Ondane
ONDANE
Composition :
Each mL of ONDANE® 4 contains Ondansetron HCl Dihydrate 2.5 mg equivalent to Ondansetron base 2 mg
Each mL of ONDANE® 8 contains Ondansetron HCl Dihydrate 2.5 mg equivalent to Ondansetron base 2 mg
Each ONDANE®-4 tablet contains Ondansetron HCl Dihydrate equivalent to Ondansetron 4 mg
Each ONDANE®-8 tablet contains Ondansetron HCl Dihydrate equivalent to Ondansetron 8 mg
Each 5 mL of ONDANE® Syrup contains Ondansetron HCl equivalent to Ondansetron 4 mg
Pharmacology :
Ondansetron is a potent and selective 5-HT3 receptor antagonist. Administration of chemotherapy drugs and radiotherapy can cause the release of 5-HT3 into the intestine which will stimulate the gag reflex by activating vagal afferent fibers via 5-HT3 receptors. Ondansetron inhibits the initiation of this reflex. Activation of vagal afferent fibers can also cause 5-HT3 release in the area postrema, which is located at the floor of the fourth ventricle, which can stimulate emesis through a central mechanism. Therefore, the effect of Ondansetron in the treatment of nausea and vomiting induced by chemotherapy and cytotoxic radiotherapy may be due to the antagonism of 5-HT3 receptors on neurons located in the central nervous system as well as in the peripheral nervous system. In psychomotor trials, Ondansetron did not interfere with appearance and did not cause sedation. Ondansetron does not interfere with plasma prolactin concentrations.
Indication
Ondansetron is used to prevent nausea and vomiting after chemotherapy, surgery and radiotherapy including high doses of cisplatin. Should not be used in conditions of nausea and vomiting due to other reasons.
Dosage:
Prevention of postoperative nausea and vomiting:
Initial dose: 8 mg, given 1 hour before anesthesia followed by 8 mg every 8 hours.
Alternatively given 4 mg as a single dose IM or IV slowly
– Mature :
Administration of highly emetogenic chemotherapy, such as cisplatin: Initially, 8 mg of Ondansetron injection was given i.v. slowly or infused for 15 minutes immediately prior to chemotherapy, followed by a continuous infusion of 1 mg Ondansetron/hour for less than 24 hours or 2 injections of 8 mg i.v. slowly or infused over 15 minutes at 4 hour intervals.
Less emetogenic chemotherapy, eg cyclophosphamide, doxorubicin, carboplastin:
Given an i.v. injection. 8 mg of Ondansetron slowly or infused over 15 minutes immediately prior to chemotherapy, followed by oral administration of 8 mg twice daily for less than 5 days.
Nausea and vomiting due to chemotherapy induction:
Given 8 mg of Ondansetron orally 12 hours. The first dose should be given 1-2 hours before radiotherapy. The duration of treatment depends on the duration of radiotherapy.
– Children aged > 4 years:
5 mg/mL IV over 15 minutes before chemotherapy, followed by 4 mg every 12 hours orally for 5 days
– Elderly
Ondansetron is well tolerated in patients over 65 years of age without changing the dose, frequency or route of administration
– Patients with impaired renal function
It is not necessary to adjust the dose of Ondansetron in patients with impaired renal function
- Patients with impaired liver function
Ondansetron administration to patients with impaired liver function should not exceed 8 mg per day because the clearance time of Ondansetron is significantly reduced and the serum half-life is significantly increased in patients with moderate or severe hepatic dysfunction.
How to Give Fast Dissolving Tablets:
Place the tablet on the tongue, let it disintegrate by itself and then swallow it without the help of water
Storage :
Store at temperatures below 300C.
Packaging :
ONDANE® 4 Injection Box, 5 ampoules @ 2 ml Reg Number. : DKL1008015743A1
ONDANE® 8 Injection Box, 5 ampoules @ 4 ml Reg Number. : DKL1008015743A1
ONDANE®-4 Fast Dissolving Tablets Box, 1 strip @ 10 tablets Reg Number. : DKL1908026681A1
ONDANE®-8 Fast Dissolving Tablets Box, 1 strip @ 10 tablets Reg Number. : DKL1908026681B1
ONDANE® Syrup Box, bottle @ 60 ml Reg Number. : DKL1408021937A1
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