Metoclopramide 5mg/ml Inj, 2ml

Metoclopramide is a dopamine D2 receptor antagonist. Its antiemetic effects are primarily due to antagonism of D2 receptors in the chemoreceptor trigger zone (CTZ) in the central nervous system, which prevents nausea and vomiting. Its prokinetic effects are due to antagonism of D2 receptors in the gastrointestinal tract, which increases acetylcholine release from postganglionic cholinergic neurons, leading to enhanced gastrointestinal motility, increased lower esophageal sphincter tone, and accelerated gastric emptying.

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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

Life-Threatening Conditions

Two rare but potentially deadly health problems may 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
+ 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
+ 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 any of the following, contact your doctor immediately:

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 serious 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, upset stomach, or vomiting
Fatigue or weakness
* Headache

Reporting Side Effects

If you have questions about side effects or want to report any, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects 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. Be sure to 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.
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 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 how you respond to this treatment.
Use of medications that may increase the risk of involuntary movements. There are many medications that can cause this side effect, so it is crucial to consult with your doctor or pharmacist if you are unsure.
Concurrent use of medications that should not be taken with this drug, such as certain antidepressants, pain relievers, or Parkinson's disease treatments. Please note that this is not an exhaustive list, and you should discuss all your medications with your doctor.

To ensure your safety, it is vital 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. This will help you avoid potential interactions and confirm that it is safe to take this medication with your existing treatments. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you.

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, and refrain from taking prescription or over-the-counter medications that may cause drowsiness or impair your reactions.

If you suddenly stop taking this medication, you may experience withdrawal symptoms. Report any adverse effects to your doctor promptly.

Adhere strictly to the dosage prescribed by your doctor. Taking more than the recommended dose 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 drug, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or are 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 due to metoclopramide or other neuroleptics

• Anticholinergics (e.g., atropine, dicyclomine) - antagonize metoclopramide's GI effects
• Opioid analgesics (e.g., morphine, fentanyl) - antagonize metoclopramide's GI effects
• CNS depressants (e.g., alcohol, benzodiazepines, sedatives, hypnotics) - additive sedative effects
• Neuroleptics (e.g., haloperidol, phenothiazines) - increased risk of extrapyramidal symptoms (EPS) and tardive dyskinesia
• Dopamine agonists (e.g., bromocriptine, cabergoline) - metoclopramide may antagonize their effects
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - may increase metoclopramide levels and risk of adverse effects

• Digoxin - metoclopramide may decrease digoxin absorption
• Cimetidine - metoclopramide may decrease cimetidine absorption
• Levodopa - metoclopramide may decrease levodopa absorption and efficacy
• Monoamine Oxidase Inhibitors (MAOIs) - theoretical risk of hypertensive crisis (though less direct interaction than with other prokinetics)

• Acetaminophen - metoclopramide may accelerate absorption of acetaminophen

• Nausea and vomiting (for efficacy)
• Abdominal pain/discomfort (for efficacy in gastroparesis)
• Drowsiness/sedation
• Restlessness/akathisia
• Muscle spasms/stiffness (dystonia)
• Tremors, rigidity, bradykinesia (parkinsonism)
• Involuntary movements of face, tongue, or limbs (tardive dyskinesia)
• Diarrhea or constipation
• Headache
• Dizziness
• Depression or suicidal ideation

Generally considered safe for use during pregnancy (Category B). Studies in animals have not shown harm, and human data suggest no increased risk of major birth defects. However, use should be limited to clear indications and the lowest effective dose.

Metoclopramide is excreted into breast milk in clinically significant amounts. While generally considered compatible with breastfeeding by some experts, it can cause drowsiness, irritability, and potentially EPS in the infant. It can also increase prolactin levels in the mother, which may affect milk supply. Use with caution, monitor infant for adverse effects.

Use with extreme caution due to increased risk of extrapyramidal symptoms (EPS), including acute dystonic reactions, especially in neonates and young children. The risk of tardive dyskinesia is also present. Dosing should be carefully calculated based on weight, and duration of therapy should be as short as possible. Not recommended for routine use in children under 1 year of age.

Increased risk of tardive dyskinesia, especially with prolonged use. Also, increased risk of other CNS effects (e.g., sedation, confusion) and renal impairment. Dose reduction is often necessary due to age-related decline in renal function. Use the lowest effective dose for the shortest possible duration.

• Metoclopramide IV should be administered slowly over at least 1-2 minutes to avoid transient but intense anxiety and restlessness, followed by drowsiness.
• For high-dose CINV, IV administration should be diluted and infused over at least 15 minutes.
• The black box warning for tardive dyskinesia emphasizes avoiding use for longer than 12 weeks, except in rare cases where benefits outweigh risks.
• Acute dystonic reactions can occur, especially in children and young adults, and can be treated with anticholinergic agents (e.g., diphenhydramine, benztropine).
• Patients should be educated on the signs of tardive dyskinesia and instructed to report them immediately.
• Careful dose adjustment is crucial in patients with renal impairment.

• For nausea/vomiting: Ondansetron (5-HT3 antagonist), Granisetron (5-HT3 antagonist), Dexamethasone (corticosteroid), Prochlorperazine (phenothiazine), Aprepitant (NK1 receptor antagonist).
• For gastroparesis: Erythromycin (macrolide antibiotic, prokinetic effect), Domperidone (D2 antagonist, not FDA approved in US but available elsewhere).

If your symptoms or health problems do not improve or worsen over time, 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.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which provide a safe and responsible way to dispose of unwanted medications.

This medication is accompanied by a Medication Guide, which provides important information about its safe and effective use. Carefully read this guide when you first receive your medication and each time your prescription is refilled. If you have any questions or concerns about your medication, consult with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, including the dosage, time of ingestion, and any other relevant details to ensure prompt and effective treatment.