Dilaudid 1mg/ml Pf Inj, 1ml

Manufacturer FRESENIUS KABI USA Active Ingredient Hydromorphone Injection(hye droe MOR fone) Pronunciation hye droe MOR fone
WARNING: This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing. Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life-threatening if not treated.Make sure you have the right drug; there is more than one strength. A lower strength may not ease pain well enough. A higher strength could lead to accidental overdose and death.Certain strengths of this drug may only be used by people who have been taking drugs like this drug and are used to their effects. The use of these strengths by people who have not been taking drugs like this drug may cause very bad and sometimes deadly breathing problems. Talk with the doctor. @ COMMON USES: It is used to manage pain when non- opioid pain drugs do not treat your pain well enough or you cannot take them.
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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 (shot) into a vein, muscle, or under the skin.
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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 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.
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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.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose: 1-2 mg IV/IM/SC every 4-6 hours as needed. Adjust dose based on patient response and tolerability.
Dose Range: 0.5 - 4 mg

Condition-Specific Dosing:

postoperativePain: 0.5-1 mg IV/IM/SC every 3-4 hours as needed.
chronicPain: Individualized titration, often starting with lower doses and titrating upwards.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and individualized dosing if used for severe pain in critical care settings (e.g., 0.015 mg/kg/dose IV/SC every 4-6 hours, max 0.02 mg/kg/dose).
Infant: 0.015 mg/kg/dose IV/SC every 4-6 hours as needed. Max 0.02 mg/kg/dose.
Child: 0.015 mg/kg/dose IV/SC every 4-6 hours as needed. Max 0.02 mg/kg/dose.
Adolescent: 0.015 mg/kg/dose IV/SC every 4-6 hours as needed. Max 0.02 mg/kg/dose or adult dose if weight appropriate.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Reduce initial dose by 25-50%; titrate carefully. Monitor for increased sedation and respiratory depression.
Severe: Reduce initial dose by 50-75%; titrate very carefully. Avoid if possible. Monitor for increased sedation and respiratory depression.
Dialysis: Hydromorphone is not significantly removed by hemodialysis. Administer after dialysis. Monitor closely for prolonged effects.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Hydromorphone is a full opioid agonist that binds primarily to the mu-opioid receptor in the central nervous system (CNS). Its analgesic effects are mediated through activation of these receptors, leading to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces CNS depression, respiratory depression, miosis, euphoria, and physical dependence.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV/IM/SC)
Tmax: IV: 5-10 minutes; IM: 15-30 minutes; SC: 30-90 minutes
FoodEffect: Not applicable for parenteral administration.

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; IM: 15-30 minutes; SC: 30-60 minutes
PeakEffect: IV: 10-20 minutes; IM: 30-60 minutes; SC: 60-90 minutes
DurationOfAction: 3-5 hours

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; ACCIDENTAL INGESTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.

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 patient’s 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.
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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 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.
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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
  • Pinpoint pupils
  • Severe constipation
  • Difficulty urinating
  • Signs of an allergic reaction (rash, itching, swelling of face/lips/tongue, 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. 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.
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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, 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.
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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
  • 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

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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
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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.
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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.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pain level (using a validated scale)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to first dose

Respiratory rate and depth

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

Timing: Prior to first dose

Level of consciousness/sedation

Rationale: To assess baseline neurological 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

Renal and hepatic function tests (e.g., BUN, creatinine, LFTs)

Rationale: To identify impairment that may necessitate dose adjustment.

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

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Routine Monitoring

Pain level

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.

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: >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.

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; administer naloxone, provide respiratory support.

Blood pressure and heart rate

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.

Bowel function

Frequency: Daily

Target: Regular bowel movements

Action Threshold: Constipation; initiate bowel regimen.

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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

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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. Monitor neonates for signs of NOWS.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations with opioid exposure. Risk generally considered low for short-term use.
Second Trimester: Risk of NOWS increases with prolonged exposure.
Third Trimester: High risk of NOWS with prolonged exposure. Risk of respiratory depression in the neonate if administered close to delivery.
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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.

Infant Risk: Moderate (L3 - Moderately safe; monitor infant for adverse effects)
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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.

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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

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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.
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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)
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Cost & Coverage

Average Cost: Varies widely by supplier and contract per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often requires prior authorization for chronic use)
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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, 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.