Generic Name: METOCLOPRAMIDE - ORAL
Pronounced: (met-o-KLO-pruh-mide)

Reglan Oral Warning

This medication may cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tardive dyskinesia is more likely to occur when metoclopramide is used for longer than 3 months, in high doses, or when used in the elderly (especially elderly women). Contact your doctor immediately if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms or legs). There is no treatment for tardive dyskinesia, but in some cases symptoms may lessen or stop once metoclopramide is stopped.

Because of the risk for tardive dyskinesia, metoclopramide should not be used for longer than 3 months (12 weeks), except in rare cases where the benefits of this drug outweigh the risk of developing tardive dyskinesia. Discuss the risks and benefits with your doctor.

Reglan Oral Side Effects

See also Warning section.

Drowsiness, dizziness, tiredness, trouble sleeping, agitation, headache, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• mental/mood changes (such as anxiety, confusion, depression, thoughts of suicide)
• decreased sexual ability
• inability to keep still/need to pace
• muscle spasms/uncontrolled muscle movements (such as twisting neck, arching back)
• abnormal breast-milk production
• enlarged/tender breasts
• swelling of the hands/feet
• changes in menstruation in women

This medication may cause side effects that look like Parkinson's disease. Tell your doctor immediately if any of these unlikely side effects occur:

• shaking (tremors)
• slowed/difficult movement
• muscle stiffness
• mask-like facial expression

This drug may infrequently cause a serious (sometimes fatal) nervous system problem (neuroleptic malignant syndrome). Seek immediate medical attention if you notice any of the following rare but very serious side effects:

• fever
• rigid muscles
• increased sweating
• fast heartbeat
• confusion

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Reglan Oral Precautions

Before taking metoclopramide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding/blockage/hole in the intestines/stomach
• breast cancer
• diabetes
• high blood pressure
• kidney problems
• heart failure
• mental/mood problems (such as depression, thoughts of suicide)
• Parkinson's disease
• liver problems (such as cirrhosis, porphyria)
• pheochromocytoma
• seizures
• a certain blood enzyme problem (NADH-cytochrome b5 reductase deficiency)

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Liquid products may contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, or any other condition that requires you to limit alcohol. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you have diabetes, this product may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have high or low blood sugar. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Children may be more sensitive to the side effects of this drug, especially muscle spasms.

Older adults may be more sensitive to the effects of this drug, especially drowsiness, tardive dyskinesia, and Parkinson's type muscle problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Copyright 2007 First DataBank, Inc.