Hydromorphone 10mg/ml Inj, 5ml

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.
🏷️
Drug Class
Opioid Analgesic
🧬
Pharmacologic Class
Opioid Agonist
🀰
Pregnancy Category
Not available
βœ…
FDA Approved
Jan 1942
βš–οΈ
DEA Schedule
Schedule II

Overview

ℹ️

What is this medicine?

Hydromorphone is a strong pain medicine, similar to morphine, used to treat moderate to severe pain. It works in your brain to change how your body feels and responds to pain. It is given as an injection (shot) into a vein, muscle, or under the skin.
πŸ“‹

How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all instructions provided. This medication is administered via injection into a muscle, vein, or the fatty layer under the skin.

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

If you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
πŸ’‘

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.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and discuss a bowel regimen with your doctor.
  • Keep this medication in a safe place, out of reach of children and pets, as accidental ingestion can be fatal.

Dosing & Administration

πŸ‘¨β€βš•οΈ

Adult Dosing

Standard Dose: Initial dose 1-2 mg IV/SC/IM every 4-6 hours as needed. Titrate to effect.
Dose Range: 0.5 - 4 mg

Condition-Specific Dosing:

severe_pain: Higher initial doses may be considered for opioid-tolerant patients or severe pain, but always titrate carefully.
post_operative_pain: 0.2-1 mg IV every 1-2 hours as needed, titrate to effect.
πŸ‘Ά

Pediatric Dosing

Neonatal: Not established (use with extreme caution, if at all, due to risk of respiratory depression and withdrawal)
Infant: Not established (use with extreme caution, if at all, due to risk of respiratory depression and withdrawal)
Child: 0.015 mg/kg/dose IV/SC/IM every 4-6 hours as needed (max 0.1 mg/kg/dose, not to exceed 2 mg/dose). Titrate carefully.
Adolescent: 0.015 mg/kg/dose IV/SC/IM every 4-6 hours as needed (max 0.1 mg/kg/dose, not to exceed 2 mg/dose). Titrate carefully.
βš•οΈ

Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor for increased effects.
Moderate: Reduce initial dose by 25-50%, extend dosing interval, and titrate carefully.
Severe: Reduce initial dose by 50-75%, extend dosing interval, and titrate carefully. Avoid if possible.
Dialysis: Not significantly removed by hemodialysis. Administer after dialysis. Monitor closely.

Hepatic Impairment:

Mild: No specific adjustment, monitor for increased effects.
Moderate: Reduce initial dose by 25-50%, extend dosing interval, and titrate carefully.
Severe: Reduce initial dose by 50-75%, extend dosing interval, and titrate carefully. Avoid if possible.

Pharmacology

πŸ”¬

Mechanism of Action

Hydromorphone is a full opioid agonist that acts primarily at the mu-opioid receptors in the central nervous system (CNS). It produces analgesia by mimicking the effects of endogenous opioid peptides, leading to inhibition of pain transmission, alteration of pain perception, and induction of euphoria. It also causes respiratory depression, miosis, and reduced gastrointestinal motility.
πŸ“Š

Pharmacokinetics

Absorption:

Bioavailability: 100% (IV/IM/SC)
Tmax: 5-10 minutes (IV), 30-60 minutes (IM/SC)
FoodEffect: Not applicable for injection

Distribution:

Vd: 3-4 L/kg
ProteinBinding: 8-19%
CnssPenetration: Yes

Elimination:

HalfLife: 2-3 hours
Clearance: 1.2-1.8 L/min
ExcretionRoute: Renal (primarily as H3G)
Unchanged: <10%
⏱️

Pharmacodynamics

OnsetOfAction: Within 5 minutes (IV), 15-30 minutes (IM/SC)
PeakEffect: 15-30 minutes (IV), 30-90 minutes (IM/SC)
DurationOfAction: 3-4 hours (IV/IM/SC)

Safety & Warnings

⚠️

BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM 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. Accidental ingestion of Hydromorphone Injection, especially by children, can result in a fatal overdose. Prolonged use of Hydromorphone Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. 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.
⚠️

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 fainting
Confusion
Severe constipation or stomach pain, which may indicate a serious 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
Urination difficulties
Uncontrolled eye movements
Trouble controlling body movements
Changes in vision
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
Abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

Long-Term Use and Hormonal Changes

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

Decreased interest in sex
Fertility problems
Irregular or absent menstrual periods
Ejaculation problems

Other Possible Side Effects

While many people may not experience any side effects or only mild ones, it's essential to be aware of the following potential side effects:

Constipation
Diarrhea
Stomach pain
Nausea
Vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Flushing
Excessive sweating
Headache
Itching
* Sleep disturbances

If you're concerned about any side effects or have questions, contact your doctor. 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 or inability to pass urine
  • Signs of an allergic reaction (rash, itching, swelling of face/lips/tongue, difficulty breathing)
πŸ“‹

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, 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 your medications, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss your health problems with your doctor and pharmacist
Verify that it is safe to take this medication with your existing medications and health conditions
Avoid starting, stopping, or changing the dose of any medication without consulting your doctor first
⚠️

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. Consult with your doctor to discuss the necessary laboratory tests.

