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ondansetron injection, USP - VIAL
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
ondansetron injection, USP - VIAL Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy
Ondansetron Injection is...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Chemotherapy
...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Ondansetron Injection, USP, 2 mg/mL is a clear, colorless, nonpyrogenic, sterile solution available as a 2 mL single-dose vial and 20 mL multiple-dose vial.
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Contraindications
4 CONTRAINDICATIONS
Ondansetron Injection is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. Anaphylactic reactions have been reported in patients...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions [see Warnings and...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Drugs Affecting Cytochrome P-450 Enzymes
Ondansetron does not appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Published...
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Drug Abuse and Dependence
9 DRUG ABUSE AND DEPENDENCE
Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.
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Overdosage
10 OVERDOSAGE
There is no specific antidote for ondansetron overdose. Patients should be managed with appropriate supportive therapy. Individual intravenous doses as large as 150 mg and total daily intravenous doses as large...
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Description
11 DESCRIPTION
The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT3 receptor type. Its chemical name is (±) 1, 2, 3, 9...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Ondansetron is a selective 5-HT3 receptor antagonist. While ondansetron's mechanism of...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenic effects were not seen in 2-year studies in rats and mice with oral...
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Clinical Studies
14 CLINICAL STUDIES
The clinical efficacy of ondansetron hydrochloride, the active ingredient of ondansetron, was assessed in clinical trials as described below.
14.1...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Ondansetron Injection, USP, 2 mg/mL, is supplied as follows:
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Hypersensitivity Reactions
Inform patients that Ondansetron Injection may cause hypersensitivity reactions,...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.