Hydromorphone 8mg 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
Not available
FDA Approved
Mar 2010
DEA Schedule
Schedule II
Overview
What is this medicine?
Hydromorphone extended-release tablets are a strong opioid pain medicine used to manage severe and persistent pain that requires around-the-clock treatment and cannot be managed by other pain medicines. It is an extended-release medicine, meaning it releases slowly over 24 hours. It is only for patients who are already used to taking opioid pain medicines.
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 adhere to the guidelines.
Take this medication with or without food, but if it causes stomach upset, take it with food.
Always take this medication by mouth. 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 cause severe side effects and death.
Important Usage Considerations
Do not use this medication for quick pain relief or on an as-needed basis.
If you have not been taking medications like this one, do not use it for pain relief after surgery.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and in a dry place. Avoid storing it in a bathroom.
Keep your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to safeguard your medication.
Keep all medications away from pets.
Missing a Dose
If you miss a dose, skip it and return to 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 adhere to the guidelines.
Take this medication with or without food, but if it causes stomach upset, take it with food.
Always take this medication by mouth. 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 cause severe side effects and death.
Important Usage Considerations
Do not use this medication for quick pain relief or on an as-needed basis.
If you have not been taking medications like this one, do not use it for pain relief after surgery.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and in a dry place. Avoid storing it in a bathroom.
Keep your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to safeguard your medication.
Keep all medications away from pets.
Missing a Dose
If you miss a dose, skip it and return to 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 medicine, as it can cause dangerous side effects.
- Avoid driving or operating heavy machinery until you know how this medicine affects you, as it can cause drowsiness and dizziness.
- Take this medicine exactly as prescribed; do not crush, chew, or dissolve the tablet, as this can lead to a dangerous overdose.
- Store this medicine securely away from children and pets, as accidental ingestion can be fatal.
- Discuss a bowel regimen with your doctor to prevent constipation, a common side effect of opioids.
- Inform your doctor or pharmacist about all other medications you are taking, including over-the-counter drugs, herbal supplements, and illicit drugs.
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 prior opioid exposure and tolerance. Typically initiated at 8 mg once daily for opioid-tolerant patients, or converted from other opioids using an equianalgesic conversion table.
Dose Range:
8 - 64 mg
Condition-Specific Dosing:
opioidTolerantPatients:
Initial dose of 8 mg once daily. Doses should be titrated slowly, no more frequently than every 3-4 days, in increments of 4 mg to 8 mg once daily, to achieve adequate analgesia with acceptable tolerability. Maximum recommended dose is 64 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment for mild impairment, but monitor closely for adverse effects.
Moderate:
Reduce initial dose by 50% (e.g., 4 mg once daily) and titrate cautiously. Monitor closely for respiratory depression and sedation.
Severe:
Reduce initial dose by 75% (e.g., 2 mg once daily) and titrate very cautiously. Not recommended for severe impairment unless benefits outweigh risks and close monitoring is feasible.
Dialysis:
Not recommended for use in patients on dialysis due to accumulation of parent drug and active metabolites. If used, extreme caution and significant dose reduction are required.
Hepatic Impairment:
Mild:
No specific dose adjustment for mild impairment, but monitor closely for adverse effects.
Moderate:
Reduce initial dose by 50% (e.g., 4 mg once daily) and titrate cautiously. Monitor closely for respiratory depression and sedation.
Severe:
Reduce initial dose by 75% (e.g., 2 mg once daily) and titrate very cautiously. Not recommended for severe impairment unless benefits outweigh risks and close monitoring is feasible.
Pharmacology
Mechanism of Action
Hydromorphone is a full opioid agonist that acts primarily at the mu-opioid receptor, producing analgesia by binding to opioid receptors in the central nervous system (CNS) and other tissues. Its actions include inhibition of ascending pain pathways, altering the perception of and response to pain, and producing generalized CNS depression.
Pharmacokinetics
Absorption:
Bioavailability:
20-60% (oral, variable)
Tmax:
12-16 hours (for ER formulation)
FoodEffect:
Food does not significantly affect the extent of absorption (AUC) but may slightly delay Tmax.
