Ondansetron (Lexi-Drugs)

Drug Shortages

One or more forms of this drug may be in short supply or unavailable. Refer to the following for additional information:

ASHP: http://www.ashp.org/menu/DrugShortages

FDA: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Ondansetron Hydrochloride Injection&st=c&tab=tabs-1

Pronunciation

(on DAN se tron)

Brand Names: US

Zofran; Zofran ODT [DSC]; Zuplenz

Brand Names: Canada

ACT Ondansetron; APO-Ondansetron; CCP-Ondansetron; DOM-Ondansetron; JAMP-Ondansetron; Mar-Ondansetron; MINT-Ondansetron; MYLAN-Ondansetron; NAT-Ondansetron; Ondansetron Omega; Ondansetron-ODAN [DSC]; Ondissolve ODF; PHL-Ondansetron [DSC]; PMS-Ondansetron; RAN-Ondansetron; RATIO-Ondansetron [DSC]; RIVA-Ondansetron [DSC]; SANDOZ Ondansetron; SANDOZ Ondansetron ODT; Septa-Ondansetron; TEVA-Ondansetron [DSC]; VAN-Ondansetron; Zofran; Zofran ODT

Dosing: Adult

Note: Single IV doses >16 mg are no longer recommended due to the potential for QT prolongation (FDA 2012).

Carcinoid syndrome-associated diarrhea, severe, refractory (alternative agent) (off-label use): Based on limited data (case reports):

Oral: 8 mg 3 times daily (Wymenga 1998) or 8 mg twice daily for 3 days, followed by a maintenance dose of 4 to 8 mg/day for 4 to 12 weeks (Kiesewetter 2013)

IV: 4 to 8 mg every 8 hours (Schwörer 1995)

Chemotherapy-induced nausea and vomiting, prevention: Single-day IV chemotherapy regimens:

Highly emetogenic chemotherapy (>90% risk of emesis [eg, cisplatin, breast cancer regimens that include an anthracycline combined with cyclophosphamide]):

Day of chemotherapy: Administer prior to chemotherapy and in combination with a neurokinin 1 (NK1) receptor antagonist, dexamethasone, with or without olanzapine (ASCO [Hesketh 2017]; MASCC/ESMO [Roila 2016]).

IV: 8 mg or 0.15 mg/kg (maximum: 16 mg/dose) as a single dose (manufacturer’s labeling)

Oral:

All oral formulations except for the oral soluble film: 8 mg twice daily for 2 doses with the first dose administered prior to chemotherapy administration

Manufacturer’s labeling: Dosing in the prescribing information may not reflect current clinical practice: 24 mg as a single dose

Oral soluble film: 24 mg (three 8 mg doses given together) as a single dose

Post-chemotherapy days: 5-HT3 receptor antagonist use is not recommended (alternative agents are recommended) (ASCO [Hesketh 2017]; MASCC/ESMO [Roila 2016])

Moderately emetogenic chemotherapy (30% to 90% risk of emesis): Carboplatin-based regimens:

Day of chemotherapy: Administer prior to chemotherapy and in combination with an NK1 receptor antagonist and dexamethasone (ASCO [Hesketh 2017]; MASCC/ESMO [Roila 2016])

IV: 8 mg or 0.15 mg/kg (maximum: 16 mg/dose) as a single dose (manufacturer’s labeling)

Oral: 8 mg twice daily for 2 doses with the first dose administered prior to chemotherapy administration (manufacturer’s labeling)

Post-chemotherapy days: Antiemetic use is not necessary (ASCO [Hesketh 2017]; MASCC/ESMO [Roila 2016]).

Moderately emetogenic chemotherapy (30% to 90% risk of emesis): Non-carboplatin-based regimens (alternative agent):

Note: ASCO guidelines and MASCC/ESMO guidelines do not state a preference for which 5-HTreceptor antagonist should be used in this setting; however, some experts recommend palonosetron as the preferred 5-HT3 receptor antagonist (Celio 2015; Hesketh 2018; Popovic 2014).

Day of chemotherapy: Administer prior to chemotherapy and in combination with dexamethasone (ASCO [Hesketh 2017]; MASCC/ESMO [Roila 2016])

IV: 8 mg or 0.15 mg/kg (maximum: 16 mg/dose) as a single dose (manufacturer’s labeling)

Oral: 8 mg twice daily for 2 doses with the first dose administered prior to chemotherapy administration (manufacturer’s labeling)

Post-chemotherapy days: 5-HT3 receptor antagonist use is not recommended (alternative agents, depending on the chemotherapy regimen administered, may be recommended) (ASCO [Hesketh 2017]; MASCC/ESMO [Roila 2016]); however, if a first-generation 5-HT3 receptor antagonist (eg, ondansetron, granisetron) was used on day 1 of chemotherapy rather than palonosetron, some experts suggest the first-generation 5-HT3 receptor antagonist be continued for post-chemotherapy emetic prophylaxis on days 2 and 3 (Hesketh 2018).

Low emetogenic risk (10% to 30% risk of emesis):

Note: Single-agent ondansetron is one of many options for prophylaxis (ASCO [Hesketh 2017; MASCC/ESMO [Roila 2016]).

Day of chemotherapy: Administer as a single dose prior to chemotherapy (ASCO [Hesketh 2017])

IV: 8 mg or 0.15 mg/kg (maximum: 16 mg/dose) (ASCO [Hesketh 2017]; manufacturer’s labeling)

Oral (off-label): 8 mg (ASCO [Hesketh 2017])

Post-chemotherapy days: Prophylaxis is not necessary on subsequent days (ASCO [Hesketh 2017]; MASCC/ESMO [Roila 2016])

Chemotherapy-induced nausea and vomiting, prevention: Oral chemotherapy agents: Limited data; based on expert opinion:

High/moderate emetogenic risk oral agent: Oral: 8 to 16 mg/day administered before chemotherapy and continued daily (Hesketh 2018)

Low/minimal emetogenic risk oral agent: Oral: 8 to 16 mg/day on an as-needed basis (Hesketh 2018)

Gastroparesis, symptomatic treatment of nausea and vomiting (alternative agent) (off-label use): Note: For patients with persistent symptoms refractory to prokinetic therapy. No data available; recommendations for use and dose are based on expert opinion: Oral: 4 to 8 mg 3 times daily (ACG [Camilleri 2013]; Camilleri 2018)

Nausea and/or vomiting, acute, severe (off-label use): Note: Use has primarily been evaluated in patients with undifferentiated nausea/vomiting presenting to the emergency department; however, clinical experience also suggests utility in nausea/vomiting due to viral gastroenteritis, acute mountain sickness, and a variety of other medical conditions associated with severe, self-limiting acute nausea/vomiting (Alexandraki 2018; Gallagher 2018).

Oral, IV, IM: 4 mg as a single dose (Barrett 2011; Braude 2008; Egerton-Warburton 2014; Patanwala 2010; Patka 2011; Salvucci 2011). Note: For parenteral therapy, IV administration is preferred over IM when possible (Salvucci 2011).

Postoperative nausea and vomiting (PONV), prevention:

Moderate- to high-risk patients: Note: In patients at moderate risk, may combine ondansetron with other prophylactic interventions (eg, another antiemetic agent from a different pharmacologic class, modification of anesthetic technique, acupuncture); in patients at high risk, combine 3 or more interventions (Apfel 2004; Feinleib 2018; Gan 2014)

Usual dose: IV: 4 mg as a single dose at the end of surgery (Gan 2014)

Alternative strategy: Oral (oral disintegrating tablet or oral soluble film): 8 mg as a single dose given 30 to 60 minutes prior to surgery (Gan 2014; Grover 2009; Kenny 1992)

Low-risk patients:Although prophylaxis is not always indicated in low-risk patients, consensus guidelines acknowledge that some experts may administer an antiemetic in these patients; however, clinicians are also advised that this strategy comes with the potentially unnecessary risk of rare adverse effects (Gan 2014). If ondansetron is given, the dosing is the same as for moderate- to high-risk patients.

