Hydromorphone 12mg 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
Aug 2004
DEA Schedule
Schedule II
Overview
What is this medicine?
Hydromorphone extended-release is a strong opioid pain medicine used to manage severe and persistent pain that requires around-the-clock treatment for a long time. It is an extended-release tablet, meaning it releases the medicine slowly over 24 hours. It is NOT for pain that you can control with other medicines or for pain after surgery. It is only for people 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 also cause severe side effects and death.
Important Usage Guidelines
Do not use this medication for rapid 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 ensure safety.
* 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 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 also cause severe side effects and death.
Important Usage Guidelines
Do not use this medication for rapid 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 ensure safety.
* 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.
Lifestyle & Tips
- Take exactly as prescribed; do not crush, chew, or dissolve the tablet, as this can lead to a rapid release of a fatal dose.
- Do not consume alcohol while taking this medication, as it can cause a dangerous increase in drug levels.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Store this medication securely away from children and pets, as accidental ingestion can be fatal.
- Discuss all other medications, including over-the-counter drugs, herbal supplements, and illicit drugs, with your doctor to avoid dangerous interactions.
- Maintain regular bowel habits with adequate fluid intake, fiber, and possibly laxatives to prevent constipation.
- Do not stop taking this medication suddenly without consulting your doctor, as it can lead to withdrawal symptoms.
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. For opioid-tolerant patients, initial dose should be based on conversion from previous opioid. Typically administered once daily.
Dose Range:
4 - 64 mg
Condition-Specific Dosing:
opioid_naive:
Hydromorphone ER is NOT for opioid-naive patients. Use immediate-release opioids for titration.
conversion_from_other_opioids:
Consult product labeling for equianalgesic conversion tables. Start with a conservative dose and titrate slowly.
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:
Use with caution, consider dose reduction and extended dosing interval.
Severe:
Contraindicated in severe renal impairment (CrCl < 30 mL/min) due to accumulation of active and inactive metabolites.
Dialysis:
Not recommended. Hydromorphone is not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
Use with caution, consider dose reduction.
Moderate:
Use with caution, consider dose reduction and extended dosing interval.
Severe:
Contraindicated in severe hepatic impairment due to increased systemic exposure.
Pharmacology
Mechanism of Action
Hydromorphone is a full opioid agonist, primarily acting at the mu-opioid receptor. Its analgesic effects are mediated by binding to mu-opioid receptors in the central nervous system (CNS), leading to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces CNS depression, respiratory depression, and gastrointestinal motility reduction.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 24-62% (oral)
Tmax:
12-16 hours (extended-release)
FoodEffect:
Food does not significantly affect the extent of absorption but may slightly delay Tmax.
Distribution:
Vd:
4 L/kg
ProteinBinding:
Approximately 8-19%
CnssPenetration:
Yes
Elimination:
HalfLife:
18-22 hours (extended-release)
Clearance:
Approximately 1.9 L/min
ExcretionRoute:
Renal (primarily as H3G)
Unchanged:
Less than 10%
Pharmacodynamics
OnsetOfAction:
Not applicable for ER formulation for acute pain relief; steady-state concentrations are reached after several days of dosing.
PeakEffect:
12-16 hours (based on Tmax)
DurationOfAction:
24 hours
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; ALCOHOL INTERACTION.
Addiction, Abuse, and Misuse: 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. Assess each patient’s risk prior to prescribing Hydromorphone Extended-Release Tablets, and monitor all patients regularly for the development of these behaviors and conditions.
Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of Hydromorphone Extended-Release Tablets or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose of Hydromorphone Extended-Release Tablets, especially by children, can result in a fatal overdose of hydromorphone.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of Hydromorphone Extended-Release Tablets 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.
Cytochrome P450 3A4 Interaction: The concomitant use of Hydromorphone Extended-Release Tablets with all cytochrome P450 3A4 inhibitors may result in an increase in hydromorphone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydromorphone plasma concentration. Monitor patients receiving Hydromorphone Extended-Release Tablets and any CYP3A4 inhibitor or inducer.
Alcohol Interaction: Concomitant use of alcohol with Hydromorphone Extended-Release Tablets can result in an increase in hydromorphone plasma levels and a potentially fatal overdose of hydromorphone.
Addiction, Abuse, and Misuse: 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. Assess each patient’s risk prior to prescribing Hydromorphone Extended-Release Tablets, and monitor all patients regularly for the development of these behaviors and conditions.
Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of Hydromorphone Extended-Release Tablets or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose of Hydromorphone Extended-Release Tablets, especially by children, can result in a fatal overdose of hydromorphone.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of Hydromorphone Extended-Release Tablets 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.
