INDICATIONS

Metoclopramide is used for short term treatment of gastroesophageal reflux disease (GERD) in certain patients who do not respond to other therapy. It is used to treat symptoms of a certain digestive problem in diabetic patients (diabetic gastroparesis). Metoclopramide is a gastrointestinal stimulant and antinauseant. It works by increasing the movement of the stomach and intestines to help move food and acid out of the stomach more quickly. It also works in certain areas in the brain to decrease nausea.

INSTRUCTIONS 

Use Metoclopramide as directed by your doctor.

• Take Metoclopramide by mouth 30 minutes before meals unless directed otherwise by your doctor.
• It may take several days to weeks for Metoclopramide to work. Do not stop taking Metoclopramide without checking with your doctor.
• If you miss a dose of Metoclopramide, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Metoclopramide.

STORAGE

Store Metoclopramide at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Metoclopramide out of the reach of children and away from pets.

SAFETY INFORMATION

Do NOT use Metoclopramide if:

• you are allergic to any ingredient in Metoclopramide
• you have seizures (eg, epilepsy); bleeding, blockage, or perforation in your stomach or intestines; or tumors on your adrenal gland (pheochromocytoma)
• you are taking cabergoline or pergolide
• you are taking medicines, such as phenothiazines (eg, chlorpromazine), that may cause extrapyramidal reactions (abnormal, involuntary muscle movements of the head, neck, or limbs). Check with your doctor if you are unsure if any of your medicines may cause extrapyramidal reactions.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Metoclopramide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of mental or mood problems (eg, depression) or suicidal thoughts or actions
• if you have a history of asthma, heart failure, high blood pressure, diabetes, Parkinson disease, blood problems (eg, porphyria), kidney problems, liver problems (eg, cirrhosis), breast cancer, or low levels of an enzyme called methemoglobin reductase
• if you are taking another form of Nilatika (eg, syrup, orally disintegrating tablet).

Some medicines may interact with Metoclopramide. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Monoamine oxidase inhibitors (MAOIs) (eg, phenelzine) because the risk of serious side effects (eg, high blood pressure, seizures) may be increased
• Anticholinergic medicine (eg, hyoscyamine) or narcotic pain medicines (eg, codeine) because they may decrease Metoclopramide's effectiveness
• Acetaminophen, benzodiazepines (eg, diazepam), cyclosporine, insulin, levodopa, phenothiazines (eg, chlorpromazine), sedatives (eg, zolpidem), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), succinylcholine, or tetracycline because the risk of their side effects may be increased by Metoclopramide
• Cabergoline, digoxin, or pergolide because their effectiveness may be decreased by Metoclopramide.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Metoclopramide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Metoclopramide may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Metoclopramide with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Metoclopramide without first checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use Metoclopramide for longer than 12 weeks without checking with your doctor.
• Diabetes patients - Metoclopramide may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Tell your doctor or dentist that you take Metoclopramide before you receive any medical or dental care, emergency care, or surgery.
• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Metoclopramide. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Some patients who take Metoclopramide may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Metoclopramide in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Metoclopramide.
• Patients who take Metoclopramide may be at increased risk for new or worsening mental or mood changes (eg, depression) or suicidal thoughts or actions. Watch patients who take Metoclopramide closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
• Metoclopramide may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
• Lab tests, including liver and kidney function tests, may be performed while you use Metoclopramide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Metoclopramide with caution in the elderly; they may be more sensitive to its effects, especially drowsiness, confusion, and uncontrolled muscle movements, including tardive dyskinesia.
• Metoclopramide should be used with extreme caution in children; safety and effectiveness in children have not been confirmed. The risk of developing uncontrolled muscle movements may be greater in children.
• Pregnancy and breast feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Metoclopramide while you are pregnant. Metoclopramide is found in breast milk. If you are or will be breast-feeding while you use Metoclopramide, check with your doctor. Discuss any possible risks to your baby.

A small number of patients have experienced withdrawal symptoms when stopping Metoclopramide. These symptoms may include dizziness, nervousness, and headache.

SIDE EFFECTS

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Decreased energy; diarrhea; dizziness; drowsiness; headache; nausea; restlessness; tiredness; trouble sleeping.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thinking; confusion; dark urine; decreased balance or coordination; decreased sexual ability; fast, slow, or irregular heartbeat; fever; hallucinations; loss of bladder control; mental or mood changes (eg, depression, anxiety, agitation, jitteriness); seizures; severe or persistent dizziness, headache, or trouble sleeping; severe or persistent restlessness, including inability to sit still; shortness of breath; stiff or rigid muscles; sudden increased sweating; sudden, unusual weight gain; suicidal thoughts or actions; swelling of the arms, legs, or feet; uncontrolled muscle spasms or movements (eg, of the arms, legs, tongue, jaw, cheeks; twitching; tremors); vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.