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|Reglan

METOCLOPRAMIDE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Reglan

In Canada—

• Apo-Metoclop
• Metoclopramide omega
• Nu-Metoclopramide
• PMS-Metoclopramide

Generic name product may be available in the U.S.

Category

• Dopaminergic blocking agent
• Gastrointestinal emptying (delayed) adjunct
• Peristaltic stimulant
• Antiemetic

Description

Metoclopramide (met-oh-kloe-PRA-mide) is a medicine that increases the movements or contractions of the stomach and intestines. When given by injection, it is used to help diagnose certain problems of the stomach and/or intestines. It is also used by injection to prevent the nausea and vomiting that may occur after treatment with anticancer medicines. Another medicine may be used with metoclopramide to prevent side effects that may occur when metoclopramide is used with anticancer medicines.

When taken by mouth, metoclopramide is used to treat the symptoms of a certain type of stomach problem called diabetic gastroparesis. It relieves symptoms such as nausea, vomiting, continued feeling of fullness after meals, and loss of appetite. Metoclopramide is also used, for a short time, to treat symptoms such as heartburn in patients who suffer esophageal injury from a backward flow of gastric acid into the esophagus.

Metoclopramide may also be used for other conditions as determined by your doctor.

Metoclopramide is available only with your doctor"s prescription. It is available in the following dosage forms:

• Oral
• Tablets (U.S. and Canada)
• Oral Concentrate (U.S.)
• Oral Solution (U.S. and Canada)

• Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For metoclopramide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to metoclopramide, procaine, or procainamide. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Not enough studies have been done in humans to determine metoclopramide"s safety during pregnancy. However, metoclopramide has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—Metoclopramide passes into the breast milk and may cause unwanted effects in nursing babies. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Muscle spasms, especially of jaw, neck, and back, and tic-like (jerky) movements of head and face may be especially likely to occur in children, who are usually more sensitive than adults to the effects of metoclopramide. Premature and full-term infants may develop blood problems if given high doses of metoclopramide.

Older adults—Shuffling walk and trembling and shaking of hands may be especially likely to occur in elderly patients after they have taken metoclopramide over a long time.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking metoclopramide, it is especially important that your health care professional know if you are taking the following:

• Central nervous system (CNS) depressants (medicine that causes drowsiness)—Use with metoclopramide may cause severe drowsiness

Other medical problems—The presence of other medical problems may affect the use of metoclopramide. Make sure you tell your doctor if you have any other medical problems, especially:

• Abdominal or stomach bleeding or
• Asthma or
• Cirrhosis (liver disease) or
• Congestive heart failure or
• High blood pressure or
• Intestinal blockage or
• Mental depression or
• Parkinson"s disease or
• Pheochromocytoma (catecholamine-producing tumor)—Metoclopramide may make these conditions worse

• Epilepsy—Metoclopramide may increase the risk of having a seizure

• Kidney disease (severe)—Higher blood levels of metoclopramide may result, possibly increasing the chance of side effects

• Nicotinamide adenine dinucleotide (NADH) methemoglobin reductase deficiency—Metoclopramide may increase your chance of side effects affecting the blood.

Proper Use of This Medicine

Take this medicine 30 minutes before meals and at bedtime , unless otherwise directed by your doctor.

Take metoclopramide only as directed . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

To take metoclopramide oral concentrate : This medicine should be mixed with another liquid, such as water, juices, soda or soda-like beverages, or with a semi-solid food, such as applesauce or pudding.

Dosing—The dose of metoclopramide will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of metoclopramide. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets or teaspoonfuls of solution that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking metoclopramide .

• For oral dosage forms (concentrate, solution, or tablets):
  • To treat the symptoms of a stomach problem called diabetic gastroparesis:
    • Adults and teenagers—10 milligrams (mg) thirty minutes before symptoms are likely to begin or before each meal and at bedtime. The dose may be taken up to four times a day. However, most people usually will not take more than 500 micrograms (mcg) per kilogram (kg) (227 mcg per pound) of body weight a day.
    • Children—Dose must be determined by your doctor.
  • For heartburn:
    • Adults and teenagers—10 to 15 mg thirty minutes before symptoms are likely to begin or before each meal and at bedtime. The dose may be taken up to four times a day. However, most people usually will not take more than 500 mcg per kg (227 mcg per pound) of body weight a day.
    • Children—Dose must be determined by your doctor.
  • To increase movements or contractions of the stomach and intestines:
    • Children 5 to 14 years of age—2.5 to 5 mg three times a day, thirty minutes before meals.
• For injection dosage form:
  • To increase movements or contractions of the stomach and intestine:
    • Adults and teenagers—10 mg injected into a vein.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 mg per kilogram (kg) (0.45 mg per pound) of body weight injected into a vein. Your doctor may repeat this dose after sixty minutes if needed.
  • To prevent nausea and vomiting caused by anticancer medicines:
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 2 mg per kg (0.45 to 0.9 mg per pound) of body weight, injected slowly into a vein, thirty minutes before you take your anticancer medicine. Your doctor may repeat this dose every two or three hours if needed. Some people may need a larger dose to start.
    • Children—1 mg per kg (0.45 mg per pound) of body weight injected into a vein. Your doctor may repeat this dose after sixty minutes if needed.
  • To prevent vomiting after surgery:
    • Adults and teenagers—10 to 20 mg injected into a muscle near the end of surgery.
    • Children—Dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the concentrate and solution forms of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

This medicine will add to the effects of alcohol and other CNS depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, metoclopramide is used in certain patients with the following medical conditions:

• Failure of the stomach to empty its contents
• Nausea and vomiting caused by other medicines
• Persistent hiccups
• Prevention of aspirating fluid into the lungs during surgery
• Vascular headaches

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 04/02/2004

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