Ondansetron Hydrochloride (Page 4 of 6)

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

Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in US- 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).

ADVERSE REACTIONS

The following have been reported as adverse events in clinical trials of patients treated with ondansetron, the active ingredient of ondansetron hydrochloride tablets. A causal relationship to therapy with ondansetron has been unclear in many cases.

Chemotherapy-Induced Nausea and Vomiting

The adverse events in Table 5 have been reported in ≥5% of adults receiving a single 24 mg ondansetron hydrochloride tablet in 2 trials. These patients were receiving concurrent highly emetogenic cisplatin-based chemotherapy regimens (cisplatin dose ≥50 mg/m2).

Table 5. Principal Adverse Events in US Trials: Single Day Therapy With 24 mg Ondansetron Hydrochloride 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 hydrochloride 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 US Trials: 3 Days of Therapy With 8 mg Ondansetron Hydrochloride 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 US 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 hydrochloride 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 was unclear.

Radiation-Induced Nausea and Vomiting

The adverse events reported in patients receiving ondansetron hydrochloride tablets and concurrent radiotherapy were similar to those reported in patients receiving ondansetron hydrochloride 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 hydrochloride 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 Hydrochloride 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 disorder

36 (7%)

33 (6%)

Anxiety/agitation

33 (6%)

29 (5%)

Bradycardia

32 (6%)

30 (6%)

Shiver(s)

28 (5%)

30 (6%)

Urinary retention

28 (5%)

18 (3%)

Hypotension

27 (5%)

32 (6%)

Pruritus

27 (5%)

20 (4%)

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.