Hydromorphone 8mg 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. @ COMMON USES: It is used to manage pain 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
Jan 1942
DEA Schedule
Schedule II
Overview
What is this medicine?
Hydromorphone is a strong pain medicine, similar to morphine, used to treat moderate to severe pain. It works by changing how your brain and nervous system respond to pain. Because it is a strong medicine, it carries risks of addiction 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 adhere to the guidelines.
Take this medication by mouth only, with or without food. If it causes stomach upset, take it with food to help alleviate discomfort.
Do not inject or snort this medication, as this can lead to severe side effects, including breathing difficulties and potentially fatal overdose.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep this medication in a secure location, out of sight and reach of children and pets, and inaccessible to others. Consider using a locked box or area.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and explore potential drug take-back programs in your area.
Managing Missed Doses
If you take this medication regularly and miss a dose:
Take the missed dose as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses.
* If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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 by mouth only, with or without food. If it causes stomach upset, take it with food to help alleviate discomfort.
Do not inject or snort this medication, as this can lead to severe side effects, including breathing difficulties and potentially fatal overdose.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep this medication in a secure location, out of sight and reach of children and pets, and inaccessible to others. Consider using a locked box or area.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and explore potential drug take-back programs in your area.
Managing Missed Doses
If you take this medication regularly and miss a dose:
Take the missed dose as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses.
* If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Do not drink alcohol or use other sedating medications (like tranquilizers or sleeping pills) while taking hydromorphone, as this can cause dangerous breathing problems or extreme sleepiness.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and consider using a stool softener or laxative as recommended by your doctor.
- Store this medication securely, out of reach of children and pets, to prevent accidental ingestion, which can be fatal.
Available Forms & Alternatives
Available Strengths:
- Hydromorphone 3mg Rectal Supp
- Hydromorphone 2mg/ml Inj, 20ml Vial
- Hydromorphone 4mg Tablets
- Hydromorphone Hcl 2mg Tablets
- Hydromorphone 8mg Tablets
- Hydromorphone 4mg/ml Inj, 1ml
- Hydromorphone 2mg/ml Inj, 1ml (pf)
- Hydromorphone 10mg/ml Inj, 5ml
- Hydromorphone 50mg/5ml Inj, 5ml
- Hydromorphone 1mg/ml Liquid
- Hydromorphone 1mg/ml Inj, 1ml
- Hydromorphone 10mg/ml Inj, 1ml
- Hydromorphone 10mg/ml Inj, 50ml
- Hydromorphone 2mg/ml Inj, 1ml
- Hydromorphone 32mg ER Tablets
- Hydromorphone 8mg ER Tablets
- Hydromorphone 12mg ER Tablets
- Hydromorphone 16mg ER Tablets
- Hydromorphone 1mg/ml Pf Inj, 0.5ml
- Hydromorphone 0.25mg/0.5ml Pf Inj
- Hydromorphone 0.2mg/ml Pf Inj, 1ml
- Hydromorphone 8mg ER Tablets
- Hydromorphone 16mg ER Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
For moderate to severe pain: 2 to 4 mg orally every 4 to 6 hours as needed. The 8mg tablet is a higher strength typically used for patients with established opioid tolerance or severe pain.
Dose Range:
2 - 8 mg
Condition-Specific Dosing:
opioid_tolerant:
Higher doses may be required and should be titrated carefully based on patient response and tolerability. For patients converting from other opioids, use an equianalgesic conversion table.
Pediatric Dosing
Neonatal:
Not established; generally not recommended due to high risk of respiratory depression.
Infant:
Not established; generally not recommended due to high risk of respiratory depression.
Child:
Not established for routine oral use; IV hydromorphone may be used in carefully selected cases under strict monitoring. Oral dosing is generally not recommended.
Adolescent:
Not established for routine oral use; if used, initiate with lowest effective dose and titrate carefully. Consider lower starting doses.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required, but monitor closely.
Moderate:
Reduce initial dose by 50% and titrate carefully. Monitor for increased sedation and respiratory depression.
Severe:
Reduce initial dose by 75% or more and extend dosing interval. Avoid if possible. Monitor closely for accumulation and adverse effects.
