Hydromorphone 1mg/ml Liquid

Manufacturer ROXANE Active Ingredient Hydromorphone Liquid(hye droe MOR fone) Pronunciation hye droe MOR fone
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.Be sure that you know how to measure your dose. Dosing errors can lead to accidental overdose and death. If you have any questions, talk with your doctor or pharmacist. @ 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.
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Drug Class
Opioid Analgesic
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Pharmacologic Class
Opioid Agonist
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Pregnancy Category
C
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FDA Approved
Jun 1926
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DEA Schedule
Schedule II

Overview

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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. It comes as a liquid that you take by mouth.
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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. Take your medication with or without food, but if it causes stomach upset, take it with food. Always take this medication by mouth and never inject or snort it, as this can lead to severe side effects, including breathing difficulties and overdose, which can be fatal.

When taking the liquid form of this medication, measure your dose carefully using the measuring device that comes with it. If one is not provided, ask your pharmacist for a suitable measuring device. Avoid using a household teaspoon or tablespoon, as this can result in an incorrect dose.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. To prevent accidental ingestion, store your medication in a secure location where children and pets cannot access it. Consider using a locked box or area to keep your medication safe.

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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it is 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 recommended.
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Lifestyle & Tips

  • Do not drink alcohol while taking this medication, as it can increase side effects like drowsiness and breathing problems.
  • Avoid driving or operating 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, preferably in a locked cabinet, to prevent accidental ingestion.
  • Do not share this medication with anyone else, as it can be dangerous and is against the law.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose: 2.5 to 10 mg (2.5 to 10 mL of 1 mg/mL solution) orally every 3 to 6 hours as needed for pain. Titrate to effect.
Dose Range: 2.5 - 10 mg

Condition-Specific Dosing:

acutePain: Initial dose: 2.5 to 10 mg orally every 3 to 6 hours as needed. Adjust dose based on patient response and tolerability.
chronicPain: Individualize dosing based on patient's prior opioid exposure and pain severity. Administer on a scheduled basis, with breakthrough doses as needed. Avoid abrupt discontinuation.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and specialized monitoring required if used.
Infant: 0.03 to 0.08 mg/kg/dose orally every 4 to 6 hours as needed. Max single dose: 5 mg. Max daily dose: 0.5 mg/kg/day.
Child: 0.03 to 0.08 mg/kg/dose orally every 4 to 6 hours as needed. Max single dose: 5 mg. Max daily dose: 0.5 mg/kg/day.
Adolescent: 0.03 to 0.08 mg/kg/dose orally every 4 to 6 hours as needed. Max single dose: 5 mg. Max daily dose: 0.5 mg/kg/day (or adult dosing if appropriate weight/age).
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Dose Adjustments

Renal Impairment:

Mild: Consider starting at the lower end of the dosing range and titrate carefully. Monitor for increased adverse effects.
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor closely for respiratory depression and sedation.
Severe: Reduce initial dose by 50-75% and extend dosing interval. Avoid if possible. Monitor very closely for accumulation and toxicity.
Dialysis: Hydromorphone and its active metabolite (H3G) are dialyzable to some extent. Administer after dialysis. Significant dose reduction is required. Monitor closely.

Hepatic Impairment:

Mild: Consider starting at the lower end of the dosing range and titrate carefully.
Moderate: Reduce initial dose by 25-50%. Monitor closely for respiratory depression and sedation.
Severe: Reduce initial dose by 50-75%. Avoid if possible. Monitor very closely for accumulation and toxicity.

Pharmacology

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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 inhibits ascending pain pathways, altering the perception of and response to pain. It also produces generalized CNS depression, including respiratory depression, sedation, and antitussive effects.
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Pharmacokinetics

Absorption:

Bioavailability: 25-60%
Tmax: 30-60 minutes (oral solution)
FoodEffect: Food may 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: 2-4 hours
Clearance: Not available
ExcretionRoute: Primarily renal (as H3G)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: 15-30 minutes (oral solution)
PeakEffect: 30-90 minutes (oral solution)
DurationOfAction: 3-6 hours
Confidence: High

Safety & Warnings

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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 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 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.
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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 medical attention immediately:

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
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Feeling confused
Severe constipation or stomach pain, which may indicate a severe bowel problem
Abnormal heartbeat, including fast, slow, or irregular rhythms
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Seizures
Shakiness
Trouble passing urine
Inability to control eye movements
Trouble controlling body movements
Changes in eyesight
Chest pain or pressure
Changes in balance
Memory problems or loss
Thoughts of hurting yourself 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 a severe and potentially deadly condition called serotonin syndrome. Seek medical help immediately if you experience:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Vomiting
Severe headache

Long-Term Use and Hormonal Changes

Long-term use of opioid medications like this one may lead to lower sex hormone levels. If you experience any of the following symptoms, contact your doctor:

Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems

Other Possible Side Effects

While many people may not experience side effects or may only have mild symptoms, it's essential to be aware of the following possible side effects:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dizziness
Sleepiness
Tiredness
Weakness
Dry mouth
Flushing
Excessive sweating
Headache
Itching
* Trouble sleeping

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.
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Seek Immediate Medical Attention If You Experience:

  • Slow or shallow breathing (respiratory depression)
  • Extreme drowsiness or difficulty waking up
  • Severe dizziness or lightheadedness
  • Confusion or disorientation
  • Blue-tinged lips or fingernails
  • Severe constipation or abdominal pain
  • Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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 like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications can lead to severely high blood pressure.
If you are currently taking any of the following medications:
+ Buprenorphine
+ Butorphanol
+ Linezolid
+ Methylene blue
+ Nalbuphine
+ Pentazocine

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. They will help determine whether it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

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.

