Hydromorphone 2mg/ml Inj, 1ml
Overview
What is this medicine?
How to Use This Medicine
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.
If you miss a dose, contact your doctor immediately to receive guidance on the next steps to take.
Lifestyle & Tips
- Avoid alcohol and other sedating medications (like sleeping pills, anxiety medications) unless specifically approved by your doctor, as this can lead to dangerous breathing problems.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Report any difficulty breathing, extreme drowsiness, or feeling faint immediately to a healthcare professional.
- To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and discuss a bowel regimen with your doctor or nurse.
Available Forms & Alternatives
Available Strengths:
- Hydromorphone 3mg Rectal Supp
- Hydromorphone 2mg/ml Inj, 20ml Vial
- Hydromorphone 4mg Tablets
- Hydromorphone Hcl 2mg Tablets
- Hydromorphone 8mg Tablets
- Hydromorphone 4mg/ml Inj, 1ml
- Hydromorphone 2mg/ml Inj, 1ml (pf)
- Hydromorphone 10mg/ml Inj, 5ml
- Hydromorphone 50mg/5ml Inj, 5ml
- Hydromorphone 1mg/ml Liquid
- Hydromorphone 1mg/ml Inj, 1ml
- Hydromorphone 10mg/ml Inj, 1ml
- Hydromorphone 10mg/ml Inj, 50ml
- Hydromorphone 2mg/ml Inj, 1ml
- Hydromorphone 32mg ER Tablets
- Hydromorphone 8mg ER Tablets
- Hydromorphone 12mg ER Tablets
- Hydromorphone 16mg ER Tablets
- Hydromorphone 1mg/ml Pf Inj, 0.5ml
- Hydromorphone 0.25mg/0.5ml Pf Inj
- Hydromorphone 0.2mg/ml Pf Inj, 1ml
- Hydromorphone 8mg ER Tablets
- Hydromorphone 16mg ER Tablets
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Addiction, Abuse, and Misuse: Hydromorphone Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientβs risk prior to prescribing hydromorphone, and monitor all patients regularly for the development of these behaviors and conditions.
REMS: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.
Accidental Ingestion: Accidental ingestion of hydromorphone injection, especially by children, can result in a fatal overdose.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of hydromorphone injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Feeling confused
Severe constipation or stomach pain, which may indicate a severe bowel problem
Abnormal heartbeat (fast, slow, or irregular)
Breathing difficulties, including:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Seizures
Shakiness
Trouble passing urine
Inability to control eye movements
Trouble controlling body movements
Changes in eyesight
Chest pain or pressure
Changes in balance
Memory problems or loss
Thoughts of self-harm or suicide
Swelling in the arms or legs
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Vomiting
Severe headache
Long-Term Use and Hormonal Changes
Long-term use of opioid medications like this one may lead to lower sex hormone levels. If you experience any of the following symptoms, contact your doctor:
Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following possible side effects:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dizziness
Sleepiness
Tiredness
Weakness
Dry mouth
Flushing
Excessive sweating
Headache
Itching
* Trouble sleeping
If any of these side effects bother you or persist, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Slow or shallow breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion or disorientation
- Blue-tinged lips or skin
- Severe constipation or inability to pass urine
- Signs of an allergic reaction (rash, itching, swelling of face/lips/tongue)
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems, such as asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of severely high blood pressure
If you are currently taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.
Adhere strictly to your doctor's prescribed dosage and frequency. Taking more than prescribed, or taking it more often or for a longer duration, can increase the risk of severe side effects.
Do not combine this medication with other strong pain medications or use a pain patch without first consulting your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not exceed the prescribed dosage.
If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your health. Discuss this with your doctor.
If you have a sulfite allergy, inform your doctor, as some formulations of this medication may contain sulfites.
Avoid consuming alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal interactions.
Long-term or high-dose use of this medication can lead to tolerance, reducing its effectiveness. If you find that this medication is no longer working as well as it did initially, contact your doctor. Do not increase your dosage without medical guidance.
Prolonged or regular use of opioid medications like this one can result in dependence. Suddenly lowering your dose or stopping this medication can increase the risk of withdrawal or other severe complications. Consult your doctor before making any changes to your dosage. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
This medication may increase the risk of seizures, particularly in individuals with a history of seizure disorders. Discuss your risk with your doctor.
Opioid medications like this one can rarely cause a severe adrenal gland problem. Seek immediate medical attention if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and potentially harm your baby. Seek medical help immediately if your baby appears overly sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Pinpoint pupils
- Slowed or stopped breathing (respiratory depression)
- Extreme drowsiness, unresponsiveness, or coma
- Limp muscles
- Cold, clammy skin
- Slowed heart rate
- Low blood pressure
What to Do:
Seek immediate emergency medical attention. Call 911 or your local emergency number. If naloxone (Narcan) is available and you are trained to use it, administer it as directed. Stay with the person until emergency help arrives. Call 1-800-222-1222 (Poison Control) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome or severe respiratory depression)
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): Risk of serotonin syndrome.
