Hydromorphone 2mg/ml Inj, 1ml

Manufacturer FRESENIUS KABI USA Active Ingredient Hydromorphone Injection(hye droe MOR fone) Pronunciation hye droe MOR fone
WARNING: This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing. Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life-threatening if not treated.Make sure you have the right drug; there is more than one strength. A lower strength may not ease pain well enough. A higher strength could lead to accidental overdose and death.Certain strengths of this drug may only be used by people who have been taking drugs like this drug and are used to their effects. The use of these strengths by people who have not been taking drugs like this drug may cause very bad and sometimes deadly breathing problems. Talk with the doctor. @ COMMON USES: It is used to manage pain when non- opioid pain drugs do not treat your pain well enough or you cannot take them.
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Drug Class
Opioid Analgesic
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Pharmacologic Class
Opioid Agonist
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Pregnancy Category
Not available
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FDA Approved
Jan 1942
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Hydromorphone is a strong pain medicine, similar to morphine, used to treat severe pain. It works by changing how your brain and nervous system respond to pain. It is given as an injection, usually in a hospital setting.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. Take this medication exactly as directed, and be sure to follow all instructions provided. This medication is administered via injection into a muscle, vein, or the fatty layer under the skin.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.

If you miss a dose, contact your doctor immediately to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Avoid alcohol and other sedating medications (like sleeping pills, anxiety medications) unless specifically approved by your doctor, as this can lead to dangerous breathing problems.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
  • Report any difficulty breathing, extreme drowsiness, or feeling faint immediately to a healthcare professional.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and discuss a bowel regimen with your doctor or nurse.

Dosing & Administration

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Adult Dosing

Standard Dose: IV: 0.2-1 mg every 2-3 hours as needed
Dose Range: 0.2 - 4 mg

Condition-Specific Dosing:

opioid_naive: Initial dose 0.2-0.5 mg IV every 2-3 hours, titrate slowly.
opioid_tolerant: Higher doses may be required, titrate based on prior opioid exposure and pain severity.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, if at all, due to risk of respiratory depression and withdrawal)
Infant: Not established (use with extreme caution, if at all, due to risk of respiratory depression and withdrawal)
Child: Not established (use with extreme caution, if at all, due to risk of respiratory depression and withdrawal)
Adolescent: Not established (use with extreme caution, if at all, due to risk of respiratory depression and withdrawal)
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Dose Adjustments

Renal Impairment:

Mild: Consider dose reduction and extended dosing interval.
Moderate: Reduce initial dose by 50% and extend dosing interval. Monitor closely.
Severe: Reduce initial dose by 75% or more and extend dosing interval. Avoid if possible. Monitor closely for respiratory depression and sedation.
Dialysis: Hydromorphone is not significantly removed by hemodialysis. Dose adjustment needed, monitor for accumulation of parent drug and active metabolites (e.g., H3G).

Hepatic Impairment:

Mild: Consider dose reduction and extended dosing interval.
Moderate: Reduce initial dose by 50% and extend dosing interval. Monitor closely.
Severe: Reduce initial dose by 75% or more and extend dosing interval. Avoid if possible. Monitor closely for respiratory depression and sedation.

Pharmacology

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Mechanism of Action

Hydromorphone is a full opioid agonist, primarily acting at the mu-opioid receptors in the central nervous system (CNS). It produces analgesia, sedation, euphoria, and respiratory depression by mimicking the actions of endogenous opioid peptides.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: Rapid (IV)
FoodEffect: Not applicable for IV injection

Distribution:

Vd: Approximately 4 L/kg
ProteinBinding: Low (8-19%)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 2-3 hours
Clearance: Not readily available (highly variable)
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Within 5 minutes (IV)
PeakEffect: 10-20 minutes (IV)
DurationOfAction: 3-4 hours (IV)

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.

Addiction, Abuse, and Misuse: Hydromorphone Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing hydromorphone, and monitor all patients regularly for the development of these behaviors and conditions.

REMS: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products.

Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.

Accidental Ingestion: Accidental ingestion of hydromorphone injection, especially by children, can result in a fatal overdose.

