WARNINGS
WARNINGS
Neuroleptic Malignant Syndrome (NMS)
There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac arrhythmias).
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever and primary central nervous system (CNS) pathology.
The management of NMS should include 1) immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. Bromocriptine and dantrolene sodium have been used in treatment of NMS, but their effectiveness have not been established (see ADVERSE REACTIONS).
Extrapyramidal Symptoms (EPS)
Acute Dystonic Reactions
Acute dystonic reactions occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at the higher doses used in prophylaxis of vomiting due to cancer chemotherapy. These symptoms may include involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions may present as stridor and dyspnea, possibly due to laryngospasm. If these symptoms should occur, inject 50 mg Benadryl® (diphenhydramine hydrochloride) intramuscularly, and they usually will subside. Cogentin® (benztropine mesylate), 1 to 2 mg intramuscularly, may also be used to reverse these reactions.
Tardive Dyskinesia (see Boxed Warnings)
Treatment with metoclopramide can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. The risk of tardive dyskinesia increases with the duration of treatment and the total cumulative dose. An analysis of utilization patterns showed that about 20% of patients who used metoclopramide took it longer than 12 weeks. Treatment with metoclopramide for longer than the recommended 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD.
Although the risk of developing TD in the general population may be increased among the elderly, women, and diabetics, it is not possible to predict which patients will develop metoclopramide-induced TD. Both the risk of developing TD and the likelihood that TD will become irreversible increase with duration of treatment and total cumulative dose.
Metoclopramide should be discontinued in patients who develop signs or symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients, TD may remit, partially or completely, within several weeks to months after metoclopramide is withdrawn.
Metoclopramide itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown. Therefore, metoclopramide should not be used for the symptomatic control of TD.
Parkinsonian-like Symptoms
Parkinsonian-like symptoms, including bradykinesia, tremor, cogwheel rigidity, or mask-like facies, have occurred, more commonly within the first 6 months after beginning treatment with metoclopramide, but occasionally after longer periods. These symptoms generally subside within 2 to 3 months following discontinuance of metoclopramide. Patients with pre-existing Parkinson's disease should be given metoclopramide cautiously, if at all, since such patients may experience exacerbation of parkinsonian symptoms when taking metoclopramide.
Depression
Mental depression has occurred in patients with and without prior history of depression. Symptoms have ranged from mild to severe and have included suicidal ideation and suicide. Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks.
MEDICATION GUIDE
MEDICATION GUIDE
Metoclopramide (met” oh kloe’ pra mide) Injection, USP
You or your caregiver should read the Medication Guide before you start receiving metoclopramide injection and before you get another dose of metoclopramide injection. There may be new information. If you take another product that contains metoclopramide (such as metoclopramide tablets, metoclopramide orally disintegrating tablets, or metoclopramide oral solution), you should read the Medication Guide that comes with that product. Some of the information may be different. This Medication Guide does not take the place of talking to your doctor about your medical condition or your treatment.
What is the most important information I should know about metoclopramide?
Metoclopramide can cause serious side effects, including:
Abnormal muscle movements called tardive dyskinesia (TD). These movements happen mostly in the face muscles. You can not control these movements. They may not go away even after stopping metoclopramide. There is no treatment for TD, but symptoms may lessen or go away over time after you stop taking metoclopramide.
Your chances for getting TD go up:
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- the longer you take metoclopramide and the more metoclopramide you take. You should not take metoclopramide for more than 12 weeks.
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- if you are older, especially if you are a woman
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- if you have diabetes
It is not possible for your doctor to know if you will get TD if you take metoclopramide.
Call your doctor right away if you get movements you can not stop or control, such as:
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- lip smacking, chewing, or puckering up your mouth
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- frowning or scowling
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- sticking out your tongue
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- blinking and moving your eyes
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- shaking of your arms and legs
See the section "What are the possible side effects of metoclopramide?" for more information about side effects.
What is metoclopramide?
Metoclopramide is a prescription medicine used to:
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- relieve symptoms of slow stomach emptying in people with diabetes
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- prevent nausea and vomiting that can happen with cancer chemotherapy
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- prevent nausea and vomiting that may happen after surgery, if your doctor decides that you should not be treated with a stomach tube and suction
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- help make it easier to insert a tube into the small intestine in both adults and children, if the tube does not pass into the stomach normally.
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- to help empty stomach contents or to help barium move through your intestine, when you get an X-ray examination of the stomach or small intestine. It is not known if metoclopramide is safe and works in children except when used to help insert a tube into the small intestine.