Post-discharge management in high-risk patients: Limited data available; dosage regimen studied in a single clinical trial: Oral (oral disintegrating tablet or oral soluble film): 8 mg to be taken on discharge and in the morning of postoperative days 1 and 2 (Pan 2008)

Postoperative nausea and vomiting (PONV), treatment or rescue therapy (off-label use): IV: 4 mg as a single dose when a prophylactic agent was not utilized (treatment) or following failure of an agent utilized as prophylaxis (rescue therapy) (Gan 2014). Note: Rescue therapy should always include an antiemetic from a different class than the one used for prophylaxis, unless a potentially inadequate dose was initially administered or the effect of the first drug has worn off (>6 hours since initial dose for most 5-HT3 receptor antagonists) (Feinleib 2018; Gan 2014). However, some experts do not recommend repeat administration of a 5-HT3 antagonist unless triple therapy has been used for prophylaxis and no alternatives are available for rescue that were not used for prophylaxis (Gan 2014).

Pregnancy-associated nausea and vomiting, severe or refractory (off-label use): Note: May be considered for adjunctive treatment of nausea and vomiting when symptoms persist following initial pharmacologic therapy (ACOG 2018).

Patients without hypovolemia: Oral, IV (bolus): 4 mg every 8 hours, as needed, added to current treatment regimen (Abas 2014; ACOG 2018; Oliveira 2014). If necessary, some experts increase to a maximum of 8 mg/dose (Niebyl 2010; Smith 2018)

Patients with hypovolemia: Note: For patients with persistent symptoms despite intravenous fluid replacement: IV: 8 mg administered over 15 minutes every 12 hours, added to current treatment regimen (ACOG 2018). Some experts use 4 to 8 mg administered as an IV bolus every 8 hours until stabilization (Smith 2018).

Radiation therapy-associated nausea and vomiting, prevention:

High-emetogenic risk radiation therapy (total body irradiation):

Radiation day(s):

IV (off-label): 8 mg or 0.15 mg/kg (maximum: 16 mg/dose) once daily or twice daily prior to each fraction of radiation; give in combination with dexamethasone (ASCO [Hesketh 2017]; MASCC/ESMO [Roila 2016])

Oral: 8 mg once daily or twice daily administered 1 to 2 hours prior to each fraction of radiation; give in combination with dexamethasone (ASCO [Hesketh 2017]) or, in one clinical trial of 4 days of hyperfractionated total body irradiation, 8 mg (without dexamethasone) was administered 1.5 hours prior to every fraction of radiation (3 times daily for the first 3 days and twice daily on day 4) (Spitzer 2000)

Post-radiation days:

IV (off-label), Oral: The appropriate duration of therapy following radiotherapy days is not well defined; ASCO guidelines recommend continuing ondansetron once daily or twice daily on the day after each day of radiation (ASCO [Hesketh 2017])

Moderate-emetogenic risk radiation therapy (upper abdomen, craniospinal irradiation [off-label use]):

Radiation day(s):

IV (off-label): 8 mg or 0.15 mg/kg (maximum: 16 mg/dose) once daily or twice daily prior to each fraction of radiation; may give with or without dexamethasone before the first 5 fractions (ASCO [Hesketh 2017]; MASCC/ESMO [Roila 2016])

Oral: 8 mg once daily or twice daily administered 1 to 2 hours prior to each fraction of radiation; may give with or without dexamethasone before the first 5 fractions (ASCO [Hesketh 2017]) or, in clinical trials involving upper abdomen radiation (high-dose single exposure or multiple-day fractionated course), 8 mg 3 times daily (without dexamethasone) has been given; doses were administered 1 to 2 hours prior to radiation therapy (Priestman 1990; Priestman 1993).

Vertigo-associated nausea and vomiting (alternative agent) (off-label use): Limited data available:

IV (preferred), IM: 4 to 8 mg once for acute symptoms (Furman 2018)

Oral: 4 mg every 8 to 12 hours (Furman 2018; Rice 1995)

Dosing: Geriatric

Oral: No dosing adjustment required; refer to adult dosing.

IV: Single IV doses >16 mg are no longer recommended due to the potential for QT prolongation (FDA 2012). In patients ≥75 years, Canadian recommendations place additional restrictions to limit initial IV doses to ≤8 mg due to this risk (Health Canada 2014).

Dosing: Renal Impairment: Adult

IV: No dosage adjustment is necessary.

Oral: No dosage adjustment is necessary; however, according to the manufacturer, there is no experience for oral ondansetron in renal impairment beyond first-day administration (has not been studied beyond day 1).

Dosing: Hepatic Impairment: Adult

Mild to moderate impairment: No dosage adjustment necessary.

Severe impairment (Child-Pugh class C):

IV: Day 1: Maximum daily dose: 8 mg; however, according to the manufacturer, there is no experience beyond first-day administration (has not been studied beyond day 1)

Oral: Maximum daily dose: 8 mg

Dosing: Pediatric

Chemotherapy-induced nausea and vomiting, prevention:

Manufacturer’s labeling:

IV: Infants ≥6 months, Children, and Adolescents: 0.15 mg/kg/dose; maximum dose: 16 mg/dose; administer first dose 30 minutes before the start of chemotherapy with subsequent doses administered 4 and 8 hours after the first dose for 3 doses total

Oral: Moderately emetogenic antineoplastic therapy:

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

Children ≥12 years and Adolescents: 8 mg beginning 30 minutes before chemotherapy; repeat dose 8 hours after initial dose, then 8 mg every 12 hours for 1 to 2 days after chemotherapy completed

Alternate dosing:

Weight-directed dosing: Infants, Children, and Adolescents:

Highly emetogenic antineoplastic therapy: IV, Oral: 0.15 mg/kg/dose; maximum dose: 16 mg/dose; administer first dose before the start of chemotherapy and then every 8 hours (Dupuis 2013); a once-daily single dose of 0.3 mg/kg or 0.45 mg/kg (maximum dose: 16 mg) dependent upon emetogenic potential of chemotherapy has also been reported (Holdsworth 2006)

Moderately emetogenic antineoplastic therapy: IV, Oral: 0.15 mg/kg/dose; maximum dose: 8 mg/dose; administer first dose before the start of chemotherapy with subsequent doses every 12 hours (Dupuis 2013)

Low emetogenic antineoplastic therapy: IV, Oral: 0.3 mg/kg/dose once; maximum dose: 16 mg/dose; administered 30 minutes before the start of chemotherapy (Dupuis 2013)

BSA-directed dosing:

Highly emetogenic antineoplastic therapy: Infants, Children, and Adolescents: IV, Oral: 5 mg/m2/dose; maximum dose: 16 mg/dose; administer first dose before the start of chemotherapy with subsequent doses administered every 8 hours (Dupuis 2013)

Moderately emetogenic antineoplastic therapy: Infants, Children, and Adolescents: IV, Oral: 5 mg/m2/dose; maximum dose: 8 mg/dose; administer first before the start of chemotherapy with subsequent doses every 12 hours (Dupuis 2013)

Low emetogenic antineoplastic therapy: Infants, Children, and Adolescents: IV, Oral: 10 mg/m2/dose once; maximum dose: 16 mg/dose; administered before the start of chemotherapy (Dupuis 2013)

Cyclic vomiting syndrome (CVS); treatment of acute attack Limited data available; dosing based on case reports and clinical experience: Children >2 years and Adolescents:

Low dose: IV: 0.15 mg/kg every 4 hours as needed for up to 3 doses; maximum dose: 16 mg/dose (Fleisher 1995)

High dose: IV: 0.3 to 0.4 mg/kg/dose every 4 to 6 hours; maximum dose: 16 mg/dose (Li 2008); per manufacturer labeling, should not exceed 3 doses in a 24-hour period

Gastroenteritis, acute; treatment: Note: Routine use of ondansetron is not recommended in most cases of acute gastroenteritis (AAP 2004; CDC 2003)

IV: Infants and Children ≥1 month: 0.15 or 0.3 mg/kg/dose once; maximum dose: 16 mg/dose (DeCamp 2008)

Oral: Infants and Children 6 months to 10 years, ≥8 kg (Freedman 2006):

8 to 15 kg: 2 mg/dose once

>15 to 30 kg: 4 mg/dose once

>30 kg: 8 mg/dose once

Postoperative nausea and vomiting; prevention: Administer immediately before or following induction of anesthesia, or postoperatively if the patient is symptomatic. Repeat doses given in response to inadequate control of nausea/vomiting from preoperative doses are generally ineffective.

