Dilaudid 4mg 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
Mu-opioid receptor agonist
Pregnancy Category
Not assigned under new FDA labeling; risk of neonatal opioid withdrawal syndrome
FDA Approved
Jan 1942
DEA Schedule
Schedule II
Overview
What is this medicine?
Hydromorphone is a strong pain medicine (an opioid) used to treat moderate to severe pain. It works in your brain to change how your body feels and responds to pain. It is important to use this medicine exactly as prescribed because it can be habit-forming and cause serious side effects like slow breathing.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, but if it causes stomach upset, take it with food. It's essential to take this medication by mouth only. Do not inject or snort this medication, as this can lead to severe side effects, including breathing difficulties and overdose, which can be fatal.
Storing and Disposing of Your Medication
Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. To prevent accidental ingestion, store this medication in a secure location where children and pets cannot access it. Consider using a locked box or area to keep it safe. Keep all medications out of reach of pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method, and explore local drug take-back programs.
Missing a Dose
If you take this medication regularly, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular 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 prescribed.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, but if it causes stomach upset, take it with food. It's essential to take this medication by mouth only. Do not inject or snort this medication, as this can lead to severe side effects, including breathing difficulties and overdose, which can be fatal.
Storing and Disposing of Your Medication
Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. To prevent accidental ingestion, store this medication in a secure location where children and pets cannot access it. Consider using a locked box or area to keep it safe. Keep all medications out of reach of pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method, and explore local drug take-back programs.
Missing a Dose
If you take this medication regularly, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular 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 prescribed.
Lifestyle & Tips
- Do not drink alcohol or use other sedating medications (like tranquilizers, sleeping pills, or other pain medicines) while taking hydromorphone, as this can lead to dangerous breathing problems or extreme drowsiness.
- Avoid driving or operating heavy machinery until you know how this medicine affects you, as it can cause dizziness and drowsiness.
- To prevent constipation, which is a common side effect, drink plenty of fluids, eat fiber-rich foods, and consider using a stool softener or laxative as recommended by your doctor.
- Store this medicine securely away from children and pets, as accidental ingestion can be fatal.
- Do not share this medication with anyone else, even if they have similar symptoms.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose for opioid-naive patients: 2 mg to 4 mg orally every 4 to 6 hours as needed for pain.
Dose Range:
2 - 8 mg
Condition-Specific Dosing:
severePain:
May require higher initial doses or more frequent administration, titrated to effect and tolerability.
opioidTolerant:
Dose should be individualized based on prior opioid exposure and cross-tolerance calculations.
Pediatric Dosing
Neonatal:
Not established (risk of respiratory depression and withdrawal)
Infant:
Not established (risk of respiratory depression and withdrawal)
Child:
Not established for oral tablets; use with extreme caution and individualized dosing if considered, typically in opioid-tolerant patients in specialized settings.
Adolescent:
Not established for oral tablets; use with extreme caution and individualized dosing if considered, typically in opioid-tolerant patients in specialized settings.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor for increased effects.
Moderate:
Consider a 25-50% dose reduction and/or increased dosing interval. Monitor closely for respiratory depression and sedation.
Severe:
Consider a 50-75% dose reduction and/or increased dosing interval. Avoid if possible. Monitor closely for respiratory depression and sedation.
Dialysis:
Hydromorphone and its active metabolite (H3G) are not significantly removed by hemodialysis. Administer after dialysis. Monitor closely.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but monitor for increased effects.
Moderate:
Consider a 25-50% dose reduction and/or increased dosing interval. Monitor closely for respiratory depression and sedation.
Severe:
Consider a 50-75% dose reduction and/or increased dosing interval. Avoid if possible. Monitor closely for respiratory depression and sedation.
