansetron.
Hepatic: In 723 patients receiving cyclophosphamide-based chemotherapy in US clinical trials, AST and/or ALT values have been reported to exceed twice the upper limit of normal in approximately 1% to 2% of patients receiving ondansetron HCl tablets. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur. The role of cancer chemotherapy in these biochemical changes cannot be clearly determined. There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear.
Integumentary: Rash has occurred in approximately 1% of patients receiving ondansetron.
Other: Rare cases of anaphylaxis, bronchospasm, tachycardia, angina (chest pain), hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures have been reported. Except for bronchospasm and anaphylaxis, the relationship to ondansetron was unclear.
Radiation-Induced Nausea and Vomiting
The adverse events reported in patients receiving ondansetron HCl tablets and concurrent radiotherapy were similar to those reported in patients receiving ondansetron HCl tablets and concurrent chemotherapy. The most frequently reported adverse events were headache, constipation, and diarrhea.
Postoperative Nausea and Vomiting
Table 3: Adverse Events Reported in ≥5% of Adult Patients After Single Dose Therapy With Ondansetron HCl Tablets Adverse Event a,b Ondansetron 16 mg N=550 Placebo N=531
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