[See Clinical Studies Management: Consider an alternative for one of the interacting drugs. The surgical procedures included tonsillectomy with or without adenoidectomy, strabismus surgery, herniorrhaphy, and orchidopexy. Mukilteo, WA 98275, Also supplied in the following manufacture supplied dosage forms. Using the established exposure-response relationship, 24 mg infused intravenously over 15 minutes had a mean predicted (95% upper prediction interval) QTcF of 14.0 (16.3) ms. Monitor therapy, CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. ONDANSETRON INJECTION, USP is supplied in the following dosage forms. 7-(7.3)]. Ondansetron works in the stomach to block the signals to the brain that cause nausea and vomiting. A case-control study evaluating associations between several common non-cardiac malformations and multiple antiemetic drugs reported an association between maternal use of ondansetron and isolated cleft palate (reported adjusted OR = 2.37 [95% CI (1.18, 4.76)]). Ondansetron Injection was administered intravenously over 15 minutes in three doses of 0.15 mg/kg. Ileus or gastric distention: Ondansetron does not stimulate gastric or intestinal peristalsis (do not use in place of nasogastric suction). 3 For pediatric patients (1 month to 12 years) prevention of nausea and vomiting was only studied in patients who had not received prophylactic ondansetron. In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. Adults and pediatric patients 6 months of age and older: The recommended dosage is 0.15 mg/kg per dose for 3 doses (maximum of 16 mg per dose), infused intravenously over 15 minutes. 6-(6.1). Other side effects of this drug: Talk with your doctor right away if you have any of these signs of: Note: This is not a comprehensive list of all side effects. Patients who experienced two or more emetic episodes within 2 hours following discontinuation of nitrous oxide were randomized to either single intravenous doses of ondansetron (0.1 mg/kg for pediatric patients weighing 40 kg or less, 4 mg for pediatric patients weighing more than 40 kg) or placebo administered over at least 30 seconds. Monitor therapy, Pimozide: May enhance the QTc-prolonging effect of Ondansetron. Monitor therapy, QT-prolonging Antipsychotics (Moderate Risk): Ondansetron may enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). 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. Ondansetron may mask progressive ileus and/or gastric distension; monitor for decreased bowel activity. However, it has been demonstrated that ondansetron is present in the milk of rats. Patients with additional risk factors for QTc prolongation may be at even higher risk. Sign up for free e-newsletters. 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. Oral soluble film: 24 mg (three 8 mg doses given together) as a single dose. Hypotension (and faintness) occurred in another patient that took 48 mg of ondansetron hydrochloride tablets. For pediatric patients between 6 months and 1 year of age and/or 10 kg or less: Depending on the fluid needs of the patient, Ondansetron Injection may be diluted in 10 to 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection. In the US trial, Ondansetron Injection was administered intravenously (only) in three doses of 0.15 mg/kg each for a total daily dose of 7.2 to 39 mg. In terms of overall ondansetron turnover, CYP3A4 plays a predominant role while formation of the major in vivo metabolites is apparently mediated by CYP1A2. The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. Prophylaxis. ZOFRAN ODT orally disintegrating tablets are white, round, and plano-convex tablets available in the following strengths: 4 mg - debossed with "Z4" on one side. 6-(6.1) The pharmacokinetics of intravenous ondansetron did not differ between subjects who were poor metabolizers of CYP2D6 and those who were extensive metabolizers of CYP2D6, further supporting the limited role of CYP2D6 in ondansetron disposition in vivo. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. The patient should report any signs and symptoms of hypersensitivity reactions, including fever, chills, rash, or breathing problems. Comments: Multi-day, single-dose administration of 24 mg orally for HEC has not been studied. Transient blurred vision, in some cases associated with abnormalities of accommodation, have also been reported. 14-(14.1), Dosage and Administration ( Use diluted solutions within 24 hours of preparation. Monitor therapy, Tapentadol: Antiemetics (5HT3 Antagonists) may diminish the analgesic effect of Tapentadol. ZOFRAN oral solution, 4 mg/5 mL, is a clear, colorless to light yellow liquid with a characteristic strawberry 5-(5.3), Use in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distention. Little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months. Why is this medication prescribed? In a crossover trial in 76 pediatric patients, intravenous ondansetron did not increase blood levels of high-dose methotrexate. The results of this analysis are included in Table 5 and are compared with the pharmacokinetic results in cancer patients aged 4 to 18 years. As shown in Table 6, the 41 patients with pharmacokinetic data were divided into 2 groups, patients aged 1 month to 4 months and patients aged 5 to 24 months, and are compared with pediatric patients aged 3 to 12 years. Pregnancy-associated nausea and vomiting, severe or refractorybyes. 