Metoclopramide ODT 5mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at least 30 minutes before eating and at bedtime, unless your doctor has given you different instructions.
Only remove the medication from the blister pack when you are ready to take it. Take the medication immediately after opening the blister pack, and do not store it for later use.
Handling Your Medication
When taking your medication:
Do not push the tablet out of the foil packaging. Instead, use dry hands to remove it from the foil.
Place the tablet on your tongue and let it dissolve. You do not need to drink water with it.
Do not swallow the tablet whole, and avoid chewing, breaking, or crushing it.
Storing and Disposing of Your Medication
To keep your medication effective and safe:
Store it at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.
Missing a Dose
If you miss a dose:
Take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and return to your regular 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.
- Do not take for longer than 12 weeks due to the risk of a serious movement disorder (tardive dyskinesia).
- Avoid alcohol and other medications that cause drowsiness, as metoclopramide can increase these effects.
- Be cautious when driving or operating machinery until you know how this medication affects you.
- Report any unusual or uncontrolled movements (especially of the face, tongue, or limbs) to your doctor immediately.
- Report any new or worsening depression or thoughts of self-harm.
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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Shakiness, trouble moving around, or stiffness
Restlessness
Trouble sleeping
Difficulty controlling body movements, twitching, changes in balance, trouble swallowing or speaking
Shortness of breath, significant weight gain, or swelling in the arms or legs
Abnormal heartbeat (fast, slow, or irregular)
Changes in urination frequency
Loss of bladder control
Changes in eyesight
Fever, chills, or sore throat
Enlarged breasts, nipple discharge, erectile dysfunction, or menstrual changes
Serious but Rare Side Effects
Two potentially life-threatening conditions can occur while taking this medication:
Neuroleptic Malignant Syndrome (NMS): Call your doctor immediately if you experience:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast or abnormal heartbeat
+ Excessive sweating
Serotonin Syndrome: If you take this medication with certain other drugs, you may be at risk for serotonin syndrome. Seek medical help right away if you experience:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, upset stomach, 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 ups and downs
Abnormal thinking
Anxiety
Lack of interest in life
contact your doctor immediately.
Other Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you experience any of the following, contact your doctor or seek medical attention if they bother you or do not go away:
Drowsiness
Diarrhea, upset stomach, or vomiting
Fatigue or weakness
* Headache
This is not an exhaustive list of potential 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, uncontrolled arm/leg movements)
- Muscle stiffness, rigidity, or spasms
- Restlessness or inability to sit still
- Tremors or shaking
- Difficulty speaking or swallowing
- Fever, sweating, confusion, severe muscle stiffness (signs of Neuroleptic Malignant Syndrome)
- Agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, loss of coordination, nausea, vomiting, diarrhea (signs of Serotonin Syndrome)
- Depression or suicidal thoughts
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, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of severe muscle problems, including tardive dyskinesia, or other muscle-related issues that occurred while taking this medication.
Past or present experiences with depression or suicidal thoughts.
Certain health conditions, including:
+ Gastrointestinal (GI) bleeding or a hole in the GI tract
+ Bowel blockage
+ Pheochromocytoma (a type of tumor)
+ Seizure disorders
+ Parkinson's disease
+ High blood pressure
Kidney or liver disease, as these conditions may affect the medication's metabolism and excretion.
If your doctor has informed you that you are a slow metabolizer of certain medications, as this may impact the dosage and efficacy of this treatment.
Concurrent use of medications that may increase the risk of involuntary movements. There are numerous medications that can cause this side effect, so it is crucial to consult your doctor or pharmacist if you are unsure.
Use of medications that are contraindicated with this treatment, such as certain antidepressants, pain relievers, or medications for Parkinson's disease. This is not an exhaustive list, and you should verify the safety of all your medications with your doctor.
To ensure your safety, it is vital to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. Your doctor and pharmacist need this information to assess potential interactions and determine the suitability of this medication for you. Never start, stop, or modify the dosage of any medication without consulting your doctor.
Precautions & Cautions
Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor. If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication.
To minimize potential risks, avoid consuming alcohol, marijuana, or other forms of cannabis, and refrain from taking prescription or over-the-counter drugs that may cause drowsiness or impaired reaction times.
If you suddenly stop taking this medication, you may experience withdrawal symptoms. Notify your doctor immediately if you encounter any adverse effects. Adhere strictly to the prescribed dosage, as taking more than recommended can increase your risk of severe side effects. Additionally, do not take this medication for a longer duration than prescribed by your doctor.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. It is also important to inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Disorientation
- Extrapyramidal reactions (e.g., muscle spasms, involuntary movements)
- Seizures
- Cardiovascular collapse
- Respiratory depression
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. Anticholinergic agents (e.g., diphenhydramine) or benzodiazepines may be used to control extrapyramidal symptoms.
