ONDANSETRON ODT LUPIN

What it is

ONDANSETRON ODT LUPIN is an orally disintegrating tablet containing 4 mg or 8 mg ondansetron as the active ingredient. The tablet is administered by placing on top of the tongue where it dissolves within seconds, and is swallowed. Ondansetron is a potent, highly selective 5HT3 receptor-antagonist.

Approved indications

— Prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

Dosing overview

The dose of ondansetron should be flexible in the range of 8 to 32 mg a day and selected according to the emetogenic potential of cancer treatment, with the lowest effective dose used. For emetogenic chemotherapy and radiotherapy in adults, two oral doses of 8 mg each at 12 hourly intervals may be given, the first dose being administered 2 hours prior to chemotherapy or radiotherapy. To protect against delayed emesis after the first 24 hours, ondansetron should be continued orally at a dosage of 8 mg twice daily for up to 5 days after a course of treatment. For highly emetogenic chemotherapy, a single oral dose of up to 24 mg ondansetron taken with oral dexamethasone 12 mg, 1 to 2 hours before commencing chemotherapy is recommended. Initial treatment may be followed by oral ondansetron 8 mg 12-hourly for up to 5 days to protect against delayed emesis. In elderly patients aged over 65 years, efficacy and tolerance was similar to that seen in younger adults indicating no need to alter dosage or route of administration. No alteration of daily dosage or frequency of dosing, or route of administration are required in patients with renal impairment. A total daily dose of 8 mg should not be exceeded for patients with moderate or severe hepatic dysfunction.

Key safety warnings

Ondansetron prolongs the QT interval in a dose-dependent manner, and post-marketing cases of Torsade de Pointes have been reported. Ondansetron should be avoided in patients with congenital long QT syndrome. Ondansetron should be administered with caution to patients who have or may develop prolongation of QTc, including patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation or electrolyte abnormalities. Hypokalaemia and hypomagnesemia should be corrected prior to ondansetron administration. Serotonin syndrome has been described following the concomitant use of ondansetron and other serotonergic drugs. If concomitant treatment with ondansetron and other serotonergic drugs is clinically warranted, appropriate observation of the patient is advised. Cases of myocardial ischaemia have been reported in patients treated with ondansetron, with symptoms appearing immediately after administration in some patients, particularly with intravenous administration. Patients should be alerted to the signs and symptoms of myocardial ischaemia. As ondansetron is known to increase large bowel transit time, patients with signs of subacute intestinal obstruction should be monitored following administration.

Contraindications

Based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphine is contraindicated. Ondansetron is also contraindicated in patients with hypersensitivity to any component of the preparation.

Regulatory history

ONDANSETRON ODT LUPIN was first listed on the ARTG on 24 September 2018 for both the 4 mg and 8 mg orally disintegrating tablet formulations.