Metoclopramide

Common Side Effects of Reglan

You should tell your doctor if any of the following side effects are severe or don't go away:

• Excessive fatigue
• Drowsiness
• Weakness
• Headache
• Dizziness
• Diarrhea
• Nausea or vomiting
• Breast enlargement or discharge
• Decreased sexual ability
• Frequent urination or inability to control urination
• Missed menstrual periods

Serious Side Effects of Reglan

You should call your doctor immediately if you experience any of the following serious side effects:

• Problems with speech
• Tightening of the muscles, especially in the jaw or neck
• Muscle stiffness
• Slow or stiff movements
• Uncontrollable shaking of a part of the body
• Depression or thoughts of harming/killing yourself
• Fever
• Confusion
• Agitation
• Slow, fast, or irregular heartbeat
• Sweating
• Restlessness, nervousness, pacing, foot tapping, or jitteriness
• Difficulty falling asleep or staying asleep
• Difficulty with balance
• Rash or hives
• Swelling of the face, eyes, lips, tongue, mouth, throat, arms, hands, feet, ankles, or lower legs
• Difficulty breathing or swallowing
• Sudden weight gain
• Vision trouble
• High-pitched sounds while breathing

Metoclopramide increases muscle contractions in the upper digestive tract. This speeds up the rate at which the stomach empties into the intestines.

Metoclopramide is used short-term to treat heartburn caused by gastroesophageal reflux in people who have used other medications without relief of symptoms.

Metoclopramide is also used to treat slow gastric emptying in people with diabetes (also called diabetic gastroparesis), which can cause nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness after meals.

Metoclopramide may also be used for purposes not listed in this medication guide.

You should not take this medication if you are allergic to metoclopramide, or if you have:

• bleeding or blockage in your stomach or intestines;
• a perforation (hole) in your stomach or intestines;
• epilepsy or other seizure disorder; or
• an adrenal gland tumor (pheochromocytoma).

To make sure you can safely take metoclopramide, tell your doctor if you have any of these other conditions:

• kidney disease;
• liver disease (especially cirrhosis);
• congestive heart failure, a heart rhythm disorder;
• high blood pressure;
• breast cancer;
• Parkinson's disease;
• diabetes (your insulin dose may need adjusting); or
• depression or mental illness.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Metoclopramide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The metoclopramide orally disintegrating tablet (ODT) may contain phenylalanine. Talk to your doctor before using this form of metoclopramide if you have phenylketonuria (PKU).

Metoclopramide should not be given to a child.

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 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 will harm your unborn baby.
• you are breastfeeding. Metoclopramide 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.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• your kidney function
• your weight

Metoclopramide dosing for GERD:

• The usual recommended metoclopramide dose for the treatment of GERD is 10 mg or 15 mg taken four times a day before meals and at bedtime.
• For some patients, instead of the continuous dosing regimen, single doses of up to 20 mg are preferred.

Metoclopramide is approved for short-term treatment of GERD (up to 12 weeks).

Metoclopramide dosing for Diabetic Gastroparesis:

• The usual recommended metoclopramide dose for the treatment of diabetic gastroparesis is 10 mg taken four times a day before meals and at bedtime.
• Treatment may continue for two to eight weeks.
• If severe diabetic gastroparesis symptoms are present, metoclopramide therapy may begin with an injectable form (IM or IV) of metoclopramide.

Metoclopramide dosing for prevention of nausea and vomiting associated with chemotherapy:

• The usual recommended metoclopramide dose range for the prevention of nausea and vomiting associated with chemotherapy is 1 mg/kg -2 mg/kg, and is to be given through the vein (IV). Metoclopramide should be given 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses.

Metoclopramide dosing for prevention of nausea and vomiting after surgery:

• The usual recommended metoclopramide dose range for the prevention of nausea and vomiting after surgery is 10-20 mg, and is to be given into the muscle (IM).

Metoclopramide dosing to facilitate small bowel intubation and to aid in radiological examinations:

• The usual recommended metoclopramide doses to facilitate small bowel intubation is the following is the following:
  • Pediatric patients above 14 years of age and adults:10 mg metoclopramide base
  • Pediatric patients (6-14 years of age): 2.5 to 5 mg metoclopramide base
  • Uunder 6 years of age: 0.1 mg/kg metoclopramide base

In the U.S.

• Metozolv ODT
• Reglan

Available Dosage Forms:

• Syrup
• Tablet, Disintegrating
• Tablet
• Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Dopamine Antagonist

(met oh KLOE pra mide)

Reduced plasma clearance, renal clearance, and nonrenal clearance, and increased elimination half-life.