Pharmacology
Mechanism of Action
Hydromorphone is a full opioid agonist that acts primarily at the mu-opioid receptors in the central nervous system (CNS). Its analgesic effects are mediated by binding to these receptors, 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:
Oral: 26-62% (highly variable)
Tmax:
Oral: 0.5-1 hour
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
4 L/kg
ProteinBinding:
8-19%
CnssPenetration:
Yes
Elimination:
HalfLife:
Oral: 2-4 hours
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (primarily as H3G and other conjugates)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Oral: 15-30 minutes
PeakEffect:
Oral: 30-90 minutes
DurationOfAction:
Oral: 4-6 hours
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
+ Trouble 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
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a severe 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
Seizures
Shakiness
Difficulty urinating
Uncontrolled eye movements or body movements
Changes in vision
Chest pain or pressure
Balance problems
Memory problems or loss
Thoughts of self-harm or suicide
Swelling in the arms or legs
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Balance problems
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Long-Term Use and Hormonal Changes
Prolonged use of opioid medications like this one may lead to decreased sex hormone levels. If you experience any of the following, contact your doctor:
Decreased interest in sex
Fertility problems
Irregular or absent menstrual periods
Ejaculation problems
Other Possible Side Effects
While many people may not experience side effects or may only have mild ones, it's essential to be aware of the following:
Constipation
Diarrhea
Stomach pain
Nausea or vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Flushing
Excessive sweating
Headache
Itching
* Sleep disturbances
If any of these side effects bother you or persist, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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
+ Trouble 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
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a severe 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
Seizures
Shakiness
Difficulty urinating
Uncontrolled eye movements or body movements
Changes in vision
Chest pain or pressure
Balance problems
Memory problems or loss
Thoughts of self-harm or suicide
Swelling in the arms or legs
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Balance problems
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Long-Term Use and Hormonal Changes
Prolonged use of opioid medications like this one may lead to decreased sex hormone levels. If you experience any of the following, contact your doctor:
Decreased interest in sex
Fertility problems
Irregular or absent menstrual periods
Ejaculation problems
Other Possible Side Effects
While many people may not experience side effects or may only have mild ones, it's essential to be aware of the following:
Constipation
Diarrhea
Stomach pain
Nausea or vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Flushing
Excessive sweating
Headache
Itching
* Sleep disturbances
If any of these side effects bother you or persist, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Slow, shallow, or difficult breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion or disorientation
- Pinpoint pupils
- Severe constipation or abdominal pain
- Signs of an 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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the 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 lead to severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss all your health problems with your doctor
Verify that it is safe to take this medication with your existing medications and health conditions
Avoid starting, stopping, or changing the dose of any medication without consulting your doctor first
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. Describe the allergic reaction you experienced, including the 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 lead to severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss all your health problems with your doctor
Verify that it is safe to take this medication with your existing medications and health conditions
Avoid starting, stopping, or changing the dose of any medication without consulting your doctor first
Precautions & Cautions
Important Warnings and Cautions
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. Be cautious when using stairs.
Adhere to your doctor's instructions regarding dosage and frequency. Do not exceed the recommended dose, take it more often, or use it for a longer period than prescribed, as this may increase the risk of severe side effects.
Before taking this medication with other strong pain relievers or using a pain patch, consult your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not take more medication than ordered.
If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your health. Discuss this with your doctor.
If you have a sulfite allergy, inform your doctor, as some products contain sulfites. Avoid consuming alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially life-threatening effects.
Long-term or high-dose use of this medication may lead to tolerance, reducing its effectiveness. If you find that the medication is no longer working as well, contact your doctor. Do not take more than the prescribed dose.
Prolonged or regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking the medication, consult your doctor to minimize the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.
Taking an opioid medication like this one can 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.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and 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.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. Be cautious when using stairs.
Adhere to your doctor's instructions regarding dosage and frequency. Do not exceed the recommended dose, take it more often, or use it for a longer period than prescribed, as this may increase the risk of severe side effects.
Before taking this medication with other strong pain relievers or using a pain patch, consult your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not take more medication than ordered.
If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your health. Discuss this with your doctor.
If you have a sulfite allergy, inform your doctor, as some products contain sulfites. Avoid consuming alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially life-threatening effects.
Long-term or high-dose use of this medication may lead to tolerance, reducing its effectiveness. If you find that the medication is no longer working as well, contact your doctor. Do not take more than the prescribed dose.
Prolonged or regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking the medication, consult your doctor to minimize the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.
Taking an opioid medication like this one can 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.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. Seek medical help immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing (respiratory depression)
- Extreme drowsiness, unresponsiveness, or coma
- Pinpoint pupils
- Cold, clammy skin
- Limp muscles
- Blue lips or fingernails
- 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 Center) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of serotonin syndrome or severe respiratory depression)
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, gabapentinoids) - increased risk of profound sedation, respiratory depression, coma, and death.
- Mixed agonist/antagonist opioids (e.g., butorphanol, nalbuphine, pentazocine) - may precipitate withdrawal symptoms or reduce analgesic effect.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol) - increased risk of serotonin syndrome.
- Anticholinergics (e.g., atropine, scopolamine, tricyclic antidepressants) - increased risk of severe constipation and/or urinary retention.
