Clinical Pharmacology Details


TROPISETRON


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Indications & Dose:

Prevention of cancer chemotherapy-induced nausea and vomiting:


Adults: 6-day course of 5 mg per day, given i.v. on day 1,  shortly before cancer chemotherapy, either as an infusion or as a slow injection (not less than 1 minute), followed by oral administration on days 2 to 6. If tropisetron alone produces insufficient anti-emetic control, its therapeutic efficacy can be enhanced by dexamethasone. 


Treatment and prevention of postoperative nausea and vomiting: 


Adult: 2-mg dose given i.v. either as an infusion or as a slow injection (not less than 30 seconds). In the case of prevention of postoperative nausea and vomiting, Navo-ban should be administered shortly before the induction of anaesthesia.


Children: over 2 years of age is 0.2 mg/kg, up to a maximum daily dose of 5 mg per day. i.v. on day 1, shortly before cancer chemotherapy, either as an infusion or as a slow injection (not less than 1 minute), followed by oral administration on days 2 up to 6. Drink  solution immediately after diluting the appropriate amount of tropisetron from the ampoule in orange juice or cola, and should be taken in the morning, 1 hour before food intake.

Contraindications:

Known hypersensitivity to tropisetron, other 5-HT3 receptor antagonists, or any other components of the formulations. Pregnant women unless, in the case of prevention of postoperative nausea and vomiting, the surgical procedure involves therapeutic abortion.

Side Effects:

Transient at the recommended dose. Headache, whereas, at the 5-mg dose, constipation and, less frequently, dizziness, fatigue, and gastrointestinal disorders such as abdominal pain and diarrhoea were observed as well. As with other 5-HT3  receptor antagonists: Facial flushing and/or generalized urticaria, chest tightness, dyspnea, acute bronchospasm, hypotension. In very rare instances, collapse, syncope or cardiovascular arrest.

Cautions:

Precautions:

Interaction:

Drugs


With food : Results in a slight increase in bioBrands Available with Cost from approximately 60% to approximately 80%, which is not clinically relevant.


Rifampicinor with other liver enzyme-inducing drugs (e.g. phenobarbital): Results in lower plasma concentrations. 


Cimetidine: Are negligible, and do not require dose adjustment.


No interaction studies were performed with tropisetron and drugs used in anaesthesia.


 


 

Warnings:

Adverse Effects:

Lactations:

PREGNANCY AND LACTATION:Use with cautions.

Special Precautions:

The elimination half-life is prolonged. However,  i.v. at doses up to 40 mg twice a day over a period of 7 days to healthy volunteers known to be poor metabolizers, no serious adverse events occurred. These observations indicate that, for 6-day courses in patients with poor metabolism, the usual daily dose of 5 mg does not need to be reduced. Use in patients with impaired hepatic or renal function:No change In contrast, patients with liver cirrhosis or impaired kidney function may have plasma con-centrations up to 50% higher than those found in healthy volunteers. Use in patients with hypertension: Daily doses higher than 10 mg should be avoided since they may cause a further increase in blood pressure. Use in cardiac patients: Use with cautions.  Use in CHILDREN: Above 2 years of age,  has been found to be well tolerated. 


Use in the elderly:Can be used.

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: