Metoclopramide Hcl 5mg/5ml Solution
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.
Drug Class
Antiemetic, Prokinetic
Pharmacologic Class
Dopamine D2 Receptor Antagonist, Serotonin 5-HT3 Receptor Antagonist, Serotonin 5-HT4 Receptor Agonist
Pregnancy Category
Category B
FDA Approved
Jan 1980
DEA Schedule
Not Controlled
Overview
What is this medicine?
Metoclopramide is a medication that helps move food through your stomach and intestines faster. It can also help stop nausea and vomiting. It works by affecting certain natural substances in your brain and gut.
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 advised you to do otherwise. When taking the liquid form, measure your dose carefully using the device that comes with the medication. If no device is provided, ask your pharmacist for a measuring tool to ensure accurate dosing.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, avoiding storage in a bathroom. Do not freeze your medication. It is essential to keep all medications in a safe location, out of the reach of children and pets.
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.
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 advised you to do otherwise. When taking the liquid form, measure your dose carefully using the device that comes with the medication. If no device is provided, ask your pharmacist for a measuring tool to ensure accurate dosing.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, avoiding storage in a bathroom. Do not freeze your medication. It is essential to keep all medications in a safe location, out of the reach of children and pets.
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.
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 12 weeks due to the risk of serious side effects.
- Avoid alcohol and other medications that cause drowsiness while taking metoclopramide, as it can increase sedation.
- Be cautious when driving or operating machinery until you know how this medication affects you.
- Report any unusual or involuntary movements, especially of the face, tongue, or limbs, to your doctor immediately.
- Report any changes in mood, such as depression or anxiety, to your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For symptomatic gastroesophageal reflux: 10-15 mg orally up to 4 times daily, 30 minutes before meals and at bedtime. For diabetic gastroparesis: 10 mg orally 30 minutes before each meal and at bedtime for 2 to 8 weeks.
Dose Range:
10 - 15 mg
Condition-Specific Dosing:
diabeticGastroparesis:
10 mg orally 30 minutes before each meal and at bedtime for 2 to 8 weeks.
gastroesophagealReflux:
10-15 mg orally up to 4 times daily, 30 minutes before meals and at bedtime (short-term use, typically 4-12 weeks).
Pediatric Dosing
Neonatal:
Not established (increased risk of EPS, especially in premature infants).
Infant:
Not established for routine use. Off-label: 0.1-0.2 mg/kg/dose orally, 3-4 times daily (use with extreme caution due to high risk of EPS).
Child:
Not established for routine use. Off-label: 0.1-0.2 mg/kg/dose orally, 3-4 times daily (use with extreme caution due to high risk of EPS). Max 0.5 mg/kg/day.
Adolescent:
Similar to adult dosing for specific indications, but with caution and consideration of lower doses due to increased sensitivity to EPS.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for CrCl > 60 mL/min.
Moderate:
Reduce dose by 50% if CrCl 40-60 mL/min.
Severe:
Reduce dose by 50% if CrCl < 40 mL/min.
Dialysis:
Reduce dose by 50% for patients on hemodialysis or peritoneal dialysis. Administer after dialysis.
Hepatic Impairment:
Mild:
No specific adjustment.
Moderate:
No specific adjustment, but monitor for adverse effects.
Severe:
Consider 50% dose reduction in severe hepatic impairment (e.g., cirrhosis) due to reduced clearance and increased bioavailability.
Pharmacology
Mechanism of Action
Metoclopramide is a dopamine D2 receptor antagonist, which increases the release of acetylcholine from enteric neurons, leading to enhanced gastrointestinal motility and accelerated gastric emptying. It also has antiemetic properties due to its antagonism of D2 receptors in the chemoreceptor trigger zone (CTZ) in the brain. At higher doses, it may also exhibit weak 5-HT3 receptor antagonism and 5-HT4 receptor agonism, contributing to its prokinetic and antiemetic effects.
Pharmacokinetics
Absorption:
Bioavailability:
75-95% (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 30%
CnssPenetration:
Yes
Elimination:
HalfLife:
5-6 hours (can be prolonged to 10-15 hours in renal impairment)
Clearance:
Approximately 0.5-0.7 L/kg/hr
ExcretionRoute:
Renal (primarily)
Unchanged:
Approximately 30% of the dose is excreted unchanged in urine within 72 hours.
Pharmacodynamics
OnsetOfAction:
Oral: 30-60 minutes
PeakEffect:
1-2 hours
DurationOfAction:
1-2 hours (prokinetic effect); antiemetic effect may last longer.
Safety & Warnings
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, metoclopramide therapy should not exceed 12 weeks in duration. Avoid metoclopramide in patients with Parkinson's disease.
