Ondansetron HCL 8 mg/1
Ondansetron HCL · TABLET, FILM COATED · Advanced Rx of Tennessee, LLC
Ondansetron HCL is a tablet, film coated containing ondansetron hcl at 8 mg/1, taken oral. Manufactured by Advanced Rx of Tennessee, LLC.
Key Facts
- Brand Name
- Ondansetron HCL
- Generic Name
- Ondansetron HCL
- NDC Code (Product)
80425-0075- Manufacturer
- Advanced Rx of Tennessee, LLC
- Strength
- 8 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA078539
- Marketing Start
- 07/31/2007
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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.
Advanced Pharma Inc.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Sentara Enterprises
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Full Prescribing Information
Indications & Usage
1. Indications and Usage Section 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/m2 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.
Dosage & Administration
2. Dosage and Administration Section 2 DOSAGE AND ADMINISTRATION 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, ondansetron orally disintegrating tablets and ondansetron oral solution 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/m2 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 radiotherapy, with subsequent 8 mg doses every 8 hours after the first dose fo…
Contraindications
4. Contraindications Ondansetron tablets are 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
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-HT3 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 dru…
Adverse Reactions
6. Adverse Reactions Section 6 ADVERSE REACTIONS 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 trials of another drug and may not reflect the rates observed in practice. The following adverse reactions have been reported in clinical trials of patients treated with ondansetron, the active ingredient of ondansetron tablets. A causal relationship to therapy with ondansetron was unclear in many cases. Prevention of Chemotherapy-Induced Nausea and Vomiting The most common adverse reactions reported in greater than or equal to 4% of 300 adults receiving a single 24 mg dose of ondansetron orally in 2 trials for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy (cisplatin greater than or equal to 50 mg/m2) were: headache (11%) and diarrhea (4%). The most common adverse reactions reported in 4 trials in adults for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy (primarily cyclophosphamide-based regimens) are shown in Table 3. Table 3: Most Com…
Frequently Asked Questions
What is Ondansetron HCL used for?
Ondansetron HCL contains Ondansetron HCL. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Ondansetron HCL a controlled substance?
Ondansetron HCL is not classified as a controlled substance by the DEA.
What is the generic name for Ondansetron HCL?
The generic name for Ondansetron HCL is Ondansetron HCL. There are no other listed brand versions of Ondansetron HCL.
What is the NDC code for Ondansetron HCL 8 mg/1?
The NDC (National Drug Code) for Ondansetron HCL 8 mg/1 is 80425-0075, listed by Advanced Rx of Tennessee, LLC.
Other Ondansetron HCL Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)