Hydromorphone 4mg/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
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 that belongs to a group of drugs called opioids. It works in your brain and nervous system to change how your body feels and responds to pain. It is given by injection (shot) for severe pain.
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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 instructions carefully. This medication is administered via injection into a muscle, vein, or the fatty tissue 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, 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.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and consider using a stool softener or laxative as directed by your doctor.
  • Store this medication securely to prevent accidental ingestion by children or pets, which can be fatal.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose for opioid-naive patients: 0.2-1 mg IV every 2-3 hours as needed. For opioid-tolerant patients, convert from prior opioid dose.
Dose Range: 0.2 - 4 mg

Condition-Specific Dosing:

acute_pain_iv: 0.2-1 mg IV every 2-3 hours as needed, titrate to effect.
acute_pain_sc_im: 1-2 mg SC/IM every 2-3 hours as needed, titrate to effect.
chronic_pain_iv_continuous_infusion: Initial rate 0.5-1 mg/hr, titrate based on patient response and prior opioid use.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, risk of respiratory depression).
Infant: Not established (use with extreme caution, risk of respiratory depression).
Child: 0.015 mg/kg/dose IV/SC/IM every 4-6 hours as needed (max 0.1 mg/kg/dose or 2 mg/dose). Use with extreme caution and close monitoring.
Adolescent: Similar to adult dosing, but start with lower doses (0.2-0.5 mg IV) and titrate carefully.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment, but monitor closely.
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor closely for adverse effects.
Severe: Reduce initial dose by 50-75% and extend dosing interval significantly. Avoid if possible. Monitor closely.
Dialysis: Hydromorphone is not significantly removed by hemodialysis. Dose adjustment needed based on renal function. Administer after dialysis if possible.

Hepatic Impairment:

Mild: No specific dose adjustment, but monitor closely.
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor closely for adverse effects.
Severe: Reduce initial dose by 50-75% and extend dosing interval significantly. Avoid if possible. Monitor closely.

Pharmacology

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Mechanism of Action

Hydromorphone is a full opioid agonist that binds to mu-opioid receptors in the central nervous system (CNS), peripheral tissues, and gastrointestinal tract. Its primary actions are analgesia and sedation. It produces its analgesic effects by mimicking the actions of endogenous opioid peptides, leading to inhibition of pain transmission pathways.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable for IV/IM/SC (100% for IV)
Tmax: IV: 5-10 minutes (onset of action)
FoodEffect: Not applicable for injectable forms.

Distribution:

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

Elimination:

HalfLife: 2-3 hours
Clearance: Not available
ExcretionRoute: Renal (primarily as H3G)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: IV: 5 minutes; IM: 15-30 minutes; SC: 15-30 minutes
PeakEffect: IV: 10-20 minutes; IM/SC: 30-90 minutes
DurationOfAction: 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 is for intravenous, subcutaneous, or intramuscular use. Hydromorphone Injection 4 mg/mL is a highly concentrated solution and should be used with caution. This formulation should be used only in opioid-tolerant patients. Fatal respiratory depression could occur in opioid non-tolerant patients.
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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, 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 side effects or may only have mild ones, it's essential to be aware of the following:

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:

  • Slow or shallow breathing
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness when standing up
  • Confusion
  • Severe constipation
  • Difficulty urinating
  • Hives or rash (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. 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 blockage 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. 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

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Avoid driving and engaging in activities 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 down 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 Your Condition
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.

Long-Term Use and Blood Work
If you are taking this medication for an extended period, your doctor may recommend regular blood tests to monitor your condition.

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

Alcohol Interaction
Do not consume alcohol or use products containing alcohol while taking this medication, as this 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 to avoid withdrawal or other severe problems. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.

Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those 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 medical attention immediately if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.

Special Considerations for Older Adults
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:

  • Slowed or stopped breathing (respiratory depression)
  • Extreme drowsiness, unresponsiveness, or coma
  • Pinpoint pupils
  • Cold, clammy skin
  • Limp muscles
  • Bluish discoloration of lips or fingernails (cyanosis)

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).

