ondansetron injection, USP - VIAL Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ONDANSETRON safely and effectively. See full prescribing information for ONDANSETRON.

ONDANSETRON injection, for intravenous or intramuscular use
Initial U.S. Approval: 1991

RECENT MAJOR CHANGES

Warnings and Precautions, Myocardial Ischemia (5.4)10/2021

INDICATIONS AND USAGE

Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of:

  • nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1)
  • postoperative nausea and/or vomiting. (1.2)

DOSAGE AND ADMINISTRATION

Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy (2.1):

  • Dilution of Ondansetron Injection in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection is required before administration to adult and pediatric patients.
  • 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.
  • Administer the first dose 30 minutes before the start of chemotherapy and subsequent doses 4 and 8 hours after the first dose.

Prevention of Postoperative Nausea and/or Vomiting (2.2):

  • Dilution of Ondansetron Injection is not required before administration to adult and pediatric patients.
  • See full prescribing information for the recommended dosage and administration instructions for adult and pediatric patients 1 month of age and older.

Patients With Severe Hepatic Impairment (2.3):

  • Do not exceed a total daily dose of 8 mg.

DOSAGE FORMS AND STRENGTHS

Injection: 2 mL single-dose vial and 20 mL multiple-dose vial. (3)

CONTRAINDICATIONS

  • Patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. (4)
  • Concomitant use of apomorphine. (4, 7.2)

WARNINGS AND PRECAUTIONS

  • Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis and bronchospasm have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. (5.1)
  • QT Prolongation and Torsade de Pointes: QT prolongation occurs in a dose-dependent manner. Cases of Torsade de Pointes have been reported. Avoid ondansetron in patients with congenital long QT syndrome. (5.2)
  • Serotonin Syndrome: Serotonin syndrome has been reported with 5-HT3 receptor agonists alone but particularly with concomitant use of serotonergic drugs. (5.3)
  • Myocardial Ischemia: Do not exceed the recommended infusion rate and monitor patients during and after administration. (2.1, 2.2, 5.4)
  • Masking of Progressive Ileus and/or Gastric Distension Following Abdominal Surgery or Chemotherapy-Induced Nausea and Vomiting: Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. (5.5)

ADVERSE REACTIONS

Chemotherapy-Induced Nausea and Vomiting:

  • The most common adverse reactions (≥ 7%) in adults are diarrhea, headache, and fever. (6.1)

Postoperative Nausea and/or Vomiting:

  • The most common adverse reaction (≥ 10%) which occurs at a higher frequency compared with placebo in adults is headache. (6.1)
  • The most common adverse reaction (≥ 2%) which occurs at a higher frequency compared with placebo in pediatric patients aged 1 to 24 months is diarrhea. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 1/2022

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ONDANSETRON safely and effectively. See full prescribing information for ONDANSETRON.

ONDANSETRON injection, for intravenous or intramuscular use
Initial U.S. Approval: 1991

RECENT MAJOR CHANGES

Warnings and Precautions, Myocardial Ischemia (5.4)10/2021

INDICATIONS AND USAGE

Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of:

  • nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1)
  • postoperative nausea and/or vomiting. (1.2)

DOSAGE AND ADMINISTRATION

Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy (2.1):

  • Dilution of Ondansetron Injection in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection is required before administration to adult and pediatric patients.
  • 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.
  • Administer the first dose 30 minutes before the start of chemotherapy and subsequent doses 4 and 8 hours after the first dose.

Prevention of Postoperative Nausea and/or Vomiting (2.2):

  • Dilution of Ondansetron Injection is not required before administration to adult and pediatric patients.
  • See full prescribing information for the recommended dosage and administration instructions for adult and pediatric patients 1 month of age and older.

Patients With Severe Hepatic Impairment (2.3):

  • Do not exceed a total daily dose of 8 mg.

DOSAGE FORMS AND STRENGTHS

Injection: 2 mL single-dose vial and 20 mL multiple-dose vial. (3)

CONTRAINDICATIONS

  • Patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. (4)
  • Concomitant use of apomorphine. (4, 7.2)

WARNINGS AND PRECAUTIONS

  • Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis and bronchospasm have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. (5.1)
  • QT Prolongation and Torsade de Pointes: QT prolongation occurs in a dose-dependent manner. Cases of Torsade de Pointes have been reported. Avoid ondansetron in patients with congenital long QT syndrome. (5.2)
  • Serotonin Syndrome: Serotonin syndrome has been reported with 5-HT3 receptor agonists alone but particularly with concomitant use of serotonergic drugs. (5.3)
  • Myocardial Ischemia: Do not exceed the recommended infusion rate and monitor patients during and after administration. (2.1, 2.2, 5.4)
  • Masking of Progressive Ileus and/or Gastric Distension Following Abdominal Surgery or Chemotherapy-Induced Nausea and Vomiting: Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. (5.5)

ADVERSE REACTIONS

Chemotherapy-Induced Nausea and Vomiting:

  • The most common adverse reactions (≥ 7%) in adults are diarrhea, headache, and fever. (6.1)

Postoperative Nausea and/or Vomiting:

  • The most common adverse reaction (≥ 10%) which occurs at a higher frequency compared with placebo in adults is headache. (6.1)
  • The most common adverse reaction (≥ 2%) which occurs at a higher frequency compared with placebo in pediatric patients aged 1 to 24 months is diarrhea. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 1/2022

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