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ondansetron injection, USP - VIAL Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy

1.2 Prevention of Postoperative Nausea and/or Vomiting

2 DOSAGE AND ADMINISTRATION

2.1 Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Chemotherapy

2.2 Prevention of Postoperative Nausea and/or Vomiting

2.3 Dosage Adjustment for Patients With Hepatic Impairment

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

5.2 QT Prolongation

5.3 Serotonin Syndrome

5.4 Myocardial Ischemia

5.5 Masking of Progressive Ileus and Gastric Distension

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Drugs Affecting Cytochrome P-450 Enzymes

7.2 Apomorphine

7.3 Phenytoin, Carbamazepine, and Rifampin

7.4 Tramadol

7.5 Serotonergic Drugs

7.6 Chemotherapy

7.7 Temazepam

7.8 Alfentanil and Atracurium

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

8.7 Renal Impairment

9 DRUG ABUSE AND DEPENDENCE

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Chemotherapy-Induced Nausea and Vomiting

14.2 Prevention of Postoperative Nausea and/or Vomiting

14.3 Prevention of Further Postoperative Nausea and/or Vomiting

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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