Each 5 ml ONDANE® Sirup contains Ondansetron HCl equivalent with Ondansetron 4 mg
Ondansetron is a potent and selective 5HT3 receptor antagonist. The administration of chemotherapy drugs and radiotherapy may lead to the release of 5HT3 into the small intestine which will stimulate the vomiting reflex that activates the vagal afferent fibers by 5HT3 receptors.
Ondansetron inhibits the starting this reflex. As a result of the afferent fibers vagal can also cause 5HT3 release in the postrema area, located at the base of the fourth ventricle, and this can also stimulate the emotions through a central mechanism. Therefore the Ondansetron effect in the treatment of nausea and vomiting induced by chemotherapy and cytostatic radiotherapy may be due to the receptor antagonism of 5HT3 neurons located in the central nervous system as well as in the peripheral nervous system. In psychomotor experiments, Ondansetron does not interfere with the appearance nor does it cause sedation. Ondansetron does not interfere with the concentration of prolactin in plasma.
Treatment of nausea and vomiting caused by chemotherapy and radiotherapy as well as surgery.
Taking highly emetogenic chemotherapy, eg cisplatin:
First intravenous 8 mg of intravenous Ondansetron injection is given slowly or infused for 15 minutes immediately before chemotherapy, followed by continuous 1 mg of Ondansetron infusion for less than 24 hours or 2 intravenous injection 8 mg slowly or infused for 15 minutes at intervals 4 hours. Or it could be followed by giving of 8 mg per oral every 12 hours for 5 days.
Taking less emetogenic chemotherapy, eg cyclophosphamide, doxorubricin, carboplastin:
An intravenous injection of 8 mg of Ondansetron was administered slowly or infused for 15 minutes immediately prior to chemotherapy, or 8 mg of Ondansetron given orally 1-2 hours before chemotherapy, followed by 8 mg orally every 12 hours for 5 days.
Nausea and vomiting due to chemotherapy induction:
Given 8 mg of Ondansetron by oral 12 hours. The first dose should be given 1-2 hours before radiotherapy. The duration of treatment depends on the duration of radiotherapy.
The experience is limited, but Ondansetron is effective and well tolerated by children over 4 years old when administered intravenously 5mg/m2 doses for 15 minutes, immediately before chemotherapy, followed by 4 mg orally per 12 hours for 5 days.
Ondansetron can be well tolerated in patients over 65 years without changing the dosage, frequency, or mode of administration.
Patients with impaired renal function
Does not require daily dose adjustment, frequency or administration.
Patients with impaired liver function
Ondansetron clearance time decreased significantly and serum half-life increased significantly in patients with moderate or severe liver dysfunction. In some patients the total daily dose should not be more than 8 mg.
Presentation and Registration Number :
ONDANE® Syrup Box, bottle @ 60 ml; DKL1408021937A1
ON MEDICAL PRESCRIPTION ONLY
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