Metoclopramide ODT 5mg Tablets

Manufacturer LUPIN PHARMACEUTICALS Active Ingredient Metoclopramide Orally Disintegrating Tablets(met oh KLOE pra mide) Pronunciation met oh KLOE pra mide
WARNING: Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping this drug, but it may not go away. The risk is greater with diabetes and in older adults, especially older females. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.Avoid taking this drug for more than 12 weeks. Talk with the doctor. @ COMMON USES: It is used to treat heartburn.It is used to treat or prevent upset stomach and throwing up.It is used to treat gastroesophageal reflux disease (GERD; acid reflux).It is used to treat a slow moving GI (gastrointestinal) tract in some people.It may be given to you for other reasons. Talk with the doctor.Children:This drug is not approved for use in children. However, the doctor may decide the benefits of taking this drug outweigh the risks. If your child has been given this drug, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this drug to your child.
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Drug Class
Antiemetic; Gastrointestinal Prokinetic
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Pharmacologic Class
Dopamine D2 Receptor Antagonist; Serotonin 5-HT3 Receptor Antagonist; Serotonin 5-HT4 Receptor Agonist
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Pregnancy Category
Category B
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FDA Approved
Sep 2009
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Metoclopramide ODT is a medication that helps move food through your stomach faster and can also help stop nausea and vomiting. It works by affecting certain chemicals in your brain and stomach. The ODT (Orally Disintegrating Tablet) form dissolves quickly in your mouth without water.
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How to Use This Medicine

Taking Your Medication Correctly

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.
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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.

Dosing & Administration

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Adult Dosing

Standard Dose: 5 mg orally disintegrating tablet, 30 minutes before each meal and at bedtime (total 4 times daily)
Dose Range: 5 - 10 mg

Condition-Specific Dosing:

Diabetic Gastroparesis: 5-10 mg ODT, 30 minutes before each meal and at bedtime for 2-8 weeks. Max duration 12 weeks due to tardive dyskinesia risk.
Gastroesophageal Reflux Disease (GERD): Not recommended for routine GERD treatment due to tardive dyskinesia risk, but may be used for short-term (4-12 weeks) symptomatic relief in patients unresponsive to conventional therapy. 10-15 mg ODT, 30 minutes before each meal and at bedtime.
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Pediatric Dosing

Neonatal: Not established (increased risk of extrapyramidal symptoms)
Infant: Not established (increased risk of extrapyramidal symptoms)
Child: Not established for ODT form; oral solution/tablet dosing for specific indications (e.g., chemotherapy-induced nausea/vomiting) exists but generally avoided due to EPS risk.
Adolescent: Not established for ODT form; oral solution/tablet dosing for specific indications (e.g., chemotherapy-induced nausea/vomiting) exists but generally avoided due to EPS risk.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl 60-90 mL/min)
Moderate: Reduce dose by 50% (CrCl 30-59 mL/min)
Severe: Reduce dose by 75% (CrCl < 30 mL/min)
Dialysis: Reduce dose by 75%; administer after dialysis on dialysis days.

Hepatic Impairment:

Mild: No specific adjustment recommended
Moderate: Consider dose reduction by 50% in severe hepatic impairment (Child-Pugh C)
Severe: Reduce dose by 50% (Child-Pugh C)

Pharmacology

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Mechanism of Action

Metoclopramide is a dopamine D2 receptor antagonist, a serotonin 5-HT3 receptor antagonist, and a serotonin 5-HT4 receptor agonist. Its prokinetic effects are primarily mediated through dopamine D2 receptor antagonism, which increases acetylcholine release in the gut, enhancing gastrointestinal motility and accelerating gastric emptying. Its antiemetic effects are due to antagonism of D2 receptors in the chemoreceptor trigger zone (CTZ) in the brain and 5-HT3 receptor antagonism.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80% (oral)
Tmax: 1-2 hours
FoodEffect: Food delays the rate of absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: 2.5-3.5 L/kg
ProteinBinding: Approximately 13-30%
CnssPenetration: Yes

Elimination:

HalfLife: 5-6 hours (can be prolonged in renal impairment)
Clearance: Approximately 0.5-0.7 L/kg/hr
ExcretionRoute: Renal (approximately 85% within 72 hours)
Unchanged: Approximately 20-30% (renal)
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Pharmacodynamics

OnsetOfAction: Oral: 30-60 minutes
PeakEffect: Oral: 1-2 hours
DurationOfAction: 4-6 hours

Safety & Warnings

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BLACK BOX WARNING

Treatment with metoclopramide can cause tardive dyskinesia (TD), a serious and potentially irreversible movement disorder. The risk of developing TD increases with duration of treatment and total cumulative dose. Therefore, metoclopramide therapy should not exceed 12 weeks in duration. Avoid metoclopramide in patients with Parkinson's disease.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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.
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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
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

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.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until you understand how this drug affects you, avoid operating a vehicle or engaging in activities that require alertness.

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.
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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

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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)
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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
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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
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Minor Interactions

  • Acetaminophen - metoclopramide may increase the rate of acetaminophen absorption

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: To determine appropriate dosing, especially in patients with impaired kidney function.

Timing: Prior to initiation of therapy

Neurological assessment for pre-existing movement disorders

Rationale: To identify patients at higher risk for extrapyramidal symptoms (EPS) or tardive dyskinesia (TD).

Timing: Prior to initiation of therapy

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Routine Monitoring

Signs and symptoms of tardive dyskinesia (TD)

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.

Signs and symptoms of extrapyramidal symptoms (EPS)

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.

Mental status changes (e.g., depression, anxiety, agitation)

Frequency: Periodically

Target: Stable mood and cognitive function

Action Threshold: Evaluate for drug-induced changes; consider discontinuation if severe.

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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

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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:

First Trimester: Limited data, but no clear evidence of increased risk of major birth defects.
Second Trimester: Generally considered safe for use if indicated.
Third Trimester: Generally considered safe for use if indicated. No evidence of adverse effects on fetal development or labor.
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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.

Infant Risk: Low risk; monitor for drowsiness, irritability, or gastrointestinal upset.
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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.

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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

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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.
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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.
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Cost & Coverage

Average Cost: $20 - $50 per 30 tablets (5mg ODT)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.