2-(2.3), Use in Specific Populations Adverse events were not observed in animal reproduction studies. Thus, prevention of vomiting in these pediatric patients was essentially the same as for patients older than 18 years. The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT3 receptor type. Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea, Hypersensitivity: Hypersensitivity reactions (including anaphylaxis and bronchospasm) have been reported; discontinue if hypersensitivity occurs. The results of these trials are summarized in Table 10. Monitor for signs of serotonin syndrome; monitor for decreased bowel activity. 1.2 Prevention of Postoperative Nausea and/or Vomiting Radiation therapy-associated nausea and vomiting, prevention: High-emetogenic risk radiation therapy (total body irradiation): 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]). Total body radiation therapy: 8 mg PO 1-2 hours before radiation therapy; administered each day. Systemic exposure as measured by mean AUC were equivalent, with values of 156 [95% CI:136, 180] and 161 [95% CI: 137, 190] ngh/mL for intravenous and intramuscular groups, respectively. In addition, postmarketing cases of Torsade de Pointes have been reported in patients using ondansetron. A reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see Clinical Pharmacology Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second-degree heart block, QT/QTc interval prolongation, and ST segment depression), palpitations, and syncope. IV: 8 mg or 0.15 mg/kg (maximum: 16 mg/dose) (ASCO [Hesketh 2017]; manufacturer's labeling). Mean terminal half-life was slightly reduced in pediatric patients (range: 2.5 to 3 hours) in comparison with adults (range: 3 to 3.5 hours). In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. In a trial of 21 pediatric patients (3 to 12 years) who were undergoing surgery requiring anesthesia for a duration of 45 minutes to 2 hours, a single intravenous dose of ondansetron, 2 mg (3 to 7 years) or 4 mg (8 to 12 years), was administered immediately prior to anesthesia induction. 6-(6.2).]. Monitor therapy, Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). 14.2 Prevention of Postoperative Nausea and/or Vomiting 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 Barrett 2011, Braude 2008, Egerton-Warburton 2014, Patka 2011, Salvucci 2011; however, definitive, high-quality trials supporting efficacy are lacking Furyk 2015. Transient dizziness during or shortly after intravenous infusion. Urticaria, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Rectal suppositories: Calibrate a suppository mold for the base being used. Tablet, Oral, as hydrochloride [strength expressed as base]: Zofran ODT: 4 mg [DSC], 8 mg [DSC] [contains aspartame, methylparaben sodium, propylparaben sodium; strawberry flavor], Ondansetron is a selective 5-HT3-receptor antagonist which blocks serotonin, both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone, Oral: 100%; nonlinear absorption occurs with increasing oral doses; Zofran ODT tablets are bioequivalent to Zofran tablets; absorption does not occur via oral mucosa, Children and Adolescents: Cancer patients: 4 to 18 years: 1.9 L/kg, Extensively hepatic via hydroxylation, followed by glucuronide or sulfate conjugation; CYP1A2, CYP2D6, and CYP3A4 substrate, some demethylation occurs, Urine (44% to 60% as metabolites, ~5% as unchanged drug); feces (~25%), 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, Oral: ~2 hours; Oral soluble film: ~1 hour, 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. In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), clearance is reduced 2-fold to 3-fold and apparent volume of distribution is increased with a resultant increase in half-life to 20 hours [see Dosage and Administration Adult. About Mayo Clinic. 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). An open-label, multicenter, noncomparative trial has been performed in 75 pediatric cancer patients aged 6 to 48 months receiving at least one moderately or highly emetogenic chemotherapeutic agent. 1.2 Prevention of Postoperative Nausea and/or Vomiting IV: Single IV doses >16 mg are no longer recommended due to the potential for QT prolongation (FDA 2012). Monitor therapy, Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). 14-(14.3)]. 5.1 Hypersensitivity Reactions Instruct patients to immediately report any signs or symptoms consistent with a potential bowel obstruction to their healthcare provider. 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]). 