Hydromorphone 0.25mg/0.5ml Pf Inj

Manufacturer HOSPIRA 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.
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Drug Class
Opioid Analgesic
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Pharmacologic Class
Opioid Agonist
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Pregnancy Category
Not available
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FDA Approved
Jan 1942
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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 is given as an injection, often in a hospital or clinic setting, for quick pain relief.
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How to Use This Medicine

Taking Your Medication

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 tissue 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 for guidance on proper storage.

Missing a Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
  • Avoid alcohol and other sedatives while taking this medication, as they can increase the risk of serious side effects like severe drowsiness and breathing problems.
  • Inform your doctor if you are taking any other medications, especially those that make you sleepy or affect your breathing.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and discuss a bowel regimen with your healthcare provider.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose for opioid-naive patients: IV 0.2-0.6 mg every 2-3 hours as needed. Titrate to effect.
Dose Range: 0.2 - 4 mg

Condition-Specific Dosing:

severe_pain: IV: 0.5-1 mg every 2-3 hours, titrated to effect. SC/IM: 1-2 mg every 2-3 hours. Oral: 2-4 mg every 3-6 hours.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution if used.
Infant: Not established for routine use; extreme caution if used. IV: 0.015 mg/kg/dose every 4 hours, max 0.02 mg/kg/dose.
Child: IV: 0.015 mg/kg/dose every 4 hours, max 0.02 mg/kg/dose. Oral: 0.03-0.08 mg/kg/dose every 4-6 hours.
Adolescent: Similar to adult dosing, but start with lower doses and titrate carefully.
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Dose Adjustments

Renal Impairment:

Mild: Reduce initial dose by 25-50%.
Moderate: Reduce initial dose by 50-75%.
Severe: Reduce initial dose by 75% or more; extend dosing interval. Avoid if possible.
Dialysis: Supplemental dose not typically needed after hemodialysis; monitor closely for prolonged effects.

Hepatic Impairment:

Mild: Reduce initial dose by 25-50%.
Moderate: Reduce initial dose by 50-75%.
Severe: Reduce initial dose by 75% or more; extend dosing interval. Avoid if possible.

Pharmacology

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Mechanism of Action

Hydromorphone is a full opioid agonist, primarily acting at the mu-opioid receptors in the central nervous system (CNS). It produces analgesia by altering the perception of pain and the emotional response to pain. It also causes respiratory depression, miosis, euphoria, and physical dependence.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (IV formulation is 100%)
Tmax: IV: 5-10 minutes
FoodEffect: Not applicable for IV injection

Distribution:

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

Elimination:

HalfLife: 2-3 hours
Clearance: Not available
ExcretionRoute: Renal (primarily as H3G)
Unchanged: <10%
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Pharmacodynamics

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

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; ACCIDENTAL INGESTION; and CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. 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 patient’s risk prior to prescribing hydromorphone injection, and monitor all patients regularly for the development of these behaviors and conditions. Serious, life-threatening, or fatal respiratory depression may occur. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Accidental ingestion of hydromorphone injection, especially by children, can result in a fatal overdose. Concomitant use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
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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 immediately or seek emergency 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
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, or vomiting
Severe headache

Long-Term Use and Hormonal Changes

Prolonged 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
Drowsiness
Fatigue
Weakness
Dry mouth
Flushing
Excessive sweating
Headache
Itching
* Sleep disturbances

If any of these side effects bother you or persist, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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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
  • Bluish 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. 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 potential interactions. To ensure your safety, it is crucial to inform your doctor and pharmacist about:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
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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.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to minimize the risk of dizziness or fainting. Be cautious when climbing stairs.

Adhere strictly to your doctor's prescribed dosage and frequency. Do not exceed the recommended dose, take it more frequently, or use it for a longer duration than instructed, as this may increase the risk of severe side effects.

Before taking this medication with other strong pain relievers or using a pain patch, consult your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not take more medication than prescribed.

If you are using this medication long-term, your doctor may recommend regular blood tests to monitor your health. Discuss this with your doctor.

If you have a sulfite allergy, inform your doctor, as some formulations of this medication may contain sulfites.

Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal interactions.

Long-term or high-dose use of this opioid medication may result in tolerance, reducing its effectiveness. If you find that the medication is no longer working as well, contact your doctor. Do not increase your dose without consulting your doctor.

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

This medication may increase the risk of seizures, particularly in individuals with a history of seizure disorders. Discuss your risk with your doctor.

Opioid medications like this one can rarely cause a severe adrenal gland problem. Seek immediate medical attention if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.

