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Zofran

Clinical Pharmacology
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Clinical Pharmacology

Zofran

In 1 double-blind US study in 336 patients, ZOFRAN Tablets 8 mg administered twice a day were as effective as ZOFRAN Tablets 8 mg administered 3 times a day in preventing nausea and vomiting induced by cyclophosphamide-based chemotherapy containing either methotrexate or doxorubicin.

Treatment response is based on the total number of emetic episodes over the 3-day study period. The results of this study are summarized in Table 4:

Table 4. Emetic Episodes: Treatment Response

  Ondansetron
  8-mg b.i.d.
ZOFRAN Tablets*		 8-mg t.i.d.
ZOFRAN Tablets†
Number of patients 165 171
Treatment response
0 Emetic episodes 101 (61%) 99 (58%)
1-2 Emetic episodes 16 (10%) 17 (10%)
More than 2 emetic episodes/withdrawn 48 (29%) 55 (32%)
Median number of emetic episodes 0.0 0.0
Median time to first emetic episode (h) Undefined‡ Undefined‡
Median nausea scores (0-100)§ 6 6
* The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. An 8-mg ZOFRAN Tablet was administered twice a day for 2 days after completion of chemotherapy.
† The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. An 8-mg ZOFRAN Tablet was administered 3 times a day for 2 days after completion of chemotherapy.
‡ Median undefined since at least 50% of patients did not have any emetic episodes.
§ Visual analog scale assessment: 0 = no nausea, 100 = nausea as bad as it can be.

Re-treatment: In uncontrolled trials, 148 patients receiving cyclophosphamide-based chemotherapy were re-treated with ZOFRAN Tablets 8 mg 3 times daily during subsequent chemotherapy for a total of 396 re-treatment courses. No emetic episodes occurred in 314 (79%) of the re-treatment courses, and only 1 to 2 emetic episodes occurred in 43 (11%) of the re-treatment courses.

Pediatric Studies: Three open-label, uncontrolled, foreign trials have been performed with 182 pediatric patients 4 to 18 years old with cancer who were given a variety of cisplatin or noncisplatin regimens. In these foreign trials, the initial dose of ZOFRAN® (ondansetron HCl) Injection ranged from 0.04 to 0.87 mg/kg for a total dose of 2.16 to 12 mg. This was followed by the administration of ZOFRAN Tablets ranging from 4 to 24 mg daily for 3 days. In these studies, 58% of the 170 evaluable patients had a complete response (no emetic episodes) on day 1. Two studies showed the response rates for patients less than 12 years of age who received ZOFRAN Tablets 4 mg 3 times a day to be similar to those in patients 12 to 18 years of age who received ZOFRAN Tablets 8 mg 3 times daily. Thus, prevention of emesis in these pediatric patients was essentially the same as for patients older than 18 years of age. Overall, ZOFRAN Tablets were well tolerated in these pediatric patients.

Radiation-Induced Nausea and Vomiting: Total Body Irradiation : In a randomized, double-blind study in 20 patients, ZOFRAN Tablets (8 mg given 1.5 hours before each fraction of radiotherapy for 4 days) were significantly more effective than placebo in preventing vomiting induced by total body irradiation. Total body irradiation consisted of 11 fractions (120 cGy per fraction) over 4 days for a total of 1,320 cGy. Patients received 3 fractions for 3 days, then 2 fractions on day 4.

Brand Name: Zofran
Generic Name: Ondansetron Hydrochloride

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