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). Patients should be informed that Ondansetron Injection may cause serious cardiac arrhythmias such as QT prolongation. If using more than one film, each film should be allowed to dissolve completely before administering the next film. Patients with additional risk factors for QTc prolongation may be at even higher risk. The role of CYP2D6 in ondansetron in vivo metabolism is relatively minor. Pharmacokinetics in Pediatric Surgery Patients Aged 1 Month to 12 Years. In a gender balanced pharmacodynamic trial (n = 56), ondansetron 4 mg administered intravenously or intramuscularly was dynamically similar in the prevention of nausea and vomiting using the ipecacuanha model of emesis. Adverse Reactions Reported in 2% (and with Greater Frequency than the Placebo Group) of Adult Patients Receiving Ondansetron at a Dosage of 4 mg Intravenous over 2 to 5 Minutes, a Adverse reactions: Rates of these reactions were not significantly different in the ondansetron and placebo groups 1.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Cancer Chemotherapy 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 Furman 2018, Rice 1995. Oral soluble film: Do not remove from pouch until immediately before use. HF Acquisition Co LLC, DBA HealthFirst, These highlights do not include all the information needed to use Ondansetron Injection, USP safely and effectively. Clearance is reduced 2- to 3-fold and the volume of distribution is increased. 8-(8.6)]. If nausea/vomiting occur in a patient who had not received prophylactic ondansetron, IV ondansetron may be administered to prevent further episodes. Patients with Hepatic Impairment: In patients with mild-to-moderate hepatic impairment, clearance is reduced 2-fold and mean half-life is increased to 11.6 hours compared with 5.7 hours in those without hepatic impairment. A double-blind, multicenter, placebo-controlled trial was conducted in 670 pediatric patients aged 1 month to 24 months who were undergoing routine surgery under general anesthesia. Mean peak plasma concentrations were 42.9 [95% CI: 33.8, 54.4] ng/mL at 10 minutes after intravenous infusion and 31.9 [95% CI: 26.3, 38.6] ng/mL at 41 minutes after intramuscular injection. 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]). 7-(7.6)]. 13 NONCLINICAL TOXICOLOGY 8-(8.5)]. Monitor therapy, Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). The reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ondansetron. In a trial of 51 pediatric patients (aged 1 month to 24 months) who were undergoing surgery requiring general anesthesia, a single intravenous dose of ondansetron, 0.1 or 0.2 mg/kg, was administered prior to surgery. Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. Pediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeding estimated ingestion of 5 mg/kg) in young children. 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). Consider therapy modification, Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). ECG (if applicable in high-risk or elderly patients); potassium, magnesium. Daily fractions to abdomen: Administer 8 mg PO 1-2 hr . These patients were receiving multiple concomitant perioperative and postoperative medications. Oculogyric crisis, appearing alone, as well as with other dystonic reactions. Geriatric Patients: A reduction in clearance and increase in elimination half-life are seen in patients older than 75 years of age [see Use in Specific Populations Inform patients following abdominal surgery or those with chemotherapy-induced nausea and vomiting that Ondansetron Injection may mask signs and symptoms of bowel obstruction. Pour the mixture into the suppository mold and cool. 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). Patients should be informed of the increased risk of serotonin syndrome, especially if Ondansetron Injection is used concomitantly with other serotonergic drugs [see Drug Interactions While ondansetron's mechanism of action has not been fully characterized, it is not a dopamine-receptor antagonist. In such patients, a total daily dose of 8 mg should not be exceeded [see Dosage and Administration 6.2 Postmarketing Experience Consider therapy modification, Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Patients with additional risk factors for QTc prolongation may be at even higher risk. For patients who do not receive prophylactic Ondansetron Injection and experience nausea and/or vomiting postoperatively, Ondansetron Injection may be given to prevent further episodes. Cardiovascular: Rare cases of angina (chest pain), electrocardiographic alterations, hypotension, and tachycardia have been reported. Ondansetron is in a class of medications called serotonin 5-HT 3 receptor antagonists. Consider therapy modification, QT-prolonging Antidepressants (Moderate Risk): Ondansetron may enhance the QTc-prolonging effect of QT-prolonging Antidepressants (Moderate Risk). Consider therapy modification, QT-prolonging Kinase Inhibitors (Moderate Risk): Ondansetron may enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see Clinical Pharmacology If ondansetron is given, the dosing is the same as for moderate- to high-risk patients. Prevention of vomiting in these pediatric patients, intravenous ondansetron did not increase blood levels of high-dose methotrexate, supplied! 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