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 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
+ Difficulty 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
+ Fainting
+ Changes in vision
Shakiness, difficulty moving, or stiffness
Restlessness
Difficulty sleeping
Trouble controlling body movements, twitching, changes in balance, or difficulty 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
Changes in vision
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 this condition. 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, nausea, or vomiting
+ Severe headache
Mental Health Concerns
This medication may increase the risk of depression and suicidal thoughts. If you experience any of the following, contact your doctor immediately:
Signs of depression
Suicidal thoughts
Emotional instability
Abnormal thinking
Anxiety
Loss of interest in life
Other Side Effects
Most people who take this medication do not experience severe side effects. However, 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, nausea, or vomiting
Fatigue or weakness
* Headache
Reporting Side Effects
If you have questions or concerns about side effects, 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.
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
+ Difficulty 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
+ Fainting
+ Changes in vision
Shakiness, difficulty moving, or stiffness
Restlessness
Difficulty sleeping
Trouble controlling body movements, twitching, changes in balance, or difficulty 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
Changes in vision
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 this condition. 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, nausea, or vomiting
+ Severe headache
Mental Health Concerns
This medication may increase the risk of depression and suicidal thoughts. If you experience any of the following, contact your doctor immediately:
Signs of depression
Suicidal thoughts
Emotional instability
Abnormal thinking
Anxiety
Loss of interest in life
Other Side Effects
Most people who take this medication do not experience severe side effects. However, 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, nausea, or vomiting
Fatigue or weakness
* Headache
Reporting Side Effects
If you have questions or concerns about side effects, 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, repetitive chewing, rapid eye blinking, tremors, muscle spasms)
- Restlessness or inability to sit still
- Stiff muscles or difficulty moving
- Depressed mood or thoughts of self-harm
- Severe drowsiness or dizziness
- Confusion
- Fever, sweating, rigid muscles, fast heart rate, or very high blood pressure (signs of Neuroleptic Malignant Syndrome)
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 circumstances 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 type of tumor)
+ Seizures
+ 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.
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 with your doctor or pharmacist if you are unsure.
Use of medications that should not be taken with this medication, such as certain antidepressants, pain relievers, or medications for Parkinson's disease. This is not an exhaustive list, and you should consult with your doctor or pharmacist to ensure safe combinations.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications
Natural products
Vitamins
Health problems
This information will enable your healthcare team to assess potential interactions and ensure that it is safe for you to take this medication. Never start, stop, or modify the dosage of any medication without consulting 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. 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 type of tumor)
+ Seizures
+ 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.
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 with your doctor or pharmacist if you are unsure.
Use of medications that should not be taken with this medication, such as certain antidepressants, pain relievers, or medications for Parkinson's disease. This is not an exhaustive list, and you should consult with your doctor or pharmacist to ensure safe combinations.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications
Natural products
Vitamins
Health problems
This information will enable your healthcare team to assess potential interactions and ensure that it is safe for you to take this medication. Never start, stop, or modify the dosage of any medication without consulting your doctor.
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 discuss any adverse effects with your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), consult your doctor before taking this medication, as some products may contain this ingredient. Adhere strictly to the dosage and duration of treatment prescribed by your doctor, as taking more than the recommended amount or using it for an extended period may increase the risk of severe side effects.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the potential benefits and risks of this medication with their doctor to ensure informed decision-making.
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 discuss any adverse effects with your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), consult your doctor before taking this medication, as some products may contain this ingredient. Adhere strictly to the dosage and duration of treatment prescribed by your doctor, as taking more than the recommended amount or using it for an extended period may increase the risk of severe side effects.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the potential benefits and risks of this medication with their doctor to ensure informed decision-making.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Disorientation
- Extrapyramidal reactions (e.g., dystonia, akathisia)
- Seizures
- Cardiovascular collapse
- Respiratory depression
What to Do:
Seek immediate medical attention or call a poison control center (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
Contraindicated Interactions
- Drugs that can cause extrapyramidal symptoms (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, obstruction, or perforation - risk of exacerbating condition.
Major Interactions
- Anticholinergics (e.g., atropine, dicyclomine) - antagonize metoclopramide's prokinetic effect.
- Opioid analgesics - antagonize metoclopramide's prokinetic effect.
- CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics) - additive sedative effects.
- SSRIs/SNRIs/TCAs/MAOIs - increased risk of serotonin syndrome.
- Digoxin - metoclopramide may decrease the absorption of digoxin.
- Cyclosporine - metoclopramide may increase the absorption of cyclosporine, leading to increased cyclosporine levels.
