FDA OKs Zofran injection postoperatively for adults
The U.S. Food and Drug Administration in Rockville, MD, recently cleared Glaxo Wellcome in Research Triangle Park, NC, to use the intramuscular (IM) administration of Zofran for postoperative nausea and vomiting in adults.
Since August 1993, the FDA has allowed Zofran, an antiemetic drug, to be used to prevent postoperative nausea and vomiting. Normally, Zofran is given through an IV injection or in tablet form. The intramuscular administration bypasses difficulties some patients may encounter. For example, some patients have difficulty swallowing, have small veins, or have veins that won't allow an IV to enter.
"For those patients without an IV line, the addition of Zofran IM for [postoperative nausea and vomiting] in adults provides a convenient option," says Judy Bryson, PharmD, director of U.S. medical affairs for oncology/emesis at Glaxo Wellcome. "Zofran, given as an intravenous injection, has already been rated high in patient satisfaction."
Not approved for childrenWhile IM administration has been approved in adults, it has not gained clearance for use in children. It is permissible to use Zofran in children, but as of yet, the IM method has not been studied in them.
To combat postoperative nausea and vomiting in adults, Zofran is given as a 4 mg to 8 mg single IV or IM dose immediately before the induction of anesthesia or for the prevention of further postoperative episodes. It also has been used for the management of nausea and vomiting induced by chemotherapy and radiotherapy.
Negative side effects have been noted in postoperative clinical tests. The most common are dizziness, headache, drowsiness, sedation, and constipation. Other adverse effects are diarrhea, dry mouth, and skin rash.
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