Hydromorphone 0.2mg/ml Pf Inj, 1ml

Manufacturer HIKMA PHARMACEUTICALS 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
C
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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 severe pain. It works by changing how your brain and nervous system respond to pain. It is given as an injection, often in a hospital setting, for quick pain relief.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the dosage instructions carefully. This medication is administered via injection into a muscle, vein, or the fatty 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 (e.g., benzodiazepines, sleeping pills) unless specifically approved by your doctor, as this can increase the risk of serious breathing problems and sedation.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • Report any difficulty breathing, extreme drowsiness, or feeling faint immediately to a healthcare professional.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and use a stool softener or laxative as directed by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose highly individualized based on patient's opioid exposure, pain severity, and route of administration. For opioid-naive patients, typically 0.2-1 mg IV every 2-3 hours as needed. The 0.2 mg/ml concentration is often used for careful titration or patient-controlled analgesia (PCA).
Dose Range: 0.2 - 4 mg

Condition-Specific Dosing:

acutePain_IV_opioidNaive: 0.2-1 mg IV every 2-3 hours as needed, titrated to effect.
acutePain_IV_opioidTolerant: Higher initial doses may be required, based on prior opioid use and cross-tolerance calculations. Consult equianalgesic tables.
PCA_loadingDose: 0.2-0.5 mg IV (optional)
PCA_demandDose: 0.05-0.2 mg IV
PCA_lockoutInterval: 5-15 minutes
PCA_hourlyLimit: Not available (highly variable, depends on patient and clinical setting)
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and reduced doses if used for severe pain in specific circumstances (e.g., post-surgical). Risk of respiratory depression is high.
Infant: Not established for routine use; extreme caution and reduced doses if used for severe pain in specific circumstances. Risk of respiratory depression is high.
Child: 0.015 mg/kg/dose IV every 4-6 hours as needed, not to exceed 0.02 mg/kg/dose. Max single dose 2 mg. Close monitoring for respiratory depression is critical.
Adolescent: Similar to adult dosing, but start with lower end of adult range (0.2-0.5 mg IV) and titrate carefully.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but monitor closely.
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor for increased sedation and respiratory depression.
Severe: Reduce initial dose by 50-75% and extend dosing interval significantly. Avoid if possible. Monitor closely for prolonged effects.
Dialysis: Hydromorphone is not significantly removed by hemodialysis. Administer after dialysis. Reduce dose and extend interval due to accumulation of active and inactive metabolites.

Hepatic Impairment:

Mild: No specific dose adjustment required, but monitor closely.
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor for increased sedation and respiratory depression.
Severe: Reduce initial dose by 50-75% and extend dosing interval significantly. Avoid if possible. Monitor closely for prolonged effects.

Pharmacology

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Mechanism of Action

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

Absorption:

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

Distribution:

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

Elimination:

HalfLife: 2-3 hours (parent drug); H3G has a longer half-life and can accumulate in renal impairment.
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)

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING 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, 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, especially by children, can result in a fatal overdose. Prolonged use of hydromorphone 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. 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.
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Side Effects

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

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 be signs of a severe bowel problem
Abnormal heartbeat, including fast, slow, or irregular rhythms
Breathing difficulties, including:
+ 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
Inability to control eye movements
Trouble controlling body movements
Changes in eyesight
Chest pain or pressure
Changes in balance
Memory problems or loss
Thoughts of hurting yourself 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 a severe and potentially deadly condition called serotonin syndrome. Seek medical help immediately if you experience any of the following symptoms:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Throwing up
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 symptoms, contact your doctor:

Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems

Other 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
Throwing up
Decreased appetite
Dizziness
Sleepiness
Tiredness
Weakness
Dry mouth
Flushing
Excessive sweating
Headache
Itching
* Trouble sleeping

If any of these side effects bother you or do not go away, contact your doctor or seek medical attention. You may 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 or inability to pass urine
  • Hives, rash, or swelling of the face, lips, or tongue (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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage 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 certain medications, such as 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 and any potential interactions with this medication
* Never start, stop, or change the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

Important Warnings and Cautions

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

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

Adhere strictly to your doctor's prescribed dosage and frequency. Taking more than prescribed, or taking it more often or for a longer duration, can increase the risk of severe side effects.