Who should not receive metoclopramide?
Do not receive metoclopramide if you:
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- have stomach or intestine problems that could get worse with metoclopramide, such as bleeding, blockage or a tear in your stomach or bowel wall
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- have an adrenal gland tumor called pheochromocytoma
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- are allergic to metoclopramide or anything in it. See the end of this Medication Guide for a list of ingredients in metoclopramide.
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- take medicines that can cause uncontrolled movements, such as medicines for mental illness
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- have seizures
What should I tell my doctor before receiving metoclopramide?
Tell your doctor about all of your medical conditions, including if you have:
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- depression
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- Parkinson's disease
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- high blood pressure
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- kidney problems. Your doctor may start with a lower dose.
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- liver problems or heart failure. Metoclopramide may cause your body to hold fluids.
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- diabetes. Your dose of insulin may need to be changed.
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- breast cancer
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- you are pregnant or plan to become pregnant. It is not known if metoclopramide will harm your unborn child.
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- you are breastfeeding. Metoclopramide is passed into human milk and may harm your baby. Talk with your doctor about the best way to feed your baby if you take metoclopramide.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Metoclopramide and some other medicines can affect each other and may not work as well, or cause possible side effects. Do not start any new medicines while receiving metoclopramide until you talk with your doctor.
Especially tell your doctor if you take:
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- another medicine that contains metoclopramide, such as metoclopramide tablets, metoclopramide orally disintegrating tablets, or metoclopramide oral solution
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- a blood pressure medicine
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- a medicine for depression, especially a Monoamine Oxidase Inhibitor (MAOI)
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- insulin
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- a medicine that can make you sleepy, such as anti-anxiety medicine, sleep medicines, and narcotics.
If you are not sure if your medicine is one listed above, ask your doctor or pharmacist. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How will I receive metoclopramide?
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- Metoclopramide will be given to you by intravenous (IV) infusion into your vein or by intramuscular (IM) injection into a large muscle. Where and how you receive your metoclopramide injection (IV or IM) will depend on why you are receiving it.
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- Certain side effects can happen if metoclopramide is given too fast. See the section "What are the possible side effects of metoclopramide?"
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- You should not take or receive metoclopramide for more than 12 weeks.
What should I avoid while receiving metoclopramide?
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- Do not drink alcohol while receiving metoclopramide. Alcohol may make some side effects of metoclopramide worse, such as feeling sleepy.
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- Do not drive, work with machines, or do dangerous tasks until you know how metoclopramide affects you. Metoclopramide may cause sleepiness.
What are the possible side effects of metoclopramide?
Metoclopramide can cause serious side effects, including:
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- Abnormal muscle movements. See the section "What is the most important information I should know about metoclopramide?"
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- 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 under age 30.
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- Depression, thoughts about suicide, and suicide. Some people who take metoclopramide become depressed. You may have thoughts about hurting or killing yourself. Some people who take metoclopramide have ended their own lives (suicide).
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- Neuroleptic Malignant Syndrome (NMS). NMS is a very rare but very serious condition that can happen with metoclopramide. 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.
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- Parkinsonism. Symptoms include slight shaking, body stiffness, trouble moving or keeping your balance. If you already have Parkinson's disease, your symptoms may become worse while you are receiving metoclopramide.
Call your doctor and get medical help right away if you:
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- feel depressed or have thoughts about hurting or killing yourself
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- have high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, and increased sweating
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- have muscle movements you can not stop or control
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- have muscle movements that are new or unusual
Common side effects of metoclopramide include:
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- feeling restless, sleepy, tired, dizzy, or exhausted
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- headache
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- confusion
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- trouble sleeping
Infusion related side effects can happen if metoclopramide is given too fast. You may feel very anxious and restless for a short time, and then become sleepy while you are receiving a dose of metoclopramide. Tell your doctor or nurse right away if this happens.
You may have more side effects the longer you take metoclopramide and the more metoclopramide 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 metoclopramide.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about metoclopramide
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide summarizes the most important information about metoclopramide. If you would like more information about metoclopramide, talk with your doctor. You can ask your doctor or pharmacist for information about metoclopramide that is written for healthcare professionals. For more information go to www.hospira.com or call 1-800-615-0187.
What are the ingredients in metoclopramide?
Active ingredient: metoclopramide
Inactive ingredients: sodium chloride, water, hydrochloric acid or sodium hydroxide
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
LAB-1291-2.0
Revised: 09/2023
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