Hydromorphone 1mg/ml Inj, 1ml

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, usually in a hospital or clinic setting.
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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 provided guidelines. This medication is administered via injection into a muscle, vein, or the fatty tissue under the skin.

For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.

If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Avoid alcohol and other sedating medications (e.g., sleeping pills, anxiety medications) unless specifically approved by your doctor, as this can increase the risk of serious side effects like severe 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 use stool softeners or laxatives as recommended by your healthcare provider.
  • Keep this medication in a secure place, out of reach of children and pets, due to the risk of accidental overdose.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 0.2-1 mg IV every 2-3 hours as needed for pain. Adjust dose based on patient response and tolerability.
Dose Range: 0.2 - 4 mg

Condition-Specific Dosing:

severe_pain: Higher doses (e.g., 1-4 mg IV) may be required for severe pain in opioid-tolerant patients, titrated carefully.
post_operative_pain: 0.2-0.6 mg IV every 2-3 hours as needed.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and specialized monitoring required if used.
Infant: 0.015 mg/kg/dose IV every 4-6 hours as needed; maximum single dose 0.02 mg/kg or 1 mg, whichever is less. Not for routine use in infants <6 months.
Child: 0.015 mg/kg/dose IV every 4-6 hours as needed; maximum single dose 0.02 mg/kg or 1 mg, whichever is less.
Adolescent: 0.015 mg/kg/dose IV every 4-6 hours as needed; maximum single dose 0.02 mg/kg or 1 mg, whichever is less. For adolescents >50 kg, adult dosing may be considered.
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Dose Adjustments

Renal Impairment:

Mild: Consider starting at lower end of dosing range and extend dosing interval.
Moderate: Reduce initial dose by 50% and extend dosing interval. Monitor closely for respiratory depression and sedation.
Severe: Reduce initial dose by 75% or more and significantly extend dosing interval. Avoid if possible. Monitor closely for respiratory depression and sedation.
Dialysis: Hydromorphone and its active metabolite (H3G) are not significantly removed by hemodialysis. Dose adjustment is necessary; monitor closely.

Hepatic Impairment:

Mild: Consider starting at lower end of dosing range and extend dosing interval.
Moderate: Reduce initial dose by 50% and extend dosing interval. Monitor closely for respiratory depression and sedation.
Severe: Reduce initial dose by 75% or more and significantly extend dosing interval. Avoid if possible. Monitor closely for respiratory depression and sedation.

Pharmacology

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Mechanism of Action

Hydromorphone is a full opioid agonist that binds to and activates mu-opioid receptors in the central nervous system (CNS), peripheral nervous system, and gastrointestinal tract. This binding mimics the action of endogenous endorphins, leading to analgesia, sedation, euphoria, and respiratory depression. It also affects the perception of pain and emotional response to pain.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: Rapid (within minutes for IV)
FoodEffect: Not applicable for IV formulation

Distribution:

Vd: Approximately 4 L/kg
ProteinBinding: Low (8-19%)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 2-3 hours
Clearance: Not readily available as a single value, but primarily hepatic metabolism and renal excretion.
ExcretionRoute: Renal (primarily as H3G)
Unchanged: <10% (renal)
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Pharmacodynamics

OnsetOfAction: 5-15 minutes (IV)
PeakEffect: 15-30 minutes (IV)
DurationOfAction: 3-4 hours (IV)

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; and ACCIDENTAL INGESTION. Hydromorphone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Serious, life-threatening, or fatal respiratory depression may occur. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome. Concomitant use with benzodiazepines or other CNS depressants may result in profound sedation, respiratory depression, coma, and death. Accidental ingestion of even one dose, especially by a child, 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
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 (fast or irregular)
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 side effects or may only have mild symptoms, it's essential to be aware of the following possible side effects:

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

If you're concerned about side effects or experience any symptoms that 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
  • Pinpoint pupils
  • Severe constipation or abdominal pain
  • Hives, rash, or itching (signs of allergic reaction)
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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 like 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, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of severely high blood pressure
Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe 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.
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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.

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 period, 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.

Long-term Use and Blood Work
If you are taking this medication for an extended period, have your blood work checked regularly. Consult with your doctor to discuss the necessary precautions.

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 use 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 making any changes to your dosage. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, or suicidal thoughts.

