MEDICATION GUIDE
Metoclopramide Tablets, USP
Read the Medication Guide that comes with metoclopramide tablets before you
start taking it and each time you get a refill. There may be new information. If
you take another product that contains metoclopramide (such as metoclopramide
injection, metoclopramide orally disintegrating tablets, or metoclopramide oral
syrup), 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 with your doctor about your medical condition or your
treatment.
What is the most important information I should know about
metoclopramide tablets?
Metoclopramide tablets 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
tablets. There is no treatment for TD, but symptoms may lessen or go away over
time after you stop taking metoclopramide tablets.
Your chances for getting TD go up:
- the longer you take metoclopramide tablets and the more metoclopramide
tablets you take. You should not take metoclopramide tablets for more than 12
weeks.
- if you are older, especially if you are a woman
- if you have diabetes
It is not possible for your doctor to know if you will get TD if you take metoclopramide tablets.
Call your doctor right away if you get movements you can not stop or control,
such as:
- lip smacking, chewing, or puckering up your mouth
- frowning or scowling
- sticking out your tongue
- blinking and moving your eyes
- shaking of your arms and legs
See the section "What are the possible side effects of
metoclopramide tablets?" for more information about side effects.
What are metoclopramide tablets?
Metoclopramide tablets are a prescription medicine used:
- in adults for 4 to 12 weeks to relieve heartburn symptoms with
gastroesophageal reflux disease (GERD) when certain other treatments do not
work. Metoclopramide tablets relieve daytime heartburn and heartburn after
meals. It also helps ulcers in the esophagus to heal.
- to relieve symptoms of slow stomach emptying in people with diabetes.
Metoclopramide tablets help treat symptoms such as nausea, vomiting, heartburn,
feeling full long after a meal, and loss of appetite. Not all these symptoms get
better at the same time.
It is not known if metoclopramide tablets are safe and work
in children.
Who should not take metoclopramide tablets?
Do not take metoclopramide tablets if you:
- have stomach or intestine problems that could get worse with metoclopramide
tablets, such as bleeding, blockage or a tear in the stomach or bowel wall
- have an adrenal gland tumor called a pheochromocytoma
- are allergic to metoclopramide tablets or anything in it. See the end of
this Medication Guide for a list of ingredients in metoclopramide tablets.
- take medicines that can cause uncontrolled movements, such as medicines for
mental illness
- have seizures
What should I tell my doctor before taking
metoclopramide tablets?
Tell your doctor about all your medical conditions,
including if you have:
- depression
- Parkinson’s disease
- high blood pressure
- kidney problems. Your doctor may start with a lower dose.
- liver problems or heart failure. Metoclopramide tablets may cause your body
to hold fluids.
- diabetes. Your dose of insulin may need to be changed.
- breast cancer
- you are pregnant or plan to become pregnant. It is not known if
metoclopramide tablets will harm your unborn baby.
- you are breast-feeding. Metoclopramide tablets can pass into breast milk and
may harm your baby. Talk with your doctor about the best way to feed your baby
if you take metoclopramide tablets.
Tell your doctor about all the medicines
you take, including prescription and non-prescription medicines, vitamins, and
herbal supplements. Metoclopramide tablets and some other medicines may
interact with each other and may not work as well, or cause possible side
effects. Do not start any new medicines while taking metoclopramide tablets
until you talk with your doctor.
Especially tell your doctor if you take:
- another medicine that contains metoclopramide, such as metoclopramide orally
disintegrating tablets, or metoclopramide oral syrup
- a blood pressure medicine
- a medicine for depression, especially an Monoamine Oxidase Inhibitor
(MAOI)
- insulin
- a medicine that can make you sleepy, such an 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 should I take metoclopramide tablets?
- Metoclopramide tablets come as a tablet you take by mouth.
- Take metoclopramide tablets exactly as your doctor tells you. Do not change
your dose unless your doctor tells you.
- You should not take metoclopramide tablets for more than 12 weeks.
- If you take too much metoclopramide tablets, call your doctor or Poison
Control Center right away.
What should I avoid while taking
metoclopramide tablets?
- Do not drink alcohol while taking metoclopramide tablets. Alcohol may make
some side effects of metoclopramide tablets worse, such as feeling sleepy.
- Do not drive, work with machines, or do dangerous tasks until you know how
metoclopramide tablets affect you. Metoclopramide tablets may cause
sleepiness.
What are the possible side effects of
metoclopramide tablets?
Metoclopramide tablets can cause serious side effects,
including:
-
Abnormal muscle movements. See "What is the most
important information I need to know about metoclopramide tablets?"
-
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.
-
Depression, thoughts about suicide, and suicide.
Some people who take metoclopramide tablets become depressed. You may
have thoughts about hurting or killing yourself. Some people who take
metoclopramide tablets have ended their own lives (suicide).
-
Neuroleptic Malignant Syndrome (NMS). NMS is a very
rare but very serious condition that can happen with metoclopramide tablets. 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.
-
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 tablets.
Call your doctor and get medical help
right away if you:
- feel depressed or have thoughts about hurting or killing yourself
- have high fever, stiff muscles, problems thinking, very fast or uneven
heartbeat, and increased sweating
- have muscle movements you cannot stop or control
- have muscle movements that are new or unusual
Common side effects of metoclopramide
tablets include:
- feeling restless, sleepy, tired, dizzy, or exhausted
- headache
- confusion
- trouble sleeping
You may have more side effects the longer you take
metoclopramide tablets and the more metoclopramide tablets you take.
You may still have side effects after stopping metoclopramide tablets. You
may have symptoms from stopping (withdrawal) metoclopramide tablets such as
headaches, and feeling dizzy or nervous.
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 tablets.
Call your doctor for medical advice about side effects. You
may report side effects to FDA at 1–800–FDA-1088.
How should I store metoclopramide tablets?
- Keep metoclopramide tablets at room temperature between 20ºC and 25ºC (68º
and 77ºF) [See USP Controlled Room Temperature].
- Keep metoclopramide tablets in the bottle it comes in. Keep the bottle
closed tightly.
Keep metoclopramide tablets and all
medicines out of the reach of children.
General information about metoclopramide tablets
Medicines are sometimes prescribed for purposes other than those listed in a
Medication Guide. Do not use metoclopramide tablets for a condition for which it
was not prescribed. Do not give metoclopramide tablets to other people, even if
they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about
metoclopramide tablets. If you would like more information, talk with your
doctor. You can ask your doctor or pharmacist for information about
metoclopramide tablets that is written for health professionals.
What are the ingredients in metoclopramide tablets?
Active ingredient: metoclopramide
Inactive ingredients:
Metoclopramide tablets, USP 5 mg: microcrystalline
cellulose, corn starch, pregelatinized starch, colloidal silicon dioxide and
stearic acid.
Metoclopramide tablets, USP 10 mg: microcrystalline
cellulose, corn starch, pregelatinized starch, colloidal silicon dioxide and
stearic acid.
Physicians Total Care, Inc.