If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.

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 products containing alcohol while taking this medication, as it may lead to unsafe and potentially life-threatening effects.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not take more than the prescribed dose.

Regular use of opioid medications like this one may cause dependence. If you need to reduce the dose or stop taking this medication, consult your doctor to avoid withdrawal or other severe problems. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

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 immediate medical attention if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.

Special Precautions
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.
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Overdose Information

Overdose Symptoms:

  • Pinpoint pupils
  • Slowed or stopped breathing
  • Extreme drowsiness or unresponsiveness
  • Limp muscles
  • Cold, clammy skin
  • Bluish skin, especially around the lips and fingernails
  • Slowed heartbeat
  • Loss of consciousness

What to Do:

If you suspect an overdose, call 911 immediately. Administer naloxone (Narcan) if available and you are trained to do so. Stay with the person until emergency medical help arrives. Provide rescue breathing if necessary. Call 1-800-222-1222 for Poison Control Center assistance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome, severe respiratory depression, coma, death)
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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants): Increased risk of respiratory depression, profound sedation, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid, methylene blue): Risk of serotonin syndrome.
  • Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and severe constipation, which may lead to paralytic ileus.
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Moderate Interactions

  • P-glycoprotein (P-gp) inhibitors (e.g., quinidine, verapamil, amiodarone, cyclosporine): May increase hydromorphone plasma concentrations.
  • Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
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Minor Interactions

  • Not available

Monitoring

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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 history

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 that may necessitate dose adjustment.

Timing: Prior to initiation of therapy, especially in patients with suspected impairment

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Routine Monitoring

Pain assessment

Frequency: Regularly, especially after dose adjustments and prior to subsequent doses

Target: Patient-specific pain relief goals

Action Threshold: Inadequate pain control or excessive pain, requiring dose adjustment or alternative strategies

Respiratory rate and depth

Frequency: Frequently during initiation and dose titration; periodically during maintenance

Target: Normal for age (e.g., >12 breaths/min for adults), unlabored

Action Threshold: Respiratory rate <10-12 breaths/min (adults), shallow breathing, cyanosis, or signs of hypoxemia, requiring immediate intervention (e.g., naloxone, respiratory support)

Level of consciousness/sedation

Frequency: Frequently during initiation and dose titration; periodically during maintenance

Target: Alert, easily aroused, or mild sedation (e.g., Pasero Opioid-Induced Sedation Scale 0-1)

Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolent, Pasero Opioid-Induced Sedation Scale 3-4), requiring dose reduction or naloxone

Bowel function

Frequency: Daily or every other day

Target: Regular bowel movements (e.g., every 1-2 days)

Action Threshold: Constipation (e.g., no bowel movement for >3 days, straining, hard stools), requiring laxative intervention

Blood pressure and heart rate

Frequency: Periodically, especially during initiation or dose escalation

Target: Within patient's normal range

Action Threshold: Significant hypotension or bradycardia, requiring intervention

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation/drowsiness
  • Dizziness/lightheadedness
  • Nausea and vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Confusion or disorientation
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, loss of coordination, nausea, vomiting, diarrhea)

Special Patient Groups

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Pregnancy

Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening if not treated. Use only 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 cannot be entirely ruled out.
Second Trimester: Risk of NOWS increases with prolonged exposure.
Third Trimester: High risk of NOWS with prolonged exposure. Risk of respiratory depression in the neonate if administered close to delivery.
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Lactation

Hydromorphone is excreted into breast milk. Monitor breastfed infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms if the mother discontinues the drug. Use with caution, or consider alternative analgesics.

Infant Risk: Moderate risk (L3). Potential for infant sedation, respiratory depression, and withdrawal.
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Pediatric Use

Use with caution. Dosing is weight-based and requires careful titration. Neonates and very young infants are particularly sensitive to respiratory depressant effects. Close monitoring for respiratory depression and sedation is essential.

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Geriatric Use

Increased sensitivity to opioid effects (e.g., respiratory depression, sedation, constipation). Start with lower doses and titrate slowly. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Hydromorphone is approximately 5-7 times more potent than oral morphine. Always verify the dose and concentration carefully to avoid medication errors.
  • Oral liquid formulations are useful for patients who have difficulty swallowing tablets or require precise dose titration.
  • Educate patients and caregivers on the safe storage and disposal of hydromorphone to prevent accidental ingestion, especially by children.
  • Always have naloxone readily available for patients at high risk of opioid overdose (e.g., those on high doses, concomitant CNS depressants, or with a history of substance use disorder).
  • Proactive management of opioid-induced constipation is crucial; recommend a bowel regimen (e.g., stimulant laxative plus stool softener) from the start of therapy.
  • Monitor for signs of hydromorphone-3-glucuronide (H3G) accumulation, especially in patients with renal impairment, which can manifest as neuroexcitatory symptoms (e.g., myoclonus, hyperalgesia, delirium).
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Alternative Therapies

  • Other strong opioid analgesics (e.g., morphine, oxycodone, fentanyl)
  • Moderate opioid analgesics (e.g., hydrocodone, tramadol)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
  • Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
  • Regional anesthesia or nerve blocks
  • Non-pharmacological pain management strategies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and formulation per mL
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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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, which is 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 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 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 seeking help, be prepared to provide information about the substance involved, the quantity taken, and the time of the incident.