Hydromorphone 10mg/ml Inj, 1ml

Manufacturer HOSPIRA 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
Mu-opioid receptor 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 moderate to severe pain. It works in your brain to change how your body feels and responds to pain. Because it is a strong medicine, it can cause serious side effects like very slow breathing, and it can be addictive. It is usually given by injection 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 to determine the best storage method.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on what to do next.
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Lifestyle & Tips

  • Avoid alcohol and other sedating medications unless approved by your doctor.
  • Do not drive or operate heavy machinery until you know how this medication affects you.
  • Do not share this medication with anyone else.
  • Store this medication securely away from children and pets.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial IV dose: 0.2-1 mg every 4-6 hours as needed. Dosage must be individualized.
Dose Range: 0.2 - 1 mg

Condition-Specific Dosing:

severePain: Higher doses may be required for severe pain in opioid-tolerant patients, titrated to effect.
postoperativePain: Typically 0.2-0.6 mg IV every 2-3 hours as needed.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor closely.
Moderate: Reduce initial dose by 50% and extend dosing interval. Monitor closely for respiratory depression and sedation.
Severe: Reduce initial dose by 75% and extend dosing interval. Monitor closely for respiratory depression and sedation.
Dialysis: Hydromorphone is not significantly removed by hemodialysis. Dose adjustment needed based on renal function.

Hepatic Impairment:

Mild: No specific adjustment, monitor closely.
Moderate: Reduce initial dose by 50% and extend dosing interval. Monitor closely for respiratory depression and sedation.
Severe: Reduce initial dose by 75% and extend dosing interval. Monitor closely for respiratory depression and sedation.

Pharmacology

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Mechanism of Action

Hydromorphone is a full opioid agonist that acts primarily at the mu-opioid receptors in the central nervous system (CNS). Its analgesic effects are mediated by binding to these receptors, leading to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces CNS depression, respiratory depression, and antitussive effects.
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Pharmacokinetics

Absorption:

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

Distribution:

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

Elimination:

HalfLife: 2-3 hours (IV)
Clearance: Not available
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; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. 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 injection, and monitor all patients regularly for the development of these behaviors and conditions. Serious, life-threatening, or fatal respiratory depression may occur. Accidental ingestion of hydromorphone injection, especially by children, can result in a fatal overdose. Prolonged use of hydromorphone injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, 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 medical help immediately 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 or absent menstrual periods
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 potential side effects:

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

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:

  • Difficulty breathing or very slow breathing
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness
  • Confusion
  • Blue lips or fingernails
  • Severe constipation
  • Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, such as:
+ Respiratory problems, including 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
+ Rasagiline
Note: Combining these medications can lead to severely high blood pressure.
If you are currently taking any of the following medications:
+ Buprenorphine
+ Butorphanol
+ Linezolid
+ Methylene blue
+ Nalbuphine
+ Pentazocine

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing treatments and health status. 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 a decrease in the medication's effectiveness, 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. If you need to reduce the dose or stop taking this medication, consult your doctor first, as sudden changes may lead to withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

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. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.

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

Breastfeeding
If you are breastfeeding, inform your doctor, 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 breathing difficulties.
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Overdose Information

Overdose Symptoms:

  • Slow, shallow, or stopped breathing
  • Extreme drowsiness or inability to wake up
  • Pinpoint pupils
  • Cold, clammy skin
  • Limp muscles
  • Low blood pressure
  • Slow heart rate
  • Coma

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. Naloxone (Narcan) may be administered by trained personnel. Inform medical staff of all medications taken. Call 1-800-222-1222 (Poison Control) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - within 14 days of use (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, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, gabapentinoids, alcohol) - increased risk of profound sedation, respiratory depression, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, fentanyl) - risk of serotonin syndrome.
  • Mixed agonist/antagonist and partial agonist opioids (e.g., butorphanol, nalbuphine, pentazocine, buprenorphine) - may precipitate withdrawal symptoms or reduce analgesic effect.
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Moderate Interactions

  • Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants) - increased risk of urinary retention and severe constipation.
  • Diuretics - may reduce the efficacy of diuretics due to ADH release.
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Minor Interactions

  • Not available

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 initiation of therapy

Respiratory rate and depth

Rationale: To assess baseline respiratory function, as respiratory depression is a major adverse effect.

