Metozolv ODT
The first available orally disintegrating metoclopramide tablet1-3
Metozolv ODT (metoclopramide HCl) is the first available orally disintegrating tablet that treats diabetic
gastroparesis and refractory GERD.*1-3 With Metozolv ODT, you can take
metoclopramide anywhere, on the go, without liquid. Metozolv ODT combines the efficacy of established metoclopramide medication with the convenience of a
tablet that rapidly† melts on the tongue.
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 metoclopramide when liquid is not
available or if you have difficulty swallowing.
That means you can now take Metozolv ODT in situations where you may not be able to take a regular metoclopramide tablet.
Metozolv ODT may be right for you
Discover the benefits of metoclopramide in an orally disintegrating tablet by reading through the Metozolv ODT web site. If you have any questions, ask your healthcare professional for additional information and whether Metozolv ODT may be right for you.
Learn more about Metozolv ODT
Discover valuable tools and resources about diabetic gastroparesis, refractory GERD, and Metozolv ODT
*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
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.
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.