May result in tardive dyskinesia. Risk increases with increasing duration of therapy and total cumulative dose. (See Tardive Dyskinesia under Cautions.)
Discontinue metoclopramide in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia; however, symptoms may lessen or resolve in some patients after discontinuance.
Avoid use for >12 weeks in all but rare cases where therapeutic benefit is thought to outweigh risk of developing tardive dyskinesia.
REMS:
FDA approved a REMS for metoclopramide to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of metoclopramide and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
METOCLOPRAMIDE (met oh kloe PRA mide) is used to treat the symptoms of gastroesophageal reflux disease (GERD) like heartburn. It is also used to treat people with slow emptying of the stomach and intestinal tract.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, about 30 minutes before eating. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
It may take a few weeks for your stomach condition to start to get better. However, do not take this medicine for longer than 12 weeks. The longer you take this medicine, and the more you take it, the greater your chances are of developing serious side effects. If you are an elderly patient, a female patient, or you have diabetes, you may be at an increased risk for side effects from this medicine. Contact your doctor immediately if you start having movements you cannot control such as lip smacking, rapid movements of the tongue, involuntary or uncontrollable movements of the eyes, head, arms and legs, or muscle twitches and spasms.
Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for any sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your doctor.
Do not treat yourself for high fever. Ask your doctor or health care professional for advice.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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