Dilaudid 0.2mg/ml Pf Inj, 1ml

Manufacturer FRESENIUS KABI USA Active Ingredient Hydromorphone Injection(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.Make sure you have the right drug; there is more than one strength. A lower strength may not ease pain well enough. A higher strength could lead to accidental overdose and death.Certain strengths of this drug may only be used by people who have been taking drugs like this drug and are used to their effects. The use of these strengths by people who have not been taking drugs like this drug may cause very bad and sometimes deadly breathing problems. Talk with the doctor. @ 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 1970
âš–ī¸
DEA Schedule
Schedule II

Overview

â„šī¸

What is this medicine?

Hydromorphone is a strong pain medicine (an opioid) that works in your brain to change how your body feels and responds to pain. It is given by injection, usually in a hospital setting, for severe pain.
📋

How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered via injection into a muscle, vein, or the fatty layer under the skin.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on the next steps to take.
💡

Lifestyle & Tips

  • Avoid alcohol and other sedating medications unless specifically approved by your doctor.
  • Do not drive or operate heavy machinery until you know how this medication affects you.
  • Do not share this medication with anyone else, as it can be dangerous and even fatal.
  • Keep this medication out of reach of children and pets, as accidental ingestion can be fatal.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Initial IV dose typically 0.2-1 mg every 3-4 hours as needed. The 0.2 mg/ml concentration is often used for titration or PCA.
Dose Range: 0.2 - 4 mg

Condition-Specific Dosing:

acute_pain_iv: 0.2-1 mg IV every 3-4 hours as needed, titrate to effect. For opioid-naive patients, start with lower doses (e.g., 0.2-0.5 mg).
pca_loading_dose: 0.5-1 mg IV (optional)
pca_demand_dose: 0.1-0.5 mg, lockout 5-15 minutes
pca_basal_rate: 0.01-0.04 mg/kg/hr (highly individualized, often avoided in opioid-naive patients)
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (use with extreme caution, if at all, due to risk of respiratory depression)
Infant: Not established (use with extreme caution, if at all, due to risk of respiratory depression)
Child: 0.015 mg/kg/dose IV every 4-6 hours as needed (max 0.1 mg/kg/dose or 2 mg/dose, whichever is less). Use with extreme caution and titrate slowly.
Adolescent: Similar to adult dosing, but start with lower doses (e.g., 0.2-0.5 mg IV) and titrate carefully.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor for increased sedation and respiratory depression.
Severe: Reduce initial dose by 50-75% and extend dosing interval significantly. Avoid if possible. Monitor for increased sedation and respiratory depression due to accumulation of active metabolite (hydromorphone-3-glucuronide).
Dialysis: Not dialyzable. Reduce dose significantly and monitor closely. Avoid if possible.

Hepatic Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Reduce initial dose by 25-50% and titrate slowly. Monitor for increased sedation and respiratory depression.
Severe: Reduce initial dose by 50-75% and titrate slowly. Avoid if possible. Monitor for increased sedation and respiratory depression.
Confidence: Medium

Pharmacology

đŸ”Ŧ

Mechanism of Action

Hydromorphone is a full opioid agonist that binds to mu-opioid receptors in the central nervous system (CNS), peripheral tissues, and gastrointestinal tract. This binding inhibits ascending pain pathways, altering the perception of and response to pain. It also produces generalized CNS depression, including respiratory depression, cough suppression, and miosis.
📊

Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: Rapid (IV)
FoodEffect: Not applicable (IV)

Distribution:

Vd: 4 L/kg
ProteinBinding: 8-19%
CnssPenetration: Yes

Elimination:

HalfLife: 2-3 hours (terminal half-life)
Clearance: Not available
ExcretionRoute: Renal (primarily as H3G)
Unchanged: <10%
âąī¸

Pharmacodynamics

OnsetOfAction: Within 5 minutes (IV)
PeakEffect: 10-20 minutes (IV)
DurationOfAction: 3-4 hours (IV)

Safety & Warnings

âš ī¸

BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. Hydromorphone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Life-threatening respiratory depression may occur. Accidental ingestion of hydromorphone, especially by children, can result in a fatal overdose. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome. Concomitant use with benzodiazepines or other CNS depressants may result in profound sedation, respiratory depression, coma, and death.
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 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
+ 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 serotonin syndrome, a severe and potentially deadly condition. 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 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:

  • Extreme drowsiness or difficulty waking up
  • Slow, shallow, or difficult breathing
  • Bluish lips or fingernails
  • Severe dizziness or lightheadedness
  • Confusion
  • Pinpoint pupils
  • Unusual weakness
📋

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 blockage or narrowing
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure
Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
âš ī¸

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.

Laboratory Tests
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 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.

Dependence and Withdrawal
Regular use of opioid medications like this one may cause dependence. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dosage, 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 problem. Seek medical attention immediately 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 overly sleepy, limp, or has breathing difficulties.
🆘

Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate emergency medical attention. Administer naloxone if available and trained. Call 911 or 1-800-222-1222 (Poison Control).

Drug Interactions

đŸšĢ

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) - increased risk of profound sedation, respiratory depression, coma, and death.
  • Mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine, butorphanol, buprenorphine) - may precipitate withdrawal symptoms or reduce analgesic effect.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol) - increased risk of serotonin syndrome.
🟡

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.
  • Antihypertensives - increased hypotensive effects.
đŸŸĸ

Minor Interactions

  • Not available

Monitoring

đŸ”Ŧ

Baseline Monitoring

Pain assessment (intensity, character, location)

Rationale: To establish baseline pain level and guide initial dosing.

