Metozolv ODT– an orally disintegrating metoclopramide tablet
Metozolv ODT (metoclopramide HCl) is the first available orally disintegrating tablet that provides convenient relief of diabetic gastroparesis and
refractory GERD.1-3 Metozolv ODT combines the reliability of traditional metoclopramide with the convenience of a tablet that rapidly† melts
on the tongue.
Metozolv ODT features Zydis® technology, an innovative formulation that makes it possible for Metozolv ODT to be delivered as an orally
disintegrating tablet that rapidly† melts on the tongue.4 That means you can conveniently take Metozolv ODT when liquid is not available
or if you have difficulty swallowing.
Numerous clinical studies have proven that metoclopramide, the active ingredient in Metozolv ODT, is effective for treating diabetic gastroparesis and
refractory GERD.5-11 The digestive systems in people with diabetic gastroparesis and refractory GERD may have trouble moving food out of the
stomach or have difficulty keeping acidic stomach contents from entering the esophagus. This can cause a variety of uncomfortable symptoms including nausea,
vomiting, bloating, heartburn, regurgitation, and chest pain. To relieve these symptoms, metoclopramide works in the digestive system by promoting
muscular contractions in the esophagus, stomach, and small intestine.
Salix Pharmaceuticals is pleased to provide you with a patient-friendly web site dedicated to Metozolv ODT at www.MetozolvODT.com.
Please visite the site to learn more about Metozolv ODT, diabetic gastroparesis, and refractory GERD.
To learn more, talk to your healthcare provider. He or she can help make sure that Metozolv ODT is the right choice for you.
*Refractory GERD is symptomatic, documented gastroesophageal reflux disease that fails to respond to conventional therapy.
†Metozolv ODT disintegrates on the tongue in a median of 53.5 seconds (mean ± standard deviation, 76.8 ± 110.6 seconds).1
Metozolv ODT is a trademark of Salix Pharmaceuticals, Inc.
Zydis is a registered trademark of Catalent Pharma Solutions.
References:
1. METOZOLV ODT [package insert]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2009.
2. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=REGLAN. Accessed May 6, 2009.
3. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=METOCLOPRAMIDE%20HYDROCHLORIDE. Accessed May 6, 2009.
4. Zydis fast-dissolve technology. Catalent. Available at: http://www.catalent.com/drug/oral/zydis/. Accessed December 5, 2008.
5. McCallum RW, Ricci DA, Rakatansky H, et al. A multicenter placebo-controlled clinical trial of oral metoclopramide in diabetic gastroparesis. Diabetes Care. 1983;6:463-467.
6. Ricci DA, Saltzman MB, Meyer C, Callachan C, McCallum RW. Effect of metoclopramide in diabetic gastroparesis. J Clin Gastroenterol. 1985;7:25-32.
7. Snape WJ, Battle WM, Schwartz SS, Braunstein SN, Goldstein HA, Alavi A. Metoclopramide to treat gastroparesis due to diabetes mellitus: a double-blind, controlled trial. Ann Intern Med. 1982;96;444-446.
8. Erbas T, Varoglu E, Erbas B, Tastekin G, Akalin S. Comparison of metoclopramide and erythromycin in the treatment of diabetic gastroparesis. Diabetes Care. 1993;16:1511-1514.
9. Patterson D, Abell T, Rothstein R, Koch K, Barnett J. A double-blind multicenter comparison of domperidone and metoclopramide in the treatment of diabetic patients with symptoms of gastroparesis. Am J Gastroenterol. 1999;94:1230-1234.
10. McCallum RW, Fink SM, Lerner E, Berkowitz DM. Effects of metoclopramide and bethanechol on delayed gastric emptying present in gastroesophageal reflux patients. Gastroenterology. 1983;84:1573-1577.
11. McCallum RW, Fink SM, Winnan GR, Avella J, Callachan C. Metoclopramide in gastroesophageal reflux disease: rationale for its use and results of a double-blind trial. Am J Gastroenterol. 1984;79:165-172.
Important Safety Information about METOZOLV ODT
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive
dyskinesia increases with the duration of treatment and the total cumulative dose.
Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive
dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh
the risk of developing tardive dyskinesia.
Please see accompanying Prescribing Information for METOZOLV ODT, including
BOXED WARNINGS.
METOZOLV™ ODT
(metoclopramide HCl) is indicated as short-term therapy for adults with symptomatic, documented gastroesophageal reflux disease (GERD)
who fail to respond to conventional therapy and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (diabetic gastric
stasis) in adults. Therapy should not exceed 12 weeks in duration. METOZOLV ODT is contraindicated in patients with intestinal obstruction, hemorrhage,
or perforation; pheochromocytoma; known sensitivity or intolerance to metoclopramide; epilepsy; or are receiving concomitant medications with extrapyramidal
reactions. METOZOLV ODT should be used with caution in patients showing acute dystonic reactions, drug-induced Parkinsonism, or other extrapyramidal symptoms;
neuroleptic malignant syndrome; with a prior history of depression; hypertension; congestive heart failure and ventricular arrhythmia. Patients may experience
withdrawal symptoms after stopping the use of METOZOLV ODT.
In clinical studies, the most frequently reported adverse events (>2% occurrence) were headache, nausea, fatigue, somnolence, and vomiting.
For complete Prescribing Information, please click here.
For product information, adverse event reports, and product complaint reports please call:
Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: