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Hydromorphone 50mg/5ml Inj, 5ml

Manufacturer TEVA PARENTERAL MEDICINES 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
Category C (D if used for prolonged periods or near term)
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FDA Approved
Jan 1970
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Hydromorphone is a strong pain medicine (an opioid) used to treat severe pain. It works in your brain to change how your body feels and responds to pain. This specific injection is a very concentrated form, usually given in hospitals for patients who need a lot of pain relief, often those who are already used to strong pain medicines.
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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, which can be given into a muscle, a vein, or under the skin (subcutaneously) into the fatty tissue.

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 procedures.

Missing a Dose

If you miss a dose, contact your doctor to determine the best course of action. They will advise you on what to do next.
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Lifestyle & Tips

  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • Avoid alcohol and other sedatives (like benzodiazepines, sleeping pills) while taking this medication, as this can lead to dangerous breathing problems and extreme drowsiness.
  • To prevent severe constipation, increase fluid intake, eat fiber-rich foods, and use stool softeners or laxatives as directed by your doctor.
  • Do not share this medication with anyone else, as it can be fatal if taken by someone for whom it is not prescribed.
  • Store this medication securely away from children and pets.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: For severe pain in opioid-tolerant patients: Initial IV dose typically 0.5-1 mg every 3-4 hours as needed. The 50mg/5ml (10mg/ml) concentration is a high potency formulation intended for opioid-tolerant patients requiring high doses, often for continuous infusion or patient-controlled analgesia (PCA). Initial dose for opioid-naive patients is much lower (e.g., 0.2-0.6 mg IV).
Dose Range: 0.2 - 10 mg

Condition-Specific Dosing:

opioid_naive_iv: 0.2-0.6 mg every 3-4 hours
opioid_tolerant_iv: 0.5-1 mg or more, titrated to effect, every 3-4 hours or via continuous infusion/PCA. The 50mg/5ml concentration is for this population.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and specialized care required. Risk of respiratory depression.
Infant: Not established for routine use; extreme caution and specialized care required. Risk of respiratory depression.
Child: 0.015 mg/kg/dose IV/SC every 4-6 hours, max 0.08 mg/kg/dose or 2 mg/dose. Use with extreme caution and only if benefits outweigh risks.
Adolescent: Similar to adult opioid-naive dosing, 0.2-0.6 mg IV every 3-4 hours, titrated to effect. Use with caution.
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Dose Adjustments

Renal Impairment:

Mild: Reduce initial dose by 25-50%. Monitor closely for sedation and respiratory depression.
Moderate: Reduce initial dose by 50-75%. Monitor closely for sedation and respiratory depression.
Severe: Avoid or use with extreme caution; significant dose reduction (e.g., 75% or more) and extended dosing intervals are necessary due to accumulation of active metabolite (hydromorphone-3-glucuronide).
Dialysis: Not significantly removed by hemodialysis. Dose adjustment required; monitor closely for prolonged effects.

Hepatic Impairment:

Mild: Reduce initial dose by 25-50%. Monitor closely.
Moderate: Reduce initial dose by 50-75%. Monitor closely.
Severe: Avoid or use with extreme caution; significant dose reduction (e.g., 75% or more) and extended dosing intervals are necessary. Monitor closely for prolonged effects.

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 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, decreased gastrointestinal motility, and antitussive effects.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: 5-20 minutes (IV), 30-60 minutes (IM), 30-90 minutes (SC)
FoodEffect: Not applicable for injection

Distribution:

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

Elimination:

HalfLife: 2-3 hours (parent drug)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10%
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Pharmacodynamics

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

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH ALCOHOL AND OTHER CNS DEPRESSANTS; ACCIDENTAL INGESTION. Hydromorphone 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 and monitor all patients regularly for the development of these behaviors and conditions. Serious, life-threatening, or fatal respiratory depression may occur. Concomitant use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. If opioid use is required, limit dosages and durations to the minimum required and follow patients closely for signs and symptoms of respiratory depression and sedation. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Accidental ingestion of even one dose, especially by children, can result in a fatal overdose.
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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 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 or 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 (fast, slow, or irregular)
Breathing difficulties, including:
+ Trouble breathing
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
 Hallucinations (seeing or hearing things that are not there)
Mood changes
 Seizures
Shakiness
 Difficulty urinating
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 (fast or irregular)
Flushing
 Muscle twitching or stiffness
Seizures
 Shivering or shaking
Excessive sweating
 Severe diarrhea, stomach upset, 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 minor ones, 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
  • Severe dizziness or lightheadedness when standing up
  • Confusion or disorientation
  • Pinpoint pupils
  • Severe constipation or abdominal pain
  • Signs of 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
 Certain health conditions, including:
+ Respiratory problems, such as 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, including 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

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. Your doctor and pharmacist need this information to ensure it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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
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 than prescribed, 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, 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.

Dependence and Withdrawal
Regular use of opioid medications like this one may cause dependence. If you need to reduce the dose or stop taking this medication, consult your doctor to minimize the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.