Moderate Interactions
- Diuretics - opioids may reduce the efficacy of diuretics by causing ADH release.
- Antihypertensives - additive hypotensive effects.
- CYP3A4 inhibitors/inducers (less relevant for hydromorphone as it's primarily glucuronidated, but some minor CYP metabolism exists for other opioids, so caution is still advised with strong inhibitors/inducers if used with other opioids).
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 score
Rationale: To assess baseline neurological status and identify risk factors for excessive sedation.
Timing: Prior to initiation of therapy
Bowel function/history of constipation
Rationale: To anticipate and proactively manage 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, especially in at-risk patients
Routine Monitoring
Pain assessment
Frequency: Regularly, especially after dose changes (e.g., 30-60 min after acute dose, daily for chronic therapy)
Target: Patient-specific pain goal (e.g., reduction by 30% or to a tolerable level)
Action Threshold: Uncontrolled pain, or pain exceeding patient's goal
Respiratory rate and depth
Frequency: Frequently during initiation/titration (e.g., every 15-30 min for first hour, then hourly), less frequently for stable chronic therapy (e.g., daily)
Target: Typically >10-12 breaths/minute, regular rhythm
Action Threshold: <10 breaths/minute, shallow breathing, irregular rhythm, or signs of hypoxemia
Level of consciousness/sedation score (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Frequently during initiation/titration (e.g., every 15-30 min for first hour, then hourly), less frequently for stable chronic therapy (e.g., daily)
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Difficult to arouse, somnolent, or unarousable
Bowel function
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-2 days)
Action Threshold: No bowel movement for >2-3 days, straining, or severe abdominal discomfort
Signs of opioid abuse/misuse
Frequency: Periodically, at each visit for chronic therapy
Target: Not applicable
Action Threshold: Aberrant drug-related behaviors (e.g., requesting early refills, lost prescriptions, multiple prescribers)
Symptom Monitoring
- Excessive sedation
- Dizziness
- Nausea/vomiting
- Constipation
- Pruritus
- Confusion
- Difficulty breathing (shallow, slow, or irregular breathing)
- Pinpoint pupils
- Cold, clammy skin
- Hypotension
Special Patient Groups
Pregnancy
Prolonged use of hydromorphone during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Advise pregnant patients of the risk of NOWS and ensure appropriate treatment will be available. Use during labor may cause respiratory depression in the neonate.
Trimester-Specific Risks:
First Trimester:
Limited data; potential for congenital malformations with first-trimester opioid exposure, though evidence is mixed and often confounded.
Second Trimester:
Risk of NOWS increases with prolonged exposure.
Third Trimester:
High risk of NOWS with prolonged exposure. Use during labor may cause neonatal respiratory depression.
Lactation
Hydromorphone is excreted into breast milk. Monitor 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 dependence and withdrawal upon discontinuation.
Infant Risk:
Moderate risk (L3). Potential for sedation, respiratory depression, and withdrawal symptoms in the infant. Use lowest effective dose for shortest duration. Observe infant closely.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established for oral tablets. Use is generally not recommended due to the risk of serious adverse events, including respiratory depression and death. If used, extreme caution, individualized dosing, and close monitoring are required, typically only in opioid-tolerant patients in specialized settings.
Geriatric Use
Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, including respiratory depression, sedation, and constipation. Start with lower doses and titrate slowly. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Hydromorphone is a potent opioid; start low and go slow, especially in opioid-naive patients.
- Due to its short half-life, it is suitable for acute pain or breakthrough pain in opioid-tolerant patients.
- The major metabolite, hydromorphone-3-glucuronide (H3G), can accumulate in renal impairment and contribute to neurotoxicity (e.g., myoclonus, hyperalgesia, delirium). Dose reduction is crucial in kidney disease.
- Always have naloxone readily available when prescribing opioids, especially for patients at high risk of overdose.
- Educate patients thoroughly on safe storage, disposal, and the risks of respiratory depression and addiction.
- Proactive management of opioid-induced constipation is essential.
Alternative Therapies
- Other strong opioid agonists (e.g., morphine, oxycodone, fentanyl)
- Tramadol (for moderate pain)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for mild to moderate pain or as adjuncts
- Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
- Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (4mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic, Tier 3 or higher for brand if available.
General Drug Facts
If your symptoms or health problems do not improve or worsen, contact your doctor immediately. It is essential to use your medication responsibly: do not share it with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When seeking help, be prepared to provide information about what was taken, the quantity, and the time of the incident.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When seeking help, be prepared to provide information about what was taken, the quantity, and the time of the incident.