Distribution:
Vd:
4 L/kg
ProteinBinding:
8-19%
CnssPenetration:
Yes
Elimination:
HalfLife:
18-22 hours (for ER formulation)
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (primarily as H3G)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Not applicable for ER (designed for sustained release, not rapid onset for acute pain)
PeakEffect:
12-16 hours (for ER formulation)
DurationOfAction:
24 hours (for ER formulation)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION (Note: Hydromorphone is not significantly metabolized by CYP3A4, but this warning is common for many opioids and should be checked against the specific product label); RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
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
+ Trouble 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
+ Feeling weak, shaking, or having a fast heartbeat
+ Confusion, hunger, or 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:
+ Trouble breathing
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Hallucinations (seeing or hearing things that are not there)
Mood changes or unstable emotions
Seizures or convulsions
Shakiness or tremors
Difficulty urinating or controlling bladder function
Uncontrolled eye movements or body movements
Changes in vision or balance
Chest pain or pressure
Memory problems or loss
Thoughts of self-harm or suicidal ideation
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 restlessness
Changes in balance or coordination
Confusion or disorientation
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing or sweating
Muscle twitching or stiffness
Seizures or convulsions
Shivering or shaking
Severe diarrhea, nausea, or vomiting
Severe headache
Long-Term Use and Hormonal Changes
Prolonged 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
Irregular or absent menstrual periods
Ejaculation problems
Other Possible Side Effects
While many people may not experience any side effects or only mild 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
Flushing or sweating
Headache
Itching or skin irritation
Sleep disturbances
Joint pain or stiffness
If you notice any of these side effects or have concerns about your medication, talk to your doctor. 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
+ Trouble 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
+ Feeling weak, shaking, or having a fast heartbeat
+ Confusion, hunger, or 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:
+ Trouble breathing
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Hallucinations (seeing or hearing things that are not there)
Mood changes or unstable emotions
Seizures or convulsions
Shakiness or tremors
Difficulty urinating or controlling bladder function
Uncontrolled eye movements or body movements
Changes in vision or balance
Chest pain or pressure
Memory problems or loss
Thoughts of self-harm or suicidal ideation
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 restlessness
Changes in balance or coordination
Confusion or disorientation
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing or sweating
Muscle twitching or stiffness
Seizures or convulsions
Shivering or shaking
Severe diarrhea, nausea, or vomiting
Severe headache
Long-Term Use and Hormonal Changes
Prolonged 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
Irregular or absent menstrual periods
Ejaculation problems
Other Possible Side Effects
While many people may not experience any side effects or only mild 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
Flushing or sweating
Headache
Itching or skin irritation
Sleep disturbances
Joint pain or stiffness
If you notice any of these side effects or have concerns about your medication, talk to your doctor. 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 dizziness
- Feeling faint or lightheaded
- Confusion or disorientation
- Bluish lips or fingernails
- Severe constipation or abdominal pain
- Signs of allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
- Signs 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.
Existing health conditions, such as:
+ Respiratory problems (e.g., asthma, breathing difficulties, sleep apnea)
+ High levels of carbon dioxide in the blood
+ Stomach or bowel blockage or narrowing
Recent use (within the last 14 days) of certain 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 any of the following medications: 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, such as:
+ Small bowel disease
+ Short gut syndrome
+ Slow-moving esophagus or bowel tract
* History of certain health conditions, including:
+ Cystic fibrosis
+ Long-term bowel pseudo-block
+ Meckel's diverticulum
+ Peritonitis
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems. Verify that it is safe to take this medication with your existing medications and health conditions. Do not initiate, stop, or modify the dosage 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.
Existing health conditions, such as:
+ Respiratory problems (e.g., asthma, breathing difficulties, sleep apnea)
+ High levels of carbon dioxide in the blood
+ Stomach or bowel blockage or narrowing
Recent use (within the last 14 days) of certain 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 any of the following medications: 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, such as:
+ Small bowel disease
+ Short gut syndrome
+ Slow-moving esophagus or bowel tract
* History of certain health conditions, including:
+ Cystic fibrosis
+ Long-term bowel pseudo-block
+ Meckel's diverticulum
+ Peritonitis
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems. Verify that it is safe to take this medication with your existing medications and health conditions. Do not initiate, stop, or modify the dosage 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, rise 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, as taking more than recommended may increase the risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring and Follow-up
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose. 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, inform your doctor, as some products may contain sulfites. Do not consume alcohol or products containing alcohol while taking this medication, as it may lead to unsafe and potentially fatal 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. Additionally, 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.
Seizure Risk and Adrenal Gland Problems
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor. Furthermore, 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.
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, rise 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, as taking more than recommended may increase the risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring and Follow-up
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose. 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, inform your doctor, as some products may contain sulfites. Do not consume alcohol or products containing alcohol while taking this medication, as it may lead to unsafe and potentially fatal 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. Additionally, 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.
Seizure Risk and Adrenal Gland Problems
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor. Furthermore, 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.
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. Administer naloxone if available and trained to do so. Call 1-800-222-1222 (Poison Control) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or use within 14 days of MAOI therapy (risk of serotonin syndrome or severe respiratory depression)
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected paralytic ileus
- Hypersensitivity to hydromorphone or any component of the formulation
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol) - increased risk of profound sedation, respiratory depression, coma, and death.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, fentanyl, St. John's Wort) - potential for serotonin syndrome (though less common with hydromorphone than other opioids).
- Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants) - increased risk of urinary retention and severe constipation, potentially paralytic ileus.
- Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol) or partial agonist opioids (e.g., buprenorphine) - may reduce the analgesic effect of hydromorphone or precipitate withdrawal symptoms.