- Mixed agonist/antagonist and partial agonist opioids (e.g., butorphanol, nalbuphine, pentazocine, buprenorphine): May reduce the analgesic effect of hydromorphone or precipitate withdrawal symptoms.
Moderate Interactions
- Anticholinergics: Increased risk of urinary retention and/or severe constipation.
- Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
- Antihypertensives: May cause additive hypotensive effects.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To establish baseline pain severity and guide initial dosing.
Timing: Prior to first dose
Rationale: To assess baseline respiratory function and identify risk for respiratory depression.
Timing: Prior to first dose
Rationale: To assess baseline CNS status and identify risk for over-sedation.
Timing: Prior to first dose
Rationale: To assess baseline cardiovascular status.
Timing: Prior to first dose
Rationale: To anticipate and manage opioid-induced constipation.
Timing: Prior to first dose
Routine Monitoring
Frequency: Every 1-2 hours initially, then as needed based on patient response and pain control.
Target: Acceptable pain level as defined by patient and clinician.
Action Threshold: Uncontrolled pain or adverse effects warranting dose adjustment.
Frequency: Every 15-30 minutes for the first hour after IV dose, then every 1-2 hours or as clinically indicated.
Target: >10-12 breaths/min, regular rhythm, adequate depth.
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of respiratory distress (e.g., cyanosis, labored breathing).
Frequency: Every 15-30 minutes for the first hour after IV dose, then every 1-2 hours or as clinically indicated.
Target: Awake and alert or mildly drowsy, easily aroused.
Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolent, unresponsive).
Frequency: Periodically, especially with initial doses or dose escalations.
Target: Within patient's normal range.
Action Threshold: Significant hypotension or bradycardia.
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-3 days).
Action Threshold: Constipation (no bowel movement for >3 days, straining, hard stools).
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation or somnolence
- Dizziness, lightheadedness
- Nausea, vomiting
- Constipation
- Pruritus (itching)
- Urinary retention
- Hypotension
- Signs of allergic reaction (rash, hives, swelling)
Special Patient Groups
Pregnancy
Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening if not treated. Use only if the potential benefit justifies the potential risk to the fetus. Monitor neonates for signs of NOWS.
Trimester-Specific Risks:
Lactation
Hydromorphone is excreted in breast milk. Monitor breastfed infants for signs of sedation, respiratory depression, poor feeding, and poor weight gain. Short-term, single-dose use may be acceptable with close infant monitoring. Chronic use is generally not recommended.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is generally not recommended due to the high risk of respiratory depression and other adverse effects, especially in opioid-naive children. If used, extreme caution, careful titration, and close monitoring are essential.
Geriatric Use
Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, including respiratory depression, sedation, and constipation. Start with lower doses and titrate slowly. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Hydromorphone is a potent opioid; ensure appropriate dose selection, especially in opioid-naive patients, to avoid overdose and respiratory depression.
- Always have naloxone readily available when administering hydromorphone, especially in acute care settings.
- Be aware of the potential for rapid onset and short duration of action with IV hydromorphone, which may lead to frequent redosing if not managed appropriately.
- Educate patients and caregivers about the signs of respiratory depression and over-sedation.
- Proactive management of opioid-induced constipation is crucial for patients receiving hydromorphone.
- Tolerance and physical dependence can develop with prolonged use; discuss tapering strategies if long-term use is anticipated.
Alternative Therapies
- Other strong opioid analgesics (e.g., Morphine, Fentanyl, Oxycodone)
- Non-opioid analgesics (e.g., NSAIDs, Acetaminophen) for less severe pain or as adjuncts
- Regional anesthesia (e.g., nerve blocks, epidural analgesia)
- Non-pharmacological pain management techniques (e.g., physical therapy, heat/cold therapy, massage, acupuncture, cognitive behavioral therapy)
Cost & Coverage
General Drug Facts
To ensure safe use, keep the following guidelines in mind:
Do not share your medication with others, and never take someone else's medication.
Store all medications in a secure location, out of reach of children and pets.
* Properly dispose of unused or expired medications. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you have questions about the best disposal method, consult your pharmacist. You may also want to explore local drug take-back programs.
This medication is accompanied by a Medication Guide, which provides important information about its use. Read this guide carefully and review it again each time you receive a refill. If you have any questions or concerns about this medication, discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be used as part of the treatment. Talk to your doctor or pharmacist about obtaining and using naloxone. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide information about the medication taken, the amount, and the time it was taken.
If you think an overdose has occurred, contact your local poison control center or seek medical attention right away. Have the following information available: the name of the medication, the amount taken, and the time of ingestion.