Dialysis:
Hydromorphone is not significantly removed by hemodialysis. Dose adjustments are still necessary due to impaired renal excretion of metabolites. Administer after dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment required, but monitor closely.
Moderate:
Reduce initial dose by 50% and titrate carefully. Monitor for increased sedation and respiratory depression.
Severe:
Reduce initial dose by 75% or more and extend dosing interval. Avoid if possible. Monitor closely for accumulation and adverse effects.
Pharmacology
Mechanism of Action
Hydromorphone is a full opioid agonist that binds to mu-opioid receptors in the central nervous system (CNS), primarily in the brain and spinal cord. This binding leads to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces generalized CNS depression, including respiratory depression, sedation, and antitussive effects.
Pharmacokinetics
Absorption:
Bioavailability:
30-60% (oral)
Tmax:
0.5-1 hour (immediate-release oral)
FoodEffect:
Food may slightly delay Tmax but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
3-4 L/kg
ProteinBinding:
8-19%
CnssPenetration:
Yes
Elimination:
HalfLife:
2-3 hours (immediate-release oral)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
15-30 minutes (oral)
PeakEffect:
30-90 minutes (oral)
DurationOfAction:
4-5 hours (oral)
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
Addiction, Abuse, and Misuse: Hydromorphone exposes 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, and monitor all patients regularly for the development of these behaviors and conditions.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of hydromorphone or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose of hydromorphone, especially by children, can result in a fatal overdose of hydromorphone.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of hydromorphone 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.
Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Addiction, Abuse, and Misuse: Hydromorphone exposes 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, and monitor all patients regularly for the development of these behaviors and conditions.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of hydromorphone or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose of hydromorphone, especially by children, can result in a fatal overdose of hydromorphone.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of hydromorphone 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.
Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Side Effects
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
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Rapid heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a serious bowel problem
Abnormal heartbeat (fast, slow, or irregular)
Breathing difficulties, including:
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Seizures
Shakiness
Difficulty urinating
Uncontrolled eye movements
Trouble controlling body movements
Changes in vision
Chest pain or pressure
Balance problems
Memory problems or loss
Thoughts of self-harm or suicide
Swelling in the arms or legs
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Balance problems
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Long-Term Use and Hormonal Changes
Prolonged use of opioid medications like this one may lead to decreased sex hormone levels. If you experience any of the following 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 minor ones, it's essential to be aware of the following potential side effects:
Constipation
Diarrhea
Stomach pain
Nausea or vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Flushing
Excessive sweating
Headache
Itching
Sleep disturbances
If you're concerned about any side effects or have questions, contact your doctor. You can 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 or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Rapid heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a serious bowel problem
Abnormal heartbeat (fast, slow, or irregular)
Breathing difficulties, including:
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Seizures
Shakiness
Difficulty urinating
Uncontrolled eye movements
Trouble controlling body movements
Changes in vision
Chest pain or pressure
Balance problems
Memory problems or loss
Thoughts of self-harm or suicide
Swelling in the arms or legs
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Balance problems
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Long-Term Use and Hormonal Changes
Prolonged use of opioid medications like this one may lead to decreased sex hormone levels. If you experience any of the following 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 minor ones, it's essential to be aware of the following potential side effects:
Constipation
Diarrhea
Stomach pain
Nausea or vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Flushing
Excessive sweating
Headache
Itching
Sleep disturbances
If you're concerned about any side effects or have questions, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Slow or shallow breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion or disorientation
- Severe constipation or inability to have a bowel movement
- Signs of an 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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems, such as asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
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 increase the risk of severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine, as these may interact with this medication
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. This will enable them to verify the safety of taking this medication in conjunction with your other medications and health conditions. Never initiate, terminate, or adjust the dosage of any medication without first 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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems, such as asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
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 increase the risk of severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine, as these may interact with this medication
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. This will enable them to verify the safety of taking this medication in conjunction with your other medications and health conditions. Never initiate, terminate, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Precautions
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position. Be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended dose, or taking it more frequently or for a longer duration, may increase the risk of severe side effects.
Interactions with Other Medications
Do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring 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.
