What is Metozolv ODT?
Metozolv ODT is an orally disintegrating form of metoclopramide
Metozolv ODT* (metoclopramide HCl) is a prescription medicine used in adults for 4 to 12 weeks to relieve heartburn symptoms of gastroesophageal reflux disease (GERD) when certain other treatments do not work (refractory GERD) and to relieve the symptoms of slow stomach emptying in people with diabetes (diabetic gastroparesis).
Metozolv ODT rapidly† disintegrates and is designed to be taken without liquid.‡ Metozolv ODT can be taken up to 4 times daily, at least 30 minutes before eating and at bedtime. To take Metozolv ODT, handle the tablet with dry hands and place on the tongue.
How does Metozolv ODT work?
Metozolv ODT is a prokinetic medication that helps decrease the transit time 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 keeping acid out of the esophagus, which can cause many uncomfortable symptoms.
Metozolv ODT is an orally disintegrating dosage form that is bioequivalent to traditional metoclopramide tablets. That means Metozolv ODT has the same effect in the body as traditional metoclopramide.
Talk to your healthcare professional to find out if Metozolv ODT is right for you.
Important Safety Information About METOZOLV® ODT
METOZOLV ODT can cause serious side effects including abnormal muscle movements called tardive dyskenisia (TD). You cannot control these movements, and they may not go away even after stopping METOZOLV ODT. There is no treatment for TD, but symptoms may lessen or go away over time after you stop taking METOZOLV ODT.
Call your doctor right away if you experience symptoms you cannot stop or control such as lip smacking, chewing, or puckering of your lips; frowning or scowling; sticking out of your tongue; blinking and moving your eyes; or shaking of your arms and legs.
It is not possible for your doctor to know if you will get TD if you take METOZOLV ODT. Factors that increase your risk for TD include increased age, especially for females; a diagnosis of diabetes; extended use and increased dosage of METOZOLV ODT. You should not take METOZOLV ODT for more than 12 weeks.
METOZOLV ODT can cause other serious side effects including uncontrolled muscle spasms; depression, thoughts about suicide, and suicide; a rare but potentially fatal disorder known as neuroleptic malignant syndrome (NMS), the symptoms of which include high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased swelling; Parkinsonism, the symptoms of which include slight body shaking, body stiffness, and trouble moving or keeping your balance; high blood pressure; and too much body water. If you experience any of these symptoms, call your doctor and get medical help right away.
The most common side effects of METOZOLV ODT include headache, nausea, vomiting, tiredness, and sleepiness. Tell your doctor about any side effects that bother you or do not go away.
Do not drink alcohol while taking METOZOLV ODT, as it may worsen some side effects. Do not drive, work with machines, or do dangerous tasks until you know how METOZOLV ODT affects you.
Do not take METOZOLV ODT if you have stomach or intestinal problems, such as bleeding, blockage, or a tear in your stomach or bowel wall; have an adrenal tumor (pheochromocytoma); are allergic to metoclopramide or any of the ingredients in METOZOLV ODT; take medications that can cause uncontrolled movements, such as medicines for mental illness; or have seizures.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Patient Medication Guide and full Prescribing Information for METOZOLV ODT.
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.