Metoclopramide 5mg Tablets

Metoclopramide is a dopamine D2 receptor antagonist, primarily acting in the chemoreceptor trigger zone (CTZ) to block dopamine-mediated nausea and vomiting. It also has serotonin 5-HT3 receptor antagonist properties in the CTZ and gastrointestinal tract, contributing to its antiemetic effect. Additionally, it is a serotonin 5-HT4 receptor agonist, which enhances acetylcholine release in the enteric nervous system, leading to increased gastrointestinal motility (prokinetic effect) by increasing lower esophageal sphincter tone, gastric contractions, and accelerating gastric emptying and small bowel transit.

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 immediately or seek emergency medical attention:

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 right away 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 immediately 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, stomach upset, or vomiting
+ Severe headache

Mental Health Concerns

Depression and suicidal thoughts have been reported in people taking this medication. If you experience any of the following, contact your doctor right away:

Signs of depression
Suicidal thoughts
Emotional ups and downs
Abnormal thinking
Anxiety
Lack of interest in life

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following, contact your doctor or seek medical help if they bother you or do not go away:

Drowsiness
Diarrhea, stomach upset, 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.

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

It is essential to inform your doctor about the following conditions and circumstances 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.
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 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 increase the risk of side effects.
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 medication.
Use of medications that may increase the risk of involuntary movements, as there are many drugs that can cause this side effect. Consult your doctor or pharmacist if you are unsure.
Concurrent use of medications that should not be taken with this medication, such as certain antidepressants, pain relievers, or medications for Parkinson's disease. Note that this is not an exhaustive list, and you should discuss all your medications with your doctor.

To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Verify that it is safe to take this medication with your existing medications and health conditions.
* Avoid starting, stopping, or changing the dosage of any medication without consulting your doctor.

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 your full attention.

As directed by your doctor, regular blood tests will be necessary to monitor your condition. 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, 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. Notify your doctor immediately if you encounter any adverse effects. Adhere strictly to the prescribed dosage, as taking more than recommended may 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.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.

• Patients with pheochromocytoma (risk of hypertensive crisis)
• Patients with epilepsy (may increase seizure frequency)
• Patients with gastrointestinal hemorrhage, mechanical obstruction, or perforation (risk of exacerbating condition)
• Patients with a history of tardive dyskinesia or neuroleptic malignant syndrome (NMS) with metoclopramide or other neuroleptics

• Anticholinergics (e.g., atropine, dicyclomine): Antagonize metoclopramide's prokinetic effect.
• Opioid analgesics (e.g., morphine, oxycodone): Antagonize metoclopramide's prokinetic effect.
• CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics): Additive sedative effects.
• Dopamine agonists (e.g., bromocriptine, cabergoline, levodopa): Metoclopramide is a dopamine antagonist and may antagonize their effects.
• Neuroleptics/Antipsychotics (e.g., haloperidol, chlorpromazine): Increased risk of extrapyramidal symptoms (EPS) and tardive dyskinesia (TD).
• SSRIs/SNRIs (e.g., fluoxetine, venlafaxine): Increased risk of serotonin syndrome (rare, but possible with high doses or other serotonergic agents).
• QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics): Potential for additive QT prolongation, increasing risk of Torsades de Pointes.

• Digoxin: Metoclopramide may reduce the absorption of digoxin.
• Cimetidine: May increase metoclopramide levels due to inhibition of renal tubular secretion.
• Paracetamol (Acetaminophen): Metoclopramide may increase the rate and extent of paracetamol absorption.
• Cyclosporine: Metoclopramide may increase cyclosporine absorption, potentially leading to increased cyclosporine levels and toxicity.

• Not available

• Nausea and vomiting frequency and severity
• Abdominal pain or discomfort
• Bloating
• Early satiety
• Headache
• Drowsiness or sedation
• Dizziness
• Restlessness or agitation (akathisia)
• Involuntary muscle contractions or spasms (dystonia)
• Tremors, rigidity, bradykinesia (parkinsonism)
• Involuntary repetitive movements of the face, tongue, or limbs (tardive dyskinesia)
• Fever, muscle rigidity, altered mental status, autonomic instability (Neuroleptic Malignant Syndrome)

Metoclopramide is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and human data from observational studies suggest no increased risk of major birth defects. It is generally considered safe for use during pregnancy when clinically indicated, particularly for severe nausea and vomiting of pregnancy.

Metoclopramide is excreted into breast milk. The American Academy of Pediatrics considers it 'compatible with breastfeeding'. Monitor breastfed infants for potential adverse effects such as drowsiness, irritability, or gastrointestinal upset. It can increase prolactin levels, potentially increasing milk supply.

Use with caution due to increased risk of extrapyramidal symptoms (EPS), especially in infants and children. Dosing should be carefully calculated based on weight, and the lowest effective dose should be used for the shortest duration. Not recommended for routine use in children under 1 year of age.

Increased risk of adverse effects, particularly extrapyramidal symptoms (EPS) and tardive dyskinesia (TD), due to age-related decline in renal function and increased sensitivity to dopamine blockade. Start with lower doses and monitor closely for adverse effects. Renal dose adjustment is often necessary.

• Metoclopramide's use should be limited to 12 weeks due to the risk of irreversible tardive dyskinesia (Black Box Warning).
• Renal dose adjustment is crucial; failure to adjust can lead to accumulation and increased risk of adverse effects, especially EPS.
• Avoid concomitant use with other drugs that can cause EPS (e.g., antipsychotics) or prolong the QT interval.
• Patients should be educated on the signs of EPS and TD and instructed to report them immediately.
• While effective for gastroparesis and GERD, its long-term use is restricted. Consider alternative therapies for chronic conditions.
• Can be used off-label for lactation induction due to its prolactin-increasing effect, but this is not an FDA-approved indication and should be done under medical supervision.

• For Nausea/Vomiting: Ondansetron, Granisetron, Prochlorperazine, Promethazine, Dimenhydrinate.
• For Gastroparesis: Erythromycin (macrolide antibiotic with prokinetic properties), Domperidone (not FDA-approved in US, but available elsewhere, similar mechanism to metoclopramide but less CNS penetration).
• For GERD: Proton Pump Inhibitors (PPIs), H2-receptor antagonists, antacids.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. 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, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.

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 name of the medication taken, the amount consumed, and the time it occurred.