Hydromorphone 16mg ER Tablets
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.Swallow whole. Do not chew, break, crush, or dissolve before swallowing. Doing these things can cause very bad side effects and death. @ COMMON USES: It is used to manage pain when daily pain treatment is needed for a long time. It is for use when non-opioid pain drugs do not treat your pain well enough or you cannot take them.
Drug Class
Opioid analgesic
Pharmacologic Class
Opioid agonist
Pregnancy Category
Category C/D (prolonged use in 3rd trimester)
FDA Approved
Mar 2010
DEA Schedule
Schedule II
Overview
What is this medicine?
Hydromorphone extended-release is a strong opioid pain medicine used to manage severe and long-lasting pain that requires around-the-clock treatment. It is not for occasional or 'as-needed' pain. Because it is a strong opioid, it carries risks of addiction, overdose, and serious breathing problems.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
Take the medication by mouth only. Do not inject or snort it, as this can lead to severe side effects, including breathing difficulties and overdose, which can be fatal.
Take your medication at the same time every day to establish a routine.
Swallow the medication whole. Do not chew, break, crush, or dissolve it before swallowing, as this can also cause severe side effects and increase the risk of death.
Important Usage Guidelines
Do not use this medication for rapid pain relief or on an as-needed basis.
If you are scheduled for surgery, do not use this medication for pain relief after the procedure if you have not been taking it regularly beforehand.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep the medication in a safe and secure location, out of the reach of children and pets. Consider using a locked box or area to prevent accidental access or misuse.
Keep all medications away from pets to avoid any potential harm.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
Take the medication by mouth only. Do not inject or snort it, as this can lead to severe side effects, including breathing difficulties and overdose, which can be fatal.
Take your medication at the same time every day to establish a routine.
Swallow the medication whole. Do not chew, break, crush, or dissolve it before swallowing, as this can also cause severe side effects and increase the risk of death.
Important Usage Guidelines
Do not use this medication for rapid pain relief or on an as-needed basis.
If you are scheduled for surgery, do not use this medication for pain relief after the procedure if you have not been taking it regularly beforehand.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep the medication in a safe and secure location, out of the reach of children and pets. Consider using a locked box or area to prevent accidental access or misuse.
Keep all medications away from pets to avoid any potential harm.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Do not drink alcohol while taking this medication, as it can increase the risk of serious side effects, including fatal overdose.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Take this medication exactly as prescribed; do not crush, chew, or dissolve the tablet, as this can lead to rapid release and a fatal overdose.
- Store this medication securely away from children and pets, and dispose of unused medication properly (e.g., drug take-back programs).
- Discuss a bowel regimen with your doctor to prevent constipation, a common side effect of opioids.
- Inform your doctor about all other medications you are taking, especially sedatives, tranquilizers, or other pain medications.
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
Standard Dose:
Individualized based on patient's opioid tolerance and pain severity. For opioid-tolerant patients, initial dose is typically 8 mg or 16 mg orally once daily, based on prior opioid intake.
Dose Range:
8 - 64 mg
Condition-Specific Dosing:
opioidTolerant:
Patients receiving at least 30 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 15 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer.
opioidNaive:
Not for use in opioid-naive patients due to risk of fatal respiratory depression. If conversion from other opioids, use equianalgesic tables carefully and initiate at the lowest possible dose.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
Use with caution, consider dose reduction.
Moderate:
Reduce initial dose by 50% and titrate slowly. Monitor closely for adverse effects.
Severe:
Reduce initial dose by 75% and titrate slowly. Monitor closely for adverse effects. Not recommended for severe impairment unless benefits outweigh risks.
Dialysis:
Not recommended. Hydromorphone is not significantly removed by dialysis. Accumulation of active metabolites may occur.
Hepatic Impairment:
Mild:
Use with caution, consider dose reduction.
Moderate:
Reduce initial dose by 50% and titrate slowly. Monitor closely for adverse effects.
Severe:
Reduce initial dose by 75% and titrate slowly. Monitor closely for adverse effects. Not recommended for severe impairment unless benefits outweigh risks.
Pharmacology
Mechanism of Action
Hydromorphone is a full opioid agonist, primarily acting at the mu-opioid receptors in the central nervous system (CNS). It produces analgesia by binding to these receptors, mimicking the effects of endogenous opioid peptides. This binding inhibits ascending pain pathways, altering the perception of and response to pain. It also produces CNS depression, respiratory depression, miosis, euphoria, and physical dependence.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 24-62% (oral, varies by formulation)
Tmax:
Approximately 12-16 hours (for ER formulation)
FoodEffect:
Food may increase absorption (AUC and Cmax) for some ER formulations; administer consistently with or without food.
Distribution:
Vd:
Approximately 4 L/kg
ProteinBinding:
Approximately 8-19%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 18-22 hours (for ER formulation)
Clearance:
Approximately 1.9 L/min
ExcretionRoute:
Renal (primarily as glucuronide conjugates)
Unchanged:
Less than 10%
Pharmacodynamics
OnsetOfAction:
Not for acute pain; steady-state plasma concentrations achieved after 3-4 days of once-daily dosing.
