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Zofran (Ondansetron) - Indications and Dosage

 
 



INDICATIONS & USAGE

     1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin50 mg/m2.
     2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
     3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
     4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ZOFRAN Tablets, ZOFRAN ODT Orally Disintegrating Tablets, and ZOFRAN Oral Solution are recommended even where the incidence of postoperative nausea and/or vomiting is low.



DOSAGE & ADMINISTRATION

Instructions for Use/Handling ZOFRAN ODT Orally Disintegrating Tablets
Do not attempt to push ZOFRAN ODT Tablets through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ZOFRAN ODT Tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
The recommended adult oral dosage of ZOFRAN is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

Pediatric Use
There is no experience with the use of a 24 mg dosage in pediatric patients.

Geriatric Use
The dosage recommendation is the same as for the general population.

Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
The recommended adult oral dosage is one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

Pediatric Use
For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ZOFRAN Tablet or one 4-mg ZOFRAN ODT Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ZOFRAN Oral Solution given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ZOFRAN Tablet or one 4-mg ZOFRAN ODT Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ZOFRAN Oral Solution should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

Geriatric Use
The dosage is the same as for the general population.

Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen
The recommended oral dosage is one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution given 3 times a day.
For total body irradiation, one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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, one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN 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.

Pediatric Use
There is no experience with the use of ZOFRAN Tablets, ZOFRAN ODT Tablets, or ZOFRAN Oral Solution in the prevention of radiation-induced nausea and vomiting in pediatric patients.

Geriatric Use
The dosage recommendation is the same as for the general population.

Postoperative Nausea and Vomiting
The recommended dosage is 16 mg given as two 8-mg ZOFRAN Tablets or two 8-mg ZOFRAN ODT Tablets or 20 mL (4 teaspoonfuls equivalent to 16 mg of ondansetron) of ZOFRAN Oral Solution 1 hour before induction of anesthesia.

Pediatric Use
There is no experience with the use of ZOFRAN Tablets, ZOFRAN ODT Tablets, or ZOFRAN Oral Solution in the prevention of postoperative nausea and vomiting in pediatric patients.

Geriatric Use
The dosage is the same as for the general population.

Dosage Adjustment for Patients With Impaired Renal Function
The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

Dosage Adjustment for Patients With Impaired Hepatic Function
In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

HOW SUPPLIED

ZOFRAN Tablets, 4 mg (ondansetron HCl dihydrate equivalent to 4 mg of ondansetron), are white, oval, film-coated tablets engraved with "Zofran" on one side and "4" on the other in daily unit dose packs of 3 tablets (NDC 0173-0446-04), bottles of 30 tablets (NDC 0173-0446-00), and unit dose packs of 100 tablets (NDC 0173-0446-02).
Bottles:Store between 2and 30(36and 86Protect from light. Dispense in tight, light-resistant container as defined in the USP.
Unit Dose Packs: Store between 2and 30(36and 86Protect from light. Store blisters in cartons.
ZOFRAN Tablets, 8 mg (ondansetron HCl dihydrate equivalent to 8 mg of ondansetron), are yellow, oval, film-coated tablets engraved with "Zofran" on one side and "8" on the other in daily unit dose packs of 3 tablets (NDC 0173-0447-04), bottles of 30 tablets (NDC 0173-0447-00), and unit dose packs of 100 tablets (NDC 0173-0447-02).
Bottles:Store between 2and 30(36and 86Dispense in tight container as defined in the USP.
Unit Dose Packs: Store between 2and 30(36and 86
ZOFRAN ODT Orally Disintegrating Tablets, 4 mg (as 4 mg ondansetron base) are white, round and plano-convex tablets debossed with aZ4on one side in unit dose packs of 30 tablets (NDC 0173-0569-00).
ZOFRAN ODT Orally Disintegrating Tablets, 8 mg (as 8 mg ondansetron base) are white, round and plano-convex tablets debossed with aZ8on one side in unit dose packs of 10 tablets (NDC 0173-0570-04) and 30 tablets (NDC 0173-0570-00).
Store between 2and 30(36and 86
ZOFRAN Oral Solution, a clear, colorless to light yellow liquid with a characteristic strawberry odor, contains 5 mg of ondansetron HCl dihydrate equivalent to 4 mg of ondansetron per 5 mL in amber glass bottles of 50 mL with child-resistant closures (NDC 0173-0489-00).
Store upright between 15and 30(59and 86Protect from light. Store bottles upright in cartons.

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