Indication for METOZOLV ODT
METOZOLV® ODT is indicated for short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease that fails to respond to conventional therapy (refractory GERD) and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis) in adults.
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.
Do not take METOZOLV ODT (metoclopramide hydrochloride) if you have stomach or intestine problems that could get worse with METOZOLV ODT, such as bleeding, blockage or a tear in your stomach or bowel wall; have an adrenal tumor called pheochromocytoma; are allergic to metoclopramide or any of the ingredients in METOZOLV ODT; take medicines that can cause uncontrolled movements, such as medicines for mental illness; or have seizures.
METOZOLV ODT can cause serious side effects, including:
Tardive dyskinesia (abnormal muscle movements): these movements happen mostly in the face muscles. You cannot control these movements. They may not go away even after stopping METOZOLV ODT. There is no treatment for tardive dyskinesia, but symptoms may lessen or go away over time after you stop taking METOZOLV ODT.
Uncontrolled spasms of your face and neck muscles, or muscles of your body, arms, and legs (dystonia): these muscle spasms can cause abnormal movements and body positions. These spasms usually start within the first 2 days of treatment. These spasms happen more often in children and adults younger than 30.
Parkinsonism: symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you have Parkinson’s Disease, your symptoms may become worse while you are taking METOZOLV ODT.
Neuroleptic Malignant Syndrome (NMS): NMS is a rare but very serious condition that can happen with METOZOLV ODT. NMS can cause death and must be treated in a hospital. Symptoms of NMS include: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating.
Depression, thoughts about suicide, and suicide: some people who take METOZOLV ODT may become depressed. You may have thoughts about hurting or killing yourself. Some people who have taken metoclopramide products have ended their own lives (suicide).
High blood pressure: METOZOLV ODT can cause your blood pressure to increase.
Too much body water: people who have certain liver problems or heart failure and take METOZOLV ODT may hold too much water in their body (fluid retention). Tell your doctor right away if you have sudden weight gain, or swelling of your hands, legs, or feet.
Symptoms from stopping (withdrawal) METOZOLV ODT: you may still have side effects after you stop METOZOLV ODT such as headaches, and feeling dizzy or nervous.
METOZOLV ODT comes as a tablet that melts in your mouth. Take METOZOLV ODT exactly as prescribed by your doctor. Do not change your dose unless your doctor tells you to. You should not take METOZOLV ODT for more than 12 weeks. Take METOZOLV ODT at least 30 minutes before eating and at bedtime.
It is not known if METOZOLV ODT is safe or works in children.
The elderly may be at greater risk for sleepiness and movement disorders with METOZOLV ODT.
If you have kidney problems, speak with your healthcare provider before taking METOZOLV ODT.
The most common side effects of METOZOLV ODT are: headache, nausea, vomiting, tiredness, and sleepiness. You may have more side effects the longer you take METOZOLV ODT and the more you take. Tell your doctor about any side effects that bother you or do not go away. These are not all the possible side effects of METOZOLV ODT.
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.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Please see complete Prescribing Information for METOZOLV ODT, including BOXED WARNING.
The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.