PeakEffect:
Not applicable for immediate pain relief; peak plasma levels reached at Tmax.
DurationOfAction:
24 hours (due to extended-release formulation)
Safety & Warnings
BLACK BOX WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION (not primary for hydromorphone, but common for opioids); RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; and REMS. Hydromorphone Extended-Release Tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Serious, life-threatening, or fatal respiratory depression may occur. Accidental ingestion of even one dose can result in a fatal overdose. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome. Concomitant use with benzodiazepines or other CNS depressants may result in profound sedation, respiratory depression, coma, and death. Because of these risks, it is reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are inadequate or not tolerated.
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness or lightheadedness
+ Headache or feeling sleepy or weak
+ Shaking or rapid heartbeat
+ Confusion, hunger, or excessive sweating
Severe dizziness or fainting
Confusion or disorientation
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 or seizures
Shakiness or tremors
Difficulty urinating
Uncontrolled eye movements or body movements
Changes in vision
Chest pain or pressure
Balance problems or memory 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 or changes in balance
Confusion or hallucinations
Fever or abnormal heartbeat
Flushing or muscle twitching/stiffness
Seizures or shivering/shaking
Excessive sweating or 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 any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Dizziness, drowsiness, fatigue, or weakness
Dry mouth or excessive sweating
Flushing or headache
Itching or joint pain
Sleep disturbances
If you notice any of these side effects or any other unusual symptoms, contact your doctor for guidance. You may also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness or lightheadedness
+ Headache or feeling sleepy or weak
+ Shaking or rapid heartbeat
+ Confusion, hunger, or excessive sweating
Severe dizziness or fainting
Confusion or disorientation
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 or seizures
Shakiness or tremors
Difficulty urinating
Uncontrolled eye movements or body movements
Changes in vision
Chest pain or pressure
Balance problems or memory 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 or changes in balance
Confusion or hallucinations
Fever or abnormal heartbeat
Flushing or muscle twitching/stiffness
Seizures or shivering/shaking
Excessive sweating or 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 any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Dizziness, drowsiness, fatigue, or weakness
Dry mouth or excessive sweating
Flushing or headache
Itching or joint pain
Sleep disturbances
If you notice any of these side effects or any other unusual symptoms, contact your doctor for guidance. You may 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, shallow, or difficult breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Severe constipation that does not improve
- Confusion or unusual thoughts
- Signs of an allergic reaction (hives, rash, swelling of face/lips/tongue/throat)
- Symptoms of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea)
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. Describe the allergic reaction and its symptoms.
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
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
If you are breastfeeding, as you should not breastfeed while taking this medication
Presence of gastrointestinal (GI) tract narrowing or other GI problems, including small bowel disease, short gut syndrome, or slow-moving esophagus or bowel tract
* History of certain health conditions, such as cystic fibrosis, long-term bowel pseudo-block, Meckel's diverticulum, or peritonitis
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. Ensure that it is safe to take this medication with your existing medications and health conditions. Do not initiate, stop, or modify the dose of any medication without consulting 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. Describe the allergic reaction and its symptoms.
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
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
If you are breastfeeding, as you should not breastfeed while taking this medication
Presence of gastrointestinal (GI) tract narrowing or other GI problems, including small bowel disease, short gut syndrome, or slow-moving esophagus or bowel tract
* History of certain health conditions, such as cystic fibrosis, long-term bowel pseudo-block, Meckel's diverticulum, or peritonitis
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. Ensure that it is safe to take this medication with your existing medications and health conditions. Do not initiate, stop, or modify the dose of any medication without consulting your doctor.
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
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may increase your risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without first consulting your doctor.
Monitoring and Follow-up
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed amount. If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.
Allergies and Interactions
If you are allergic to sulfites, discuss this with your doctor, as some products may contain sulfites. Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal effects.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and you may require 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 amount. Furthermore, regular use of opioid medications like this one can result in dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as suddenly stopping or lowering the dose can increase the risk of withdrawal or other severe problems.
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 can 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 for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
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
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may increase your risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without first consulting your doctor.
Monitoring and Follow-up
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed amount. If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.
Allergies and Interactions
If you are allergic to sulfites, discuss this with your doctor, as some products may contain sulfites. Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal effects.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and you may require 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 amount. Furthermore, regular use of opioid medications like this one can result in dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as suddenly stopping or lowering the dose can increase the risk of withdrawal or other severe problems.
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 can 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 for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Overdose Information
Overdose Symptoms:
- Pinpoint pupils
- Slowed or stopped breathing
- Extreme drowsiness or unresponsiveness
- Limp muscles
- Cold, clammy skin
- Bluish discoloration of lips and fingernails
- Loss of consciousness
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 for poison control advice.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, alcohol)
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid, methylene blue) - risk of serotonin syndrome
- Anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, antipsychotics, muscle relaxants) - risk of severe constipation and/or paralytic ileus
Moderate Interactions
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pain assessment (intensity, location, quality)
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 and identify risk factors for respiratory depression.