Timing: Prior to initiation of therapy

Level of consciousness/sedation score

Rationale: To assess baseline neurological status and risk of over-sedation.

Timing: Prior to initiation of therapy

Blood pressure and heart rate

Rationale: To assess baseline cardiovascular status.

Timing: Prior to initiation of therapy

Renal and hepatic function tests (e.g., BUN, creatinine, LFTs)

Rationale: To identify impairment that may necessitate dose adjustment.

Timing: Prior to initiation of therapy, especially in patients with suspected impairment

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Routine Monitoring

Pain level

Frequency: Regularly, based on clinical need (e.g., every 1-2 hours initially, then every 4-6 hours or as needed)

Target: Acceptable pain relief with minimal side effects

Action Threshold: Inadequate pain control or excessive side effects warrant dose adjustment or alternative therapy.

Respiratory rate and depth

Frequency: Every 15-30 minutes for 1-2 hours after IV dose, then every 1-4 hours or as clinically indicated.

Target: Typically >10-12 breaths/min, regular rhythm

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoventilation (e.g., cyanosis, somnolence) require immediate intervention (e.g., naloxone, respiratory support).

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

Frequency: Every 15-30 minutes for 1-2 hours after IV dose, then every 1-4 hours or as clinically indicated.

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

Action Threshold: Difficult to arouse, somnolent, or unarousable requires immediate intervention.

Blood pressure and heart rate

Frequency: Every 1-4 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

Action Threshold: Constipation (opioid-induced constipation) requires prophylactic laxatives.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Prolonged use of hydromorphone during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Advise pregnant women of the risk of NOWS. Use during labor may cause 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.
Second Trimester: Risk of NOWS increases with prolonged exposure.
Third Trimester: High risk of NOWS with prolonged exposure; risk of respiratory depression in neonate if used during labor.
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Lactation

Hydromorphone is excreted in breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Risk of sedation, respiratory depression, and withdrawal symptoms in breastfed infants. L3 (Moderately Safe - use with caution).
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended due to lack of data and potential for serious adverse effects, especially respiratory depression.

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of hydromorphone, particularly respiratory depression. Start with lower doses and titrate slowly, monitoring closely for sedation and respiratory depression. Renal and hepatic impairment are more common in the elderly, requiring further dose adjustments.

Clinical Information

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Clinical Pearls

  • Hydromorphone is 5-7 times more potent than morphine on a milligram basis. Extreme caution is needed when converting from other opioids or when switching routes of administration.
  • Always dilute hydromorphone injection for IV administration to avoid rapid injection and potential for severe adverse events.
  • Rapid IV push can cause severe respiratory depression, hypotension, and circulatory collapse. Administer slowly over at least 2-3 minutes.
  • Patients should be monitored closely for respiratory depression and sedation, especially during initiation of therapy or dose escalation.
  • Opioid-induced constipation is a common side effect; prophylactic laxative regimens should be considered.
  • Tolerance and physical dependence can develop with prolonged use. Do not discontinue abruptly to avoid withdrawal symptoms.
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Alternative Therapies

  • Morphine
  • Fentanyl
  • Oxycodone
  • Hydrocodone
  • Tramadol
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain
  • Regional anesthesia
  • Nerve blocks
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Cost & Coverage

Average Cost: Not available Not available
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, never share your medication with others, and do not 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 by checking with your pharmacist for guidance. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain. You may also want to inquire about drug take-back programs available 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 you receive a refill. If you have any questions or concerns about this medication, consult 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. Discuss obtaining and using naloxone with your doctor or pharmacist. 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.

If you believe an overdose has occurred, contact your local poison control center or seek medical care right away. Have the necessary information available, including the medication taken, the quantity, and the time of the incident, to ensure prompt and effective treatment.