Dilaudid-5 1mg/ml Liquid

Manufacturer RHODES PHARMACEUTICAL 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.
đŸˇī¸
Drug Class
Opioid analgesic
đŸ§Ŧ
Pharmacologic Class
Opioid agonist
🤰
Pregnancy Category
Not available
✅
FDA Approved
Jan 1942
âš–ī¸
DEA Schedule
Schedule II

Overview

â„šī¸

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 comes as a liquid that you take by mouth.
📋

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 serious 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 household teaspoons or tablespoons, as this can result in an incorrect dose.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. 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. Dispose of unused or expired medication responsibly. 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 way to dispose of your medication, and explore local drug take-back programs.

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 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 while taking this medicine, as it can increase side effects like drowsiness and breathing problems.
  • Avoid driving or operating heavy machinery until you know how this medicine 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 directed by your doctor.
  • Store this medicine securely to prevent accidental ingestion by children or pets, which can be fatal.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Initial dose: 2.5 to 10 mg orally every 3 to 6 hours as needed for pain. Titrate to effect.
Dose Range: 2.5 - 10 mg

Condition-Specific Dosing:

opioid_naive: Lower initial doses (e.g., 2.5 mg) are recommended.
chronic_pain: Dosing should be individualized and titrated to achieve adequate analgesia with acceptable side effects. May require higher doses in opioid-tolerant patients.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 0.03 to 0.08 mg/kg/dose orally every 4 to 6 hours as needed. Max single dose: 5 mg. Not recommended for routine use in children due to risk of respiratory depression.
Adolescent: Similar to adult dosing, but start with lower doses and titrate carefully.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor for increased effects.
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor closely.
Severe: Reduce initial dose by 50-75% and extend dosing interval. Avoid if possible. Monitor closely for respiratory depression and sedation.
Dialysis: Hydromorphone is not significantly removed by hemodialysis. Administer after dialysis. Reduce dose and/or extend interval.

Hepatic Impairment:

Mild: No specific adjustment, but monitor for increased effects.
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor closely.
Severe: Reduce initial dose by 50-75% and extend dosing interval. Avoid if possible. Monitor closely for respiratory depression and sedation.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Hydromorphone is a full opioid agonist that binds to and activates mu-opioid receptors in the central nervous system (CNS), peripheral tissues, and gastrointestinal tract. 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: 20-60% (oral)
Tmax: 0.5-1 hour (oral solution)
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: 2-4 hours (oral)
Clearance: Not available
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10%
âąī¸

Pharmacodynamics

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

Safety & Warnings

âš ī¸

BLACK BOX WARNING

WARNING: ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION (for ER forms, but general opioid warning applies); RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
âš ī¸

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 any side effects or only minor ones, 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 do not go away, 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 or shallow breathing
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness when standing up
  • Severe constipation or abdominal pain
  • Confusion or unusual thoughts
  • 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. Be sure to describe the allergic reaction you experienced, including any 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, or rasagiline, as this may increase the risk of severely high blood pressure
If you are currently taking any of the following medications: 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 the medications you are taking, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Your doctor needs to be aware of all your medications and health conditions to determine if it is safe for you to take this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
âš ī¸

Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require you to be alert. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and be cautious when climbing stairs.

Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended dose, or taking it more frequently or for a longer period than directed, may increase the risk of severe side effects.

Interactions with Other Medications
Before taking this medication with other strong pain medications or using a pain patch, consult your doctor. If you experience worsening pain, increased sensitivity to pain, or new pain, contact your doctor immediately. Do not take more than the prescribed dose.

Long-Term Use and Monitoring
If you are taking this medication for an extended period, 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. Additionally, regular use of opioid medications like this one may cause dependence. If you need to reduce the dose or stop taking the medication, consult your doctor to avoid withdrawal or other severe problems.

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

Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Breastfeeding
If you are breastfeeding, inform your doctor, as this medication passes into breast milk and may harm your baby. Seek medical help immediately if your baby appears overly sleepy, limp, or has trouble breathing.
🆘

Overdose Information

Overdose Symptoms:

  • Slowed or stopped breathing (respiratory depression)
  • Extreme drowsiness, unresponsiveness, or coma
  • Pinpoint pupils
  • Cold, clammy skin
  • Limp muscles
  • Low blood pressure
  • Slowed heart rate

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. If naloxone (Narcan) is available and you are trained to use it, administer it as directed. Call 1-800-222-1222 (Poison Control) for further guidance.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOIs (risk of serotonin syndrome or severe respiratory depression).
🔴

Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid, methylene blue): Risk of serotonin syndrome.
  • Mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine, butorphanol): May reduce the analgesic effect of hydromorphone and/or precipitate withdrawal symptoms.
  • Opioid antagonists (e.g., naltrexone, naloxone): May precipitate acute opioid withdrawal.
🟡