Infants and Children: IV:

≤40 kg: 0.1 mg/kg/dose as a single dose; maximum dose: 4 mg/dose

>40 kg: 4 mg/dose as a single dose

Adolescents: IM, IV: 4 mg/dose as a single dose

Radiation-induced nausea and vomiting, prevention: Limited data available: Oral:

Weight-directed dosing: Infants ≥5 months, Children, and Adolescents: 0.2 mg/kg/dose (maximum dose: 8 mg/dose) administered every 8 hours throughout total body irradiation (TBI) prior to HSCT (n=68; mean age: 6.7 years; range: 5 months to 20 years); doses were generally rounded to 4 mg/dose in children 4 to 11 years and 8 mg/dose in children ≥12 years and adolescents (Applegate 1998)

Alternate weight-based dosing: Children and Adolescents: 0.15 mg/kg/dose administered 3 to 4 times daily throughout TBI (n=33; mean age: 9 years; range: 13 months to 16 years) (Farah 1998)

Fixed dose: Note: Derived from rounding weight-based (0.2 mg/kg/dose) doses (Applegate 1998)

Children 4 to 11 years: 4 mg every 8 hours throughout total body irradiation (TBI) prior to HSCT

Children ≥12 years and Adolescents: 8 mg every 8 hours throughout total body irradiation (TBI) prior to HSCT

Alternate fixed-dosing: Children ≥9 years and Adolescents: 8 mg every 12 hours on days of TBI prior to bone marrow transplantation (age range: 9 to 67 years; median age range: 39 to 49 years). Note: Administered in combination with dexamethasone (Bredeson 2002).

Dosing: Renal Impairment: Pediatric

IV: No dosage adjustment is necessary.

Oral: No dosage adjustment is necessary; however, there is no experience for oral ondansetron in renal impairment beyond first-day administration (has not been studied beyond day 1)

Dosing: Hepatic Impairment: Pediatric

There are no pediatric-specific recommendations; based on experience in adult patients, no adjustment may be necessary for mild to moderate hepatic impairment; for severe impairment, dosing adjustment suggested.

Use: Labeled Indications

Cancer chemotherapy-induced nausea and vomiting:

IV: Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (including high-dose cisplatin).

Oral:

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy (including cisplatin ≥50 mg/m2).

Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

Postoperative nausea and/or vomiting: IV, IM, Oral: Prevention of postoperative nausea and/or vomiting (PONV). If nausea/vomiting occur in a patient who had not received prophylactic ondansetron, IV ondansetron may be administered to prevent further episodes.

Limitations of use: Routine prophylaxis for PONV in patients with minimal expectation of nausea and/or vomiting is not recommended, although use is recommended in patients when nausea and vomiting must be avoided in the postoperative period, even if the incidence of PONV is low.

Radiotherapy-associated nausea and vomiting: Oral: Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.

Use: Off-Label: Adult

  Carcinoid syndrome-associated diarrhea, severe, refractoryLevel of Evidence [C]

Data from a limited number of patients (case reports) suggest that ondansetron may be of benefit in the management of severe carcinoid syndrome associated-diarrhea that is refractory to preferred agents (eg, somatostatin analogues) Ref.

  Gastroparesis, symptomatic treatment of nausea and vomiting (alternative agent in patients with persistent symptoms refractory to prokinetic therapy)Level of Evidence [C]

Expert opinion suggests the utility of ondansetron as an alternative agent in patients with persistent nausea and vomiting refractory to prokinetic therapy Ref. There are no published data evaluating the role of antiemetics, including ondansetron, in the treatment of this condition.

  Nausea and/or vomiting, acute, severeLevel of Evidence [C]

Limited data from a small number of randomized and nonrandomized trials, primarily in the emergency department setting, suggest benefit with ondansetron in the treatment of severe, acute undifferentiated nausea and/or vomiting Ref; however, definitive, high-quality trials supporting efficacy are lacking Ref.

Clinical experience also suggests the utility of ondansetron in the treatment of severe, acute nausea and vomiting due to a variety of self-limiting etiologies such as viral gastroenteritis Ref, acute mountain sickness Ref, or a variety of other medical conditions associated with severe nausea/vomiting.

  Postoperative nausea and vomiting, treatment or rescue therapyLevel of Evidence [G]

Based on the Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea, it is reasonable to administer a 5-HT3 receptor antagonist for the treatment of postoperative nausea and vomiting when a prophylactic agent was not utilized or as rescue therapy when an agent from a different class was utilized as prophylaxis and failed.

  Pregnancy-associated nausea and vomiting, severe or refractoryLevel of Evidence [B, G]

Based on the Society of Obstetricians and Gynaecologists of Canada guideline on nausea and vomiting of pregnancy and the American College of Obstetricians and Gynecologists practice bulletin, the use of ondansetron may be considered in the treatment of severe or refractory nausea and vomiting when preferred agents have failed Ref.

  Vertigo-associated nausea and vomitingLevel of Evidence [C]

Data from a small, open-label, pilot study and clinical experience suggests the utility of ondansetron in the acute treatment of nausea and vomiting associated with vertigo Ref.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Antiemetics in oncology setting:

American Society of Clinical Oncology, Antiemetics: Clinical Practice Guideline Updates, July 2017

Multinational Association of Supportive Care in Cancer (MASCC)/European Society for Medical Oncology (ESMO), “Antiemetic Guidelines,” Updated 2016

National Comprehensive Cancer Network® (NCCN), Clinical Practice Guidelines in Oncology™, Antiemesis

Pediatric Oncology Group of Ontario, Guideline for the Prevention of Acute Nausea and Vomiting Due to Antineoplastic Medication in Pediatric Cancer Patients, 2013

Pediatric Oncology Group of Ontario, Guideline for the Prevention of Acute Chemotherapy-Induced Nausea and Vomiting in Pediatric Cancer Patients: A Focused Update, 2017

Antiemetics in postoperative setting:

Society for Ambulatory Anesthesiology, Consensus Guidelines for the Management of Postoperative Nausea and Vomiting, 2014

Administration: IM

Should be given undiluted.

Administration: IV

IVPB: Infuse diluted solution over 15 minutes

Chemotherapy-induced nausea and vomiting: Give first dose 30 minutes prior to beginning chemotherapy.

IV push: Prevention of postoperative nausea and vomiting: Single doses may be administered IV injection as undiluted solution over at least 30 seconds but preferably over 2 to 5 minutes

Administration: Injectable Detail

pH: 3 to 4

Administration: Oral

Oral dosage forms should be given 30 minutes prior to chemotherapy; 1 to 2 hours before radiation; 30 to 60 minutes prior to surgery or induction of anesthesia

Orally disintegrating tablets: Do not remove from blister until needed. Peel backing off the blister, do not attempt to push tablet through the foil. Using dry hands, place tablet on tongue and allow to dissolve. Swallow with saliva (no need to administer with liquids).

Oral soluble film: Do not remove from pouch until immediately before use. Using dry hands, place film on top of tongue and allow to dissolve (4 to 20 seconds). Swallow with or without liquid. If using more than one film, each film should be allowed to dissolve completely before administering the next film.

Administration: Pediatric

Oral (all dosage forms): May administer without regard to meals. Administer 30 minutes prior to chemotherapy, 1 to 2 hours prior to radiotherapy, and 1 hour prior to induction of anesthesia.

Orally disintegrating tablet (Zofran ODT): Do not remove from blister until needed. Peel backing off the blister; do not push tablet through foil backing. Using dry hands, place tablet on tongue and allow to dissolve; swallow with saliva (no need to administer with liquids).

Soluble film (Zuplenz): Do not remove from pouch until immediately before use. Using dry hands, place film on top of tongue and allow to dissolve (4 to 20 seconds). Swallow with or without liquid. If using more than one film, allow each film to dissolve completely before administering the next film.