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
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.
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Overdose Information

Overdose Symptoms:

  • Slowed or stopped breathing
  • Extreme drowsiness or unresponsiveness
  • Pinpoint pupils
  • Cold, clammy skin
  • Limp muscles
  • Bluish discoloration of lips or fingernails
  • Loss of consciousness

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. If available, administer naloxone (Narcan) if the person is unresponsive or not breathing normally. Call 1-800-222-1222 (Poison Control Center) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI discontinuation (risk of serotonin syndrome, severe respiratory depression, coma, death)
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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.
  • Mixed opioid agonist/antagonists (e.g., nalbuphine, buprenorphine, butorphanol, pentazocine): May reduce the analgesic effect of hydromorphone and/or precipitate withdrawal symptoms.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, trazodone, tramadol, linezolid, methylene blue): Risk of serotonin syndrome.
  • Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
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Moderate Interactions

  • Anticholinergics (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
  • Muscle relaxants: Enhanced neuromuscular blocking effects.
  • CYP3A4 inhibitors/inducers: While hydromorphone is primarily metabolized by glucuronidation, some minor CYP pathways may exist. Monitor for altered opioid effects.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pain assessment (intensity, location, quality)

Rationale: To establish baseline pain level and guide initial dosing.

Timing: Prior to first dose and regularly throughout therapy.

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 excessive 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 need for dose adjustment in patients with organ impairment.

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

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Routine Monitoring

Pain level (using a validated scale)

Frequency: Every 1-2 hours initially for IV, then as clinically indicated (e.g., every 2-4 hours) or before each dose.

Target: Patient-specific, aiming for acceptable pain relief with minimal side effects.

Action Threshold: Inadequate pain control or excessive pain: Re-evaluate dose, consider adjuncts. No pain: Re-evaluate need for opioid.

Respiratory rate and depth

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

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

Action Threshold: <10 breaths/min, shallow breathing, or signs of respiratory distress: Administer naloxone, provide respiratory support, notify physician.

Sedation level (e.g., Pasero Opioid-Induced Sedation Scale - POSS)

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

Target: Alert or mildly drowsy, easily aroused.

Action Threshold: Difficult to arouse or unarousable: Administer naloxone, provide respiratory support, notify physician.

Blood pressure and heart rate

Frequency: Every 1-2 hours initially, then as clinically indicated.

Target: Within patient's normal range.

Action Threshold: Significant hypotension or bradycardia: Notify physician, consider fluid bolus, reduce dose.

Bowel function

Frequency: Daily

Target: Regular bowel movements (at least every 2-3 days).

Action Threshold: Constipation: Initiate bowel regimen (stool softeners, laxatives), consider opioid-induced constipation (OIC) specific agents.

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Symptom Monitoring

  • Excessive sedation
  • Respiratory depression (slow, shallow breathing)
  • Dizziness
  • Nausea/vomiting
  • Constipation
  • Pruritus
  • Urinary retention
  • Confusion
  • Pinpoint pupils

Special Patient Groups

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Pregnancy

Prolonged use of hydromorphone 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: Limited data, but potential for congenital malformations with opioid exposure, though not definitively linked to hydromorphone.
Second Trimester: Risk of NOWS increases with prolonged exposure.
Third Trimester: Highest risk of NOWS if used chronically. Risk of respiratory depression in the neonate if used near delivery.
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Lactation

Hydromorphone is excreted in breast milk. Monitor breastfed infants for signs of sedation, respiratory depression, poor feeding, and poor weight gain. Consider alternative analgesics or temporary cessation of breastfeeding if significant concerns arise.

Infant Risk: Moderate risk (L3). Potential for infant sedation, respiratory depression, and withdrawal symptoms if maternal dose is high or prolonged.
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Pediatric Use

Use with caution. Dosing must be carefully calculated based on weight and titrated to effect. Infants and young children may be more sensitive to the respiratory depressant effects of opioids. Not recommended for routine use in infants <6 months.

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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 approximately 5-7 times more potent than morphine on a milligram-for-milligram basis when administered IV. Always verify dose and concentration carefully to avoid medication errors.
  • Rapid IV push can lead to severe hypotension and respiratory depression; administer slowly over at least 2-3 minutes.
  • Patients with renal impairment are at higher risk for accumulation of the active drug and its neuroexcitatory metabolite (H3G), leading to increased sedation, confusion, and myoclonus.
  • Tolerance and physical dependence can develop with prolonged use. Do not abruptly discontinue in physically dependent patients; taper gradually.
  • Always have naloxone readily available when administering hydromorphone, especially in opioid-naΓ―ve patients or those at high risk for respiratory depression.
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Alternative Therapies

  • Morphine
  • Fentanyl
  • Oxycodone
  • Hydrocodone
  • Tramadol
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts.
  • Regional anesthesia/nerve blocks
  • Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: Varies widely per 1mg/ml 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you are unsure about the best disposal method, consult your pharmacist, as there may be 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 and review it each time you refill your prescription. 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. Consult 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 the medication taken, the amount, and the time it was taken. You can also contact your local poison control center or seek emergency medical care; have the necessary information readily available to ensure prompt and effective treatment.