Hydromorphone 2mg/ml Inj, 20ml Vial

Manufacturer WEST-WARD 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
C
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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 moderate to 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 or clinic setting.
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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. It's essential to follow the dosage instructions carefully. This medication is administered via injection into a muscle, vein, or the fatty layer under the skin.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.

Missing a Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Avoid alcohol and other sedating medications unless approved by your doctor, as this can increase the risk of serious side effects like extreme drowsiness and breathing problems.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • Report any new or worsening pain, or signs of overdose (e.g., very slow breathing, extreme sleepiness, difficulty waking up) immediately.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and discuss a bowel regimen with your healthcare provider.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial IV dose: 0.2-1 mg every 4-6 hours as needed. Titrate to effect.
Dose Range: 0.2 - 4 mg

Condition-Specific Dosing:

moderateToSeverePain: IV: 0.2-1 mg every 4-6 hours initially, titrate to effect. SC/IM: 1-2 mg every 4-6 hours initially, titrate to effect.
opioidTolerantPatients: Higher initial doses may be required, based on prior opioid exposure and cross-tolerance calculations. Close monitoring is essential.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and specialized consultation required if used.
Infant: Not established for routine use; extreme caution and specialized consultation required if used. IV: 0.015 mg/kg/dose every 4-6 hours, max 0.08 mg/kg/dose.
Child: IV: 0.015 mg/kg/dose every 4-6 hours, max 0.08 mg/kg/dose. Max single dose 2 mg. Not to exceed 10 mg/24 hours.
Adolescent: IV: 0.015 mg/kg/dose every 4-6 hours, max 0.08 mg/kg/dose. Max single dose 2 mg. Not to exceed 10 mg/24 hours. Or adult dosing if weight/age appropriate.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but monitor closely.
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor closely for respiratory depression and sedation.
Severe: Reduce initial dose by 50-75% and extend dosing interval. Avoid if possible. Monitor closely for respiratory depression and sedation.
Dialysis: Hydromorphone is not significantly removed by hemodialysis. Administer after dialysis. Reduce dose and/or extend interval.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, but monitor closely.
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor closely for respiratory depression and sedation.
Severe: Reduce initial dose by 50-75% 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 by mimicking the effects of endogenous opioids, leading to inhibition of pain transmission pathways, alteration of pain perception, and induction of euphoria. It also causes respiratory depression, miosis, constipation, and antitussive effects.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable for IV/IM/SC. Oral bioavailability is low (20-30%).
Tmax: IV: 5-10 minutes (onset of action). IM: 30-60 minutes. SC: 30-90 minutes.
FoodEffect: Not applicable for injection.

Distribution:

Vd: 4 L/kg
ProteinBinding: 8-19%
CnssPenetration: Yes

Elimination:

HalfLife: 2-3 hours (terminal half-life)
Clearance: Not readily available, but primarily hepatic metabolism and renal excretion.
ExcretionRoute: Renal (primarily as H3G)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: IV: 5 minutes; IM/SC: 15-30 minutes
PeakEffect: IV: 15-30 minutes; IM/SC: 30-90 minutes
DurationOfAction: 3-4 hours (parenteral)

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. Hydromorphone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Serious, life-threatening, or fatal respiratory depression may occur. Accidental ingestion of hydromorphone, especially by children, can result in a fatal overdose. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome. Concomitant use with benzodiazepines or other CNS depressants may result in profound sedation, respiratory depression, coma, and death.
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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 immediate 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 low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Rapid heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a serious bowel problem
Abnormal heartbeat (fast, slow, or irregular)
Breathing difficulties, including:
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Seizures
Shakiness
Difficulty urinating
Uncontrolled eye movements
Trouble controlling body movements
Changes in vision
Chest pain or pressure
Balance problems
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 immediate medical attention if you experience:

Agitation
Balance problems
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

Long-Term Use and Hormonal Changes

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

Decreased interest in sex
Fertility problems
Irregular menstrual periods
Ejaculation problems

Other Possible Side Effects

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

Constipation
Diarrhea
Stomach pain
Nausea
Vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Flushing
Excessive sweating
Headache
Itching
* Sleep disturbances

If you're concerned about any side effects or have questions, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or visit 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
  • Pinpoint pupils
  • Severe constipation or abdominal pain
  • Hives, rash, or itching (signs of allergic reaction)
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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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
If you are currently taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

Please note that this is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. 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.

Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position. Be cautious when climbing stairs.

Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended dose, or taking it more frequently or for a longer period, may increase the risk of severe side effects.

Interactions with Other Medications
Do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.

Monitoring and Follow-up
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 take more than the prescribed dose.

Laboratory Tests
If you are taking this medication long-term, have your blood work checked regularly, and discuss the results with your doctor.

Allergies and Sensitivities
If you are allergic to sulfites, inform your doctor, as some products may contain sulfites.

Alcohol Interactions
Do not consume alcohol or products containing alcohol while taking this medication, as it may lead to unsafe and potentially life-threatening effects.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If you experience reduced efficacy, contact your doctor. Do not take more than the prescribed dose.

Dependence and Withdrawal
Regular use of opioid medications like this one may cause dependence. Suddenly lowering the dose or stopping the medication may increase the risk of withdrawal or other severe problems. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.

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

Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Seek immediate medical attention if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.

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

Breastfeeding
Inform your doctor if you are breastfeeding, as this medication passes into breast milk and may harm your baby. Seek medical help immediately if your baby appears excessively sleepy, limp, or has difficulty breathing.
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Overdose Information

Overdose Symptoms:

  • Slowed or stopped breathing (respiratory depression)
  • Extreme drowsiness, inability to wake up
  • Pinpoint pupils
  • Cold, clammy skin
  • Limp muscles
  • Bluish discoloration of lips or fingernails
  • Loss of consciousness
  • Coma

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. Naloxone (Narcan) may be administered by trained personnel to reverse the effects of opioid overdose. Provide rescue breathing if necessary. Call 1-800-222-1222 (Poison Control) for additional guidance.

Drug Interactions

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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
  • Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of MAOI discontinuation can result in unpredictable, severe, or fatal reactions (e.g., serotonin syndrome, respiratory depression, coma).
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Moderate Interactions

  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, fentanyl, lithium, St. John's Wort): Risk of serotonin syndrome.
  • Anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, antipsychotics, muscle relaxants): Increased risk of urinary retention and severe constipation.
  • Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
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Minor Interactions

  • Antihypertensives: May cause additive hypotensive effects.

Monitoring

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Baseline Monitoring

Pain assessment (intensity, character, location)

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

Timing: Prior to first dose and regularly throughout therapy.

Respiratory rate and depth

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

Timing: Prior to first dose.

Level of consciousness/sedation score

Rationale: To assess baseline neurological status and identify risk for excessive 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 assess risk for opioid-induced constipation.

Timing: Prior to first dose.

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Routine Monitoring

Pain level

Frequency: Every 1-2 hours initially after parenteral administration, then every 4-6 hours or as clinically indicated.

Target: Patient-specific pain goal (e.g., 0-3/10 on a pain scale).

Action Threshold: Pain score above goal, requiring dose adjustment or rescue medication.

Respiratory rate and depth

Frequency: Every 1-2 hours initially after parenteral administration, then every 4-6 hours or as clinically indicated.

Target: Typically >10-12 breaths/minute (adults), regular rhythm.

Action Threshold: Respiratory rate <10 breaths/minute, shallow breathing, or signs of hypoventilation (e.g., cyanosis, decreased SpO2).

Level of consciousness/sedation score (e.g., Pasero Opioid-Induced Sedation Scale)

Frequency: Every 1-2 hours initially after parenteral administration, then every 4-6 hours or as clinically indicated.

Target: Alert or mildly drowsy, easily aroused.

Action Threshold: Difficult to arouse, somnolent, or unarousable.

Blood pressure and heart rate

Frequency: Every 4-6 hours or as clinically indicated.

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: No bowel movement for >3 days, severe abdominal discomfort, or signs of ileus.

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Symptom Monitoring

  • Excessive sedation
  • Respiratory depression (slow, shallow breathing)
  • Pinpoint pupils (miosis)
  • Dizziness
  • Nausea/vomiting
  • Constipation
  • Pruritus
  • Urinary retention
  • Confusion
  • Hypotension

Special Patient Groups

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Pregnancy

Use during pregnancy is generally not recommended due to the risk of neonatal opioid withdrawal syndrome (NOWS) and potential for respiratory depression in the neonate. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations with opioid exposure. Risk generally considered low for short-term use.
Second Trimester: Risk of NOWS increases with prolonged use. Respiratory depression in the neonate if used close to delivery.
Third Trimester: High risk of NOWS with prolonged use. Risk of respiratory depression in the neonate if used close to delivery. Labor and delivery: May prolong labor and cause respiratory depression in the neonate.
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Lactation

Hydromorphone is excreted into breast milk. While levels are generally low, there is a risk of sedation, respiratory depression, and withdrawal symptoms in the infant. Monitor infants for increased sleepiness, difficulty breathing, or limpness. Use with caution, or consider alternative analgesics.

Infant Risk: L3 (Moderate risk) - Monitor infant for sedation, poor feeding, respiratory depression, and withdrawal symptoms.
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Pediatric Use

Use with extreme caution, especially in infants and young children, due to increased sensitivity to respiratory depression. Dosing must be precise and based on weight. Not recommended for routine use in neonates.

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Geriatric Use

Start with lower doses and titrate slowly due to increased sensitivity to opioid effects (e.g., respiratory depression, sedation, constipation) and potential for decreased renal/hepatic function. Monitor closely.

Clinical Information

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Clinical Pearls

  • Hydromorphone is 5-7 times more potent than morphine on a milligram-for-milligram basis when administered parenterally. Always double-check calculations to avoid overdose.
  • Rapid onset and short duration make it suitable for acute pain management and titration.
  • Patients with renal impairment are at higher risk for accumulation of hydromorphone-3-glucuronide (H3G), which can cause neuroexcitatory symptoms (e.g., myoclonus, delirium, seizures). Dose reduction is crucial.
  • Always have naloxone readily available when administering hydromorphone, especially in opioid-naΓ―ve patients or during titration.
  • Educate patients and caregivers about the signs of respiratory depression and overdose, and the importance of safe storage to prevent accidental ingestion.
  • Proactive management of opioid-induced constipation (OIC) is essential from the start of therapy.
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Alternative Therapies

  • Morphine (parenteral)
  • Fentanyl (parenteral)
  • Oxycodone (parenteral, if available)
  • Tramadol (parenteral, for less severe pain)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for mild to moderate pain or as adjuncts to opioids.
  • Regional anesthesia/nerve blocks
  • Patient-controlled analgesia (PCA) with hydromorphone or morphine.
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Cost & Coverage

Average Cost: Not available (varies widely by supplier, contract, and volume) per 20ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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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 your pharmacist or healthcare provider, do not flush medications down the toilet or pour them down the drain. Instead, consult with your pharmacist about the best disposal method or explore drug take-back programs in your area.

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 your prescription is refilled. 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. Consult with 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 happened.

In case of a suspected overdose, contact your local poison control center or seek medical care right away. Have the following information available: the name of the medication, the amount taken, and the time of the incident.