Frequency not always defined.

Cardiovascular: Atrioventricular block, bradycardia, congestive heart failure, flushing (following high IV doses), hypertension, hypotension, supraventricular tachycardia

Central nervous system: Drowsiness (~10% to 70%; dose related), dystonic reaction (<1% to 25%; dose and age related), lassitude (~10%), restlessness (~10%), fatigue (2% to 10%), headache (4% to 5%), dizziness (1% to 4%), somnolence (2% to 3%), akathisia, confusion, depression, drug-induced Parkinson's disease, hallucination (rare), insomnia, neuroleptic malignant syndrome (rare), seizure, suicidal ideation, tardive dyskinesia

Dermatologic: Skin rash, urticaria

Endocrine & metabolic: Amenorrhea, fluid retention, galactorrhea, gynecomastia, hyperprolactinemia, porphyria

Gastrointestinal: Nausea (4% to 6%), vomiting (1% to 2%), diarrhea

Genitourinary: Impotence, urinary frequency, urinary incontinence

Hematologic & oncologic: Agranulocytosis, leukopenia, methemoglobinemia, neutropenia, sulfhemoglobinemia

Hepatic: Hepatotoxicity (rare)

Hypersensitivity: Angioedema (rare), hypersensitivity reaction

Neuromuscular & skeletal: Laryngospasm (rare)

Ophthalmic: Visual disturbance

Respiratory: Bronchospasm, laryngeal edema (rare)

Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose.

Discontinue metoclopramide therapy in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms lessen or resolve after metoclopramide treatment is stopped.

Avoid treatment with metoclopramide for longer than 12 weeks in all but rare cases in which therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.

Get emergency medical help if you have any of these signs of an allergic reaction to metoclopramide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking metoclopramide and call your doctor at once if you have any of these SIGNS OF A SERIOUS MOVEMENT DISORDER, which may occur within the first 2 days of treatment:

• tremors or shaking in your arms or legs;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or

• any new or unusual muscle movements you cannot control.

Stop taking metoclopramide and call your doctor at once if you have any of these other serious side effects:

• slow or jerky muscle movements, problems with balance or walking;

• mask-like appearance in your face;

• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

• depressed mood, thoughts of suicide or hurting yourself;

• hallucinations, anxiety, agitation, jittery feeling, trouble staying still;

• swelling, feeling short of breath, rapid weight gain;

• jaundice (yellowing of your skin or eyes); or

• seizure (convulsions).

Less serious metoclopramide side effects may include:

• feeling restless, drowsy, tired, or dizzy;

• headache, sleep problems (insomnia);

• nausea, vomiting, diarrhea;

• breast tenderness or swelling;

• changes in your menstrual periods; or

• urinating more than usual.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

No adjustment recommended.

CrCl 40 mL/min or greater:
-No adjustment recommended
CrCl less than 40 mL/min:
-Initial dose: 50% of the usual recommended dose
-Subsequent dose adjustments should be made according to patient response and tolerability.

• May be taken with or without food.
• Take exactly as idrected by your doctor. Do not increase or decrease the dosage without his or her advice.
• Metoclopramide should only be taken by adults and preferably for less than 12 weeks duration.
• Do not drink alcohol while you are taking metoclopramide because it may make some side effects worse.
• Metoclopramide may make you sleepy and affect your ability to drive or operate machinery. Do not do these tasks if metoclopramide affects you in this way.
• Contact your doctor urgently if you develop thoughts about self harm; develop a high fever, stiff muscles, problems thinking, rapid or erratic heartbeat, and increased sweating; have uncontrollable muscle movements or muscle movements that are new or unusual; have any other worrying side effects.
• When used to treat diabetic gastric stasis, adjustment may be needed to the dosage of insulin or the timing of the insulin dosage.
• Do not take any other medications including those bought over the counter before checking with a doctor or pharmacist that the new medication is compatible with metoclopramide.

This drug should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: A US FDA pregnancy category: B Comments: -Use during the first and third trimesters should be avoided when possible. -Monitoring for extrapyramidal syndrome is recommended for neonates exposed during the third trimester. -After delivery, mothers are at a relatively high risk for postpartum depression, and this drug can cause depression as a side effect. Therefore, therapy should probably be avoided in women with a history of major depression and not used for prolonged periods in any mother during this time of high susceptibility.

Human data (greater than 1000 outcomes) do not indicate fetotoxicity or malformative toxicity associated with therapy. Use at the end of pregnancy may result in extrapyramidal syndrome of the neonate. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.