Metoclopramide 10mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication at least 30 minutes before eating and at bedtime, unless your doctor has given you different instructions.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Store it in a dry place, avoiding the bathroom. Ensure that all medications are kept in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take this medication 30 minutes before meals and at bedtime, as directed by your doctor.
- Do not take more than the prescribed dose or for longer than recommended, usually no more than 12 weeks, due to the risk of serious side effects.
- Avoid alcohol and other medications that can cause drowsiness (e.g., sedatives, tranquilizers, cold medicines) as metoclopramide can increase these effects.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Report any unusual muscle movements, especially of the face, tongue, or limbs, to your doctor immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Fainting or changes in vision
Shakiness, difficulty moving, or stiffness
Restlessness or trouble sleeping
Difficulty controlling body movements, twitching, balance problems, or trouble swallowing or speaking
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Abnormal heartbeat (fast, slow, or irregular)
Changes in urination frequency
Loss of bladder control
Vision changes
Fever, chills, or sore throat
Breast changes (enlargement, nipple discharge), erectile dysfunction, or menstrual changes
Life-Threatening Conditions
Two rare but potentially deadly health problems may occur:
1. Neuroleptic Malignant Syndrome (NMS): Call your doctor immediately if you experience:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion or changes in thinking
+ Rapid or irregular heartbeat
+ Excessive sweating
2. Serotonin Syndrome: If you take this medication with certain other drugs, call your doctor right away if you experience:
+ Agitation
+ Balance problems
+ Confusion
+ Hallucinations
+ Fever
+ Rapid or irregular heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, nausea, or vomiting
+ Severe headache
Mental Health Concerns
Depression and suicidal thoughts have been reported in people taking this medication. If you experience:
Signs of depression
Suicidal thoughts
Emotional instability
Abnormal thinking
Anxiety
Loss of interest in life
contact your doctor immediately.
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following, contact your doctor or seek medical attention if they bother you or do not go away:
Drowsiness
Diarrhea, nausea, or vomiting
Fatigue or weakness
Headache
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Involuntary movements (e.g., lip smacking, grimacing, tongue protrusion, rapid eye blinking, finger movements) - signs of tardive dyskinesia.
- Restlessness, agitation, anxiety, feeling of inner turmoil - signs of akathisia.
- Muscle stiffness, tremor, slow movements, mask-like face - signs of parkinsonism.
- Sudden, severe muscle spasms, especially of the neck, face, or back - signs of dystonia.
- High fever, severe muscle stiffness, confusion, sweating, fast or irregular heartbeat - signs of neuroleptic malignant syndrome (NMS).
- Depression, suicidal thoughts.
- Swelling of hands, ankles, or feet.
- Breast enlargement or milk production (in men or women not breastfeeding).
Before Using This Medicine
It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of severe muscle problems, such as tardive dyskinesia, or other muscle-related issues that occurred while taking this medication.
Depression or thoughts of suicide, as these conditions may be affected by this medication.
Certain health problems, including:
+ Gastrointestinal (GI) bleeding or a hole in the GI tract
+ Bowel blockage
+ Pheochromocytoma (a rare tumor of the adrenal gland)
+ Seizure disorders
+ Parkinson's disease
+ High blood pressure
Kidney or liver disease, as these conditions may affect how your body processes the medication.
If your doctor has informed you that you are a slow metabolizer of certain medications, as this may impact the dosage or administration of this medication.
If you are taking any medications that may increase the risk of involuntary movements, as there are many drugs that can cause this interaction. Consult your doctor or pharmacist if you are unsure.
If you are taking any medications, including prescription, over-the-counter, natural products, or vitamins, that should not be taken with this medication, such as certain antidepressants, pain medications, or medications for Parkinson's disease. Note that this is not an exhaustive list of interacting medications.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Do not start, stop, or change the dosage of any medication without consulting your doctor first.
Precautions & Cautions
To minimize potential risks, avoid consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may cause drowsiness or impair your reactions. If you suddenly stop taking this medication, you may experience withdrawal symptoms; therefore, it is vital to consult your doctor if you encounter any adverse effects.
Adhere strictly to the dosage instructions provided by your doctor, as taking more than the prescribed amount may increase your risk of severe side effects. Additionally, do not take this medication for a longer duration than recommended by your doctor. If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the potential benefits and risks of this medication with your doctor to ensure the well-being of both you and your baby.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Disorientation
- Extrapyramidal symptoms (e.g., muscle spasms, involuntary movements)
- Agitation
- Confusion
- Seizures
- Cardiovascular effects (e.g., bradycardia, hypertension or hypotension)
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. Anticholinergic agents (e.g., diphenhydramine) or benzodiazepines may be used to manage extrapyramidal symptoms.
Drug Interactions
Major Interactions
- Anticholinergics (e.g., atropine, dicyclomine): Antagonize metoclopramide's prokinetic effect.
- Opioid analgesics (e.g., morphine, oxycodone): Antagonize metoclopramide's prokinetic effect.
- Neuroleptics/Antipsychotics (e.g., haloperidol, risperidone): Increased risk of extrapyramidal symptoms (EPS) and tardive dyskinesia (TD).