Parenteral:

IV:

IVPB infusion:

Prevention of chemotherapy-induced nausea and vomiting: Infuse over 15 minutes

Cyclic vomiting syndrome: Infuse over 15 to 30 minutes (Fleischer 1995)

IV push: May be administered undiluted IV over 2 to 5 minutes for prevention of PONV

IM: Administer as undiluted injection.

Dietary Considerations

Some products may contain phenylalanine.

Storage/Stability

Oral soluble film: Store between 20°C and 25°C (68°F and 77°F). Store pouches in cartons; keep film in individual pouch until ready to use.

Oral solution: Store between 15°C and 30°C (59°F and 86°F). Protect from light.

Tablet: Store between 2°C and 30°C (36°F and 86°F).

Vial: Store between 2°C and 30°C (36°F and 86°F). Protect from light. Chemically and physically stable when mixed in D5W or NS for 48 hours at room temperature; however, diluents generally do not contain a preservative and sterile precautions should be observed. After dilution, do not use beyond 24 hours.

Premixed bag in D5W: Store at 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F); may refrigerate; avoid freezing and excessive heat; protect from light.

Preparation for Administration: Adult

Vial:

Prevention of chemotherapy-induced nausea and vomiting: Dilution is required prior to IV infusion. Dilute in 50 mL D5W or NS. In pediatric patients between 6 months and 1 year of age and/or ≤10 kg, may dilute in 10 to 50 mL D5W or NS, depending on fluid needs of the patient. Use diluted solutions within 24 hours of preparation.

Prevention of postoperative nausea and vomiting: No dilution is required.

Preparation for Administration: Pediatric

Parenteral: IVPB infusion:

Prevention of chemotherapy-induced nausea and vomiting: Dilute prior to infusion. In pediatric patients weighing ≤10 kg and/or between 6 months and 1 year of age, may dilute dose in 10 to 50 mL D5W or NS, depending on fluid needs of the patient. In older patients and adults, dilute dose in 50 mL D5W or NS. Concentrations as high as 1 mg/mL have been reported in the literature (Murray 2014).

Cyclic vomiting syndrome: Dilute in 50 to 100 mL of D5W (Fleischer 1995)

Compatibility

See Trissel’s IV Compatibility Database

Extemporaneously Prepared

Note: Commercial oral solution is available (0.8 mg/mL)

If commercial oral solution is unavailable, a 0.8 mg/mL syrup may be made with ondansetron tablets, Ora-Plus® (Paddock), and any of the the following syrups: Cherry syrup USP, Syrpalta® (HUMCO), Ora-Sweet® (Paddock), or Ora-Sweet® Sugar-Free (Paddock). Crush ten 8 mg tablets in a mortar and reduce to a fine powder (flaking of the tablet coating occurs). Add 50 mL Ora-Plus® in 5 mL increments, mixing thoroughly; mix while adding the chosen syrup in incremental proportions to almost 100 mL; transfer to a calibrated bottle, rinse mortar with syrup, and add sufficient quantity of syrup to make 100 mL. Label “shake well” and “refrigerate”. Stable for 42 days refrigerated (Trissel 1996).

Rectal suppositories: Calibrate a suppository mold for the base being used. Determine the displacement factor (DF) for ondansetron for the base being used (Fattibase® = 1.1; Polybase® = 0.6). Weigh the ondansetron tablet(s). Divide the tablet weight by the DF; this result is the weight of base displaced by the drug. Subtract the weight of base displaced from the calculated weight of base required for each suppository. Grind the ondansetron tablets in a mortar and reduce to a fine powder. Weigh out the appropriate weight of suppository base. Melt the base over a water bath (<55°C). Add the ondansetron powder to the suppository base and mix well. Pour the mixture into the suppository mold and cool. Stable for at least 30 days refrigerated (Tenjarla 1998).

Tenjarla SN, Ward ES, and Fox JL, “Ondansetron Suppositories: Extemporaneous Preparation, Drug Release, Stability and Flux Through Rabbit Rectal Membrane,” Int J Pharm Compound, 1998, 2(1):83-8.

Trissel LA, Trissel’s Stability of Compounded Formulations, Washington, DC: American Pharmaceutical Association, 1996.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, loss of strength and energy, constipation, diarrhea, anxiety, or injection site irritation. Have patient report immediately to prescriber angina, passing out, bradycardia, tachycardia, abnormal heartbeat, numbness or tingling, severe fatigue, abdominal pain, difficult urination, abnormal movements, vision changes, seizures, dizziness, chills, or signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

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

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Hypersensitivity reactions (including anaphylaxis and bronchospasm) have been reported; discontinue if hypersensitivity occurs. Use with caution in patients allergic to other 5-HT3 receptor antagonists; cross-reactivity has been reported.

• QT prolongation: ECG changes, including dose-dependent QT interval prolongation, have been observed with ondansetron use. Cases of torsades de pointes have also been reported. Selective 5-HT3 antagonists, including ondansetron, have been associated with a number of dose-dependent increases in ECG intervals (eg, PR, QRS duration, QT/QTc, JT), usually occurring 1 to 2 hours after IV administration. Single doses >16 mg ondansetron IV are no longer recommended due to the potential for an increased risk of QT prolongation. In most patients, these changes are not clinically relevant; however, when used in conjunction with other agents that prolong these intervals or in those at risk for QT prolongation, arrhythmia may occur. When used with agents that prolong the QT interval (eg, Class I and III antiarrhythmics) or in patients with cardiovascular disease, clinically relevant QT interval prolongation may occur resulting in torsades de pointes. A number of trials have shown that 5-HT3 antagonists produce QT interval prolongation to variable degrees. Avoid ondansetron use in patients with congenital long QT syndrome. Use caution and monitor ECG in patients with other risk factors for QT prolongation (eg, medications known to prolong QT interval, electrolyte abnormalities [hypokalemia or hypomagnesemia], heart failure, bradyarrhythmias, and cumulative high-dose anthracycline therapy). Reduction in heart rate may also occur with the 5-HT3 antagonists. IV formulations of 5-HT3 antagonists have more association with ECG interval changes, compared to oral formulations.

• Serotonin syndrome: Serotonin syndrome has been reported with 5-HT3 receptor antagonists, predominantly when used in combination with other serotonergic agents (eg, SSRIs, SNRIs, MAOIs, mirtazapine, fentanyl, lithium, tramadol, and/or methylene blue). Some of the cases have been fatal. The majority of serotonin syndrome reports due to 5-HT3receptor antagonist have occurred in a postanesthesia setting or in an infusion center. Serotonin syndrome has also been reported following overdose of ondansetron. Monitor patients for signs of serotonin syndrome, including mental status changes (eg, agitation, hallucinations, delirium, coma); autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis, dizziness, flushing, hyperthermia); neuromuscular changes (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination); gastrointestinal symptoms (eg, nausea, vomiting, diarrhea); and/or seizures. If serotonin syndrome occurs, discontinue 5-HT3 receptor antagonist treatment and begin supportive management.

Disease-related concerns:

• Hepatic impairment: Dose limitations are recommended for patients with severe hepatic impairment (Child-Pugh class C); use with caution in mild-moderate hepatic impairment; clearance is decreased and half-life increased in hepatic impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [“Inactive” 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Phenylalanine: Orally-disintegrating tablets contain phenylalanine.

Other warnings/precautions:

• Chemotherapy-associated emesis: Antiemetics are most effective when used prophylactically (Roila 2016). If emesis occurs despite optimal antiemetic prophylaxis, re-evaluate emetic risk, disease, concurrent morbidities and medications to assure antiemetic regimen is optimized (ASCO [Hesketh 2017]).

• Ileus or gastric distention: Ondansetron does not stimulate gastric or intestinal peristalsis (do not use in place of nasogastric suction). Ondansetron may mask progressive ileus and/or gastric distension; monitor for decreased bowel activity.

Geriatric Considerations

Elderly have a slightly decreased hepatic clearance rate. This does not, however, require a dose adjustment.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Ondansetron readily crosses the human placenta in the first trimester of pregnancy and can be detected in fetal tissue (Siu 2006). Due to pregnancy-induced physiologic changes, clearance of ondansetron may increase as pregnancy progresses (Lemon 2016).

