Ondansetron-BP (inj)

Ondansetronum

Each ml solution for injection contains ondansetron 2 mg (as ondansetron hydrochloride dihydrate). Excipient with known effect: sodium.

Indication: In adults: for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of post-operative nausea and vomiting. In children and adolescents: for chemotherapy-induced nausea and vomiting in children ≥6 months of age, and for the prevention and treatment of post-operative nausea and vomiting in children ≥1 month of age.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
− Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
− Concomitant use with apomorphine (see section 4.5)

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5HT3 receptor antagonists. Respiratory events should be treated symptomatically and healthcare professionals should be alert to them as possible precursors of hypersensitivity reactions. Ondansetron prolongs the QT interval in a dose-dependent manner (see section 5.1). In addition, post-marketing cases of torsade de pointes have been reported in patients using ondansetron. Ondansetron should be avoided in patients with congenital long QT syndrome. Ondansetron should be administered with caution in patients diagnosed with long QT syndrome or who may develop QT interval prolongation, including patients with electrolyte imbalances, congestive heart failure, […]