Presentation and Status in Health Basket
Film Coated Tablets
10 X 1 mg
1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy. The first dose of Setron should be administered within 1 hour before the start of therapy. Dexamethasone has been used concomitantly at doses up to 20 mg once a day orally.
Paediatric population: The safety and efficacy of setron tablets in children have not yet been established. No data are available.
Older people and renal impairment: There are no special precautions required for its use in either elderly patients or those patients with renal impairment.
Hepatic impairment: There is no evidence to date for an increased incidence of adverse events in patients with hepatic disorders. On the basis of its kinetics, whilst no dosage adjustment is necessary, granisetron should be used with a certain amount of caution in this patient group.
Method of administration: The tablets should be swallowed whole with water.
Setron 1 mg tablets are indicated for the prevention of nausea and vomiting induced by cytostatic therapy.
Hypersensitivity to the active substance or to any of the excipients.
Owing to the presence of lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration.
As for other 5HT3 antagonists, ECG changes including QT interval prolongation have been reported with granisetron. In patients with preexisting arrhythmias or cardiac conduction disorders this might lead to clinical consequences.
Therefore caution should be exercised in patients with cardiac comorbidities, on cardiotoxic chemotherapy and/or with concomitant electrolyte abnormalities.
Crosssensitivity between 5HT3 antagonists (e.g. dolasteron, ondansetron) has been reported.
Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucosegalactose malabsorption should not take this medicine.
There have been reports of serotonin syndrome with the use of 5HT3 antagonists either alone, but mostly in combination with other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitors (SNRIs). Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Setron contains not more than 0.20 mg of sodium.
Paediatric population: There is insufficient clinical evidence to recommend administration of these tablets to children.
The most frequently reported adverse reactions for Setron are headache and constipation, which may be transient. ECG changes including QT prolongation have been reported with Setron.
See prescribing information for full details.
As for other 5HT3 antagonists, cases of ECG modifications including QT prolongation have been reported with granisetron. In patients concurrently treated with medicinal products known to prolong QT interval and/or which are arrhythmogenic, this may lead to clinical consequences.
In studies in healthy subjects, no evidence of any interaction has been indicated between granisetron and benzodiazepines (lorazepam), neuroleptics (haloperidol) or antiulcer medicinal products (cimetidine). Additionally, granisetron has not shown any apparent medicinal product interaction with emetogenic cancer chemotherapies.
No specific interaction studies have been conducted in anaesthetised patients.
Serotonergic Drugs (e.g. SSRIs and SNRIs): there have been reports of serotonin syndrome following concomitant use of 5HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs).
Pregnancy and Lactation
Pregnancy: There is limited amount of data from the use of granisetron in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of granisetron during pregnancy.
Breastfeeding: It is unknown whether granisetron or its metabolites are excreted in human milk. As a precautionary measure, breastfeeding should not be advised during treatment with Setron.
There is no specific antidote for Setron. In the case of overdose with the tablets,
symptomatic treatment should be given.
Doses of up to 38.5 mg of Setron as a single injection have been reported, with symptoms of mild headache but no other reported sequelae.