Friday, October 11, 2013

Ondansetron

Today's med: Ondansetron (on DAN se tron) 
(brand names: Zofran, Zofran ODT, Zuplenz)

Drug Class: Antiemetic, Selective 5-HT3 Receptor Antagonist


Indications: I.V.: Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (including high-dose cisplatin); prevention of postoperative nausea and/or vomiting (PONV); treatment of PONV if no prophylactic dose of ondansetron received
Oral: Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy (including high-dose cisplatin); prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy; prevention of nausea and vomiting associated with radiotherapy (either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen); prevention of PONV

Hyperemesis gravidarum (severe or refractory); breakthrough treatment of nausea and vomiting associated with chemotherapy

Contraindications: Hypersensitivity to ondansetron or any component of the formulation; concomitant use of apomorphine

Adverse Effects: >10%:
Central nervous system: Headache (9% to 27%), malaise/fatigue (9% to 13%)
Gastrointestinal: Constipation (6% to 11%)
1% to 10%:
Central nervous system: Drowsiness (8%), fever (2% to 8%), dizziness (7%), anxiety (6%), cold sensation (2%)
Dermatologic: Pruritus (2% to 5%), rash (1%)
Gastrointestinal: Diarrhea (2% to 7%)
Genitourinary: Gynecological disorder (7%), urinary retention (5%)
Hepatic: ALT increased (>2 times ULN: 1% to 5%), AST increased (>2 times ULN: 1% to 5%)
Local: Injection site reaction (4%; pain, redness, burning)
Neuromuscular & skeletal: Paresthesia (2%)
Respiratory: Hypoxia (9%)
<1% (Limited to important or life-threatening): Abnormal hepatic function, anaphylactoid reactions, anaphylaxis, angina, angioedema, arrhythmia, atrial fibrillation, AV block, blindness (transient/following infusion; lasting ≤48 hours), blurred vision (transient/following infusion), bradycardia, cardiopulmonary arrest, dystonic reaction, electrocardiographic alterations (second-degree heart block and ST-segment depression), extrapyramidal symptoms, hepatic failure, hepatic necrosis, hepatitis, hypersensitivity reaction, hypokalemia, hypotension, oculogyric crisis, premature ventricular contractions (PVC), QT interval increased, seizure, shock, supraventricular tachycardia, syncope, tachycardia, torsade de pointes, vascular occlusive events, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia

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

Standard DosingChildren: I.V.:
Prevention of nausea and vomiting associated with emetogenic chemotherapy: 6 months to 18 years: 0.15 mg/kg/dose (maximum: 16 mg/dose) over 15 minutes for 3 doses, beginning with the first dose administered 30 minutes prior to chemotherapy, followed by subsequent doses administered 4 and 8 hours after the first dose
Prevention of postoperative nausea and vomiting: 1 month to 12 years:
≤40 kg: 0.1 mg/kg as a single dose over 2-5 minutes
>40 kg: 4 mg as a single dose over 2-5 minutes
Oral: Prevention of nausea and vomiting associated with moderately-emetogenic chemotherapy:
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
≥12 years: Refer to adult dosing.
Adults: I.V.:
Prevention of nausea and vomiting associated with emetogenic chemotherapy:
Manufacturer’s labeling: 0.15 mg/kg/dose (maximum: 16 mg/dose) over 15 minutes for 3 doses, beginning with the first dose administered 30 minutes prior to chemotherapy, followed by subsequent doses administered 4 and 8 hours after the first dose
Alternate recommendations (unlabeled dose): American Society of Clinical Oncology Antiemetic Guidelines (Basch, 2011): High emetic risk chemotherapy: Day(s) of chemotherapy: 8 mg or 0.15 mg/kg. Note:Single I.V. doses >16 mg are no longer recommended by the manufacturer due to the potential for QT prolongation.
Prevention of nausea and vomiting associated with radiation therapy (unlabeled route): American Society of Clinical Oncology Antiemetic Guidelines (Basch, 2011): 8 mg or 0.15 mg/kg (see Note below); give before each fraction throughout radiation therapy (for high emetic risk, continue for at least 24 hours after completion; for low emetic risk, may give either as prevention or rescue; for minimal emetic risk, give as rescue; if rescue used for either low or minimal emetic risk, then prophylaxis should be given until the end of radiation therapy).
Note: Single I.V. doses >16 mg are no longer recommended by the manufacturer due to the potential for QT prolongation.
Treatment of severe or refractory hyperemesis gravidum (unlabeled use): 8 mg administered over 15 minutes every 12 hours (ACOG, 2004)
I.M., I.V.: Postoperative nausea and vomiting (PONV): 4 mg as a single dose (over 2-5 minutes if giving I.V.) administered ~30 minutes before the end of anesthesia (see Note below) or as treatment if vomiting occurs after surgery (Gan, 2007).
Note: The manufacturer recommends administration immediately before induction of anesthesia; however, this has been shown not to be as effective as administration at the end of surgery (Sun, 1997). Repeat doses given in response to inadequate control of nausea/vomiting from preoperative doses are generally ineffective.
Oral: Prevention of nausea and vomiting associated with emetogenic chemotherapy:
Highly-emetogenic agents/single-day therapy:
Manufacturer’s labeling: 24 mg given as three 8 mg tablets 30 minutes prior to the start of therapy
Alternate recommendations (unlabeled dose): American Society of Clinical Oncology Antiemetic Guidelines (Basch, 2011): Day(s) of chemotherapy: 8 mg twice daily
Moderately-emetogenic agents: 8 mg beginning 30 minutes before chemotherapy; repeat dose 8 hours after initial dose, then 8 mg every 12 hours for 1-2 days after chemotherapy completed
Prevention of nausea and vomiting associated with radiation therapy:
Manufacturer’s labeling:
Total body irradiation: 8 mg 1-2 hours before each daily fraction of radiotherapy
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
Alternate recommendations (unlabeled regimen): American Society of Clinical Oncology Antiemetic Guidelines (Basch, 2011): 8 mg twice daily; give before each fraction throughout radiation therapy (for high emetic risk, continue for at least 24 hours after completion; for low emetic risk, may give either as prevention or rescue; for minimal emetic risk, give as rescue; if rescue used for either low or minimal emetic risk, then prophylaxis should be given until the end of radiation therapy)
Postoperative nausea and vomiting: 16 mg given 1 hour prior to induction of anesthesia
Treatment of severe or refractory hyperemesis gravidum (unlabeled use): 8 mg every 12 hours (Levichek, 2002).  Elderly: No dosing adjustment required


A total of 229 drugs (920 brand and generic names) are known to interact with ondansetron.
  • 43 major drug interactions (119 brand and generic names)
  • 178 moderate drug interactions (762 brand and generic names)
  • 8 minor drug interactions (39 brand and generic names)
Show all medications in the database that may interact with ondansetron.
CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates.  Consider avoiding CYP3A4 inducing herbs in order to avoid therapeutic failure of the substrate.
CYP2D6 Inhibitors.
Ondansetron before the chemo's on....

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