Answers to patients’ frequently asked questions about Metozolv ODT
What are the benefits of Metozolv ODT?
Metozolv ODT is the first available orally disintegrating metoclopramide tablet for the simple relief of diabetic gastroparesis and refractory GERD.1-3 Unlike traditional metoclopramide, Metozolv ODT features Zydis® technology, allowing it to rapidly* melt on the tongue with no chalky aftertaste.4 Thanks to this unique feature, your patients can conveniently take Metozolv ODT when liquid is not available or if they have difficulty swallowing.
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Is Metozolv ODT effective?
Numerous clinical studies have proven that metoclopramide, the active ingredient in Metozolv ODT, is effective for treating diabetic gastroparesis and refractory GERD.5-11 Metozolv ODT is bioequivalent to traditional metoclopramide tablets in a convenient dosage form.1 Learn more.
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How does Metozolv ODT work?
Metozolv ODT is a prokinetic medication that helps increase the speed at which food moves through the digestive system by promoting muscular contractions. It features Zydis® technology, which works by releasing medicine into the mouth that travels with saliva, as it is swallowed, into the digestive system.4 Learn more.
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How do I take Metozolv ODT? How often?
Metozolv ODT can conveniently be taken anywhere, without liquid. It is available in 5-mg and 10-mg orally disintegrating tablets that can be taken up to 4 times a day, 30 minutes before each meal and at bedtime.1
Simply place the tablet on the tongue. It will rapidly* melt on the tongue, and it does not need to be taken with liquid. Learn more.
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What are the benefits of taking tablets with Zydis® technology?
Zydis® is an innovative technology making it possible for Metozolv ODT to be delivered as an orally disintegrating tablet. Some of the benefits of Zydis® technology include
- Rapidly* melts on the tongue
- Can be taken without liquid
- Can be taken anywhere
- Feels smooth on the tongue and leaves no chalky aftertaste4
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How is Metozolv ODT different from traditional metoclopramide tablets?
Since Metozolv ODT is an orally disintegrating tablet,1 it gives your patients the freedom and convenience to take it anywhere, without liquid. With Metozolv ODT, your patients can take metoclopramide when liquid is not available or if they have difficulty swallowing.
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I am currently taking metoclopramide for diabetic gastroparesis/refractory GERD. What can I expect with Metozolv ODT?
Metozolv ODT changes the way your patients take metoclopramide and makes it convenient to take medicine as prescribed. It is an orally disintegrating tablet1 that can be taken anywhere, without liquid. Metozolv ODT provides on-the-go relief with no extra liquid required that may add to gastric volume.
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I am just starting treatment for diabetic gastroparesis/refractory GERD. What results can I expect with Metozolv ODT?
Metozolv ODT provides effective relief of symptoms. It's an orally disintegrating tablet,1 so your patients can take it anywhere, without liquid. That means they can take it when liquid is not available or if they have difficulty swallowing. Metozolv ODT is bioequivalent to traditional metoclopramide tablets in a convenient dosage form.1 Learn more.
For patients with diabetic gastroparesis
- Clinically proven to improve symptoms5-9
- Increases the speed at which food moves through the digestive system5-8
For patients with refractory GERD
- Decreases episodes of daytime and nighttime heartburn and vomiting10
- May reduce the need for antacids10†
- Increases the speed at which food moves through the digestive system11
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Discover the convenience of Metozolv ODT
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See examples of patients who may benefit from Metozolv ODT
*Metozolv ODT disintegrates on the tongue in a median of 53.5 seconds (mean ± standard deviation, 76.8 ± 110.6 seconds).1
†In a double-blind trial, there was a 61% reduction in antacid ingested by the metoclopramide-treated group compared with a 20% reduction in the placebo group (P<0.05).
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, 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.
11. 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.
IMPORTANT SAFETY INFORMATION
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.
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.
Please see accompanying full Prescribing Information
for Metozolv ODT, including BOXED WARNING.