Although ondansetron has been evaluated for the treatment of nausea and vomiting of pregnancy, current guidelines note data related to fetal safety are conflicting (ACOG 2018); ondansetron is generally reserved for use when other agents have failed (Arsenault 2002). Because a dose-dependent QT-interval prolongation occurs with use, the manufacturer recommends ECG monitoring in patients with electrolyte abnormalities (which can be associated with some cases of NVP; Koren 2012). An international consensus panel recommends that 5-HT3 antagonists (including ondansetron) should not be withheld in pregnant patients receiving chemotherapy for the treatment of gynecologic cancers, when chemotherapy is given according to general recommendations for chemotherapy use during pregnancy (Amant 2009).

Breast-Feeding Considerations

It is not known if ondansetron is present in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Note: Percentages reported in adult patients unless otherwise specified.

>10%:

Central nervous system: Headache (oral: 9% to 27%; IV: 17%), fatigue (oral: ≤9% to 13%), malaise (oral: ≤9% to 13%)

Gastrointestinal: Constipation (6% to 11%)

1% to 10%:

Central nervous system: Drowsiness (IV: ≤8%), sedation (IV: ≤8%), (dizziness (7%), agitation (oral: ≤6%), anxiety (oral: ≤6%), paresthesia (IV: 2%), sensation of cold (IV: 2%)

Dermatologic: Pruritus (2% to 5%), skin rash (1%)

Gastrointestinal: Diarrhea (oral: 6% to 7%; IV: Children 1 to 24 months of age: 2%)

Genitourinary: Gynecologic disease (oral: 7%), urinary retention (oral: 5%)

Hepatic: Increased serum ALT (>2 times ULN: 1% to 5%; transient), increased serum AST (>2 times ULN: 1% to 5%; transient)

Local: Injection site reaction (IV: 4%; includes burning sensation at injection site, erythema at injection site, injection site pain)

Respiratory: Hypoxia (oral: 9%)

Miscellaneous: Fever (2% to 8%)

<1%, postmarketing, and/or case reports: Abdominal pain, accommodation disturbance, anaphylactoid reaction, anaphylaxis, angina pectoris, angioedema, atrial fibrillation, bradycardia, bronchospasm, bullous skin disease, cardiac arrhythmia, cardiorespiratory arrest (IV), chest pain, chills, depression of ST segment on ECG, dyspnea, dystonic reaction, ECG changes, extrapyramidal reaction (IV), flushing, hepatic failure (when used with other hepatotoxic medications), hiccups, hypersensitivity reaction, hypokalemia, hypotension, ischemic heart disease, laryngeal edema, laryngospasm (IV), liver enzyme disorder, mucosal tissue reaction, myocardial infarction, neuroleptic malignant syndrome, oculogyric crisis, palpitations, positive lymphocyte transformation test, prolonged Q-T interval on ECG (dose dependent), second-degree atrioventricular block, serotonin syndrome, shock (IV), Stevens-Johnson syndrome, stridor, supraventricular tachycardia, syncope, tachycardia, tonic-clonic seizures, torsades de pointes, toxic epidermal necrolysis, transient blindness (lasted ≤48 hours), transient blurred vision (following infusion), urticaria, vascular occlusive events, ventricular premature contractions, ventricular tachycardia, weakness, xerostomia

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP1A2 (minor), CYP2C9 (minor), CYP2D6 (minor), CYP2E1 (minor), CYP3A4 (major), P-glycoprotein/ABCB1; Note:Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Amiodarone: May enhance the QTc-prolonging effect of Ondansetron. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

Apomorphine: Antiemetics (5HT3 Antagonists) may enhance the hypotensive effect of Apomorphine. Risk X: Avoid combination

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Domperidone: May enhance the QTc-prolonging effect of Ondansetron. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Haloperidol: Ondansetron may enhance the QTc-prolonging effect of Haloperidol. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Lorlatinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. Risk D: Consider therapy modification

MetFORMIN: Ondansetron may increase the serum concentration of MetFORMIN. Risk C: Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Risk D: Consider therapy modification

Panobinostat: Ondansetron may enhance the arrhythmogenic effect of Panobinostat. Risk C: Monitor therapy

Pentamidine (Systemic): May enhance the QTc-prolonging effect of Ondansetron. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy

Pimozide: May enhance the QTc-prolonging effect of Ondansetron. Risk X: Avoid combination

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Risk D: Consider therapy modification

QT-prolonging Agents (Highest Risk): May enhance the QTc-prolonging effect of Ondansetron. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Exceptions: Ajmaline; Amiodarone; Disopyramide; Dofetilide; Dronedarone; Ibutilide; Procainamide; QuiNIDine; Sotalol; Vernakalant. Risk D: Consider therapy modification

QT-prolonging Antidepressants (Moderate Risk): Ondansetron may enhance the QTc-prolonging effect of QT-prolonging Antidepressants (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Antipsychotics (Moderate Risk): Ondansetron may enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk.Exceptions: Pimozide. Risk C: Monitor therapy

QT-prolonging Class IA Antiarrhythmics (Highest Risk): May enhance the QTc-prolonging effect of Ondansetron. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

QT-prolonging Class IC Antiarrhythmics (Moderate Risk): May enhance the QTc-prolonging effect of Ondansetron. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Class III Antiarrhythmics (Highest Risk): May enhance the QTc-prolonging effect of Ondansetron. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

QT-prolonging Kinase Inhibitors (Moderate Risk): Ondansetron may enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Miscellaneous Agents (Moderate Risk): May enhance the QTc-prolonging effect of Ondansetron. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Exceptions: Domperidone. Risk C: Monitor therapy

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): Ondansetron may enhance the QTc-prolonging effect of QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Quinolone Antibiotics (Moderate Risk): Ondansetron may enhance the QTc-prolonging effect of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of Ondansetron. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Risk C: Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Serotonin Modulators: Antiemetics (5HT3 Antagonists) may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Exceptions: Nicergoline.Risk C: Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

St John’s Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

Tapentadol: Antiemetics (5HT3 Antagonists) may diminish the analgesic effect of Tapentadol. Risk C: Monitor therapy

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

TraMADol: Antiemetics (5HT3 Antagonists) may diminish the analgesic effect of TraMADol. Risk C: Monitor therapy

Food Interactions

Tablet: Food slightly increases the extent of absorption. Management: Administer without regard to meals.

Gene Testing May Be Considered
Monitoring Parameters

ECG (if applicable in high-risk or elderly patients); potassium, magnesium. Monitor for signs of serotonin syndrome; monitor for decreased bowel activity.

Advanced Practitioners Physical Assessment/Monitoring

Assess allergy history (selective 5-HT3 receptor antagonists) prior to administering. Avoid use in presence of, or potential for, cardiac conduction abnormalities (eg, QT prolongation, medication known to prolong QT interval, electrolyte abnormalities). Oral and IV doses have different schedules and should not be administered on “PRN” basis.

Nursing Physical Assessment/Monitoring

Allergy history to selective 5-HT3 receptor antagonists should be assessed prior to administering. Assess other drugs patient may be taking that may prolong QT interval. IV: Follow infusion specifics. Oral and IV doses have different schedules and should not be administered on “PRN” basis.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Film, Oral:

Zuplenz: 4 mg (1 ea [DSC], 10 ea [DSC], 30 ea); 8 mg (1 ea [DSC], 10 ea [DSC], 30 ea)

Solution, Injection, as hydrochloride [strength expressed as base]:

Generic: 4 mg/2 mL (2 mL); 40 mg/20 mL (20 mL)

Solution, Injection, as hydrochloride [strength expressed as base, preservative free]:

Generic: 4 mg/2 mL (2 mL)

Solution, Oral, as hydrochloride [strength expressed as base]:

Zofran: 4 mg/5 mL (50 mL [DSC]) [strawberry flavor]

Generic: 4 mg/5 mL (50 mL)

Tablet, Oral:

Generic: 24 mg

Tablet, Oral, as hydrochloride [strength expressed as base]:

Zofran: 4 mg, 8 mg

Generic: 4 mg, 8 mg, 24 mg

Tablet Disintegrating, Oral:

Zofran ODT: 4 mg [DSC], 8 mg [DSC] [contains aspartame, methylparaben sodium, propylparaben sodium; strawberry flavor]

Generic: 4 mg, 8 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Film, Oral:

Ondissolve ODF: 4 mg (6ea, 10ea, 50ea); 8 mg (6ea, 10ea, 50ea) [contains LEVOMENTHOL, POLYETHYLENE GLYCOL, POLYSORBATE 80]

Solution, Intravenous:

Zofran: 2 mg/mL (2ml, 4ml, 20ml)

Generic: 2 mg/mL (2ml, 4ml, 5ml, 20ml)

Solution, Oral, as hydrochloride [strength expressed as base]:

Zofran: 4 mg/5 mL (50ml) [contains ALCOHOL, USP, SODIUM BENZOATE]

Generic: 4 mg/5 mL (50ml)

Tablet, Oral, as hydrochloride [strength expressed as base]:

Zofran: 4 mg, 8 mg

Generic: 4 mg, 8 mg

Tablet Disintegrating, Oral:

Zofran ODT: 4 mg, 8 mg [contains ASPARTAME, METHYLPARABEN SODIUM, PROPYLPARABEN SODIUM]

Generic: 4 mg, 8 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • A04AA01
Generic Available (US)

May be product dependent

Pricing: US

Film (Zuplenz Oral)

4 mg (per each): $42.43

8 mg (per each): $42.43

Solution (Ondansetron HCl Injection)

4 mg/2 mL (per mL): $0.28 – $1.35

40 mg/20 mL (per mL): $0.16 – $1.25

Solution (Ondansetron HCl Oral)

4 mg/5 mL (per mL): $4.78 – $4.80

Tablet, orally-disintegrating (Ondansetron Oral)

4 mg (per each): $22.25 – $23.11

8 mg (per each): $36.66 – $38.50

Tablets (Ondansetron HCl Oral)

4 mg (per each): $0.54 – $24.89

8 mg (per each): $0.64 – $41.53

24 mg (per each): $105.50 – $106.51

Tablets (Zofran Oral)

4 mg (per each): $27.91

8 mg (per each): $46.48

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Ondansetron is a selective 5-HT3-receptor antagonist which blocks serotonin, both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone

Pharmacodynamics/Kinetics

Onset of action: ~30 minutes

Absorption: Oral: 100%; nonlinear absorption occurs with increasing oral doses; Zofran ODT tablets are bioequivalent to Zofran tablets; absorption does not occur via oral mucosa

Distribution: Vd:

Infants and Children: Surgical patients:

1 to 4 months: 3.5 L/kg

5 to 24 months: 2.3 L/kg

3 to 12 years: 1.65 L/kg

Children and Adolescents: Cancer patients: 4 to 18 years: 1.9 L/kg

Adults: 1.9 L/kg

Protein binding, plasma: 70% to 76%

Metabolism: Extensively hepatic via hydroxylation, followed by glucuronide or sulfate conjugation; CYP1A2, CYP2D6, and CYP3A4 substrate; some demethylation occurs

Bioavailability: Oral: 50% to 70% due to some first-pass metabolism; in cancer patients (adults), 85% to 87% bioavailability possibly related to changes in metabolism

Half-life elimination:

Children: Cancer patients: Children and Adolescents: 4 to 18 years: 2.8 hours; Surgical patients: Infants 1 to 4 months: 6.7 hours; Infants and Children 5 months to 12 years: 2.9 hours

Adults: 3 to 6 hours; Mild-to-moderate hepatic impairment (Child-Pugh classes A and B): 12 hours; Severe hepatic impairment (Child-Pugh class C): 20 hours

Time to peak: Oral: ~2 hours; Oral soluble film: ~1 hour

Excretion: Urine (44% to 60% as metabolites, ~5% as unchanged drug); feces (~25%)

Clearance:

Cancer patients: Children and Adolescents 4 to 18 years: 0.599 L/kg/hour

Surgical patients: Infants and Children: 1 to 4 months: 0.401 L/kg/hour; 5 to 24 months: 0.581 L/kg/hour; 3 to 12 years: 0.439 L/kg/hour

Adult (normal): 19 to 40 years: 0.381 L/kg/hour; 61 to 74 years: 0.319 L/kg/hour; >75 years: 0.262 L/kg/hour

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: Mean plasma clearance is reduced by 41% (IV) and 50% (oral) in patients with severe renal impairment (CrCl <30 mL/minute).

Hepatic function impairment: Clearance is reduced 2- to 3-fold and the volume of distribution is increased. The half-life is increased to 20 hours in patients with severe hepatic impairment.

Geriatric: In elderly patients >75 years of age, there is a reduction in clearance and an increase in elimination half-life.

Gender: The extent and rate of absorption is greater in women than in men. There is slower clearance, a smaller volume of distribution, and higher bioavailability in women.

Local Anesthetic/Vasoconstrictor Precautions

Ondansetron is one of the drugs confirmed to prolong the QT interval and is accepted as having a risk of causing torsade de pointes. The risk of drug-induced torsade de pointes is extremely low when a single QT interval prolonging drug is prescribed. In terms of epinephrine, it is not known what effect vasoconstrictors in the local anesthetic regimen will have in patients with a known history of congenital prolonged QT interval or in patients taking any medication that prolongs the QT interval. Until more information is obtained, it is suggested that the clinician consult with the physician prior to the use of a vasoconstrictor in suspected patients, and that the vasoconstrictor (epinephrine, mepivacaine and levonordefrin [Carbocaine® 2% with Neo-Cobefrin®]) be used with caution.

Dental Health Professional Considerations

Ondansetron is a safer alternative than phenothiazines (ie, promethazine) for the treatment of moderate-to-severe postoperative nausea and vomiting. The cost can be a limitation.

Also see Local Anesthetic/Vasoconstrictor Precautions

Effects on Dental Treatment

Ondansetron is an alternative to phenothiazines (ie, promethazine) for the treatment of moderate-to-severe postoperative nausea and vomiting. Ondansetron prolongs the QT interval in a dose-dependent manner. Avoid ondansetron in patients with congenital long QT syndrome.

Effects on Bleeding

No information available to require special precautions

Index Terms

GR38032R; Ondansetron HCl; Ondansetron Hydrochloride

FDA Approval Date
January 04, 1991
References

Abas MN, Tan PC, Azmi N, Omar SZ. Ondansetron compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial. Obstet Gynecol. 2014;123(6):1272-1279.[PubMed 24807340]

ACOG Committee on Practice Bulletins-Obstetrics. ACOG practice bulletin No. 189: nausea and vomiting of pregnancy. Obstet Gynecol. 2018;131(1):e15-e30.[PubMed 29266076]

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

Alexandraki I, Smetana GW. Acute viral gastroenteritis in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 18, 2018.

Amant F, Van Calsteren K, Halaska MJ, et al. Gynecologic cancers in pregnancy: guidelines of an international consensus meeting. Int J Gynecol Cancer. 2009;19(suppl 1):S1-S12.[PubMed 19509538]

Apfel CC, Korttila K, Abdalla M, et al; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004;350(24):2441-2451.[PubMed 15190136]

Arsenault MY, Lane CA, MacKinnon CJ, et al. The management of nausea and vomiting of pregnancy. J Obstet Gynaecol Can. 2002;24(10):817-831.[PubMed 12405123]

Barrett TW, DiPersio DM, Jenkins CA, et al. A randomized, placebo-controlled trial of ondansetron, metoclopramide, and promethazine in adults. Am J Emerg Med. 2011;29(3):247-255. doi: 10.1016/j.ajem.2009.09.028.[PubMed 20825792]

Braude D, Crandall C. Ondansetron versus promethazine to treat acute undifferentiated nausea in the emergency department: a randomized, double-blind, noninferiority trial. Acad Emerg Med. 2008;15(3):209-215. doi: 10.1111/j.1553-2712.2008.00060.x.[PubMed 18304050]

Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013;108(1):18-37. doi: 10.1038/ajg.2012.373.[PubMed 23147521]

Camilleri M. Treatment of gastroparesis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 10, 2018.