Laboratory Monitoring
If you are taking this medication long-term, have your blood work checked regularly, and discuss the results with your doctor.
Allergies and Sensitivities
If you are allergic to sulfites, inform your doctor, as some products may contain sulfites.
Alcohol Interactions
Do not consume alcohol or use 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 reduced efficacy, contact your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Regular use of opioid medications like this one may cause dependence. Suddenly lowering the dose or stopping the medication may increase the risk of withdrawal or other severe problems. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.
Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland disorder. Seek medical attention immediately if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.
Geriatric Use
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
Inform your doctor if you are breastfeeding, as this medication passes into breast milk and may harm your baby. Seek medical help immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position. Be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended dose, or taking it more frequently or for a longer duration, may increase the risk of severe side effects.
Interactions with Other Medications
Do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring 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.
Laboratory Monitoring
If you are taking this medication long-term, have your blood work checked regularly, and discuss the results with your doctor.
Allergies and Sensitivities
If you are allergic to sulfites, inform your doctor, as some products may contain sulfites.
Alcohol Interactions
Do not consume alcohol or use 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 reduced efficacy, contact your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Regular use of opioid medications like this one may cause dependence. Suddenly lowering the dose or stopping the medication may increase the risk of withdrawal or other severe problems. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.
Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland disorder. Seek medical attention immediately if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.
Geriatric Use
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
Inform your doctor if you are breastfeeding, as this medication passes into breast milk and may harm your baby. Seek medical help immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Pinpoint pupils
- Slowed or stopped breathing
- Extreme drowsiness or unresponsiveness
- Limp muscles
- Cold, clammy skin
- Bluish discoloration of lips or fingernails
- Loss of consciousness
What to Do:
If you suspect an overdose, call 911 immediately. If naloxone (Narcan) is available, administer it as directed and continue to monitor the person until emergency medical help arrives. Stay with the person and try to keep them awake and breathing. Call 1-800-222-1222 (Poison Control) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI discontinuation (risk of serotonin syndrome, respiratory depression, coma)
- Concomitant use with benzodiazepines or other CNS depressants (unless alternative treatment options are inadequate) due to profound sedation, respiratory depression, coma, and death.
Major Interactions
- Other opioid analgesics (additive CNS depression, respiratory depression)
- Alcohol (additive CNS depression, respiratory depression)
- Sedatives/Hypnotics (additive CNS depression, respiratory depression)
- General Anesthetics (additive CNS depression, respiratory depression)
- Phenothiazines (additive CNS depression, respiratory depression)
- Tranquilizers (additive CNS depression, respiratory depression)
- Skeletal Muscle Relaxants (additive CNS depression, respiratory depression)
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid, methylene blue) - risk of serotonin syndrome
- Mixed agonist/antagonist opioids (e.g., nalbuphine, buprenorphine, butorphanol, pentazocine) - may precipitate withdrawal symptoms or reduce analgesic effect.
Moderate Interactions
- Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants) - increased risk of urinary retention and severe constipation, paralytic ileus.
- Diuretics - opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
Minor Interactions
- Not specifically identified for minor interactions with significant clinical impact.
Monitoring
Baseline Monitoring
Pain assessment (intensity, quality, 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 for respiratory depression.
Timing: Prior to initiation of therapy
Level of consciousness/sedation
Rationale: To assess baseline neurological status and identify risk for excessive sedation.
Timing: Prior to initiation of therapy
Bowel function
Rationale: To assess baseline bowel habits and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy
Renal and hepatic function tests (e.g., BUN, creatinine, LFTs)
Rationale: To identify potential impairment requiring dose adjustment.
Timing: Prior to initiation of therapy, especially in at-risk patients
Routine Monitoring
Pain assessment
Frequency: Regularly, at least daily or before each dose adjustment
Target: Patient-specific pain goal (e.g., reduction by 30% or to a tolerable level)
Action Threshold: Uncontrolled pain or worsening pain requires reassessment and potential dose adjustment or alternative therapy.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration (e.g., every 1-4 hours initially, then daily)
Target: >10-12 breaths/min, regular rhythm
Action Threshold: <10 breaths/min, shallow breathing, or signs of respiratory distress require immediate intervention (e.g., naloxone, respiratory support).
