Ondansetron Hydrochloride 8 mg Tablet, Film Coated, 10-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Serotonin-3 Receptor Antagonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron is in a class of medications called serotonin 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.
Read the full MedlinePlus article ↗- Not at all. Ondansetron is approved to prevent nausea and vomiting from cancer chemotherapy, radiation therapy to the abdomen or whole body, and surgery. So you might receive it be...
- What exactly is ondansetron used for — is it just for chemo patients?
- The regular tablet is swallowed like any other pill. The orally disintegrating tablet (ODT) is placed on your tongue and allowed to dissolve — don't chew or swallow it whole. For c...
- How do I take the tablet or the dissolving tablet correctly?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
8 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1854 | $1.85 / 10 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| ondansetron 8 mg 00904-6552-61 | Major | 1 tablet | $0.081 | AB | Availability likely | — |
| Ondansetron 8 mg 16714-0160-01 | NorthStar | 30 tablets | $0.081 | AB | Availability likely | — |
| Ondansetron Hydrochloride 8 mg 50268-0622-15 | AvPAK | 1 tablet | $0.081 | AB | Availability likely | — |
| Ondansetron Hydrochloride 8 mg 57237-0076-30 | Rising | 30 tablets | $0.081 | AB | Availability likely | — |
| Ondansetron 8 mg 62135-0351-05 | Chartwell | 500 tablets | $0.081 | — | Availability likely | — |
| Ondansetron Hydrochloride 8 mg 65862-0188-03 | Aurobindo | 3 tablets | $0.081 | — | Availability likely | — |
| Ondansetron Hydrochloride 8 mg 68084-0221-01 | American | 1 tablet | $0.081 | AB | Availability likely | — |
| Ondansetron 8 mg 68462-0106-30 | Glenmark | 30 tablets | $0.081 | AB | Availability likely | — |
| Ondansetron 8 mg 69339-0172-03 | Natco | 30 tablets | $0.081 | AB | Availability likely | — |
| ondansetron hydrochloride 8 mg 62756-0131-01 | Sun | 30 tablets | $0.092 | — | FDA listed | — |
| Ondansetron 8 mg 63304-0459-30 | Sun | 30 tablets | $0.099 | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 42708-0059-05 | QPharma, | 5 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 42708-0179-05 | QPharma, | 5 tablets | — | AB | FDA listed | — |
| Ondansetron 8 mg 43063-0770-06 | PD-Rx | 6 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 43063-0792-06 | PD-Rx | 6 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 50090-3185-00 | A-S | 4 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 50090-4671-00 | A-S | 4 tablets | — | AB | FDA listed | — |
| Ondansetron 8 mg 51407-0004-05 | Golden | 500 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 51655-0016-27 | Northwind | 12 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 51655-0813-54 | Northwind | 15 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 54348-0821-00 | Pharmpak, | 1 tablet | — | AB | FDA listed | — |
| Ondansetron 8 mg 55111-0154-01 | Dr. | 100 tablets | — | AB | FDA listed | — |
| ondansetron 8 mg 55154-7879-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 55700-0627-10 | Quality | 10 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 60760-0658-10 | St. | 10 tablets | — | AB | FDA listed | — |
| Ondansetron 8 mg 63187-0065-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| ondansetron 8 mg 63187-0513-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mgthis 63187-0709-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| Ondansetron 8 mg 63850-0004-01 | Natco | 30 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 67046-1242-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 68071-1742-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Ondansetron 8 mg 68071-3713-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Ondansetron 8 mg 68071-3801-01 | NuCare | 10 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 68071-4328-01 | NuCare | 10 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 68071-4705-04 | NuCare | 4 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 68071-4966-04 | NUCARE | 4 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 68788-8582-01 | Preferred | 10 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 68788-9402-01 | Preferred | 10 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 70518-3511-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Ondansetron 8 mg 70518-4245-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 71205-0744-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| ondansetron 8 mg 71335-0815-00 | Bryant | 5 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 71335-1357-00 | Bryant | 5 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 71610-0119-88 | Aphena | 900 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 72162-2365-05 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 76420-0916-00 | Asclemed | 1000 tablets | — | AB | FDA listed | — |
| Ondansetron HCL 8 mg 80425-0074-01 | Advanced | 10 tablets | — | AB | FDA listed | — |
