Important safety information | For healthcare professionals

Important Safety Information About METOZOLV® ODT

WARNING: TARDIVE DYSKINESIA

See full prescribing information for complete boxed warning.

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.

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; and 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.

You may still have side effects after stopping METOZOLV ODT, and you may have symptoms from stopping METOZOLV ODT (withdrawal symptoms), such as headaches and feeling dizzy or nervous.

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, including BOXED WARNING.

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.