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 for Older Adults
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.
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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
  • Bluish discoloration of lips and fingernails (cyanosis)
  • Slowed heart rate
  • Low blood pressure

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 Center) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of serotonin syndrome, severe respiratory depression)
  • Patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Patients with known or suspected paralytic ileus
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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol) - increased risk of profound sedation, respiratory depression, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, trazodone, tramadol) - risk of serotonin syndrome.
  • Mixed agonist/antagonist opioids (e.g., butorphanol, nalbuphine, pentazocine) - may reduce analgesic effect and/or precipitate withdrawal symptoms.
  • Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants) - increased risk of urinary retention and severe constipation.
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Moderate Interactions

  • Diuretics - opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
  • Antihypertensives - additive hypotensive effects.
  • P-glycoprotein (P-gp) inhibitors/inducers - potential for altered hydromorphone exposure, though hydromorphone is not a major P-gp substrate.
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Minor Interactions

  • Not available (most interactions are significant due to CNS effects)

Monitoring

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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

Level of consciousness/sedation

Rationale: To assess baseline neurological status and identify risk for excessive sedation.

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 suspected dysfunction

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Routine Monitoring

Pain assessment

Frequency: Regularly (e.g., every 1-2 hours initially, then every 3-4 hours or as needed)

Target: Patient-specific pain goal (e.g., 3/10 on a 0-10 scale)

Action Threshold: Pain uncontrolled or increasing; requires dose adjustment or alternative therapy.

Respiratory rate and depth

Frequency: Regularly (e.g., every 15-30 minutes after IV dose, then every 1-2 hours)

Target: 10-20 breaths/minute (adults)

Action Threshold: <10 breaths/minute, shallow breathing, or signs of hypoventilation; requires immediate intervention (e.g., naloxone, respiratory support).

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

Frequency: Regularly (e.g., every 15-30 minutes after IV dose, then every 1-2 hours)

Target: Alert or mildly drowsy, easily aroused

Action Threshold: Difficult to arouse, somnolent, or unarousable; requires immediate intervention (e.g., naloxone, reduce dose).

Bowel function (frequency of bowel movements)

Frequency: Daily

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

Action Threshold: No bowel movement for >2-3 days; requires laxative intervention.

Blood pressure and heart rate

Frequency: Regularly (e.g., every 1-2 hours initially, then as clinically indicated)

Target: Within patient's normal range

Action Threshold: Significant hypotension or bradycardia; requires intervention.

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation or somnolence
  • Dizziness or lightheadedness
  • Nausea and vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Miosis (pinpoint pupils)

Special Patient Groups

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Pregnancy

Use during pregnancy is generally not recommended, especially for prolonged periods or near term, due to the risk of neonatal opioid withdrawal syndrome (NOWS). NOWS can be life-threatening if not recognized and treated. Discuss risks and benefits with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Potential for congenital malformations (limited data, but generally low risk compared to other opioids).
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 for prolonged periods. Risk of respiratory depression in the neonate if used near delivery.
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Lactation

Hydromorphone is excreted into breast milk. While levels are generally low, infants should be monitored for signs of sedation, respiratory depression, poor feeding, and poor weight gain. Short-term use of low doses may be acceptable with close infant monitoring. Consult with a healthcare provider.

Infant Risk: Risk of sedation, respiratory depression, poor feeding, and withdrawal symptoms if discontinued abruptly.
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Pediatric Use

Use with extreme caution due to increased sensitivity to respiratory depression. Dosing must be precise and weight-based. Not recommended for routine use in neonates or infants. Close monitoring is essential.

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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. Always verify the dose and concentration carefully to avoid overdose, especially with high-potency formulations like 50mg/5ml (10mg/ml).
  • The 50mg/5ml concentration is specifically for opioid-tolerant patients requiring high doses; it is NOT for opioid-naive patients.
  • Rapid IV administration can lead to severe respiratory depression, hypotension, and circulatory collapse. Administer slowly over 2-3 minutes.
  • Monitor for accumulation of the active metabolite (hydromorphone-3-glucuronide) in patients with renal impairment, which can cause neuroexcitatory symptoms (e.g., myoclonus, delirium).
  • Always have naloxone readily available when administering hydromorphone, especially in opioid-naive patients or when titrating doses.
  • Opioid-induced constipation is a common and persistent side effect; prophylactic bowel regimen should be initiated upon starting therapy.
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Alternative Therapies

  • Other opioid analgesics (e.g., morphine, fentanyl, oxycodone, oxymorphone)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin)
  • Regional anesthesia (e.g., nerve blocks, epidural analgesia)
  • Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: Varies widely by concentration, manufacturer, and pharmacy. For 50mg/5ml (10mg/ml) vial, typically $50-$200+ per vial. per 5ml vial
Generic Available: Yes
Insurance Coverage: Tier 2-3 (for generic), Tier 3-4 (for brand)
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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, never share your medication with others, and do not 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 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 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 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 medication taken, the amount, and the time it occurred.

In case of a suspected overdose, contact your local poison control center or seek medical care immediately. Have the necessary information readily available, including the medication taken, the quantity, and the time of the incident.