| Ondansetron HCL 8 mg 80425-0075-01 | Advanced | 10 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 85509-1076-01 | PHOENIX | 10 tablets | — | AB | FDA listed | — |
| Ondansetron Hydrochloride 8 mg 85766-0053-05 | Sportpharm | 5 tablets | — | AB | FDA listed | — |
| ondansetron 8 mg 67877-0170-30 | Ascend | 30 tablets | — | AB | FDA listed | — |
| ondansetron hydrochloride 8 mg 83980-0018-10 | Ipca | 1000 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63187-0709-06 | 6 TABLET, FILM COATED in 1 BOTTLE (63187-709-06) | 2019-03-01 | Active |
| 63187-0709-10 You're viewing this | 10 TABLET, FILM COATED in 1 BOTTLE (63187-709-10) | 2016-06-01 | Active |
| 63187-0709-15 | 15 TABLET, FILM COATED in 1 BOTTLE (63187-709-15) | 2016-06-01 | Active |
| 63187-0709-20 | 20 TABLET, FILM COATED in 1 BOTTLE (63187-709-20) | 2016-06-01 | Active |
| 63187-0709-30 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-709-30) | 2016-06-01 | Active |
You're viewing one of 5 pack sizes for this product.
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m 2 . 2.
Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 3. Prevention of 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.
4. 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 where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy The recommended adult oral dosage of ondansetron tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m 2 . Multiday, single-dose administration of a 24 mg dosage has not been studied. Pediatric Use There is no experience with the use of a 24 mg dosage in pediatric patients.
Geriatric Use The dosage recommendation is the same as for the general population. Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy The recommended adult oral dosage is one 8 mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose.
One 8 mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy. Pediatric Use For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron tablet given 3 times a day.
The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy. Geriatric Use The dosage is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen The recommended oral dosage is one 8 mg ondansetron tablet given 3 times a day. For total body irradiation , one 8 mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day. For single high-dose fraction radiotherapy to the abdomen , one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen , one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given. Pediatric Use There is no experience with the use of ondansetron tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients. Geriatric Use The dosage recommendation is the same as for the general population.
Postoperative Nausea and Vomiting The recommended dosage is 16 mg given as two 8 mg ondansetron tablets 1 hour before induction of anesthesia. Pediatric Use There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients. Geriatric Use The dosage is the same as for the general population.
Dosage Adjustment for Patients With Impaired Renal Function The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron. Dosage Adjustment for Patients With Impaired Hepatic Function In patients with severe hepatic impairment (Child-Pugh 2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life.
In such patients, a total daily dose of 8 mg should not be exceeded.
⛔ Contraindications ▾
CONTRAINDICATIONS 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. Ondansetron tablets are contraindicated for patients known to have hypersensitivity to the drug.
⚠️ Warnings ▾
WARNINGS Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists. ECG changes including QT interval prolongation has been seen in patients receiving ondansetron. In addition, postmarketing cases of Torsade de Pointes have been reported in patients using ondansetron.
Avoid ondansetron hydrochloride in patients with congenital long QT syndrome. ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation. The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists alone.
Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of ondansetron hydrochloride alone has also been reported.
The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of ondansetron hydrochloride and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue ondansetron hydrochloride and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ondansetron hydrochloride is used concomitantly with other serotonergic drugs (see PRECAUTIONS and OVERDOSAGE ).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following have been reported as adverse events in clinical trials of patients treated with ondansetron, the active ingredient of ondansetron hydrochloride. A causal relationship to therapy with ondansetron hydrochloride has been unclear in many cases. Chemotherapy-Induced Nausea and Vomiting The adverse events in Table 5 have been reported in ≥5% of adult patients receiving a single 24 mg ondansetron tablet in 2 trials.
These patients were receiving concurrent highly emetogenic cisplatin-based chemotherapy regimens (cisplatin dose ≥50 mg/m 2 ). Table 5. Principal Adverse Events in U.S.
