Dilaudid 1mg/ml Pf Inj, 1ml
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the dosage 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 best storage method.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on what to do next.
Lifestyle & Tips
- Avoid alcohol and other sedating medications unless approved by your doctor, as this can increase the risk of serious side effects like extreme drowsiness and breathing problems.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- Store this medication securely away from children and pets, as accidental ingestion can be fatal.
- Do not share this medication with anyone else, as it can be dangerous and is illegal.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Addiction, Abuse, and Misuse: Hydromorphone Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientβs risk prior to prescribing Hydromorphone Injection, and monitor all patients regularly for the development of these behaviors and conditions.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of Hydromorphone Injection. Monitor for respiratory depression, especially during initiation of Hydromorphone Injection or following a dose increase.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of Hydromorphone Injection 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.
Accidental Ingestion: Accidental ingestion of even one dose of Hydromorphone Injection, especially by children, can result in a fatal overdose of hydromorphone.
Risks from 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
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
Uncontrolled eye movements
Trouble controlling body movements
Changes in eyesight
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
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, 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 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 or shallow breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion or disorientation
- Pinpoint pupils
- Severe constipation
- Difficulty urinating
- Signs of an allergic reaction (rash, itching, swelling of face/lips/tongue, severe dizziness, trouble breathing)
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of severely high blood pressure
Current use of any of the following medications: 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 conditions to your doctor and pharmacist. They will help you 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 first.
Precautions & 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
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, and exercise caution 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
Before taking this medication with other strong pain relievers 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, discuss this with your doctor, as some products may contain sulfites.
Alcohol Interactions
Do not consume alcohol or products containing alcohol while taking this medication, as this 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 result in 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.
Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor.
Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland disorder. Seek medical attention immediately if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.
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 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
- Low blood pressure
- Slowed heart rate
- Circulatory collapse
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) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected paralytic ileus
- Hypersensitivity to hydromorphone or any component of the product
- Concurrent use of monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOIs
Major Interactions
- Other CNS depressants (e.g., benzodiazepines, 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, fentanyl): Increased risk of serotonin syndrome.
- Mixed agonist/antagonist and partial agonist opioids (e.g., buprenorphine, nalbuphine, butorphanol, pentazocine): May precipitate withdrawal symptoms or reduce analgesic effect.
- Diuretics: Opioids may reduce the efficacy of diuretics by causing the release of antidiuretic hormone.
Moderate Interactions
- Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and/or severe constipation.
- CYP3A4 inhibitors/inducers: While hydromorphone is not primarily metabolized by CYP3A4, some interactions may occur with other opioids. Monitor for altered effects.
- Muscle relaxants: Enhanced neuromuscular blocking effects.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to first dose
Rationale: To assess baseline respiratory function and risk of respiratory depression.
Timing: Prior to first dose
Rationale: To assess baseline neurological status and risk of over-sedation.
Timing: Prior to first dose
Rationale: To assess baseline cardiovascular status.
Timing: Prior to first dose
Rationale: To identify impairment that may necessitate dose adjustment.
Timing: Prior to initiation, especially in patients with suspected impairment
Routine Monitoring
Frequency: Every 1-2 hours initially, then as needed based on pain and dose frequency
Target: Acceptable pain level as defined by patient/provider
Action Threshold: Uncontrolled pain or worsening pain; consider dose adjustment or alternative analgesia.
Frequency: Every 15-30 minutes for 1-2 hours after IV dose, then every 1-4 hours or as clinically indicated
Target: Adults: >10-12 breaths/min, regular rhythm, adequate depth
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, hypoventilation, or signs of respiratory distress; administer naloxone, provide respiratory support.
Frequency: Every 15-30 minutes for 1-2 hours after IV dose, then every 1-4 hours or as clinically indicated
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Difficult to arouse, somnolent, or unarousable; administer naloxone, provide respiratory support.
Frequency: Every 1-4 hours or as clinically indicated
Target: Within patient's normal range
Action Threshold: Significant hypotension or bradycardia; consider dose reduction or supportive measures.
Frequency: Daily
Target: Regular bowel movements
Action Threshold: Constipation; initiate bowel regimen.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/drowsiness
- Dizziness
- Nausea and vomiting
- Constipation
- Pruritus (itching)
- Urinary retention
- Miosis (pinpoint pupils)
- Signs of allergic reaction (rash, hives, swelling)
Special Patient Groups
Pregnancy
Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Use only if the potential benefit justifies the potential risk to the fetus. Monitor neonates for signs of NOWS.
Trimester-Specific Risks:
Lactation
Hydromorphone is excreted in breast milk. Monitor breastfed infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. A single dose is generally considered compatible with breastfeeding with close infant monitoring. Chronic use is generally not recommended.
Pediatric Use
Use with extreme caution, especially in neonates and infants, due to increased sensitivity to respiratory depression. Dosing must be precise and based on weight. Not recommended for routine use in neonates. Close monitoring for respiratory depression and sedation is crucial.
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 significantly more potent than morphine (approximately 5-7 times). Always verify dose and concentration carefully to avoid overdose.
- Rapid IV administration can lead to severe respiratory depression, hypotension, and circulatory collapse. Administer IV doses slowly (over at least 2-3 minutes).
- Patients with renal impairment are at higher risk for accumulation of hydromorphone-3-glucuronide (H3G), which can cause neuroexcitatory symptoms (e.g., myoclonus, seizures). Dose reduction is essential.
- Tolerance and physical dependence can develop with prolonged use. Do not abruptly discontinue in physically dependent patients to avoid withdrawal symptoms.
- Consider naloxone availability and training for patients and caregivers, especially for those at high risk of overdose (e.g., concomitant CNS depressants, high doses).
- Assess for risk factors for opioid addiction, abuse, and misuse prior to initiation and monitor throughout therapy.
Alternative Therapies
- Morphine (IV, IM, SC)
- Fentanyl (IV, IM)
- Oxycodone (oral, often combined with acetaminophen)
- Hydrocodone (oral, often combined with acetaminophen)
- Tramadol (oral)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for mild to moderate pain
- Regional anesthesia/nerve blocks
- Adjuvant analgesics (e.g., gabapentin, pregabalin, antidepressants for neuropathic pain)
Cost & Coverage
General Drug Facts
To ensure safe use, keep the following guidelines in mind:
- Never share your medication with others, and do not take medication prescribed for someone else.
- Store all medications in a secure location, out of reach of children and pets.
- Properly dispose of unused or expired medications. Unless instructed otherwise, do not flush them down the toilet or pour 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 when you first receive your medication and each time your prescription is refilled. 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 used as part of the treatment. Talk to 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 information about what was taken, the amount, and the time it happened.
If you believe an overdose has occurred, contact your local poison control center or seek medical care right away. Have the necessary information ready, including what was taken, how much, and when the incident occurred.