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.

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. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other negative effects.

Seizure Risk
This medication may increase the risk of seizures in some individuals, including 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 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 difficulty breathing.
πŸ†˜

Overdose Information

Overdose Symptoms:

  • Slowed or stopped breathing (respiratory depression)
  • Extreme drowsiness, unresponsiveness, or coma
  • Pinpoint pupils
  • Cold, clammy skin
  • Limp muscles
  • Bluish discoloration of lips and fingernails (cyanosis)
  • Low blood pressure
  • Slowed heart rate

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 further guidance.

Drug Interactions

🚫

Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of serotonin syndrome or severe respiratory depression)
πŸ”΄

Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, fentanyl): Risk of serotonin syndrome.
  • Mixed agonist/antagonist opioids (e.g., butorphanol, nalbuphine, pentazocine): May precipitate withdrawal symptoms or reduce analgesic effect.
  • Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and severe constipation.
🟑

Moderate Interactions

  • Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
  • Antihypertensives: May cause additive hypotensive effects.
  • Muscle relaxants: Enhanced neuromuscular blocking effects.
🟒

Minor Interactions

  • Not available

Monitoring

πŸ”¬

Baseline Monitoring

Pain assessment (intensity, location, quality)

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

Level of consciousness/sedation score

Rationale: To assess baseline neurological 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 (e.g., BUN, creatinine, LFTs)

Rationale: To identify potential impairment that may require dose adjustment.

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

πŸ“Š

Routine Monitoring

Pain assessment

Frequency: Every 1-2 hours initially, then every 4-6 hours or as needed based on patient response and dosing interval.

Target: Acceptable pain level as defined by patient/provider.

Action Threshold: Uncontrolled pain or adverse effects requiring intervention.

Respiratory rate and depth

Frequency: Every 15-30 minutes for 1-2 hours after IV dose, then every 1-2 hours or as clinically indicated. Continuously in high-risk patients.

Target: Typically >10-12 breaths/min, regular rhythm.

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

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

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

Target: Awake and alert or mildly drowsy, easily aroused.

Action Threshold: Difficult to arouse, somnolent, or unarousable.

Blood pressure and heart rate

Frequency: Every 1-2 hours initially, then every 4-6 hours or as clinically indicated.

Target: Within patient's normal range.

Action Threshold: Significant hypotension or bradycardia/tachycardia.

Bowel function

Frequency: Daily

Target: Regular bowel movements.

Action Threshold: Constipation, abdominal distension.

πŸ‘οΈ

Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation/drowsiness
  • Dizziness/lightheadedness
  • Nausea/vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Miosis (pinpoint pupils)
  • Hypotension
  • 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:

First Trimester: Potential for congenital malformations, though data are limited and inconsistent for opioids in general.
Second Trimester: Risk of neonatal opioid withdrawal syndrome with prolonged use.
Third Trimester: High risk of neonatal opioid withdrawal syndrome with prolonged use. Risk of respiratory depression in the neonate if administered close to delivery.
🀱

Lactation

Hydromorphone is excreted in breast milk. Monitor infants for signs of sedation, respiratory depression, and poor feeding. A single dose may be acceptable, but chronic use is generally not recommended due to potential for serious adverse reactions in the infant, including respiratory depression and withdrawal symptoms.

Infant Risk: Moderate to High (L3)
πŸ‘Ά

Pediatric Use

Use with extreme caution, especially in neonates and infants, due to increased sensitivity to respiratory depression. Dosing must be precise and individualized. Not recommended for routine use in children under 6 months.

πŸ‘΄

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

πŸ’Ž

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 and hypotension. Administer slowly over at least 2-3 minutes.
  • Consider a bowel regimen (stool softener + stimulant laxative) proactively for patients on chronic opioid therapy to prevent opioid-induced constipation.
  • Tolerance and physical dependence can develop with prolonged use. Do not abruptly discontinue in physically dependent patients; taper gradually.
  • Naloxone should be readily available when administering hydromorphone, especially in opioid-naive patients or those at high risk for respiratory depression.
πŸ”„

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, tricyclic antidepressants for neuropathic pain)
πŸ’°

Cost & Coverage

Average Cost: Varies widely per 10mg/ml, 5ml vial
Generic Available: Yes
Insurance Coverage: Tier 2-3 (often requires prior authorization for chronic use or higher doses)
πŸ“š

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, never share your medication with others, and do not take anyone else's medication. Store all medications in a secure location, out of reach of children and pets. Properly dispose of unused or expired medications by checking with your pharmacist for guidance. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain. You may also want to explore local drug take-back programs for safe disposal.

This medication is accompanied by a Medication Guide, which provides crucial information. Read this guide carefully and review it again each time you refill your prescription. 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 used as part of the treatment. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide 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. Be prepared to provide details about the overdose, including the substance, quantity, and timing.