Drug Interactions
Contraindicated Interactions
- Drugs that can cause extrapyramidal reactions (e.g., antipsychotics, phenothiazines) - increased risk of EPS
- Patients with pheochromocytoma (risk of hypertensive crisis)
- Patients with epilepsy (may increase seizure frequency)
- Patients with gastrointestinal hemorrhage, mechanical obstruction, or perforation (may exacerbate condition)
Major Interactions
- Anticholinergics (e.g., atropine, dicyclomine) - antagonize metoclopramide's prokinetic effect
- CNS depressants (e.g., opioids, benzodiazepines, alcohol, sedatives, hypnotics) - additive sedative effects
- Dopaminergic agonists (e.g., levodopa, bromocriptine) - metoclopramide may antagonize their effects
- Monoamine Oxidase Inhibitors (MAOIs) - theoretical risk of hypertensive crisis (though less direct interaction than with other sympathomimetics)
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants) - increased risk of serotonin syndrome
Moderate Interactions
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - may increase metoclopramide plasma concentrations
- Digoxin - metoclopramide may reduce digoxin absorption
- Cimetidine - metoclopramide may reduce cimetidine absorption
- Cyclosporine - metoclopramide may increase cyclosporine absorption and exposure
Minor Interactions
- Acetaminophen - metoclopramide may increase the rate of acetaminophen absorption
Monitoring
Baseline Monitoring
Rationale: To determine appropriate dosing, especially in patients with impaired kidney function.
Timing: Prior to initiation of therapy
Rationale: To identify patients at higher risk for extrapyramidal symptoms (EPS) or tardive dyskinesia (TD).
Timing: Prior to initiation of therapy
Routine Monitoring
Frequency: Regularly, especially with prolonged use (>12 weeks) or higher doses
Target: Absence of involuntary movements (e.g., grimacing, lip smacking, tongue protrusion, rapid eye blinking)
Action Threshold: Discontinue metoclopramide immediately if TD symptoms appear.
Frequency: Regularly, especially during initiation and dose adjustments
Target: Absence of acute dystonia, akathisia, parkinsonism
Action Threshold: Consider dose reduction or discontinuation; manage with anticholinergics (e.g., diphenhydramine, benztropine) for acute dystonia.
Frequency: Periodically
Target: Stable mood and cognitive function
Action Threshold: Evaluate for drug-induced changes; consider discontinuation if severe.
Symptom Monitoring
- Involuntary movements (face, tongue, limbs, trunk)
- Muscle stiffness or rigidity
- Restlessness or inability to sit still (akathisia)
- Tremor, bradykinesia, postural instability (parkinsonism)
- Difficulty swallowing or speaking
- Depression, suicidal thoughts
- Anxiety, agitation
- Drowsiness or dizziness
- Serotonin syndrome symptoms (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, loss of coordination, nausea, vomiting, diarrhea)
Special Patient Groups
Pregnancy
Metoclopramide is generally considered low risk during pregnancy (Category B). Use only if clearly needed and potential benefits outweigh risks. Limited data suggest no increased risk of major birth defects.
Trimester-Specific Risks:
Lactation
Metoclopramide is excreted into breast milk. While generally considered compatible with breastfeeding (L2), monitor the infant for potential adverse effects such as drowsiness, irritability, or gastrointestinal symptoms. It can increase prolactin levels, which may increase milk supply.
Pediatric Use
Use in pediatric patients is generally not recommended for chronic conditions like GERD or gastroparesis due to the increased risk of extrapyramidal symptoms (EPS), especially in infants and children. For acute indications (e.g., chemotherapy-induced nausea/vomiting), careful risk-benefit assessment is required, and lower doses may be used. The ODT formulation is not specifically approved for pediatric use.
Geriatric Use
Geriatric patients are at increased risk for developing tardive dyskinesia (TD) and other extrapyramidal symptoms (EPS) with metoclopramide. Use the lowest effective dose for the shortest possible duration. Renal function should be assessed, and dose adjustments made accordingly. Monitor closely for adverse neurological effects.
Clinical Information
Clinical Pearls
- Metoclopramide has a Black Box Warning for tardive dyskinesia; limit treatment duration to 12 weeks, especially for chronic conditions.
- Avoid in patients with Parkinson's disease due to dopamine antagonism.
- Be vigilant for extrapyramidal symptoms (dystonia, akathisia, parkinsonism) and tardive dyskinesia, especially in the elderly and children.
- Dose adjustments are crucial in renal impairment.
- Take 30 minutes before meals for optimal prokinetic effect.
- Can cause drowsiness; advise patients to avoid driving or operating heavy machinery until effects are known.
- Can increase prolactin levels, potentially causing galactorrhea or gynecomastia.
Alternative Therapies
- For nausea/vomiting: Ondansetron, Granisetron, Prochlorperazine, Promethazine, Dimenhydrinate.
- For gastroparesis: Erythromycin (macrolide antibiotic with prokinetic effects, but limited by tachyphylaxis and side effects), Domperidone (not FDA-approved in US, but available via expanded access program for refractory cases), dietary modifications, gastric electrical stimulation.
- For GERD (if unresponsive to PPIs/H2RAs): Baclofen (off-label for refractory GERD), surgical options.