Metoclopramide 10mg Tablets

Manufacturer TEVA PHARMACEUTICALS USA Active Ingredient Metoclopramide 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, Prokinetic
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Pharmacologic Class
Dopamine D2 Receptor Antagonist, Serotonin 5-HT4 Receptor Agonist, Serotonin 5-HT3 Receptor Antagonist
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Pregnancy Category
B
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FDA Approved
Dec 1980
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Metoclopramide is a medication used to treat nausea, vomiting, and certain stomach problems like slow emptying of the stomach (gastroparesis). It works by speeding up the movement of food through your stomach and intestines, and by blocking signals in your brain that cause nausea and vomiting.
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How to Use This Medicine

Taking Your Medication

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.
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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.

Dosing & Administration

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Adult Dosing

Standard Dose: For symptomatic gastroesophageal reflux (GERD): 10 mg orally 30 minutes before each meal and at bedtime, for 4 to 12 weeks. For diabetic gastroparesis: 10 mg orally 30 minutes before each meal and at bedtime, for 2 to 8 weeks initially.
Dose Range: 5 - 10 mg

Condition-Specific Dosing:

symptomatic_gerd: 10 mg orally 30 minutes before each meal and at bedtime, for 4 to 12 weeks.
diabetic_gastroparesis: 10 mg orally 30 minutes before each meal and at bedtime, for 2 to 8 weeks initially. Max duration generally 12 weeks due to tardive dyskinesia risk.
chemotherapy_induced_nausea_vomiting_prophylaxis: 1-2 mg/kg IV 30 minutes before chemotherapy, then every 2-4 hours for 2-5 doses (often higher doses and IV for this indication, oral is less common for acute prophylaxis).
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Pediatric Dosing

Neonatal: Not established for routine use; caution due to increased risk of EPS. Limited use for severe reflux or feeding intolerance, typically 0.1 mg/kg/dose.
Infant: Not established for routine use; caution due to increased risk of EPS. Limited use for severe reflux or feeding intolerance, typically 0.1 mg/kg/dose up to 4 times daily.
Child: Not established for routine use; caution due to increased risk of EPS. For gastroparesis or severe GERD: 0.1-0.2 mg/kg/dose orally 3-4 times daily, max 0.5 mg/kg/day. Max single dose 10 mg. Duration limited.
Adolescent: Similar to adult dosing for specific indications, but with caution regarding EPS risk. Max 10 mg/dose, 40 mg/day.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: No specific adjustment, but monitor for adverse effects.
Severe: Consider 50% dose reduction; monitor closely for adverse effects due to potential for increased systemic exposure.

Pharmacology

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Mechanism of Action

Metoclopramide is a dopamine D2 receptor antagonist, which is responsible for its antiemetic effects (by blocking dopamine receptors in the chemoreceptor trigger zone, CTZ) and prokinetic effects (by increasing acetylcholine release in the gut, leading to enhanced gastric emptying and small bowel transit). It also has weak serotonin 5-HT4 receptor agonistic activity, contributing to its prokinetic effects, and serotonin 5-HT3 receptor antagonistic activity, which further contributes to its antiemetic properties.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80% (oral), but can vary (30-100%) due to first-pass metabolism.
Tmax: 0.5-2 hours (oral).
FoodEffect: Food delays absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: 2.1-3.5 L/kg.
ProteinBinding: Approximately 13-30%.
CnssPenetration: Yes, readily crosses the blood-brain barrier, leading to CNS side effects.

Elimination:

HalfLife: 4-6 hours (can be prolonged in renal impairment, up to 10-15 hours).
Clearance: Approximately 0.9 L/kg/hr.
ExcretionRoute: Renal (approximately 85% within 72 hours).
Unchanged: Approximately 20-30% (oral dose) to 80% (IV dose) excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (oral), 10-15 minutes (IM), 1-3 minutes (IV).
PeakEffect: 1-2 hours (oral).
DurationOfAction: 1-2 hours (antiemetic), 4-6 hours (prokinetic).

Safety & Warnings

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BLACK BOX WARNING

Treatment with metoclopramide can cause tardive dyskinesia, a serious and potentially irreversible movement disorder. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Therefore, treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where the therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
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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 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.
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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).
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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. 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.
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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, to monitor your condition. If you have diabetes, it is crucial to closely monitor your blood sugar levels.

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.
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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

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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).
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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.
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Minor Interactions

  • Acetaminophen: Metoclopramide may increase the rate of acetaminophen absorption.
  • Tetracyclines: Metoclopramide may increase the rate of tetracycline absorption.

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: To determine appropriate starting dose and guide dose adjustments.

Timing: Prior to initiation of therapy.

Patient history for risk factors of tardive dyskinesia (e.g., age, duration of therapy, cumulative dose, underlying neurological disorders)

Rationale: To assess baseline risk and inform treatment duration.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in nausea, vomiting, improved gastric emptying symptoms)

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.

Adverse effects, especially neurological (e.g., restlessness, agitation, dystonia, parkinsonism, akathisia)

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.

Signs of tardive dyskinesia (e.g., involuntary movements of face, tongue, extremities)

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.

Renal function (CrCl)

Frequency: Periodically, especially in elderly or those with changing renal status.

Target: Stable renal function.

Action Threshold: Decline in renal function warrants dose adjustment.

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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

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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:

First Trimester: Generally considered low risk; widely used for hyperemesis gravidarum.
Second Trimester: Low risk.
Third Trimester: Low risk; no evidence of increased risk of adverse fetal effects or neonatal complications.
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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.

Infant Risk: Low risk (L2). Monitor for drowsiness, irritability, or GI upset in the infant.
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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.

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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

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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.
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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.
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (generic 10mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (most insurance plans)
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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 use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource for patients. Please read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, we encourage you to discuss them with 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 incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.