Ondansetron (injection): Difference between revisions
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|drugClass= 5-HT3 receptor antagonist | |drugClass=5-HT3 receptor antagonist | ||
|indicationType=prevention | |indicationType=prevention | ||
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|fdaLIADAdult====Indications=== | |||
1.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Cancer Chemotherapy | |||
Ondansetron Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin [see Clinical Studies (14.1)]. | |||
1.2 Prevention of Postoperative Nausea and Vomiting | |||
Ondansetron Injection is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. 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 [see Clinical Studies (14.3)]. | |||
===Dosage=== | |||
2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy | |||
Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration. | |||
2.2 Prevention of Postoperative Nausea and Vomiting | |||
Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form. | |||
Adults: The recommended adult intravenous dosage of Ondansetron is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting. | |||
Adults: The recommended adult intravenous dosage of Ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron. | |||
2.3 Stability and Handling | |||
After dilution, do not use beyond 24 hours. Although Ondansetron Injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative. | |||
Ondansetron Injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection. | |||
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit. | |||
2.4 Dosage Adjustment for Patients with Impaired Hepatic Function | |||
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. There is no experience beyond first-day administration of ondansetron in these patients. | |||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Ondansetron (injection) in adult patients. | |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Ondansetron (injection) in adult patients. | ||
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Ondansetron (injection) in adult patients. | |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Ondansetron (injection) in adult patients. | ||
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Ondansetron (injection) in pediatric patients. | |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Ondansetron (injection) in pediatric patients. | ||
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Ondansetron (injection) in pediatric patients. | |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Ondansetron (injection) in pediatric patients. | ||
|contraindications=Ondansetron Injection, USP 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 taking ondansetron. [See Adverse Reactions (6.2)]. | |||
The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. | |||
|alcohol=Alcohol-Ondansetron (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |alcohol=Alcohol-Ondansetron (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | ||
}} | }} | ||
Revision as of 14:06, 19 May 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]
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Overview
Ondansetron (injection) is a 5-HT3 receptor antagonist that is FDA approved for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. Common adverse reactions include diarrhea, headache, and fever.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
1.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Cancer Chemotherapy Ondansetron Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin [see Clinical Studies (14.1)]. 1.2 Prevention of Postoperative Nausea and Vomiting Ondansetron Injection is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. 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 [see Clinical Studies (14.3)].
Dosage
2.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy Ondansetron Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.
2.2 Prevention of Postoperative Nausea and Vomiting Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.
Adults: The recommended adult intravenous dosage of Ondansetron is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.
Adults: The recommended adult intravenous dosage of Ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose [see Clinical Pharmacology (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron.
2.3 Stability and Handling After dilution, do not use beyond 24 hours. Although Ondansetron Injection, USP is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative.
Ondansetron Injection, USP is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
2.4 Dosage Adjustment for Patients with Impaired Hepatic Function 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. There is no experience beyond first-day administration of ondansetron in these patients.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ondansetron (injection) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ondansetron (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Ondansetron (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ondansetron (injection) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ondansetron (injection) in pediatric patients.
Contraindications
Ondansetron Injection, USP 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 taking ondansetron. [See Adverse Reactions (6.2)].
The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.
Warnings
There is limited information regarding Ondansetron (injection) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Ondansetron (injection) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Ondansetron (injection) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Ondansetron (injection) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Ondansetron (injection) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ondansetron (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ondansetron (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Ondansetron (injection) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Ondansetron (injection) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Ondansetron (injection) in geriatric settings.
Gender
There is no FDA guidance on the use of Ondansetron (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ondansetron (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ondansetron (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ondansetron (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ondansetron (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ondansetron (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Ondansetron (injection) Administration in the drug label.
Monitoring
There is limited information regarding Ondansetron (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Ondansetron (injection) and IV administrations.
Overdosage
There is limited information regarding Ondansetron (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Ondansetron (injection) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Ondansetron (injection) Mechanism of Action in the drug label.
Structure
There is limited information regarding Ondansetron (injection) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Ondansetron (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Ondansetron (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Ondansetron (injection) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ondansetron (injection) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Ondansetron (injection) How Supplied in the drug label.
Storage
There is limited information regarding Ondansetron (injection) Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Ondansetron (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Ondansetron (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Ondansetron (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Ondansetron (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Ondansetron (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Ondansetron (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.