Ondagen 8

Description

Ondagen 8 mg IM/IV Injection

Indications
Ondansetron is a serotonin subtype 3 (5-HT3) receptor antagonist indicated:
Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.
Prevention and treatment of post-operative nausea and vomiting.
Prevention of radiotherapy-induced nausea and vomiting.

Pharmacology
Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.

Dosage
Chemotherapy-Induced Nausea and Vomiting-
Adults, Pediatric patients (6 months to 18 years):
8 mg tablet/orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Radiotherapy-Induced Nausea and Vomiting-
Adults:
8 mg tablet/orodispersible tablet: Initial Dose: 8 mg orally 1 to 2 hours before radiotherapy. Post Radiotherapy: 8 mg orally every 8 hours for up to 5 days after a course of treatment.
4 mg orodispersible tablet: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose.
Injection: Three 0.15 mg/kg doses, up to a maximum of 16 mg per dose, infused intravenously over 15 minutes.
Postoperative Nausea and Vomiting-
Adults:
8 mg tablet/orodispersible tablet: 16 mg given as two 8 mg tablets
4 mg orodispersible tablet: 16 mg
Injection: 4 mg
Pediatrics (>40 kg): Injection: 4 mg
Pediatrics (40 kg): Injection: 0.1 mg/kg

Chemotherapy-induced Nausea and Vomiting-
Adults/Geriatric/Child of 12 years or over:
Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy.
Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Ondansetron Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml dose should be administered after 8 hours of the first dose. One 10 ml dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.
Pediatric (4-11 years): 5 ml (4 mg) Ondansetron Oral Solution should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 5 ml oral solution should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy.

Oral solution:
Radiotherapy induced Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):
The recommended oral dosage: 10 ml (8 mg) Ondansetron Oral Solution 3 times daily.
For total body irradiation: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen: one 10 ml Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen: 10 ml (8-mg) Ondansetron Oral Solution should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
Postoperative Nausea and Vomiting (Adults/Geriatric/Child of 12 years or over):
20 ml (16 mg) Ondansetron Oral Solution 1 hour before induction of anesthesia

Oral Soluble Film:
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:
Adult oral dose: 24 mg given successively as three 8 mg films 30 minutes before the start of chemotherapy.
Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:
Adults and pediatric patients 12 years of age and older: One 8 mg film 30 minutes before chemotherapy followed by an 8 mg dose 8 hours later. Administer one 8 mg film twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric patients 4 through 11 years of age: One 4 mg film three times a day. Administer the first dose 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours later. Administer one 4 mg film three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy: The adult dosage is one 8 mg film three times a day.
Postoperative nausea and vomiting: The adult dose is 16 mg given successively as two 8 mg films 1 hour before anesthesia