Trials: Single Day Therapy With 24 mg Ondansetron Tablets (Highly Emetogenic Chemotherapy) Event Ondansetron 24 mg q.d. n = 300 Ondansetron 8 mg b.i.d. n = 124 Ondansetron 32 mg q.d. n = 117 Headache 33 (11%) 16 (13%) 17 (15%) Diarrhea 13 (4%) 9 (7%) 3 (3%) The adverse events in Table 6 have been reported in ≥5% of adults receiving either 8 mg of ondansetron tablets 2 or 3 times a day for 3 days or placebo in 4 trials. These patients were receiving concurrent moderately emetogenic chemotherapy, primarily cyclophosphamide-based regimens.
Table 6. Principal Adverse Events in U.S. Trials: 3 Days of Therapy With 8 mg Ondansetron Tablets (Moderately Emetogenic Chemotherapy) Event Ondansetron 8 mg b.i.d. n = 242 Ondansetron 8 mg t.i.d. n = 415 Placebo n = 262 Headache 58 (24%) 113 (27%) 34 (13%) Malaise/fatigue 32 (13%) 37 (9%) 6 (2%) Constipation 22 (9%) 26 (6%) 1 (<1%) Diarrhea 15 (6%) 16 (4%) 10 (4%) Dizziness 13 (5%) 18 (4%) 12 (5%) Central Nervous System There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ondansetron.
Hepatic In 723 patients receiving cyclophosphamide-based chemotherapy in U.S. clinical trials, AST and/or ALT values have been reported to exceed twice the upper limit of normal in approximately 1% to 2% of patients receiving ondansetron tablets. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur.
The role of cancer chemotherapy in these biochemical changes cannot be clearly determined. There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear.
Integumentary Rash has occurred in approximately 1% of patients receiving ondansetron. Other Rare cases of anaphylaxis, bronchospasm, tachycardia, angina (chest pain), hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures have been reported. Except for bronchospasm and anaphylaxis, the relationship to ondansetron hydrochloride was unclear.
Radiation-Induced Nausea and Vomiting The adverse events reported in patients receiving ondansetron tablets and concurrent radiotherapy were similar to those reported in patients receiving ondansetron tablets and concurrent chemotherapy. The most frequently reported adverse events were headache, constipation, and diarrhea. Postoperative Nausea and Vomiting The adverse events in Table 7 have been reported in ≥5% of patients receiving ondansetron tablets at a dosage of 16 mg orally in clinical trials.
With the exception of headache, rates of these events were not significantly different in the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications. Table 7.
Frequency of Adverse Events From Controlled Studies With Ondansetron Tablets (Postoperative Nausea and Vomiting) Adverse Event Ondansetron 16 mg (n = 550) Placebo (n = 531) Wound problem 152 (28%) 162 (31%) Drowsiness/sedation 112 (20%) 122 (23%) Headache 49 (9%) 27 (5%) Hypoxia 49 (9%) 35 (7%) Pyrexia 45 (8%) 34 (6%) Dizziness 36 (7%) 34 (6%) Gynecological di…
🔄 Drug Interactions ▾
Drug Interactions Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). 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. On the basis of available data, no dosage adjustment is recommended for patients on these drugs.
Apomorphine Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, concomitant use of apomorphine with ondansetron is contraindicated (see CONTRAINDICATIONS ). Phenytoin, Carbamazepine, and Rifampicin In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampicin), 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 drugs.
1,3 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 selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) (see WARNINGS ). Tramadol Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small studies indicate that ondansetron may be associated with an increase in patient controlled administration of tramadol.
4,5 Chemotherapy Tumor response to chemotherapy in the P-388 mouse leukemia model is not affected by ondansetron. In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. In a crossover study in 76 pediatric patients, I.V. ondansetron did not increase blood levels of high-dose methotrexate.
Use in Surgical Patients The coadministration of ondansetron had no effect on the pharmacokinetics and pharmacodynamics of temazepam.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg/day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Little information is available about dosage in pediatric patients 4 years of age or younger (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION sections for use in pediatric patients 4 to 18 years of age).
🧓 Geriatric Use ▾
Geriatric Use Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in U.S.- and foreign-controlled clinical trials, for which there were subgroup analyses, 938 were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Dosage adjustment is not needed in patients over the age of 65 (see CLINICAL PHARMACOLOGY ).
🆘 Overdosage ▾
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 as 252 mg have been inadvertently administered without significant adverse events.
