ONDANSETRON

ONDANSETRON- ondansetron hydrochloride tablet, film coated
Sun Pharmaceutical Industries, Inc.

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.

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.

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 for 1 to 2 days after completion of radiotherapy.

For daily fractionated 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 for each day radiotherapy is given.

Postoperative

16 mg administered 1 hour before induction of anesthesia

Table 2: Pediatric Recommended Dosage Regimen for Prevention of Nausea and Vomiting

Indication

Dosage Regimen

Moderately Emetogenic Cancer Chemotherapy

12 to 17 years of age: 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 a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

4 to 11 years of age: 4 mg administered 30 minutes before

the start of chemotherapy, with a subsequent 4 mg dose 4 and 8 hours after the first dose.

Then administer 4 mg three times a day for 1 to 2 days after completion of chemotherapy.

2.2 Dosage in Hepatic Impairment

In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), do not exceed a total daily dose of 8 mg [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Ondansetron Tablets USP, are available in the following strengths:

4 mg – white, oval, film-coated tablets engraved with “4” on one side and “NO” on other side.
8 mg – yellow, oval, film-coated tablets engraved with “8” on one side and “NO” on the other side.

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.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. If hypersensitivity reactions occur, discontinue use of ondansetron tablets; treat promptly per standard of care and monitor until signs and symptoms resolve [see Contraindications (4)].

5.2 QT Prolongation

Electrocardiogram (ECG) changes including QT interval prolongation have been seen in patients receiving ondansetron. In addition, postmarketing cases of Torsade de Pointes have been reported in patients using ondansetron tablets. Avoid ondansetron tablets 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 [see Clinical Pharmacology (12.2)].

5.3 Serotonin Syndrome

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 tablets 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 tablets and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue ondansetron tablets and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ondansetron tablets is used concomitantly with other serotonergic drugs [see Drug Interactions (7.1), Overdosage (10)].

5.4 Masking of Progressive Ileus and Gastric Distension

The use of ondansetron tablets in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction.

Ondansetron tablets are not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction.

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