Celio L, Niger M, Ricchini F, Agustoni F. Palonosetron in the prevention of chemotherapy-induced nausea and vomiting: an evidence-based review of safety, efficacy, and place in therapy. Core Evid. 2015;10:75-87. doi:10.2147/CE.S65555.[PubMed 26345982]

Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]

Dupuis LL, Boodhan S, Holdsworth M, et al; Pediatric Oncology Group of Ontario. Guideline for the prevention of acute nausea and vomiting due to antineoplastic medication in pediatric cancer patients. Pediatr Blood Cancer. 2013;60(7):1073-1082.[PubMed 23512831]

Egerton-Warburton D, Meek R, Mee MJ, Braitberg G. Antiemetic use for nausea and vomiting in adult emergency department patients: randomized controlled trial comparing ondansetron, metoclopramide, and placebo. Ann Emerg Med. 2014;64(5):526-532.e1. doi: 10.1016/j.annemergmed.2014.03.017.[PubMed 24818542]

FDA. FDA drug safety communication: new information regarding QT prolongation with ondansetron (Zofran). https://www.fda.gov/Drugs/DrugSafety/ucm310190.htm. Published June 29, 2012. Accessed July 10, 2013.

Feinleib J, Kwan L, Yamani A. Postoperative nausea and vomiting. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 10, 2018.

Furman JM, Barton JJS. Treatment of vertigo. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 18, 2018.

Furyk JS, Meek RA, Egerton-Warburton D. Drugs for the treatment of nausea and vomiting in adults in the emergency department setting. Cochrane Database Syst Rev. 2015;(9):CD010106. doi: 10.1002/14651858.CD010106.pub2.[PubMed 26411330]

Gallagher SA, Hackett P. Acute mountain sickness and high altitude cerebral edema. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 18, 2018.

Gan TJ, Diemunsch P, Habib AS, et al; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting [published corrections appear in Anesth Analg. 2015;120(2):494; Anesth Analg. 2014;118(3):689]. Anesth Analg. 2014;118(1):85-113. doi:10.1213/ANE.0000000000000002.[PubMed 24356162]

Grover VK, Mathew PJ, Hegde H. Efficacy of orally disintegrating ondansetron in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy: a randomised, double-blind placebo controlled study. Anaesthesia. 2009;64(6):595-600. doi: 10.1111/j.1365-2044.2008.05860.x.[PubMed 19453311]

Health Canada. Zofran (ondansetron) – dosage and administration of intravenous ondansetron in geriatrics (>65 years of age) – for health professionals – recalls and safety alerts. http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/39943a-eng.php. Published June 12, 2014. Accessed September 18, 2018.

Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2017;35(28):3240-3261.[PubMed 28759346]

Hesketh PJ. Prevention and treatment of chemotherapy-induced nausea and vomiting in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed May 8, 2018.

“Inactive” ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Kenny GN, Oates JD, Leeser J, et al. Efficacy of orally administered ondansetron in the prevention of postoperative nausea and vomiting: a dose ranging study. Br J Anaesth. 1992;68(5):466-470.[PubMed 1386523]

Kiesewetter B and Raderer M. Ondansetron for diarrhea associated with neuroendocrine tumors. N Engl J Med. 2013;368(20):1947-1948. doi:10.1056/NEJMc1301537.[PubMed 23675671]

Koren G, “Motherisk Update. Is Ondansetron Safe for Use During Pregnancy?” Can Fam Physician, 2012, 58(10):1092-3.[PubMed 23064917]

Lemon LS, Zhang H, Hebert MF, et al. Ondansetron exposure changes in a pregnant woman. Pharmacotherapy. 2016;36(9):e139-e141. doi: 10.1002/phar.1796.[PubMed 27374186]

Navari RM, Qin R, Ruddy KJ, et al. Olanzapine for the prevention of chemotherapy-induced nausea and vomiting. N Engl J Med. 2016;375(2):134-142. doi: 10.1056/NEJMoa1515725.[PubMed 27410922]

Niebyl JR. Clinical practice. Nausea and vomiting in pregnancy [published correction appears in N Engl J Med. 2010;363(21):2078]. N Engl J Med. 2010;363(16):1544-1550. doi: 10.1056/NEJMcp1003896.[PubMed 20942670]

Oliveira LG, Capp SM, You WB, Riffenburgh RH, Carstairs SD. Ondansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial. Obstet Gynecol. 2014;124(4):735-742.[PubMed 25198265]

Pan PH, Lee SC, Harris LC. Antiemetic prophylaxis for postdischarge nausea and vomiting and impact on functional quality of living during recovery in patients with high emetic risks: a prospective, randomized, double-blind comparison of two prophylactic antiemetic regimens. Anesth Analg. 2008;107(2):429-38. doi: 10.1213/ane.0b013e318172f992.[PubMed 18633020]

Patanwala AE, Amini R, Hays DP, Rosen P. Antiemetic therapy for nausea and vomiting in the emergency department. J Emerg Med. 2010;39(3):330-336. doi:10.1016/j.jemermed.2009.08.060.[PubMed 20022195]

Patel P, Robinson PD, Thackray J, et al. Guideline for the prevention of acute chemotherapy-induced nausea and vomiting in pediatric cancer patients: a focused update. Pediatr Blood Cancer. 2017:e26542. doi: 10.1002/pbc.26542.[PubMed 28453189]

Patka J, Wu DT, Abraham P, Sobel RM. Randomized controlled trial of ondansetron vs. prochlorperazine in adults in the emergency department. West J Emerg Med. 2011;12(1):1-5.[PubMed 21691464]

Platt AJ, Heddle RM, Rake MO, et al. Ondansetron in carcinoid syndrome. Lancet. 1992;339(8806):1416.[PubMed 1375972]

Popovic M, Warr DG, Deangelis C, et al. Efficacy and safety of palonosetron for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV): a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer. 2014;22(6):1685-1697. doi: 10.1007/s00520-014-2175-6.[PubMed 24590374]

Priestman TJ, Roberts JT, Lucraft H, et al. Results of a randomized, double-blind comparative study of ondansetron and metoclopramide in the prevention of nausea and vomiting following high-dose upper abdominal irradiation. Clin Oncol (R Coll Radiol). 1990;2(2):71-75.[PubMed 1702012]

Priestman TJ, Roberts JT, Upadhyaya BK. A prospective randomized double-blind trial comparing ondansetron versus prochlorperazine for the prevention of nausea and vomiting in patients undergoing fractionated radiotherapy. Clin Oncol (R Coll Radiol). 1993;5(6):358-363.[PubMed 8305355]

Rice GP, Ebers GC. Ondansetron for intractable vertigo complicating acute brainstem disorders. Lancet. 1995;345(8958):1182-1183.[PubMed 7723573]

Roila F, Molassiotis A, Herrstedt J, et al. 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol. 2016;27(suppl 5):v119-v133.[PubMed 27664248]

Salvucci AA, Squire B, Burdick M, Luoto M, Brazzel D, Vaezazizi R. Ondansetron is safe and effective for prehospital treatment of nausea and vomiting by paramedics. Prehosp Emerg Care. 2011;15(1):34-38. doi: 10.3109/10903127.2010.519822.[PubMed 21091329]

Schwörer H, Münke H, Stöckmann F, Ramadori G. Treatment of diarrhea in carcinoid syndrome with ondansetron, tropisetron, and clonidine. Am J Gastroenterol. 1995;90(4):645-648.[PubMed 7717328]

Siu SS, Chan MT, and Lau TK, “Placental Transfer of Ondansetron During Early Human Pregnancy,” Clin Pharmacokinet, 2006, 45(4):419-23.[PubMed 16584287]

Smith JA, Fox KA. Treatment and outcome of nausea and vomiting of pregnancy. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 18, 2018.

