Generic Zofran

ONDANSETRON
Tablets: 4, 8, 24 mg (as HCl dihydrate) (Rx) Zofran (GlaxoSmithKline)
Solution, oral: 4 mg/5 ml (5 mg as HCl) (Rx)
Injection: 2 mg/ml and 32 mg/50 ml (pre-mixed)
(as HCl dihydrate) (Rx)
Tablets, orally disintegrating: 4 and 8 mg Zofran ODT GlaxoSmithKline)
(as base) (Rx)

Indications
Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin; prevention of postoperative nausea or vomiting; prevention of nausea and vomiting associated with radiotherapy in patients receiving total body irradiation, single high-dose fraction or daily fractions to the abdomen (oral ondansetron and granisetron).

Administration and Dosage
Prevention of nausea/vomiting associated with cancer chemotherapy -
Parenteral: The recommended IV dosage is three 0.15 mg/kg doses or a single 32 mg dose. With the 3 dose regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses ate administered 4 and 8 hours after the first dose. The single 32 mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemothetapy.
Children - On the basis of the limited available information, the dosage in children 4 to 18 years of age should be three 0.15 mg/kg doses. Little information is available about dosage in children < 3 years of age.
Oral (moderately emetogenic cancer chemotherapy): Recommended dose is 8 mg twice/ day. Administer the first dose 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. Administer 8 mg twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Children - For patients > 12 years of age, dosage is same as adults; tot children 4 to 11 years, use 4 mg 3 times a day. Give the first dose 30 min before chemotherapy, with subsequent doses 4 and 8 hours after the first dose. Give 4 mg 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy. Prevention of nausea and vomiting associated with radiotherapy (oral) - 8 mg 3 times/day.
Total body irradiation: 8 mg 1 to 2 hours before each fraction of radiotherapy administered each day.
Single high-dose fraction radiotherapy to the abdomen: 8 mg 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.
Daily fractionated radiotherapy to the abdomen: 8 mg 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
Children: There is no experience with tablets or oral solution use in the prevention of radiation-induced nausea and vomiting in children. Prevention of postoperative nausea or vomiting -
Parenteral: Immediately before induction of anesthesia, or postoperatively if the patient experiences nausea or vomiting shortly after surgery, administer 4 mg undiluted IV in not less than 30 seconds, preferably over 2 to 5 minutes. Alternatively, 4 mg undiluted may be administered IM as a single injection in adults. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, IV dose of ondansetron 4 mg, administration of a second IV dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.
Children - Patients 2 to 12 years of age weighing < 40 kg may receive 0.1 mg/ kg IV; give a single 4 mg dose for those weighing > 40 kg. Administer over > 30 seconds, preferably over 2 to 5 minutes.
Oral: 16 mg given as a single dose 1 hour before induction of anesthesia.
Children: There is no experience in children for use of tablets or oral solution.
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy (oral)-The recommended adult oral dosage is 24 mg administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin > 50 mg/ nr. Multi-day, single-dose administration of 24 mg has not been studied. Efficacy of the 32 mg single dose beyond 24 hrs in these patients has not been established. Children: There is no experience with the use of 24 mg tablets.
Hepatic function impairment - Do not exceed an 8 mg oral dose. For IV use, a single maximum daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy is recommended.
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