Timing: Prior to initiation of therapy
Level of consciousness/sedation
Rationale: To assess baseline mental status and identify risk factors for excessive sedation.
Timing: Prior to initiation of therapy
Bowel function
Rationale: To assess baseline bowel habits and plan for constipation prophylaxis.
Timing: Prior to initiation of therapy
Renal and hepatic function tests (e.g., CrCl, LFTs)
Rationale: To identify impairment that may require dose adjustment.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain assessment
Frequency: Regularly, especially during titration and with any change in dose; at least monthly for chronic therapy.
Target: Acceptable pain control with minimal adverse effects.
Action Threshold: Uncontrolled pain or unacceptable side effects warrant dose adjustment or re-evaluation.
Respiratory rate and depth
Frequency: Frequently during initiation and titration; periodically during stable therapy.
Target: Normal respiratory rate (e.g., 12-20 breaths/min) with adequate depth.
Action Threshold: Respiratory rate < 10 breaths/min, shallow breathing, or signs of hypoventilation (e.g., cyanosis, somnolence) require immediate intervention.
Level of consciousness/sedation
Frequency: Frequently during initiation and titration; periodically during stable therapy.
Target: Alert and oriented, able to participate in activities of daily living.
Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolence interfering with function) requires dose reduction or discontinuation.
Bowel function
Frequency: Daily, especially during initiation.
Target: Regular bowel movements (e.g., every 1-2 days).
Action Threshold: Constipation (e.g., no bowel movement for >3 days, straining, hard stools) requires intervention with laxatives or other bowel regimen.
Signs of opioid abuse, misuse, or addiction
Frequency: At every patient encounter.
Target: Absence of aberrant drug-related behaviors.
Action Threshold: Evidence of diversion, selling drugs, multiple prescribers, or escalating use requires intervention and potential discontinuation.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing; extreme drowsiness; difficulty waking up)
- Excessive sedation/somnolence
- Constipation (severe, persistent)
- Nausea and vomiting
- Dizziness/lightheadedness
- Pruritus (itching)
- Signs of allergic reaction (rash, swelling, difficulty breathing)
- Symptoms of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, loss of coordination, nausea, vomiting, diarrhea)
- Adrenal insufficiency (fatigue, weakness, dizziness, nausea, vomiting, loss of appetite)
Special Patient Groups
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. Use during labor may cause respiratory depression in the neonate. Generally, Category C, but becomes Category D with prolonged use in the third trimester due to NOWS risk.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure. Risk generally considered low.
Second Trimester:
Risk of NOWS increases with prolonged exposure. Monitor for signs of fetal distress.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used for prolonged periods. Monitor neonate for signs of withdrawal (irritability, hyperactivity, abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, poor feeding, sweating, yawning, sneezing, nasal stuffiness, fever).
Lactation
Hydromorphone is excreted into breast milk. Infants exposed through breast milk are at risk for serious adverse reactions, including excess sedation and respiratory depression. Monitor infants for signs of sedation, respiratory depression, and poor feeding. Consider alternative pain management or temporary discontinuation of breastfeeding.
Infant Risk:
Moderate risk (L3) - potential for sedation, respiratory depression, and withdrawal symptoms in the infant.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Hydromorphone extended-release is not recommended for use in patients younger than 18 years of age due to the risk of fatal respiratory depression.
Geriatric Use
Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, including respiratory depression. Start with lower doses and titrate slowly. Monitor closely for sedation, respiratory depression, and constipation. Consider age-related decreases in renal and hepatic function.
Clinical Information
Clinical Pearls
- Hydromorphone ER is for opioid-tolerant patients only. Use in opioid-naive patients can result in fatal respiratory depression.
- Do not crush, chew, or dissolve the tablets. This can lead to rapid release of hydromorphone and a potentially fatal overdose.
- This formulation is for chronic, severe pain requiring continuous, around-the-clock opioid analgesia, not for as-needed pain or acute pain.
- Patients should be educated on the risks of addiction, abuse, and misuse, and proper storage and disposal of the medication.
- Concomitant use with benzodiazepines or other CNS depressants should be avoided or used with extreme caution due to increased risk of respiratory depression, sedation, coma, and death.
- Monitor for signs of opioid-induced constipation and implement a prophylactic bowel regimen.
- Be aware of the potential for opioid-induced hyperalgesia with long-term, high-dose opioid therapy.
Alternative Therapies
- Other extended-release opioid analgesics (e.g., Morphine ER, Oxycodone ER, Fentanyl transdermal)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts
- Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants) for neuropathic pain
- Interventional pain management techniques
- Physical therapy, occupational therapy, psychological therapies
Cost & Coverage
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (requires prior authorization for many plans)
General Drug Facts
If your symptoms or health problems do not improve or worsen, contact your doctor immediately. It is essential to use your medication responsibly: do not share it with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract its effects. 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 detailed 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 information about what was taken, the quantity, and the time of the incident.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract its effects. 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 detailed 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 information about what was taken, the quantity, and the time of the incident.