These doses are more than 10 times the recommended daily dose. In addition to the adverse events listed above, the following events have been described in the setting of ondansetron overdose: “Sudden blindness” (amaurosis) of 2 to 3 minutes’ duration plus severe constipation occurred in 1 patient that was administered 72 mg of ondansetron intravenously as a single dose. Hypotension (and faintness) occurred in a patient that took 48 mg of ondansetron tablets.
Following infusion of 32 mg over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed. In all instances, the events resolved completely. Pediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeding estimated ingestion of 5 mg/kg) in young children.
Reported symptoms included somnolence, agitation, tachycardia, tachypnea, hypertension, flushing, mydriasis, diaphoresis, myoclonic movements, horizontal nystagmus, hyperreflexia, and seizure. Patients required supportive care, including intubation in some cases, with complete recovery without sequelae within 1 to 2 days.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacodynamics Ondansetron is a selective 5-HT 3 receptor antagonist. While its mechanism of action has not been fully characterized, ondansetron is not a dopamine-receptor antagonist. Serotonin receptors of the 5-HT 3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema.
It is not certain whether ondansetron’s antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine. In humans, urinary 5-HIAA (5-hydroxyindoleacetic acid) excretion increases after cisplatin administration in parallel with the onset of emesis.
The released serotonin may stimulate the vagal afferents through the 5-HT 3 receptors and initiate the vomiting reflex. In animals, the emetic response to cisplatin can be prevented by pretreatment with an inhibitor of serotonin synthesis, bilateral abdominal vagotomy and greater splanchnic nerve section, or pretreatment with a serotonin 5-HT 3 receptor antagonist. In normal volunteers, single intravenous doses of 0.15 mg/kg of ondansetron had no effect on esophageal motility, gastric motility, lower esophageal sphincter pressure, or small intestinal transit time.
Multiday administration of ondansetron has been shown to slow colonic transit in normal volunteers. Ondansetron has no effect on plasma prolactin concentrations. Ondansetron does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium.
Interactions with general or local anesthetics have not been studied. Pharmacokinetics Ondansetron is well absorbed from the gastrointestinal tract and undergoes some first-pass metabolism. Mean bioavailability in healthy subjects, following administration of a single 8 mg tablet, is approximately 56%.
Ondansetron systemic exposure does not increase proportionately to dose. AUC from a 16 mg tablet was 24% greater than predicted from an 8 mg tablet dose. This may reflect some reduction of first-pass metabolism at higher oral doses.
Bioavailability is also slightly enhanced by the presence of food but unaffected by antacids. Ondansetron is extensively metabolized in humans, with approximately 5% of a radiolabeled dose recovered as the parent compound from the urine. The primary metabolic pathway is hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation.
Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of ondansetron. In vitro metabolism studies have shown that ondansetron is a substrate for human hepatic cytochrome P-450 enzymes, including CYP1A2, CYP2D6, and CYP3A4. In terms of overall ondansetron turnover, CYP3A4 played the predominant role.
Because of the multiplicity of metabolic enzymes capable of metabolizing ondansetron, it is likely that inhibition or loss of one enzyme (e.g., CYP2D6 genetic deficiency) will be compensated by others and may result in little change in overall rates of ondansetron elimination. Ondansetron elimination may be affected by cytochrome P-450 inducers. In a pharmacokinetic study of 16 epileptic patients maintained chronically on CYP3A4 inducers, carbamazepine, or phenytoin, reduction in AUC, C max , and T ½ of ondansetron was observed.
1 This resulted in a significant increase in clearance. However, on the basis of available data, no dosage adjustment for ondansetron is recommended (see PRECAUTIONS: Drug Interactions ). In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron.
Gender differences were shown in the disposition of ondansetron given as a single dose. The extent and rate of ondansetron's absorption is greater in women than men. Slower clearance in women, a smalle…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ondansetron Tablets USP, 8 mg are yellow colored, oval shaped, film-coated tablets debossed with ‘F’ on one side and ‘92’ on the other side. Unit of 6 NDC 63187-709-06 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.
📋 Description ▾
DESCRIPTION The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C 18 H 19 N 3 O•HCl•2H 2 O, representing a molecular weight of 365.9.
Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose.
In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6. Chemical Structure