Drug Profile

Pregnancy Warning

No valid data are available from animal studies. Use during pregnancy only for clear medical reasons. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.

Breast-Feeding Warning

Metoclopramide is excreted in human milk. Because metoclopromide causes mammary tumors in animal studies, you should consult with your doctor if you are planning to nurse.

FDA BLACK-BOX WARNING

WARNING: TARDIVE DYSKINESIA

• Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage.
• Metoclopramide should be discontinued in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after the drug is stopped.
• Avoid treatment with metoclopramide for longer than 12 weeks because of the increased risk of developing TD with longer-term use.

Other Important Warnings for Metoclopramide

(1) In addition to tardive dyskinesia, metoclopramide may cause other neurologic movement disorder symptoms, including the following:

• Extrapyramidal symptoms (EPS), such as acute dystonic reactions (involuntary muscle contractions in head, neck or back. Such reactions occurred more frequently in adults less than 30 years of age and at higher than recommended dosages
• Parkinson disease-like symptoms, including bradykinesia (slowness of movements), tremor, rigidity and expressionless face.
• Motor restlessness, consisting of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, and foot tapping.

(2) Metoclopramide can cause neuroleptic malignant syndrome (NMS), particularly if overdosed or taken concomitantly with other medications that cause NMS, such as antipsychotic drugs. NMS is a life-threatening neurological disorder requiring immediate medical attention. Signs and symptoms of NMS include high fever; excessive sweating; stupor (impaired consciousness and markedly decreased responsiveness); muscle rigidity or stiffness; unstable blood pressure, which may lead to dizziness and fainting upon standing; and irregular heart rate or pulse.

(3) Depression has occurred in metoclopramide-treated patients with and without a history of depression. Symptoms have included suicidal thoughts and suicide. Metoclopramide should be avoided in patients with a history of depression.

(4) Metoclopramide may increase blood pressure. The drug should be avoided in patients with hypertension or those taking monoamine oxidase inhibitors.

(5) Metoclopramide may cause fluid retention and swelling in patients with severe liver disease or heart failure.

(6) Metoclopramide increases levels of the hormone prolactin. This may lead to galactorrhea (a milky nipple discharge unrelated to the normal milk production of breast-feeding), amenorrhea (absence of menstruation), gynecomastia (breast enlargement in men), and erectile dysfunction.

(7) Metoclopramide may impair the mental or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. Concomitant use of central nervous system depressants or drugs associated with extrapyramidal symptoms may increase this effect (for example, alcohol, benzodiazepines and opioids).

Dietary Steps to Manage Nausea Induced by Cancer Drugs

Drugs used to treat cancer often cause severe nausea and vomiting, either immediately after the drug is taken or several hours later. You can treat this kind of nausea and vomiting by changing your diet or by taking an antinausea drug. You should always try dietary changes first.

• Eat small, frequent meals so that your stomach is never empty.
• When you get up from sleeping or resting, eat some dry crackers or toast before you start being active.
• Drink carbonated drinks or other clear liquids such as soups and gelatin.
• Eat tart foods such as lemons and pickles.
• Do not eat foods with strong smells.

Do not use if you have or have had:

• epilepsy or seizures
• stomach or intestinal bleeding, obstruction, or perforation
• pheochromocytoma

Tell your doctor if you have or have had:

• allergies to metoclopramide, procaine, or procainamide
• asthma
• high blood pressure
• kidney problems
• mental depression
• Parkinson’s disease
• pregnancy or are breast-feeding

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

• Do not drink alcohol or use other drugs that can cause drowsiness.
• Until you know how you react to this drug, do not drive or perform other activities requiring alertness.

• If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Do not take double doses.
• Do not share your medication with others.
• Take the drug at the same time(s) each day.
• Take 30 minutes before meals and at bedtime for maximum effectiveness.
• Oral solution: Mix with liquid or semisolid food such as water, juice, soda, applesauce, or pudding.
• Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Do not let the liquid form freeze. Keep out of reach of children.

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

acetaminophen, cabergoline, cyclosporine, digoxin, DOSTINEX, EFFEXOR, fosfomycin, LANOXICAPS, LANOXIN, levodopa, monoamine oxidase (MAO) inhibitors (e.g., phenelzine), MONUROL, NEORAL, pergolide, PERMAX, REQUIP, ropinirole, SANDIMMUNE, SINEMET, STALEVO, SUMYCIN, tetracycline, TYLENOL, venlafaxine.

Call your doctor immediately if you experience:

• signs of tardive dyskinesia: lip smacking, chewing movements, puffing of cheeks, rapid, darting tongue movements, uncontrolled movements of arms or legs
• signs of parkinsonism: difficulty speaking or swallowing, loss of balance, masklike face, muscle spasms, stiffness of arms or legs, trembling and shaking, unusual twisting movements of body, shuffling walk
• arms or legs stiff
• blood pressure increased
• chills
• dizziness or fainting
• eyes unable to move
• fever
• headache that is severe or continued
• heartbeat that is fast or irregular
• legs aching, uncomfortable, or sensation of crawling
• muscle spasms of face, neck, and back
• nervousness, restlessness, or irritability
• paniclike sensation
• speaking or swallowing difficulty
• throat sore
• tiredness or weakness
• trembling and shaking of hands and fingers
• twisting movements of body
• twitching movements

Call your doctor if these symptoms continue:

• breast milk flow increased
• breast tenderness and swelling
• constipation or diarrhea
• depression
• dizziness
• drowsiness
• headache
• irritability
• menstruation changes
• mouth dry
• nausea
• restlessness
• skin rash
• sleeping difficulty
• tiredness or weakness that is unusual

Signs of overdose:

• confusion
• drowsiness that is severe
• hands shaking, trembling
• muscle spasms
• seizures
• ticlike, jerky movements of head and face

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.