Ondansetron-BP (tab)

Ondansetronum

Each tablet contains ondansetron 8 mg, as ondansetron hydrochloride dihydrate (9.98 mg). Excipient with known effect: lactose monohydrate.

Indication: In adults: treatment of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy; prevention of post-operative nausea and vomiting (the injectable form is recommended once symptoms have developed). In children and adolescents (≥6 months): treatment of chemotherapy-induced nausea and vomiting.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications Hypersensitivity to ondansetron or to any of the excipients listed in section 6.1. Hypersensitivity to other selective 5-HT3 receptor antagonists (e.g. granisetron or dolasetron). 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 shown hypersensitivity to other selective 5-HT3 receptor antagonists. Respiratory events should be treated symptomatically, and physicians should pay attention to them as possible precursors of hypersensitivity reactions. Ondansetron prolongs the QT interval in a dose-dependent manner (see section 5.1). In addition, cases of torsade de pointes have been reported post-marketing in patients using ondansetron. Avoid using ondansetron in patients with congenital long QT syndrome. Ondansetron should be administered with caution to patients who have or may develop QT interval prolongation, including patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias, or patients taking other […]