Spitzer TR, Friedman CJ, Bushnell W, Frankel SR, Raschko J. Double-blind, randomized, parallel-group study on the efficacy and safety of oral granisetron and oral ondansetron in the prophylaxis of nausea and vomiting in patients receiving hyperfractionated total body irradiation. Bone Marrow Transplant. 2000;26(2):203-210.[PubMed 10918432]

Svanberg A, Birgegård G. Addition of aprepitant (Emend) to standard antiemetic regimen continued for 7 days after chemotherapy for stem cell transplantation provides significant reduction of vomiting. Oncology. 2015;89(1):31-36. doi: 10.1159/000371523.[PubMed 25659986]

Wymenga AN, de Vries EG, Leijsma MK, Kema IP, Kleibeuker JH. Effects of ondansetron on gastrointestinal symptoms in carcinoid syndrome. Eur J Cancer. 1998;34(8):1293-1294.[PubMed 9849494]

Zofran (ondansetron) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals; October 2017.

Zofran (ondansetron) tablets, oral solution, and injection [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; January 2019.

Zofran injection (ondansetron) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; March 2017.

Zofran ODT (ondansetron) oral disintegrating tablets [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; January 2019.

Zuplenz (ondansetron) [prescribing information]. Raleigh, NC: Midatech Pharma US Inc.; January 2017.

Brand Names: International

Apulset (BD); Avessa (LU); Avessaron (BE); Cedantron (ID); Cetron (AR); Danac (MX); Danset (EG); Dantron (TH, ZA); Emeset (IN, LK); Emeton (UA); Emetron (HU); Emiset (BD); Emistop (ZW); Emizof (IE); Emodan (PH); Enset (PH); Finaber (PY); Frazon (ID); Glotron (ID); Invomit (ID); Izofran (CL, UY); Lartron (MX); Mefoz (ID); Modifical (CO, EC); Narfoz (ID); Nausedron (BR); Ofran (LK); Ondak (CO); Ondan (EG); Ondant (KR); Ondavell (ID, PH, SG, TH); Ondawi (LK); Ondran (IE); Onetic (ID); Onsat (BD); Onset-8 (PH); Onsetron (KR); Onsett (TZ, ZW); Onsia (TH); Onzet (PH); Onzod (TW); Osetron (AU, BD); Periset (BD); Setofilm (ES, GB); Setron (BH); Setronax (HK, MY, SG, VN); Trondamet (HK); Vomceran (ID); Vometron (ID); Vomiof (IN); Vomiz (TW); Yatrox (ES); Zetron (TH); Zilfujim (AU); Zofran (AE, AR, AT, AU, BB, BE, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CN, CY, CZ, DE, DK, EC, EE, EG, ES, ET, FI, GB, GH, GM, GN, GY, HK, HN, HR, HU, ID, IE, IL, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, LB, LR, LT, LU, LV, LY, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NL, NO, NZ, OM, PE, PH, PK, PL, PT, PY, QA, RU, SA, SC, SD, SE, SI, SK, SL, SN, SR, SY, TN, TR, TT, TW, TZ, UA, UG, VE, VN, YE, ZM, ZW); Zofran Melt (AE, BH, KW, QA, SA); Zofran ODT (BB); Zofran Zydis (CR, DO, GT, KR, NI, NZ, PA, SV); Zofron (GR); Zofsetron (BE); Zophren (FR)

Ondansetron (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(on DAN se tron)

Brand Names: US

Zofran; Zofran ODT [DSC]; Zuplenz

Brand Names: Canada

Ondissolve ODF; Zofran ODT

What is this drug used for?
  • It is used to treat or prevent upset stomach and throwing up.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to ondansetron or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have a long QT on ECG.
  • If you are taking apomorphine.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • You may need to have an ECG checked before starting this drug and while taking it. Talk with your doctor.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • Oral-disintegrating tablet:
  • If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
  • Injection:
  • The prefilled syringes are not for use in children who weigh less than 88 lb (40 kg). Talk with the doctor.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Chest pain or pressure.
  • Slow heartbeat.
  • Numbness and tingling.
  • Belly pain.
  • Trouble passing urine.
  • Trouble controlling body movements.
  • Change in eyesight.
  • Feeling very sleepy.
  • Seizures.
  • Dizziness.
  • Fever or chills.
  • A type of abnormal heartbeat (prolonged QT interval) can happen with this drug. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this drug with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • All products:
  • Headache.
  • Feeling tired or weak.
  • Constipation.
  • Diarrhea.
  • Feeling sleepy.
  • Anxiety.
  • Injection:
  • Irritation where the shot is given.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Take with or without food.
  • Oral-disintegrating tablet:
  • If the tablets come in a foil blister, do not push the tablet out of the foil when opening. Use dry hands to take it from the foil.
  • Open right before use.
  • Place on your tongue and let it dissolve. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.
  • Oral film:
  • Open right before use.
  • Be sure your hands are dry before you touch this drug.
  • Put film on tongue and let it dissolve. Water is not needed. If using more than 1 film, let each film dissolve all the way before using the next film.
  • Do not chew this drug.
  • Do not swallow it whole.
  • Wash your hands after use.
  • Liquid (solution):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Injection:
  • It is given as a shot into a vein.
  • Your doctor may teach you how to give the shot.
  • Follow how to use carefully.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
What do I do if I miss a dose?
  • If you take this drug on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Oral film:
  • Store in original container.
  • Liquid (solution):
  • Store upright with the cap on.
  • Store in original container.
  • Injection:
  • Most of the time, this drug will be given in a hospital or doctor’s office. If stored at home, follow how to store as you were told by the doctor.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Ondansetron (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(on DAN se tron)

Brand Names: US

Zofran; Zofran ODT [DSC]; Zuplenz

Brand Names: Canada

Ondissolve ODF; Zofran ODT

What is this drug used for?
  • It is used to treat or prevent upset stomach and throwing up.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has a long QT on ECG.
  • If your child is taking apomorphine.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Your child may need to have an ECG checked while taking this drug. Talk with the doctor.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
  • Oral-disintegrating tablet:
  • If your child has phenylketonuria (PKU), talk with your child’s doctor. Some products have phenylalanine.
  • Injection:
  • The prefilled syringes are not for use in children who weigh less than 88 lb (40 kg). Talk with the doctor.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Chest pain or pressure.
  • Slow heartbeat.
  • Numbness and tingling.
  • Belly pain.
  • Trouble passing urine.
  • Trouble controlling body movements.
  • Change in eyesight.
  • Feeling very sleepy.
  • Seizures.
  • Dizziness.
  • Fever or chills.
  • A type of abnormal heartbeat (prolonged QT interval) can happen with this drug. Call the doctor right away if your child has a fast heartbeat, a heartbeat that does not feel normal, or if your child passes out.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if your child takes this drug with drugs for depression, migraines, or certain other drugs. Call your child’s doctor right away if your child has agitation; change in balance; confusion; hallucinations; fever; a fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • All products:
  • Headache.
  • Feeling tired or weak.
  • Constipation.
  • Diarrhea.
  • Feeling sleepy.
  • Anxiety.
  • Injection:
  • Irritation where the shot is given.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Give this drug with or without food.
  • Oral-disintegrating tablet:
  • If the tablets come in a foil blister, do not push the tablet out of the foil when opening. Use dry hands to take it from the foil.
  • Open right before use.
  • Place on your child’s tongue and let it dissolve. Water is not needed. Do not let your child swallow it whole. Do not let your child chew, break, or crush it.
  • Liquid (solution):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Oral film:
  • Open right before use.
  • Be sure your hands are dry before you touch this drug.
  • Put film on tongue and let it dissolve. Water is not needed. If using more than 1 film, let each film dissolve all the way before using the next film.
  • Do not let your child chew or swallow.
  • Wash your hands after use.
  • Injection:
  • It is given as a shot into a vein.
  • Your child’s doctor may teach you how to give the shot.
  • Follow how to use carefully.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
What do I do if my child misses a dose?
  • If your child takes this drug on a regular basis, give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Oral film:
  • Store in original container.
  • Liquid (solution):
  • Store upright with the cap on.
  • Store in original container.
  • Injection:
  • Most of the time, this drug will be given in a hospital or doctor’s office. If stored at home, follow how to store as you were told by the doctor.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.