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

If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and potentially harm your baby. Seek medical help immediately if your baby appears overly sleepy, limp, or has breathing difficulties.
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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:

If you suspect an overdose, 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

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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, other opioids): Increased risk of respiratory depression, profound sedation, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, MAOIs): Increased risk of serotonin syndrome.
  • Mixed agonist/antagonist and partial agonist opioid analgesics (e.g., butorphanol, nalbuphine, pentazocine, buprenorphine): May reduce the analgesic effect of hydromorphone and/or precipitate withdrawal symptoms.
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Moderate Interactions

  • Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
  • Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
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Minor Interactions

  • Antihypertensives: May cause additive hypotensive effects.

Monitoring

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Baseline Monitoring

Pain level (0-10 scale)

Rationale: To establish baseline and assess treatment efficacy.

Timing: Prior to first dose

Respiratory rate and depth

Rationale: To assess baseline respiratory function and risk of depression.

Timing: Prior to first dose

Level of consciousness/sedation

Rationale: To assess baseline mental status and risk of over-sedation.

Timing: Prior to first dose

Blood pressure and heart rate

Rationale: To assess baseline cardiovascular status.

Timing: Prior to first dose

Bowel function

Rationale: To assess baseline and anticipate opioid-induced constipation.

Timing: Prior to first dose

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Routine Monitoring

Pain level (0-10 scale)

Frequency: Every 1-2 hours initially, then as needed based on patient response and dosing interval.

Target: Patient-specific goal for pain reduction.

Action Threshold: Inadequate pain relief or worsening pain.

Respiratory rate and depth

Frequency: Every 15-30 minutes for 1-2 hours after IV dose, then every 1-4 hours or as clinically indicated.

Target: Adults: 12-20 breaths/min; regular rhythm.

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of respiratory distress.

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

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.

Blood pressure and heart rate

Frequency: Periodically, especially with dose titration or in patients at risk for hypotension.

Target: Within patient's normal range.

Action Threshold: Significant hypotension or bradycardia.

Bowel function

Frequency: Daily

Target: Regular bowel movements.

Action Threshold: No bowel movement for 2-3 days; signs of constipation.

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Symptom Monitoring

  • Excessive sedation
  • Dizziness
  • Nausea/vomiting
  • Constipation
  • Itching
  • Difficulty breathing (shallow, slow, or labored breathing)
  • Pinpoint pupils
  • Confusion
  • Hallucinations

Special Patient Groups

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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.

Trimester-Specific Risks:

First Trimester: Potential for congenital malformations, though data are limited and conflicting for opioids in general.
Second Trimester: Risk of fetal growth restriction and premature birth 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.
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Lactation

Hydromorphone is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, and poor feeding. A single dose is generally considered compatible with breastfeeding, but chronic use is not recommended.

Infant Risk: Risk of sedation, respiratory depression, poor feeding, and withdrawal symptoms in the infant.
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Pediatric Use

Use with extreme caution in pediatric patients, especially infants and neonates, due to increased sensitivity to respiratory depression. Dosing must be carefully titrated based on weight and clinical response. Not recommended for routine use in neonates.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Hydromorphone is 5-7 times more potent than morphine on a milligram-for-milligram basis. Always double-check doses and concentrations to avoid medication errors.
  • The 0.25mg/0.5ml concentration is a low dose formulation, often useful for opioid-naive patients or for careful titration in sensitive individuals.
  • Rapid IV administration can lead to severe respiratory depression, hypotension, and circulatory collapse. Administer slowly over at least 2-3 minutes.
  • Tolerance and physical dependence can develop with prolonged use. Do not discontinue abruptly in physically dependent patients; taper gradually.
  • Opioid-induced constipation is a common and persistent side effect; prophylactic laxative therapy should be initiated with chronic use.
  • Assess for risk factors for opioid addiction, abuse, and misuse before initiating therapy and monitor throughout treatment.
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Alternative Therapies

  • Morphine
  • Fentanyl
  • Oxycodone
  • Hydrocodone
  • Tramadol
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain
  • Regional anesthesia/nerve blocks
  • Adjuvant analgesics (e.g., gabapentin, pregabalin, antidepressants) for neuropathic pain
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Cost & Coverage

Average Cost: Varies widely, typically $5-$50 per single-dose vial/syringe per 0.5ml vial/syringe
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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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, follow these guidelines:
- 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.
- Dispose of unused or expired medications properly. 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 important information about its use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns, 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. When seeking help, be ready to provide details about the medication, including the dose taken and the time of the incident.