Hydromorphone 4mg/ml Inj, 1ml
Overview
What is this medicine?
How to Use This Medicine
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.
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.
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
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 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.
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)
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. 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.
Precautions & 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.
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
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).
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
Baseline Monitoring
Rationale: To establish baseline pain level 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 mental 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 assess risk for opioid-induced constipation.
Timing: Prior to first dose
Rationale: To guide dose adjustments in patients with organ impairment.
Timing: Prior to initiation, if impairment suspected
Routine Monitoring
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.
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.
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.
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.
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.
Symptom Monitoring
- Sedation
- Respiratory depression (slow, shallow breathing)
- Nausea
- Vomiting
- Constipation
- Pruritus
- Dizziness
- Lightheadedness
- Confusion
- Urinary retention
Special Patient Groups
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:
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.
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.
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
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.
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.
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 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.