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ondansetron injection, USP - VIAL

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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 OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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2 DOSAGE AND ADMINISTRATION

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

...
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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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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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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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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hypersensitivity reactions [see

    6.1 Clinical Trials...

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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Published...

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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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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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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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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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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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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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16 HOW SUPPLIED/STORAGE AND HANDLING

Ondansetron Injection, USP, 2 mg/mL, is supplied as follows:

...
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17 PATIENT COUNSELING INFORMATION

QT Prolongation

Patients should be informed that Ondansetron Injection may cause serious cardiac...

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