How does Metozolv ODT work?
Metozolv ODT is a prokinetic medication, also known as a promotility agent, that treats symptoms of diabetic gastroparesis and refractory GERD1 by stimulating coordination of muscle contractions that help move food through the digestive system and preventing entry of acidic contents into the esophagus.
Diabetic gastroparesis
When a person has diabetic gastroparesis, the stomach empties more slowly than normal or food can stop moving in the digestive tract. This can cause discomfort in the form of nausea, vomiting, bloating after meals, early satiety, decreased appetite, heartburn, and abdominal pain. If untreated, it can lead to further complications, including infection and blockages in the digestive tract. Metozolv ODT works in the digestive system by promoting muscular contractions in the esophagus, stomach, and small intestine. By promoting these muscular contractions, Metozolv ODT helps increase the speed at which food moves through the digestive system, which helps alleviate diabetic gastroparesis symptoms.1-5
Refractory GERD
When a person has GERD, acidic contents from the stomach enter into the esophagus, causing discomfort and, over time, damage to the esophagus. Metozolv ODT treats refractory GERD1 by increasing pressure on the lower esophageal sphincter—the valve between the esophagus and the stomach that helps prevent acidic contents from entering the esophagus. It also helps move food out of the stomach by relaxing the pyloric valve, thereby helping to reduce refractory GERD symptoms.
The first available orally disintegrating metoclopramide tablet for simple relief of diabetic gastroparesis and refractory GERD1,6-7
With Metozolv ODT, you can take metoclopramide anywhere, without liquid, to relieve symptoms of diabetic gastroparesis and refractory GERD.1 Talk to your healthcare professional to find out if a prokinetic medication such as Metozolv ODT is right for you.
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References: 1. METOZOLV ODT [package insert]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2009.
2. 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.
3. Ricci DA, Saltzman MB, Meyer C, Callachan C, McCallum RW. Effect of metoclopramide in diabetic gastroparesis. J Clin Gastroenterol. 1985;7:25-32.
4. 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.
5. 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.
6. 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.
7. 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.
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.