ONDANSETRON 4 mg/2mL
ONDANSETRON HYDROCHLORIDE · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
Ondansetron is a prescription medication given by injection into the muscle to prevent and treat nausea and vomiting, commonly used after surgery or during cancer chemotherapy. Each vial contains 4 mg of the active ingredient in 2 mL of solution.
Key Facts
- Brand Name
- ONDANSETRON
- Generic Name
- ONDANSETRON HYDROCHLORIDE
- NDC Code (Product)
76045-216- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 4 mg/2mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA202253
- Marketing Start
- 05/31/2022
Recall History
Hospira, Inc.
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
RXQ Compounding LLC
Lack of Assurance of Sterility
Glenmark Pharmaceuticals Inc., USA
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Hospira Inc.
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications; 12 month stability time point
Sentara Infusion Services
Lack of sterility assurance
Preferred Pharmaceuticals, Inc.
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . initial and repeat courses of moderately emetogenic cancer chemotherapy. radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron tablets are 5-HT 3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 (1) nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (1) nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen (1) postoperative nausea and/or vomiting (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION See full prescribing information for the recommended dosage in adults and pediatrics (2) Patients with severe hepatic impairment: do not exceed a total daily dose of 8 mg ( 2.2 , 8.6 ) 2.1 Dosage The recommended dosage regimens for adult and pediatric patients are described in Table 1 and Table 2, respectively. Corresponding doses of ondansetron tablets may be used interchangeably. Table 1: Adult Recommended Dosage Regimen for Prevention of Nausea and Vomiting Indication Dosage Regimen Highly Emetogenic Cancer Chemotherapy A single 24 mg dose administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 Moderately Emetogenic Cancer Chemotherapy 8 mg administered 30 minutes before the start of chemotherapy, with a subsequent 8 mg dose 8 hours after the first dose. Then administer 8 mg twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy. Radiotherapy For total body irradiation : 8 mg administered 1 to 2 hours before each fraction of radiotherapy each day. For single high-dose fraction radiotherapy to the abdomen : 8 mg administered 1 to 2 hours before …
Contraindications
4 CONTRAINDICATIONS Ondansetron is contraindicated in patients: known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see Adverse Reactions (6.2) ] receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation. (4) Concomitant use of apomorphine (4)
Drug Interactions
7 DRUG INTERACTIONS 7.1 Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including SSRIs and SNRIs. Monitor for the emergence of serotonin syndrome. If symptoms occur, discontinue ondansetron and initiate supportive treatment [see Warnings and Precautions ( 5.3) ]. 7.2 Drugs Affecting Cytochrome P-450 Enzymes Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver [see Clinical Pharmacology (12.3)]. Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron. In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these d…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] QT Prolongation [see Warnings and Precautions (5.2 )] Serotonin Syndrome [see Warnings and Precautions ( 5.3 )] Myocardial Ischemia [see Warnings and Precautions ( 5.4 )] Masking of Progressive Ileus and Gastric Distension [see Warnings and Precautions [see Warnings and Precautions ( 5.5 )] The most common adverse reactions in adults for the: prevention of chemotherapy-induced (≥5%) are: headache, malaise/fatigue, constipation, diarrhea ( 6.1 ) prevention of radiation-induced nausea and vomiting (≥2%) are: headache, constipation, and diarrhea ( 6.1 ) prevention of postoperative nausea and vomiting (≥9%) are: headache and hypoxia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy's Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical tria…
Frequently Asked Questions
What is ONDANSETRON used for?
Ondansetron is a prescription medication given by injection into the muscle to prevent and treat nausea and vomiting, commonly used after surgery or during cancer chemotherapy. Each vial contains 4 mg of the active ingredient in 2 mL of solution.
Is ONDANSETRON a controlled substance?
ONDANSETRON is not classified as a controlled substance by the DEA.
What is the generic name for ONDANSETRON?
The generic name for ONDANSETRON is ONDANSETRON HYDROCHLORIDE. There are 12 other brand versions of ONDANSETRON HYDROCHLORIDE.
What is the NDC code for ONDANSETRON 4 mg/2mL?
The NDC (National Drug Code) for ONDANSETRON 4 mg/2mL is 76045-216, listed by Fresenius Kabi USA, LLC.
Other Ondansetron Brands
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- Ondansetron Hydrochloride4 mg/183008-074
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- Ondansetron Hydrochloride8 mg/151655-813
- ondansetron8 mg/155154-7879
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- Ondansetron Hydrochloride4 mg/163187-636
- Ondansetron2 mg/mL65219-323
- Ondansetron Hydrochloride4 mg/171335-0205
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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