Moderate Interactions
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pain assessment (intensity, character, location)
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 neurological status and identify risk factors for excessive sedation.
Timing: Prior to initiation of therapy
Bowel function (frequency, consistency)
Rationale: To establish baseline and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy
Renal and hepatic function tests (e.g., BUN, creatinine, LFTs)
Rationale: To identify impairment that may necessitate dose adjustment.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain level and relief
Frequency: Daily or as needed during titration, then regularly (e.g., weekly/monthly) during maintenance
Target: Acceptable pain control with minimal side effects
Action Threshold: Inadequate pain control or excessive side effects warrant dose adjustment or re-evaluation.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration (e.g., every 4-8 hours initially, then daily)
Target: 12-20 breaths/minute (adults), regular rhythm
Action Threshold: <10 breaths/minute, shallow breathing, or signs of hypoventilation (e.g., cyanosis, somnolence) require immediate intervention.
Level of sedation (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Regularly, especially during initiation and dose titration (e.g., every 4-8 hours initially, then daily)
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Difficult to arouse, somnolent, or unarousable requires immediate intervention.
Bowel function
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-2 days)
Action Threshold: Constipation (e.g., no bowel movement for >3 days) requires intervention with laxatives/stool softeners.
Signs of opioid abuse, misuse, or addiction
Frequency: At each visit
Target: Absence of aberrant drug-related behaviors
Action Threshold: Evidence of diversion, dose escalation without clinical need, or other concerning behaviors requires re-evaluation of treatment plan.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/somnolence
- Dizziness
- Nausea and vomiting
- Constipation
- Pruritus (itching)
- Urinary retention
- Confusion
- Signs of serotonin syndrome (agitation, hallucinations, tachycardia, fever, sweating, muscle rigidity, tremor, incoordination, nausea, vomiting, diarrhea)
- Signs of adrenal insufficiency (fatigue, weakness, anorexia, nausea, vomiting, hypotension)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended due to potential for neonatal opioid withdrawal syndrome (NOWS) and respiratory depression in the neonate. Benefits must clearly outweigh risks.
Trimester-Specific Risks:
First Trimester:
Limited data on major birth defects. Opioid use in early pregnancy may be associated with a small increased risk of certain birth defects (e.g., neural tube defects, congenital heart defects), but data are conflicting.
Second Trimester:
Risk of fetal growth restriction and preterm birth.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Risk of respiratory depression in the neonate if used near delivery.
Lactation
Hydromorphone is excreted into breast milk. Use is generally not recommended due to potential for serious adverse reactions in breastfed infants, including sedation, respiratory depression, and withdrawal symptoms. If use is unavoidable, monitor infant closely for signs of sedation and respiratory depression.
Infant Risk:
Sedation, respiratory depression, poor feeding, failure to thrive, and withdrawal symptoms (irritability, excessive crying, tremors, vomiting, diarrhea) in breastfed infants. Risk is higher with higher maternal doses or prolonged use.
Pediatric Use
Safety and effectiveness of hydromorphone extended-release tablets have not been established in pediatric patients. Not recommended for use in this population.
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.
Clinical Information
Clinical Pearls
- Hydromorphone ER is for opioid-tolerant patients only. Use in opioid-naïve patients can result in fatal respiratory depression.
- Do not crush, chew, or dissolve the tablets. This can lead to rapid release of a potentially fatal dose of hydromorphone.
- Patients should be educated on the risks of addiction, abuse, and misuse, and safe storage and disposal of the medication.
- Concomitant use with benzodiazepines or other CNS depressants significantly increases the risk of respiratory depression, sedation, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate.
- Monitor for signs of opioid-induced constipation and initiate a prophylactic bowel regimen.
- Due to the long half-life of the ER formulation, dose adjustments should not be made more frequently than every 3-4 days.
- Patients with renal or hepatic impairment require significant dose reductions and close monitoring due to altered metabolism and excretion.
Alternative Therapies
- Other extended-release opioid analgesics (e.g., oxycodone ER, morphine ER, fentanyl transdermal)
- Other strong opioid analgesics (e.g., oxycodone IR, morphine IR, fentanyl IR)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants, SNRIs) for neuropathic or chronic non-cancer pain
- Interventional pain management techniques (e.g., nerve blocks, spinal cord stimulation)
- Physical therapy, occupational therapy, psychological therapies (e.g., CBT)
Cost & Coverage
Average Cost:
Varies widely ($50 - $500+) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, do not share your medication with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe and effective use. It is essential to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of an overdose, a medication called naloxone can be used as an emergency treatment. Discuss the availability and use of naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, be prepared to provide details about the medication, including the dose and time it was taken, to ensure prompt and effective treatment.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe and effective use. It is essential to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of an overdose, a medication called naloxone can be used as an emergency treatment. Discuss the availability and use of naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, be prepared to provide details about the medication, including the dose and time it was taken, to ensure prompt and effective treatment.