Moderate Interactions

  • Anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, antipsychotics): Increased risk of urinary retention and/or severe constipation, paralytic ileus.
  • Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
đŸŸĸ

Minor Interactions

  • Not available

Monitoring

đŸ”Ŧ

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 mental 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

📊

Routine Monitoring

Pain assessment

Frequency: Regularly, especially during dose titration and with changes in pain status (e.g., daily, weekly)

Target: Acceptable pain level as defined by patient

Action Threshold: Uncontrolled pain or unacceptable side effects

Respiratory rate and depth

Frequency: Frequently during initiation and dose titration (e.g., every 1-2 hours initially), then periodically (e.g., daily) once stable.

Target: Normal for patient (typically >10-12 breaths/min)

Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation

Level of consciousness/sedation (e.g., Pasero Opioid-Induced Sedation Scale)

Frequency: Frequently during initiation and dose titration (e.g., every 1-2 hours initially), then periodically (e.g., daily) once stable.

Target: Alert or mildly drowsy, easily aroused

Action Threshold: Somnolent, difficult to arouse, or unarousable

Bowel function

Frequency: Daily

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

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

đŸ‘ī¸

Symptom Monitoring

  • Signs of respiratory depression (slow, shallow breathing, cyanosis, extreme drowsiness)
  • Signs of excessive sedation (difficulty waking up, confusion, slurred speech)
  • Signs of opioid-induced constipation (abdominal pain, bloating, infrequent bowel movements)
  • Signs of opioid withdrawal (restlessness, yawning, lacrimation, rhinorrhea, piloerection, sweating, muscle aches, nausea, vomiting, diarrhea)
  • Signs of serotonin syndrome (agitation, hallucinations, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
  • Signs of adrenal insufficiency (nausea, vomiting, anorexia, fatigue, weakness, dizziness, low blood pressure)

Special Patient Groups

🤰

Pregnancy

Use during pregnancy is generally not recommended due to potential for neonatal opioid withdrawal syndrome (NOWS) and respiratory depression in the neonate. Benefits must outweigh risks. Prolonged use during pregnancy can lead to physical dependence in the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations with opioid exposure. Risk generally considered low.
Second Trimester: Risk of fetal growth restriction and other adverse outcomes with prolonged use.
Third Trimester: High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Risk of respiratory depression in the neonate if used close to delivery.
🤱

Lactation

Hydromorphone is excreted into breast milk. Use is generally discouraged due to potential for infant sedation, respiratory depression, and physical dependence. If use is necessary, monitor the infant closely for signs of sedation, difficulty feeding, and breathing problems. Consider alternative analgesics or temporary cessation of breastfeeding.

Infant Risk: Moderate to High (L3)
đŸ‘ļ

Pediatric Use

Not recommended for routine use in children due to high risk of respiratory depression. If used, extreme caution and careful titration are required. Dosing is weight-based. Neonates and infants are particularly sensitive to opioid effects.

👴

Geriatric Use

Start with lower doses and titrate slowly due to increased sensitivity to opioid effects (e.g., respiratory depression, sedation, constipation) and potential for decreased renal/hepatic function. Monitor closely for adverse effects.

Clinical Information

💎

Clinical Pearls

  • Hydromorphone is a potent opioid; ensure appropriate patient selection and careful dose titration, especially in opioid-naive patients.
  • Oral liquid formulation allows for flexible dosing and easier titration, particularly useful for patients with swallowing difficulties or those requiring precise dose adjustments.
  • Always educate patients and caregivers about the risks of respiratory depression, sedation, and accidental ingestion, and the importance of safe storage.
  • Proactive management of opioid-induced constipation is crucial; initiate a bowel regimen at the start of therapy.
  • Be aware of the potential for hydromorphone-3-glucuronide (H3G) accumulation in renal impairment, which can lead to neuroexcitatory symptoms.
  • Never combine with alcohol or other CNS depressants without strict medical supervision due to the risk of severe respiratory depression and death.
🔄

Alternative Therapies

  • Other opioid analgesics (e.g., morphine, oxycodone, fentanyl, hydrocodone)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for milder pain or as adjuncts
  • Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
  • Regional anesthesia or nerve blocks
  • Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
💰

Cost & Coverage

Average Cost: Varies widely by pharmacy and formulation (e.g., $20-$100+) per 120 mL of 1 mg/mL liquid
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (requires prior authorization or step therapy for some plans)
📚

General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. 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 your medication, do not hesitate to discuss them with 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. Consult with your doctor or pharmacist about obtaining and using naloxone. 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 critical information about the overdose, including what was taken, the quantity, and the time of the incident.