Metoclopramide (Oral route)
- Metozolv ODT
- Tablet, Disintegrating
Warnings:Oral route(Tablet;Tablet, Disintegrating;Solution)
Metoclopramide treatment can cause tardive dyskinesia, a serious movement disorder that is often irreversible. Risk is increased 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, although symptoms may lessen or resolve after metoclopramide discontinuation. Prolonged treatment with metoclopramide (greater than 12 weeks) should be avoided in all but rare cases where therapeutic benefit outweighs the risks .
Uses of This Medicine:
Metoclopramide is used to treat the symptoms of a certain type of stomach problem called gastroparesis in patients with diabetes. It works by increasing the movements or contractions of the stomach and intestines. It relieves symptoms such as nausea, vomiting, heartburn, a feeling of fullness after meals, and loss of appetite. Metoclopramide is also used to treat heartburn for patients with gastroesophageal reflux disease (GERD). GERD is esophageal irritation from the backward flow of gastric acid into the esophagus.
This medicine is available only with your doctor's prescription.
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.
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of metoclopramide in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metoclopramide in the elderly. However, elderly patients are more likely to have side effects such as tardive dyskinesia, confusion, or drowsiness, and age-related kidney problems, which may require an adjustment in the dose for patients receiving metoclopramide.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abdominal or stomach bleeding or
- Intestinal blockage or perforation (hole in the intestine) or
- Pheochromocytoma (adrenal gland tumor) or
- Seizures or epilepsy—Should not be used in patients with these conditions.
- Asthma or
- Cirrhosis (liver disease) or
- Congestive heart failure or
- Diabetes or
- Heart rhythm problems (e.g., ventricular arrhythmia) or
- Hypertension (high blood pressure) or
- Mental depression, or history of or
- Neuroleptic malignant syndrome, history of or
- Parkinson's disease, history of—Use with caution. May make these conditions worse.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem) or
- Nicotinamide adenine dinucleotide (NADH) cytochrome reductase deficiency (an enzyme problem)—May increase the risk for side effects affecting the blood.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. 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.
This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Take this medicine on an empty stomach, at least 30 minutes before meals and at bedtime. If you forget and take it with food, do not repeat the dose.
If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet on your tongue. It should melt quickly. If the tablet breaks or crumbles before you take it, throw it away and get a new tablet from the blister pack.
The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine 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 using the medicine.
- For oral dosage forms (solution or tablets):
- For diabetic gastroparesis:
- Adults and teenagers—10 milligrams (mg) 30 minutes before symptoms are likely to begin or before each meal and at bedtime. The dose may be taken up to four times per day.
- Children—Use and dose must be determined by your doctor.
- For gastroesophageal reflux disease (GERD):
- Adults and teenagers—10 to 15 milligrams (mg) 30 minutes before symptoms are likely to begin or before each meal and at bedtime. The dose may be taken up to four times per day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For diabetic gastroparesis:
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using metoclopramide.
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 not alert.
This medicine may cause tardive dyskinesia (a movement disorder). Stop using this medicine and check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs. The risk of tardive dyskinesia is higher if you take this medicine longer than 12 weeks. Treatment for longer than 12 weeks should be avoided in all but rare cases.
Tell your doctor right away if you have the following symptoms while you are using this medicine: inability to move the eyes; increased blinking or spasms of the eyelid; trouble with breathing, speaking, or swallowing; uncontrolled tongue movements; uncontrolled twisting movements of the neck, trunk, arms, or legs; unusual facial expressions; or weakness of the arms and legs.
Stop taking this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures); difficulty with breathing; a fast heartbeat; a high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
You may have dizziness, headaches, or nervousness when you stop taking this medicine. These side effects should go away. Check with your doctor if any of the side effects continue or if you have any questions about them.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- Abdominal or stomach pain or tenderness
- clay colored stools
- convulsions (seizures)
- dark urine
- difficulty with breathing
- difficulty with speaking or swallowing
- dizziness or fainting
- fast or irregular heartbeat
- general feeling of tiredness or weakness
- headache (severe or continuing)
- inability to move the eyes
- increase in blood pressure
- increased sweating
- lip smacking or puckering
- loss of appetite
- loss of balance control
- loss of bladder control
- mask-like face
- muscle spasms of the face, neck, and back
- nausea and vomiting
- puffing of the cheeks
- rapid or worm-like movements of the tongue
- shuffling walk
- skin rash
- sore throat
- stiffness of the arms or legs
- swelling of the feet or lower legs
- tic-like or twitching movements
- trembling and shaking of the hands and fingers
- twisting movements of the body
- uncontrolled chewing movements
- uncontrolled movements of the arms and legs
- unusually pale skin
- weakness of the arms and legs
- yellow eyes or skin
- Symptoms of overdose
- drowsiness (severe)
- More common
- Less common or rare
- Breast tenderness and swelling
- changes in menstruation
- decreased interest in sexual intercourse
- inability to have or keep an erection
- increased flow of breast milk
- increased need to urinate
- loss in sexual ability, desire, drive, or performance
- mental depression
- passing urine more often
- skin rash
- trouble sleeping
- unusual dryness of the mouth
- unusual irritability
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 immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014