Cytochrome P450 3A4 Interaction: The concomitant use of Hydromorphone Extended-Release Tablets with all cytochrome P450 3A4 inhibitors may result in an increase in hydromorphone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydromorphone plasma concentration. Monitor patients receiving Hydromorphone Extended-Release Tablets and any CYP3A4 inhibitor or inducer.
Alcohol Interaction: Concomitant use of alcohol with Hydromorphone Extended-Release Tablets can result in an increase in hydromorphone plasma levels and a potentially fatal overdose of hydromorphone.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash 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 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:
+ 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 Rare but Serious Condition
If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a potentially life-threatening condition. Seek immediate medical attention if you experience:
Agitation or changes in balance
Confusion or hallucinations
Fever or abnormal heartbeat
Flushing or muscle twitching or 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 menstrual periods or infertility
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:
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Dizziness, drowsiness, fatigue, or weakness
Dry mouth or flushing
Excessive sweating or headache
Itching or difficulty sleeping
Joint pain
What to Expect
You may notice something that looks like the tablet in your stool. This is normal and not a cause for concern. If you have any questions or concerns about side effects, discuss them with your doctor.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and answering any questions you may have.
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 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 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:
+ 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 Rare but Serious Condition
If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a potentially life-threatening condition. Seek immediate medical attention if you experience:
Agitation or changes in balance
Confusion or hallucinations
Fever or abnormal heartbeat
Flushing or muscle twitching or 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 menstrual periods or infertility
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:
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Dizziness, drowsiness, fatigue, or weakness
Dry mouth or flushing
Excessive sweating or headache
Itching or difficulty sleeping
Joint pain
What to Expect
You may notice something that looks like the tablet in your stool. This is normal and not a cause for concern. If you have any questions or concerns about side effects, discuss them with your doctor.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and answering any questions you may have.
Seek Immediate Medical Attention If You Experience:
- Slow, shallow, or difficult breathing
- Extreme drowsiness or dizziness
- Feeling faint or lightheaded
- Confusion
- Bluish lips or fingernails
- Severe constipation or abdominal pain
- Difficulty urinating
- Signs of allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
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 conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
Respiratory issues, such as asthma, breathing difficulties, or sleep apnea.
Elevated carbon dioxide levels in the blood.
Stomach or bowel obstruction or narrowing.
Additionally, notify your doctor if:
You have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
You are currently taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
If you are breast-feeding, please note that you should not breast-feed while taking this medication.
Also, inform your doctor about any gastrointestinal problems, such as:
Narrowing of the gastrointestinal tract
Small bowel disease
Short gut syndrome
Slow-moving esophagus or bowel tract
Furthermore, disclose any history of:
Cystic fibrosis
Long-term bowel pseudo-block
Meckel's diverticulum
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 conditions with your doctor and pharmacist to ensure safe treatment. Do not initiate, stop, or modify any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
Respiratory issues, such as asthma, breathing difficulties, or sleep apnea.
Elevated carbon dioxide levels in the blood.
Stomach or bowel obstruction or narrowing.
Additionally, notify your doctor if:
You have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
You are currently taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
If you are breast-feeding, please note that you should not breast-feed while taking this medication.
Also, inform your doctor about any gastrointestinal problems, such as:
Narrowing of the gastrointestinal tract
Small bowel disease
Short gut syndrome
Slow-moving esophagus or bowel tract
Furthermore, disclose any history of:
Cystic fibrosis
Long-term bowel pseudo-block
Meckel's diverticulum
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 conditions with your doctor and pharmacist to ensure safe treatment. Do not initiate, stop, or modify 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, 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, 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 life-threatening effects.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses are required 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 can lead to dependence. If you need to reduce the dose or stop taking this medication, consult your doctor, as suddenly stopping or reducing the dose can increase the risk of 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 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, 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, 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 life-threatening effects.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses are required 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 can lead to dependence. If you need to reduce the dose or stop taking this medication, consult your doctor, as suddenly stopping or reducing the dose can increase the risk of 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 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
- Coma
What to Do:
Call 911 immediately. Administer naloxone if available and trained to do so. Stay with the person until emergency medical help arrives. Call 1-800-222-1222 (Poison Control Center) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy
- Alcohol (due to rapid release of hydromorphone)
Major Interactions
- Other CNS depressants (e.g., benzodiazepines, other opioids, sedatives/hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, gabapentin, pregabalin): Increased risk of respiratory depression, profound sedation, coma, and death.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): Increased hydromorphone plasma concentrations, leading to increased opioid effects.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans): Risk of serotonin syndrome.
- Anticholinergic drugs (e.g., atropine, scopolamine): Increased risk of urinary retention and severe constipation/paralytic ileus.
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Decreased hydromorphone plasma concentrations, potentially leading to withdrawal or reduced efficacy.
- Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
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.
Timing: Prior to initiation of therapy
Bowel function
Rationale: To assess for baseline constipation and plan for prophylaxis.
Timing: Prior to initiation of therapy
Renal and hepatic function tests (CrCl, LFTs)
Rationale: To identify impairment that may necessitate dose adjustment or contraindicate use.
Timing: Prior to initiation of therapy
History of substance abuse or mental health disorders
Rationale: To assess risk for addiction, abuse, and misuse.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain assessment
Frequency: Regularly, especially during titration and with any change in dose; at least weekly or monthly once stable.
Target: Acceptable pain control with minimal side effects.
Action Threshold: Uncontrolled pain or unacceptable side effects warrant dose adjustment or re-evaluation.
Respiratory rate and depth, oxygen saturation (if indicated)
Frequency: Regularly, especially during initiation and dose escalation; less frequently once stable.
Target: Normal respiratory rate (12-20 breaths/min), adequate oxygenation.
Action Threshold: Respiratory depression (<10 breaths/min, shallow breathing), hypoxemia, or increased sedation requires immediate intervention.
Level of consciousness/sedation (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Regularly, especially during initiation and dose escalation.
Target: Alert or mildly drowsy, easily aroused.
Action Threshold: Moderate to severe sedation (difficult to arouse, somnolent) requires intervention.
Bowel function (frequency, consistency)
Frequency: Daily or as needed.
Target: Regular bowel movements.
Action Threshold: Constipation requires proactive management (e.g., laxatives).
Signs of addiction, abuse, or misuse (e.g., drug-seeking behavior, unsanctioned dose escalation)
Frequency: Ongoing, at every patient encounter.
Target: Adherence to prescribed regimen.
Action Threshold: Suspicion of abuse/misuse requires further assessment and potential intervention (e.g., urine drug screen, referral to addiction specialist).
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/drowsiness
- Dizziness
- Nausea/vomiting
- Constipation
- Pruritus (itching)
- Urinary retention
- Confusion
- Hypotension
- Signs of opioid withdrawal (if abruptly discontinued)
Special Patient Groups
Pregnancy
Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening. Use only if the potential benefit justifies the potential risk to the fetus. Advise pregnant patients of the risk of NOWS.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations, though data are limited and inconsistent for opioids.
Second Trimester:
Risk of NOWS increases with prolonged use.
Third Trimester:
High risk of NOWS with prolonged use. Respiratory depression in the neonate if used near delivery.
Lactation
Hydromorphone is excreted in breast milk. Infants exposed through breast milk are at risk for serious adverse reactions, including respiratory depression and sedation. Monitor infants for signs of sedation and respiratory depression. Consider alternatives or advise against breastfeeding.
Infant Risk:
L3 (Moderate risk) - Monitor for sedation, poor feeding, and respiratory depression. Risk of withdrawal if mother discontinues or dose changes.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Hydromorphone ER is not indicated for use in pediatric patients. Accidental ingestion by children can be fatal.
Geriatric Use
Elderly patients may be more sensitive to the adverse effects of opioids, particularly 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. Never use in opioid-naive patients due to risk of fatal respiratory depression.
- Emphasize to patients and caregivers the critical importance of not crushing, chewing, or dissolving the tablets due to the risk of rapid, potentially fatal, drug release.
- Counsel patients on the dangers of concomitant alcohol use.
- Always assess for risk factors for addiction, abuse, and misuse prior to and during therapy.
- Proactive management of opioid-induced constipation is essential.
- Monitor for signs of respiratory depression and sedation, especially during initiation and dose titration.
- Due to its long half-life, steady-state concentrations are not achieved for several days; do not make rapid dose adjustments.
- Consider naloxone co-prescription for patients at high risk of overdose.
Alternative Therapies
- Other extended-release opioid analgesics (e.g., morphine ER, oxycodone ER, fentanyl transdermal, buprenorphine transdermal)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentinoids, antidepressants) for neuropathic pain components
- Interventional pain management (e.g., nerve blocks, spinal cord stimulation)
- Physical therapy, occupational therapy, psychological interventions (e.g., CBT)
Cost & Coverage
Average Cost:
Varies widely, typically $100 - $500+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic), Tier 3 or 4 (brand), often requires prior authorization and/or step therapy due to opioid class and ER formulation.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. 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, a patient fact sheet that provides crucial information. It is vital 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.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If an overdose is suspected, 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 immediately. When reporting the incident, be prepared to disclose what was taken, the quantity, and the time of the incident to ensure prompt and effective treatment.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital 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.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If an overdose is suspected, 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 immediately. When reporting the incident, be prepared to disclose what was taken, the quantity, and the time of the incident to ensure prompt and effective treatment.