Neonatal Opioid Withdrawal Syndrome: Prolonged use of hydromorphone injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
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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
+ 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 low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Feeling confused
Severe constipation or stomach pain, which may indicate a severe bowel problem
Abnormal heartbeat (fast, slow, or irregular)
Breathing difficulties, including:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Seizures
Shakiness
Trouble passing urine
Inability to control eye movements
Trouble controlling body movements
Changes in eyesight
Chest pain or pressure
Changes in balance
Memory problems or loss
Thoughts of self-harm or suicide
Swelling in the arms or legs

Serotonin Syndrome: A Potentially Life-Threatening Condition

If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a severe and potentially deadly condition. 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
Upset stomach
Vomiting
Severe headache

Long-Term Use and Hormonal Changes

Long-term use of opioid medications like this one may lead to lower sex hormone levels. If you experience any of the following symptoms, contact your doctor:

Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following possible side effects:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dizziness
Sleepiness
Tiredness
Weakness
Dry mouth
Flushing
Excessive sweating
Headache
Itching
* Trouble sleeping

If any of these side effects bother you or persist, contact your doctor for guidance. 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:

  • Slow or shallow breathing
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness when standing up
  • Confusion or disorientation
  • Blue-tinged lips or skin
  • Severe constipation or inability to pass urine
  • Signs of an allergic reaction (rash, itching, swelling of face/lips/tongue)
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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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems, such as asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of severely high blood pressure
If you are currently taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

Adhere strictly to your doctor's prescribed dosage and frequency. Taking more than prescribed, or taking it more often or for a longer duration, can increase the risk of severe side effects.

Do not combine this medication with other strong pain medications or use a pain patch without first consulting your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not exceed the prescribed dosage.

If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your health. Discuss this with your doctor.

If you have a sulfite allergy, inform your doctor, as some formulations of this medication may contain sulfites.

Avoid consuming alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal interactions.

Long-term or high-dose use of this medication can lead to tolerance, reducing its effectiveness. If you find that this medication is no longer working as well as it did initially, contact your doctor. Do not increase your dosage without medical guidance.

Prolonged or regular use of opioid medications like this one can result in dependence. Suddenly lowering your dose or stopping this medication can increase the risk of withdrawal or other severe complications. Consult your doctor before making any changes to your dosage. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

This medication may increase the risk of seizures, particularly in individuals with a history of seizure disorders. Discuss your risk with your doctor.

Opioid medications like this one can rarely cause a severe adrenal gland problem. Seek immediate medical attention if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and potentially harm your baby. Seek medical help immediately if your baby appears overly sleepy, limp, or has breathing difficulties.
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Overdose Information

Overdose Symptoms:

  • Pinpoint pupils
  • Slowed or stopped breathing (respiratory depression)
  • Extreme drowsiness, unresponsiveness, or coma
  • Limp muscles
  • Cold, clammy skin
  • Slowed heart rate
  • Low blood pressure

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. If naloxone (Narcan) is available and you are trained to use it, administer it as directed. Stay with the person until emergency help arrives. Call 1-800-222-1222 (Poison Control) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome or severe respiratory depression)
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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): Risk of serotonin syndrome.
  • Mixed agonist/antagonist and partial agonist opioids (e.g., butorphanol, nalbuphine, pentazocine, buprenorphine): May reduce the analgesic effect of hydromorphone or precipitate withdrawal symptoms.
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Moderate Interactions

  • Anticholinergics: Increased risk of urinary retention and/or severe constipation.
  • Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
  • Antihypertensives: May cause additive hypotensive effects.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pain level (e.g., NRS, VAS)

Rationale: To establish baseline pain severity and guide initial dosing.

Timing: Prior to first dose

Respiratory rate and depth

Rationale: To assess baseline respiratory function and identify risk for respiratory depression.

Timing: Prior to first dose

Sedation level (e.g., Pasero Opioid-Induced Sedation Scale)

Rationale: To assess baseline CNS status and identify risk for over-sedation.

Timing: Prior to first dose

Blood pressure and heart rate

Rationale: To assess baseline cardiovascular status.

Timing: Prior to first dose

Bowel function history

Rationale: To anticipate and manage opioid-induced constipation.

Timing: Prior to first dose

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Routine Monitoring

Pain level

Frequency: Every 1-2 hours initially, then as needed based on patient response and pain control.

