What is Metozolv ODT?
Metozolv ODT (metoclopramide HCl) is the first available orally disintegrating tablet that treats diabetic gastroparesis and refractory GERD.1-3 Metozolv ODT features Zydis® technology, allowing it to rapidly* melt on the tongue with no chalky aftertaste.4 Thanks to this unique feature, you can conveniently take Metozolv ODT when liquid is not available or if you have difficulty swallowing.
Metozolv ODT is a prokinetic medication that helps increase the speed at which food moves through the digestive system. It works by promoting muscular contractions in the esophagus, stomach, and small intestine. This is helpful to people with diabetic gastroparesis and refractory GERD because their digestive systems may have trouble moving food out of the stomach or have problems keeping acid out of the esophagus, which can cause many uncomfortable symptoms.
Metozolv ODT is a convenient form of metoclopramide
Metoclopramide, the active ingredient in Metozolv ODT, has been used for nearly 30 years.1,5 Metozolv ODT combines the reliability of traditional metoclopramide with the convenience of a tablet that rapidly* melts on the tongue so you can take it anywhere, without liquid.
Talk to your healthcare professional to find out if Metozolv ODT is right for you.
Effective relief for diabetic gastroparesis and refractory GERD
Find out how Metozolv ODT works
Is Metozolv ODT right for you?
*Metozolv ODT disintegrates on the tongue in a median of 53.5 seconds (mean ± standard deviation, 76.8 ± 110.6 seconds).1
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. Overview: Reglan (NDA #017854). US Food and Drug Administration. Available at:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=REGLAN. Accessed December 12, 2008.
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.