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Hydromorphone 2mg/ml Inj, 1ml (pf)

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
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 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 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 (e.g., benzodiazepines, sleeping pills) unless specifically approved by your doctor, as this can lead to dangerous breathing problems or extreme drowsiness.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • Report any changes in pain, breathing, or alertness immediately to your healthcare provider.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and ask your doctor about stool softeners or laxatives.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

moderateToSeverePain: 0.2-1 mg IV every 4-6 hours, titrate as needed. For patients tolerant to opioids, higher doses may be required.
postoperativePain: 0.2-0.6 mg IV every 2-3 hours as needed, titrate carefully.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and individualized dosing if used for severe pain in critical care settings (e.g., 0.015 mg/kg/dose IV every 4-6 hours, titrate carefully).
Infant: Not established for routine use; extreme caution and individualized dosing if used (e.g., 0.015 mg/kg/dose IV every 4-6 hours, titrate carefully).
Child: 0.015 mg/kg/dose IV every 4-6 hours as needed (max 1 mg/dose). Titrate carefully. Not recommended for routine use in children due to high potency and risk of respiratory depression.
Adolescent: Similar to adult dosing, but start with lower end of range (0.2-0.5 mg IV) and titrate carefully.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor closely for increased effects.
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor closely for respiratory depression and sedation due to accumulation of active metabolite (hydromorphone-3-glucuronide).
Severe: Reduce initial dose by 50-75% and extend dosing interval significantly (e.g., every 8-12 hours or longer). Avoid if possible. Monitor closely for neurotoxicity (myoclonus, delirium).
Dialysis: Hydromorphone is not significantly removed by hemodialysis. Dose adjustment needed as per severe renal impairment. Monitor for accumulation of active metabolite.

Hepatic Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Reduce initial dose by 25-50% and titrate slowly. Monitor for increased effects.
Severe: Reduce initial dose by 50-75% and titrate very slowly. Avoid if possible. Monitor closely for respiratory depression and sedation.

Pharmacology

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Mechanism of Action

Hydromorphone is a semi-synthetic opioid analgesic that acts primarily as a full agonist at the mu-opioid receptor (MOR) 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, miosis, euphoria, and physical dependence.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable for IV injection (100% for IV)
Tmax: IV: 5-10 minutes
FoodEffect: Not applicable for IV injection

Distribution:

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

Elimination:

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

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

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; ACCIDENTAL INGESTION; 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. Neonatal opioid withdrawal syndrome (NOWS) may occur with prolonged maternal use during pregnancy. Accidental ingestion of Hydromorphone Injection, especially by children, can result in a fatal overdose. Concomitant use of opioids with benzodiazepines or other 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
+ 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, including fast, slow, or irregular rhythms
Breathing difficulties, such as:
+ 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 hurting yourself 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 a severe and potentially deadly condition called serotonin syndrome. 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
 Throwing up
Severe headache

Long-Term Use and Hormonal Changes

Prolonged use of an opioid medication 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
 Throwing up
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
  • Confusion or hallucinations
  • Severe constipation or abdominal pain
  • Difficulty urinating
  • Itching or rash
  • Signs of allergic reaction (swelling of face/lips/tongue, difficulty 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, 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 like 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, 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. 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 consulting your doctor first.
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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 duration, 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 Monitoring
If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your health.

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 use 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. Stopping or reducing the dose suddenly may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dosage. Follow your doctor's instructions carefully and report any adverse effects, including increased pain, mood changes, suicidal thoughts, or other concerns.

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 Considerations
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 overly sleepy, limp, or has difficulty breathing.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. Administer naloxone if available and trained to do so. Call 1-800-222-1222 (Poison Control Center).

Drug Interactions

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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, alcohol): Increased risk of respiratory depression, profound sedation, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, MAOIs, linezolid, 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

  • Anticholinergics (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and severe constipation/paralytic ileus.
  • Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
  • Hypotensive agents: Increased risk of orthostatic hypotension.

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

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 mental 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

Renal and hepatic function tests (CrCl, LFTs)

Rationale: To guide dose adjustments in patients with organ impairment.

Timing: Prior to initiation, especially in at-risk patients

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Routine Monitoring

Pain assessment

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

Target: Acceptable pain level (e.g., <4/10 on NRS)

Action Threshold: Uncontrolled pain, requiring dose adjustment or alternative therapy

Respiratory rate and depth

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

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

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

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

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

Target: Awake and alert or mildly drowsy, easily aroused

Action Threshold: Difficult to arouse, somnolent, or unarousable

Oxygen saturation (SpO2)

Frequency: Continuous or frequent pulse oximetry, especially in high-risk patients

Target: >92-94%

Action Threshold: <90% or significant drop from baseline

Bowel function

Frequency: Daily

Target: Regular bowel movements

Action Threshold: Constipation, abdominal distension, or signs of ileus

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Symptom Monitoring

  • Excessive sedation
  • Respiratory depression (slow, shallow breathing)
  • Dizziness
  • Nausea/vomiting
  • Constipation
  • Pruritus
  • Urinary retention
  • Confusion/delirium (especially in renal impairment)
  • Myoclonus (especially in renal impairment)

Special Patient Groups

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Pregnancy

Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. 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 in early pregnancy. Risk generally considered low for short-term use.
Second Trimester: Risk of NOWS increases with prolonged use.
Third Trimester: High risk of NOWS with prolonged use. Respiratory depression in the neonate if administered close to delivery.
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Lactation

Hydromorphone is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, and poor feeding. A single dose is generally considered low risk, but repeated doses or high doses are not recommended. Consider alternative analgesics or temporary cessation of breastfeeding.

Infant Risk: Risk level L3 (Moderately Safe - caution advised)
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Pediatric Use

Use with extreme caution due to high potency and risk of respiratory depression. Dosing must be individualized and carefully titrated. Not recommended for routine use in children, especially opioid-naive. Neonates and infants are particularly sensitive to respiratory depressant effects.

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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. Always double-check doses and concentrations to avoid overdose.
  • IV hydromorphone has a rapid onset and short duration, making it suitable for acute, severe pain, but requires frequent redosing.
  • The active metabolite, hydromorphone-3-glucuronide (H3G), can accumulate in renal impairment, leading to neurotoxicity (myoclonus, delirium, hyperalgesia) even if the parent drug levels are not excessively high. Dose reduction is crucial in renal dysfunction.
  • Always have naloxone readily available when administering hydromorphone, especially in opioid-naive patients or those at high risk for respiratory depression.
  • Educate patients and caregivers about the risks of respiratory depression, sedation, and the importance of not combining with alcohol or other CNS depressants.
  • Tolerance and physical dependence can develop with prolonged use. Tapering is necessary to prevent withdrawal symptoms.
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Alternative Therapies

  • Morphine (IV, PO, SC)
  • Fentanyl (IV, transdermal, transmucosal)
  • Oxycodone (PO)
  • Hydrocodone (PO)
  • Tramadol (PO)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for milder pain or as adjuncts to reduce opioid dose.
  • Regional anesthesia/nerve blocks
  • Non-pharmacological pain management (e.g., physical therapy, heat/cold, massage)
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Cost & Coverage

Average Cost: Varies widely by manufacturer and pharmacy per 1ml 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 local drug take-back programs.

This medication is accompanied by a Medication Guide, which provides crucial information. Read this guide carefully and review it again each time you refill your prescription. 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. When seeking help, be prepared to provide details about the medication, including the amount taken and the time of the incident.