Timing: Prior to first dose

Respiratory rate and depth

Rationale: To assess baseline respiratory function and identify risk for respiratory depression.

Timing: Prior to first dose

Sedation level (e.g., Pasero Opioid-Induced Sedation Scale - POSS)

Rationale: To assess baseline CNS status and identify risk for over-sedation.

Timing: Prior to first dose

Blood pressure and heart rate

Rationale: To assess baseline cardiovascular status.

Timing: Prior to first dose

Renal and hepatic function tests (BUN, creatinine, LFTs)

Rationale: To identify potential impairment requiring dose adjustment.

Timing: Prior to initiation, especially in patients with known or suspected impairment

📊

Routine Monitoring

Pain assessment

Frequency: Every 15-30 minutes after IV dose until stable, then every 2-4 hours or as needed.

Target: Patient-specific pain goal (e.g., 3/10 or less)

Action Threshold: Pain uncontrolled, requiring additional dose or intervention

Respiratory rate and depth

Frequency: Every 15-30 minutes after IV dose until stable, then every 1-2 hours or as needed.

Target: 10-20 breaths/minute (adults)

Action Threshold: <10 breaths/minute, shallow breathing, or signs of distress (e.g., cyanosis)

Sedation level (POSS)

Frequency: Every 15-30 minutes after IV dose until stable, then every 1-2 hours or as needed.

Target: POSS 0-2 (awake to easily aroused)

Action Threshold: POSS 3 (frequently drowsy, arousable, drifts to sleep during conversation) or POSS 4 (somnolent, minimal or no response to stimuli)

Blood pressure and heart rate

Frequency: Every 1-4 hours or as needed.

Target: Within patient's normal range

Action Threshold: Significant hypotension or bradycardia

Bowel function

Frequency: Daily

Target: Regular bowel movements

Action Threshold: Constipation, abdominal distension, or absent bowel sounds

đŸ‘ī¸

Symptom Monitoring

  • Excessive sedation
  • Respiratory depression (slow, shallow breathing)
  • Dizziness
  • Nausea
  • Vomiting
  • Constipation
  • Pruritus
  • Urinary retention
  • Confusion
  • Miosis (pinpoint pupils)

Special Patient Groups

🤰

Pregnancy

Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Monitor neonates for signs of NOWS.

Trimester-Specific Risks:

First Trimester: Potential for congenital malformations (limited data, but generally avoided if possible).
Second Trimester: Risk of NOWS with prolonged use.
Third Trimester: High risk of NOWS with prolonged use; risk of respiratory depression in the neonate if administered close to delivery.
🤱

Lactation

Hydromorphone is excreted in breast milk. Monitor breastfed infants for signs of sedation, respiratory depression, poor feeding, and poor weight gain. A single dose may be acceptable, but chronic use is generally discouraged. Consider alternative analgesics or temporary cessation of breastfeeding.

Infant Risk: Moderate to High (risk of sedation, respiratory depression, poor feeding, and withdrawal symptoms upon discontinuation of maternal hydromorphone).
đŸ‘ļ

Pediatric Use

Use with extreme caution due to increased sensitivity to respiratory depression. Dosing must be individualized and carefully titrated. Not recommended for neonates or infants due to lack of established safety and efficacy.

👴

Geriatric Use

Start with lower doses and titrate slowly due to increased sensitivity to opioid effects, decreased renal/hepatic function, and increased risk of respiratory depression and falls. Monitor closely for adverse effects.

Clinical Information

💎

Clinical Pearls

  • Hydromorphone is significantly more potent than morphine (approximately 5-7 times). Always verify dose and concentration carefully to avoid overdose.
  • The 0.2 mg/ml concentration is very dilute and often used for precise titration, especially in opioid-naive patients, or for PCA pumps where lower demand doses are desired.
  • Rapid IV push can lead to severe hypotension and respiratory depression. Administer slowly over 2-3 minutes.
  • Patients with renal impairment are at higher risk for accumulation of the neurotoxic metabolite, hydromorphone-3-glucuronide (H3G), leading to increased sedation, delirium, and myoclonus.
  • Always have naloxone readily available when administering hydromorphone.
  • Tolerance and physical dependence can develop with prolonged use. Do not discontinue abruptly after chronic use to avoid withdrawal symptoms.
🔄

Alternative Therapies

  • Morphine
  • Fentanyl
  • Oxycodone
  • Tramadol
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain
  • Regional anesthesia/nerve blocks
💰

Cost & Coverage

Average Cost: Price varies widely by supplier and contract per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 1-3 (often covered, but may require prior authorization or step therapy for certain formulations/quantities)
📚

General Drug Facts

It is essential to monitor your symptoms and health problems while taking this medication. If you notice no improvement or a worsening of your condition, contact your doctor promptly.

To ensure safe use, keep the following guidelines in mind:
- Do not share your medication with others, and never take someone else's medication.
- Store all medications in a secure location, out of reach of children and pets.
- Properly dispose of unused or expired medications. Unless instructed to do so, avoid flushing them down the toilet or pouring them down the drain. If you are unsure about the best disposal method, consult your pharmacist. You may also want to inquire about drug take-back programs available in your area.

This medication is accompanied by a Medication Guide, which provides crucial information. Read this guide carefully and review it again each time you receive a refill. If you have any questions or concerns about this medication, 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 treat the condition. Consult 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 used. Be prepared to provide information about the overdose, including the substance taken, the amount, and the time it occurred.

If you believe an overdose has occurred, contact your local poison control center or seek medical care immediately. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.