Drugplain

Ondansetron Hydrochloride 4 mg/5mL

Ondansetron Hydrochloride · SOLUTION · Hikma Pharmaceuticals USA Inc.

1 Recall on Record
Plain English

Ondansetron is a medication used to prevent nausea and vomiting, commonly given to patients undergoing chemotherapy, radiation therapy, or surgery. This oral solution contains 4 mg of ondansetron in each 5 mL and requires a prescription.

Key Facts

Brand Name
Ondansetron Hydrochloride
Generic Name
Ondansetron Hydrochloride
NDC Code (Product)
0054-0064
Manufacturer
Hikma Pharmaceuticals USA Inc.
Strength
4 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA076960
Marketing Start
12/26/2006

Recall History

1 Recall on Record
Class II05/09/2022

Olympia Compounding Pharmacy dba Olympia Pharmacy

Lack of assurance of sterility.

CompletedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea2,247 reports
fatigue1,421 reports
off label use1,273 reports
headache1,226 reports
diarrhoea1,219 reports
vomiting1,140 reports
pain1,014 reports
dyspnoea972 reports
drug ineffective856 reports
pyrexia752 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 Hydrochloride used for?

Ondansetron is a medication used to prevent nausea and vomiting, commonly given to patients undergoing chemotherapy, radiation therapy, or surgery. This oral solution contains 4 mg of ondansetron in each 5 mL and requires a prescription.

Is Ondansetron Hydrochloride a controlled substance?

Ondansetron Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Ondansetron Hydrochloride?

The generic name for Ondansetron Hydrochloride is Ondansetron Hydrochloride. There are 2 other brand versions of Ondansetron Hydrochloride.

What is the NDC code for Ondansetron Hydrochloride 4 mg/5mL?

The NDC (National Drug Code) for Ondansetron Hydrochloride 4 mg/5mL is 0054-0064, listed by Hikma Pharmaceuticals USA Inc..

Product NDC

0054-0064

Package NDC

0054-0064-47

Other Ondansetron Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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