Level of consciousness/sedation (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Regularly, especially during initiation and dose titration (e.g., every 1-4 hours initially, then daily)
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Difficult to arouse, somnolent, or unarousable requires immediate intervention (e.g., naloxone, respiratory support).
Bowel function
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-3 days)
Action Threshold: No bowel movement for >3 days, severe straining, or abdominal discomfort requires intervention for opioid-induced constipation.
Signs of abuse, misuse, or addiction
Frequency: Ongoing, at every patient encounter
Target: Absence of aberrant drug-related behaviors
Action Threshold: Presence of aberrant behaviors requires further assessment and potential intervention (e.g., urine drug screen, referral to addiction specialist).
Symptom Monitoring
- Excessive sedation
- Dizziness
- Confusion
- Nausea
- Vomiting
- Constipation
- Pruritus
- Urinary retention
- Signs of respiratory depression (slow, shallow breathing, cyanosis)
- Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, loss of coordination, nausea, vomiting, diarrhea)
- Signs of 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 can be life-threatening if not recognized and treated. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for congenital malformations with opioid exposure, though not definitively linked to hydromorphone.
Second Trimester:
Risk of NOWS increases with prolonged exposure.
Third Trimester:
Highest risk of NOWS with prolonged exposure. Respiratory depression in the neonate at delivery is also a concern if used close to term.
Lactation
Hydromorphone is excreted into breast milk. Monitor breastfed infants for signs of sedation, respiratory depression, poor feeding, and poor weight gain. A single dose is generally considered low risk, but chronic use is not recommended due to potential for infant harm.
Infant Risk:
Moderate to High (L3-L4) depending on dose, duration, and infant age/health. Risk is higher with chronic use or in preterm/neonatal infants.
Pediatric Use
Safety and efficacy of oral hydromorphone in pediatric patients have not been established. Use is generally not recommended due to the high risk of respiratory depression and lack of clear dosing guidelines. If used, extreme caution, careful titration, and close monitoring are essential.
Geriatric Use
Elderly patients may be more sensitive to the analgesic and adverse effects of hydromorphone, particularly respiratory depression. Start with lower doses and titrate slowly. Monitor closely for sedation, respiratory depression, and constipation due to age-related decreases in renal and hepatic function and increased sensitivity to opioids.
Clinical Information
Clinical Pearls
- Hydromorphone is significantly more potent than morphine (approximately 5-7 times). Always verify the dose and formulation (e.g., immediate-release vs. extended-release) to avoid overdose.
- The 8mg tablet is a high strength and should generally be reserved for opioid-tolerant patients or those with severe, acute pain requiring rapid titration.
- Educate patients and caregivers thoroughly on the risks of addiction, respiratory depression, and accidental ingestion, and the importance of safe storage.
- Always have naloxone readily available when prescribing opioids, especially for patients at higher risk of overdose.
- Proactive management of opioid-induced constipation is crucial; start a bowel regimen at the initiation of therapy.
- Be vigilant for signs of opioid-induced hyperalgesia, especially with long-term high-dose use, which may manifest as increasing pain despite increasing opioid doses.
Alternative Therapies
- Other strong opioid analgesics (e.g., Morphine, Oxycodone, Fentanyl, Oxymorphone)
- Weaker opioid analgesics (e.g., Codeine, Tramadol) for less severe pain
- Non-opioid analgesics (e.g., NSAIDs, Acetaminophen) for mild to moderate pain or as adjunctive therapy
- Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants) for neuropathic pain
- Non-pharmacological pain management strategies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (8mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (generic often Tier 1 or 2, brand Tier 3)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. It is vital to read this guide carefully and review it again whenever 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 treat the condition. 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 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 medical care immediately. When seeking help, be prepared to provide detailed information about the overdose, including what was taken, the quantity, and the time of the incident.
This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. It is vital to read this guide carefully and review it again whenever 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 treat the condition. 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 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 medical care immediately. When seeking help, be prepared to provide detailed information about the overdose, including what was taken, the quantity, and the time of the incident.