ONDANSETRON-DRLA

What it is

Ondansetron-DRLA contains ondansetron hydrochloride dihydrate. Ondansetron is an antinauseant and antiemetic agent, and a potent, highly selective 5HT3-receptor antagonist.

Approved indications

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

Dosing overview

The route of administration and dose of ondansetron should be flexible in the range of 8 to 32 mg a day, with the lowest effective dose used. For chemotherapy or radiotherapy induced nausea and vomiting in adults, a single dose of 8 mg should be administered as a slow intravenous injection in not less than 30 seconds, immediately before treatment. Higher doses may be required in some patients, particularly those on high dose cisplatin, and doses should be adjusted according to the severity of the emetogenic challenge. For prevention of post-operative nausea and vomiting in adults, ondansetron may be administered as a single dose of 4 mg, given by intramuscular or slow intravenous injection at induction of anaesthesia. In children over 4 years of age for emetogenic chemotherapy and radiotherapy, ondansetron was effective when given intravenously at a dose of 5 mg/m² over 15 minutes immediately before chemotherapy. For prevention of post-operative nausea and vomiting in children aged 2 to 12 years, ondansetron may be administered by slow intravenous injection at a dose of 0.1 mg/kg up to a maximum of 4 mg.

Key safety warnings

Ondansetron prolongs the QT interval in a dose-dependent manner, post-marketing cases of Torsades de Pointes have been reported, and 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, and hypokalemia and hypomagnesemia should be corrected prior to ondansetron administration. Serotonin syndrome has been described following concomitant use of ondansetron and other serotonergic drugs, and appropriate observation of the patient is advised if such concomitant treatment is clinically warranted. Cases of myocardial ischaemia have been reported in patients treated with ondansetron, particularly with intravenous administration, and 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

Ondansetron is contraindicated in patients with hypersensitivity to ondansetron or to any component of the preparation. Concomitant use with apomorphine hydrochloride is contraindicated based on reports of profound hypotension and loss of consciousness.

Regulatory history

Ondansetron-DRLA 4 mg and 8 mg film-coated tablets were first listed on the ARTG on 28 October 2010.