Target: Acceptable pain level as defined by patient and clinician.

Action Threshold: Uncontrolled pain or adverse effects warranting dose adjustment.

Respiratory rate and depth

Frequency: Every 15-30 minutes for the first hour after IV dose, then every 1-2 hours or as clinically indicated.

Target: >10-12 breaths/min, regular rhythm, adequate depth.

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of respiratory distress (e.g., cyanosis, labored breathing).

Sedation level

Frequency: Every 15-30 minutes for the first hour after IV dose, then every 1-2 hours or as clinically indicated.

Target: Awake and alert or mildly drowsy, easily aroused.

Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolent, unresponsive).

Blood pressure and heart rate

Frequency: Periodically, especially with initial doses or dose escalations.

Target: Within patient's normal range.

Action Threshold: Significant hypotension or bradycardia.

Bowel function

Frequency: Daily

Target: Regular bowel movements (e.g., every 1-3 days).

Action Threshold: Constipation (no bowel movement for >3 days, straining, hard stools).

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation or somnolence
  • Dizziness, lightheadedness
  • Nausea, vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Hypotension
  • Signs of allergic reaction (rash, hives, swelling)

Special Patient Groups

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Pregnancy

Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening if not treated. Use only if the potential benefit justifies the potential risk to the fetus. Monitor neonates for signs of NOWS.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided due to potential for congenital malformations with opioid exposure.
Second Trimester: Risk of NOWS increases with prolonged use.
Third Trimester: Highest risk of NOWS with prolonged use. Risk of respiratory depression in the neonate if administered close to delivery.
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Lactation

Hydromorphone is excreted in breast milk. Monitor breastfed infants for signs of sedation, respiratory depression, poor feeding, and poor weight gain. Short-term, single-dose use may be acceptable with close infant monitoring. Chronic use is generally not recommended.

Infant Risk: Moderate to high risk, especially with chronic use or higher doses. Risk of sedation, respiratory depression, and withdrawal symptoms in the infant.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended due to the high risk of respiratory depression and other adverse effects, especially in opioid-naive children. If used, extreme caution, careful titration, and close monitoring are essential.

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, including respiratory depression, sedation, and constipation. Start with lower doses and titrate slowly. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Hydromorphone is a potent opioid; ensure appropriate dose selection, especially in opioid-naive patients, to avoid overdose and respiratory depression.
  • Always have naloxone readily available when administering hydromorphone, especially in acute care settings.
  • Be aware of the potential for rapid onset and short duration of action with IV hydromorphone, which may lead to frequent redosing if not managed appropriately.
  • Educate patients and caregivers about the signs of respiratory depression and over-sedation.
  • Proactive management of opioid-induced constipation is crucial for patients receiving hydromorphone.
  • Tolerance and physical dependence can develop with prolonged use; discuss tapering strategies if long-term use is anticipated.
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Alternative Therapies

  • Other strong opioid analgesics (e.g., Morphine, Fentanyl, Oxycodone)
  • Non-opioid analgesics (e.g., NSAIDs, Acetaminophen) for less severe pain or as adjuncts
  • Regional anesthesia (e.g., nerve blocks, epidural analgesia)
  • Non-pharmacological pain management techniques (e.g., physical therapy, heat/cold therapy, massage, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: Varies widely per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (generic often Tier 1)
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General Drug Facts

It is essential to monitor your symptoms and health problems while taking this medication. If you notice no improvement or a worsening of your condition, contact your doctor promptly.

To ensure safe use, keep the following guidelines in mind:

Do not share your medication with others, and never take someone else's medication.
Store all medications in a secure location, out of reach of children and pets.
* Properly dispose of unused or expired medications. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you have questions about the best disposal method, consult your pharmacist. You may also want to explore local drug take-back programs.

This medication is accompanied by a Medication Guide, which provides important information about its use. Read this guide carefully and review it again each time you receive a refill. If you have any questions or concerns about this medication, discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be used as part of the treatment. Talk to your doctor or pharmacist about obtaining and using naloxone. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide information about the medication taken, the amount, and the time it was taken.

If you think an overdose has occurred, contact your local poison control center or seek medical attention right away. Have the following information available: the name of the medication, the amount taken, and the time of ingestion.