Drug Interactions

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Major Interactions

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

  • Anticholinergic drugs (e.g., atropine, scopolamine): Increased risk of urinary retention and/or severe constipation.
  • Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
  • P-glycoprotein (P-gp) inhibitors/inducers: May alter hydromorphone plasma concentrations.

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, depth, and rhythm

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 over-sedation.

Timing: Prior to first dose

Blood pressure, 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

Renal and hepatic function tests (CrCl, LFTs)

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

Timing: Prior to initiation, if impairment suspected

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Routine Monitoring

Pain assessment

Frequency: Every 2-4 hours initially, then as needed based on patient response and dosing interval.

Target: Patient-specific pain goal (e.g., 3/10 or less)

Action Threshold: Pain uncontrolled, consider dose increase or alternative analgesic.

Respiratory rate, depth, and rhythm

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

Target: Respiratory rate >10 breaths/min, regular rhythm, adequate depth.

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, irregular rhythm, or signs of hypoventilation; administer naloxone, stimulate patient, call for help.

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; administer naloxone, stimulate patient, call for help.

Blood pressure, heart rate

Frequency: Periodically, especially with dose escalation or in patients at risk for hypotension.

Target: Within patient's normal range.

Action Threshold: Significant hypotension or bradycardia.

Bowel function

Frequency: Daily

Target: Regular bowel movements (e.g., every 1-2 days).

Action Threshold: No bowel movement for >2-3 days; initiate or escalate laxative regimen.

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Symptom Monitoring

  • Sedation
  • Respiratory depression (slow, shallow breathing)
  • Nausea
  • Vomiting
  • Constipation
  • Pruritus
  • Dizziness
  • Lightheadedness
  • Confusion
  • Urinary retention

Special Patient Groups

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Pregnancy

Use during pregnancy is generally not recommended due to potential for neonatal opioid withdrawal syndrome (NOWS) in the newborn. Only use 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 use.
Third Trimester: High risk of NOWS if used chronically. Monitor neonate for signs of withdrawal (irritability, hyperactivity, abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, poor feeding, sweating, yawning, sneezing, fever).
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Lactation

Hydromorphone is excreted into breast milk. Use is generally not recommended. If use is necessary, monitor the infant for signs of sedation, respiratory depression, and poor feeding.

Infant Risk: L3 (Moderate risk) - Potential for sedation, respiratory depression, and withdrawal symptoms in breastfed infants. Consider alternative analgesics or pump and dump if short-term use is unavoidable. Monitor infant closely.
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Pediatric Use

Use with extreme caution due to increased sensitivity to respiratory depression. Dosing must be individualized and titrated carefully. Not recommended for neonates or infants due to lack of established safety and efficacy.

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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 4 mg/mL is a highly concentrated solution; ensure correct concentration is selected to avoid fatal medication errors, especially in opioid-naive patients.
  • Always dilute the 4 mg/mL concentration before IV administration unless specifically ordered otherwise for rapid bolus in opioid-tolerant patients.
  • Due to its rapid onset and short duration, hydromorphone is often preferred for acute, severe pain requiring quick titration.
  • Patients should be monitored closely for respiratory depression and sedation, especially within the first hour after IV administration.
  • Tolerance and physical dependence can develop with prolonged use. Do not discontinue abruptly after chronic use to avoid withdrawal symptoms.
  • Consider a bowel regimen (stool softener + stimulant laxative) proactively to prevent opioid-induced constipation.
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Alternative Therapies

  • Morphine (IV, SC, IM)
  • Fentanyl (IV, transdermal, transmucosal)
  • Oxycodone (oral)
  • Hydrocodone (oral)
  • Tramadol (oral)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts.
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Cost & Coverage

Average Cost: Varies widely 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 about its safe use. 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, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide information about the overdose, including the substance taken, the amount, and the time it occurred.

In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When seeking help, be prepared to provide details about the overdose, including the substance, quantity, and timing.