, pancuronium, or atracurium; and supplemental isoflurane or enflurane) were eva luated in 2 double-blind studies (1 US study, 1 foreign) involving 865 patients. Ondansetron HCl tablets (16 mg) were significantly more effective than placebo in preventing postoperative nausea and vomiting.
The study populations in all trials thus far consisted of women undergoing inpatient surgical procedures. No studies have been performed in males. No controlled clinical study comparing ondansetron HCl tablets to ondansetron injection has been performed.
REFERENCES
1.Britto MR, Hussey EK, Mydlow P, et al. Effect of enzyme inducers on ondansetron (OND) metabolism in humans. Clin Pharmacol Ther. 1997;61:228.
2.Pugh RNH, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Brit J Surg. 1973;60:646-649.
3.Villikka K, Kivisto KT, Neuvonen PJ. The effect of rifampin on the pharmacokinetics of oral and intravenous ondansetron. Clin Pharmacol Ther. 1999;65:377-381.
4.De Witte JL, Schoenmaekers B, Sessler DI, et al. Anesth Analg. 2001;92:1319-1321.
5.Arcioni R, della Rocca M, Romanò R, et al. Anesth Analg. 2002;94:1553-1557.
HOW SUPPLIED / STORAGE AND HANDLING
Zuplenz (ondansetron) oral soluble film 4 mg and Zuplenz (ondansetron) oral soluble film 8 mg, are supplied as thin rectangular white opaque films in individual foil-foil sealed child resistant pouches. Individual films are identified by “4 mg” or “8 mg”, according to the respective strengths, which is printed using pharmaceutical grade edible ink.
Individual pouches of Zuplenz 4 mg oral soluble film (NDC 49884-324-52) are packaged in boxes of 10 (NDC 49884-324-62).
Individual pouches of Zuplenz 8 mg oral soluble film (NDC 49884-325-52) are packaged in boxes of 10 (NDC 49884-325-62).
Store at controlled room temperature 20° to 25°C (68° to 77°F). Store pouches in cartons. Keep product in pouch until ready to use.
Patient Counseling Information
See FDA-Approved Patient Labeling
Instructions for use
Advise patients to carefully read the “Patient Information” and “Instructions for Use” accompanying each package of Zuplenz (ondansetron) oral soluble film.
Inform patients that Zuplenz film may cause headache, malaise/fatigue, constipation, and diarrhea. The patient should report the use of all medications, especially apomorphine, to their health care provider. Concomitant use of apomorphine and ondansetron may cause a significant drop in blood pressure and loss of consciousness.
Inform patients that Zuplenz may cause hypersensitivity reactions, some as severe as anaphylaxis and bronchospasm. The patient should report any hypersensitivity reactions to this and other 5-HT 3 receptor antagonists to their health care provider.
Instruct patients on how to use Zuplenz films:
The patient should keep the film in the pouch until ready to use and not chew or swallow the film. With dry hands, the patient should fold the pouch along the dotted line to expose the tear notch. While still folded, the patient should tear the pouch carefully along the edge and remove the Zuplenz oral soluble film from the pouch. The patient should immediately place the film on top of the tongue where it dissolves in 4 to 20 seconds, and then swallow with saliva. Once the film dissolves, the patient may swallow liquid but it is not required. The patient should wash |