- Levodopa - metoclopramide may decrease the efficacy of levodopa.
Moderate Interactions
- Paracetamol (acetaminophen) - metoclopramide may increase the rate of absorption of paracetamol.
- Tetracyclines - metoclopramide may increase the rate of absorption of tetracyclines.
- Monoamine oxidase inhibitors (MAOIs) - potential for hypertensive reactions (though less common than with other prokinetics).
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Patient history (movement disorders, depression, seizure disorder, pheochromocytoma)
Rationale: To identify contraindications or increased risk for adverse effects (e.g., tardive dyskinesia, EPS, seizures, hypertensive crisis).
Timing: Prior to initiation of therapy.
Renal function (CrCl)
Rationale: To determine appropriate starting dose and guide dose adjustments.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs/symptoms of Extrapyramidal Symptoms (EPS)
Frequency: Regularly, especially during the first few days of therapy and with dose changes.
Target: Absence of symptoms (e.g., dystonia, akathisia, parkinsonism).
Action Threshold: If EPS occur, discontinue metoclopramide or reduce dose immediately. Consider anticholinergic agents for acute dystonia.
Signs/symptoms of Tardive Dyskinesia (TD)
Frequency: Regularly, especially with long-term use (>12 weeks) or in elderly patients.
Target: Absence of involuntary, repetitive movements (e.g., lip smacking, grimacing, tongue protrusion).
Action Threshold: If TD occurs, discontinue metoclopramide immediately. TD may be irreversible.
Mental status changes (e.g., depression, anxiety, agitation)
Frequency: Regularly, especially in patients with a history of depression.
Target: Stable mood and mental state.
Action Threshold: If new or worsening depression/anxiety occurs, consider discontinuing metoclopramide.
Blood pressure (especially in patients with pheochromocytoma risk)
Frequency: As clinically indicated.
Target: Within normal limits.
Action Threshold: Significant increase in BP may indicate hypertensive crisis.
Symptom Monitoring
- Involuntary movements (face, tongue, limbs, trunk)
- Muscle stiffness or spasms
- Restlessness or inability to sit still (akathisia)
- Tremors
- Depressed mood or suicidal thoughts
- Anxiety or agitation
- Drowsiness or sedation
- Dizziness
- Headache
- Diarrhea or constipation
Special Patient Groups
Pregnancy
Metoclopramide is generally considered low risk during pregnancy (Category B). Studies in animals have not shown harm, and human data suggest no increased risk of major birth defects. However, it should be used only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
No increased risk of major congenital malformations observed in human studies.
Second Trimester:
Generally considered safe for use.
Third Trimester:
No specific risks identified, but caution with prolonged use near term due to theoretical risk of neonatal EPS (though rare).
Lactation
Metoclopramide is excreted into breast milk in varying amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. Monitor breastfed infants for potential adverse effects such as drowsiness, irritability, or gastrointestinal changes (e.g., diarrhea, constipation).
Infant Risk:
Low risk. Monitor for sedation, GI upset (diarrhea/constipation), or extrapyramidal symptoms (rare).
Pediatric Use
Increased risk of extrapyramidal symptoms (EPS), especially in neonates and young children, due to an immature blood-brain barrier. Use with extreme caution and only when benefits clearly outweigh risks. Not recommended for routine use in infants for GERD. Dosing is weight-based and should be carefully calculated.
Geriatric Use
Increased risk of developing tardive dyskinesia and other extrapyramidal symptoms, especially with prolonged use. Also, increased risk of sedation and confusion. Start with lower doses and monitor closely for adverse effects. Renal function should be assessed and dose adjusted accordingly.
Clinical Information
Clinical Pearls
- Metoclopramide should be used for the shortest duration possible, typically no more than 12 weeks, due to the risk of irreversible tardive dyskinesia.
- It is most effective when taken 30 minutes before meals.
- Avoid in patients with Parkinson's disease due to its dopamine antagonist activity, which can worsen parkinsonian symptoms.
- Patients should be educated on the signs and symptoms of tardive dyskinesia and extrapyramidal symptoms and instructed to report them immediately.
- Dose adjustments are crucial in patients with renal impairment.
- Not recommended for routine use in children due to high risk of EPS.
Alternative Therapies
- Other antiemetics (e.g., ondansetron, 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
- Lifestyle modifications for GERD or gastroparesis
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100 per 300ml (5mg/5ml) solution
Generic Available:
Yes
Insurance Coverage:
Most insurance plans cover generic metoclopramide, often as a Tier 1 or Tier 2 medication.
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 provides important 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, don't hesitate to consult 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 details about the medication taken, the amount, and the time it occurred.