- Dopaminergic agents (e.g., levodopa, bromocriptine): Metoclopramide may antagonize their effects.
- SSRIs/SNRIs (e.g., fluoxetine, venlafaxine): Increased risk of serotonin syndrome (rare, but possible with high doses or other serotonergic agents).
Moderate Interactions
- CNS depressants (e.g., alcohol, benzodiazepines, sedatives, hypnotics): Additive sedative effects.
- MAOIs (e.g., phenelzine, selegiline): Potential for hypertensive crisis (theoretical, due to dopamine release, but generally low risk with metoclopramide).
- Digoxin: Metoclopramide may decrease digoxin absorption.
- Cyclosporine: Metoclopramide may increase cyclosporine absorption and levels.
- Paroxetine, Fluoxetine, Quinidine (CYP2D6 inhibitors): May increase metoclopramide levels, increasing risk of adverse effects.
Minor Interactions
- Acetaminophen: Metoclopramide may increase the rate of acetaminophen absorption.
- Tetracyclines: Metoclopramide may increase the rate of tetracycline absorption.
Monitoring
Baseline Monitoring
Rationale: To determine appropriate starting dose and guide dose adjustments.
Timing: Prior to initiation of therapy.
Rationale: To assess baseline risk and inform treatment duration.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Daily/as needed during acute treatment; periodically during chronic use.
Target: Symptom resolution or significant improvement.
Action Threshold: Lack of efficacy may warrant dose adjustment or alternative therapy.
Frequency: Daily, especially during initial treatment and dose changes; periodically during chronic use.
Target: Absence of symptoms.
Action Threshold: Appearance of symptoms requires immediate evaluation, dose reduction, or discontinuation.
Frequency: Periodically, especially with prolonged use (>12 weeks) or in high-risk patients.
Target: Absence of symptoms.
Action Threshold: Appearance of symptoms requires immediate discontinuation of metoclopramide.
Frequency: Periodically, especially in elderly or those with changing renal status.
Target: Stable renal function.
Action Threshold: Decline in renal function warrants dose adjustment.
Symptom Monitoring
- Nausea
- Vomiting
- Abdominal bloating/discomfort
- Early satiety
- Restlessness
- Agitation
- Anxiety
- Drowsiness
- Fatigue
- Dizziness
- Headache
- Muscle spasms (especially face, neck, tongue)
- Involuntary movements (lip smacking, grimacing, tongue protrusion, rapid eye blinking, finger movements)
- Tremor
- Rigidity
- Difficulty speaking or swallowing
- Fever
- Muscle stiffness
- Confusion
- Sweating
- Irregular heartbeat
Special Patient Groups
Pregnancy
Metoclopramide is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. It is generally considered safe for use during pregnancy when clinically indicated, particularly for severe nausea and vomiting of pregnancy (hyperemesis gravidarum), but should be used only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
Lactation
Metoclopramide is excreted into breast milk. The American Academy of Pediatrics considers it 'compatible with breastfeeding'. However, monitor breastfed infants for potential side effects such as drowsiness, irritability, or gastrointestinal upset (e.g., diarrhea or constipation). It is sometimes used off-label to increase milk supply, but its efficacy for this purpose is debated, and potential risks to the infant should be considered.
Pediatric Use
Use in pediatric patients is generally discouraged for chronic conditions due to the increased risk of extrapyramidal symptoms (EPS), including tardive dyskinesia, especially in infants and children. When used, it should be for short durations and at the lowest effective dose. Renal dose adjustments are crucial in neonates and infants due to immature renal function.
Geriatric Use
Elderly patients are at increased risk for developing extrapyramidal symptoms, including tardive dyskinesia, and other CNS side effects (e.g., sedation, confusion) due to decreased renal clearance and increased sensitivity. Dose reduction is often necessary, especially in those with impaired renal function. Use the lowest effective dose for the shortest possible duration. Avoid prolonged use.
Clinical Information
Clinical Pearls
- Metoclopramide's use for chronic conditions like GERD should be limited to 4-12 weeks due to the black box warning for tardive dyskinesia.
- The risk of tardive dyskinesia increases with duration of treatment and cumulative dose. Counsel patients thoroughly on this risk.
- Extrapyramidal symptoms (EPS) are more common in children and young adults, and can occur with the first dose. Acute dystonic reactions can be treated with anticholinergics (e.g., diphenhydramine, benztropine).
- Renal dose adjustment is critical to prevent accumulation and reduce the risk of adverse effects.
- Avoid concomitant use with other drugs that can cause EPS (e.g., antipsychotics) or have anticholinergic effects (which can counteract metoclopramide's prokinetic action).
- Patients should be advised to report any involuntary movements immediately.
Alternative Therapies
- Other antiemetics (e.g., ondansetron, granisetron, prochlorperazine, promethazine)
- Other prokinetics (e.g., erythromycin - off-label, domperidone - not FDA approved in US)
- Proton pump inhibitors (PPIs) or H2-receptor antagonists for GERD symptoms (address acid suppression, not motility)
- Lifestyle and dietary modifications for GERD and gastroparesis.