[see Dosage and Administration (2.6)].
For total body irradiation, one 8 mg Zuplenz oral soluble film 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 Zuplenz oral soluble film 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 Zuplenz oral soluble film 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.
Pediatrics
Safety and effectiveness of Zuplenz in pediatric patients have not been established for this indication.
Prevention of Postoperative Nausea and/or Vomiting
Adults
The recommended adult oral dosage of Zuplenz oral soluble film is 16 mg given successively as two 8 mg films 1 hour before induction of anesthesia. Each Zuplenz oral soluble film should be allowed to dissolve completely before administering the next film [see Dosage and Administration (2.6)].
Pediatrics
Safety and effectiveness of Zuplenz in pediatric patients have not been established for this indication.
Dosage Adjustment for Patients with Impaired Hepatic Function
In patients with severe hepatic impairment (Child-Pugh score of 10 or greater) 2, clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see Clinical Pharmacology (12.3)]. In such patients, a total daily dose of 8 mg should not be exceeded.
Important Administration Instructions
With dry hands, fold the pouch along the dotted line to expose the tear notch. While still folded, tear the pouch carefully along the edge and remove the Zuplenz oral soluble film from the pouch. Immediately place the film on top of the tongue where it dissolves in 4 to 20 seconds. Once the Zuplenz oral soluble film is dissolved, swallow with or without liquid [see Clinical Pharmacology (12.3)]. Wash hands after taking Zuplenz.
Dosage Forms and Strengths
Zuplenz (ondansetron) oral soluble film is available in 4 mg and 8mg strengths. The thin white opaque films are rectangularly shaped strips with a printed identifier in black ink of “4 mg” for Zuplenz 4 mg or “8 mg” for Zuplenz 8mg.
Contraindications
The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.
Zuplenz (ondansetron) oral soluble film is contraindicated for patients known to have hypersensitivity to the drug. Anaphylactic reactions have been reported in patients taking ondansetron.
Warnings and Precautions
Hypersensitivity
Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists.
Electrocardiographic Changes
Rarely and predominantly with intravenous ondansetron, transient electrocardiographic changes, including QT interval prolongation, have been reported.
Masking of Progressive Ileus and/or Gastric Distension
The use of Zuplenz in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distensi |