Do not combine this medication with other strong pain medications or use a pain patch without first consulting your doctor. 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 exceed the prescribed dose.

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

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

Avoid consuming alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal interactions.

Long-term or high-dose use of this opioid medication can lead to tolerance, where the medication becomes less effective, and you may require higher doses to achieve the same pain relief. If you find that this medication is no longer effective, contact your doctor; do not increase the dose on your own.

Prolonged or regular use of opioid medications like this one can result in dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as abruptly stopping or lowering the dose can increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

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

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

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

If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and potentially harm your baby. Monitor your baby for excessive sleepiness, limpness, or breathing difficulties, and seek medical help immediately if you notice any of these symptoms.
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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. Continue to monitor breathing and provide supportive care. Call 1-800-222-1222 (Poison Control) for additional guidance.

Drug Interactions

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Major Interactions

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

  • Anticholinergics: Increased risk of urinary retention and/or severe constipation.
  • Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
  • Monoamine Oxidase Inhibitors (MAOIs): Concomitant use is contraindicated or requires extreme caution due to potential for severe, unpredictable reactions including serotonin syndrome or opioid toxicity. Avoid within 14 days of MAOI use.
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Minor Interactions

  • Antihypertensives: May enhance hypotensive 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 status and identify risk for respiratory depression.

Timing: Prior to first dose

Oxygen saturation (SpO2)

Rationale: To assess baseline oxygenation.

Timing: Prior to first dose

Level of consciousness/sedation score

Rationale: To assess baseline mental 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 (BUN, creatinine, LFTs)

Rationale: To identify potential impairment requiring dose adjustment.

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

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Routine Monitoring

Pain assessment

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

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

Action Threshold: Pain score above goal, requiring additional dose or intervention.

Respiratory rate and depth

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

Target: 12-20 breaths/minute (adults), age-appropriate for pediatrics

Action Threshold: <10 breaths/minute (adults), shallow breathing, or signs of respiratory distress.

Oxygen saturation (SpO2)

Frequency: Continuous or every 1-2 hours, especially with higher doses or risk factors.

Target: >92-94%

Action Threshold: <90% (or patient-specific baseline), requiring intervention.

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

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

Target: Awake and alert, or mildly sedated but easily aroused.

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

Bowel function

Frequency: Daily

Target: Regular bowel movements

Action Threshold: No bowel movement for >2-3 days, requiring laxative or bowel regimen adjustment.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Category C. 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 use. Fetal respiratory depression possible.
Third Trimester: High risk of NOWS with prolonged use. Fetal respiratory depression and bradycardia possible, especially if administered close to delivery.
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Lactation

L3 (Moderately Safe). Hydromorphone is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and poor weight gain. Short-term, single-dose use may be acceptable; prolonged or high-dose use is generally not recommended. Consider alternative analgesics or pump and dump if necessary.

Infant Risk: Risk of sedation, respiratory depression, constipation, and poor feeding in breastfed infants. Risk is higher with higher maternal doses or prolonged use.
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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 very young children; reserved for severe pain where benefits outweigh risks. Close monitoring is essential.

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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. Consider age-related comorbidities and polypharmacy.

Clinical Information

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Clinical Pearls

  • Hydromorphone is 5-7 times more potent than morphine on a milligram-for-milligram basis. Always verify dose and concentration carefully to avoid overdose.
  • The 0.2 mg/ml concentration is very dilute and often used for PCA or careful IV titration, especially in opioid-naive patients or those with renal/hepatic impairment.
  • Rapid IV push can lead to severe hypotension and respiratory depression; administer slowly over 2-3 minutes.
  • Always have naloxone readily available when administering hydromorphone.
  • Tolerance and physical dependence can develop with prolonged use. Do not abruptly discontinue in physically dependent patients to avoid withdrawal symptoms.
  • Educate patients and caregivers on safe storage to prevent accidental ingestion, especially by children.
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Alternative Therapies

  • Morphine (IV, PO, SC, PR)
  • Fentanyl (IV, transdermal, transmucosal)
  • Oxycodone (PO)
  • Hydrocodone (PO)
  • Tramadol (PO)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts.
  • Regional anesthesia/nerve blocks
  • Local anesthetics
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Cost & Coverage

Average Cost: Varies widely by pharmacy and contract per 1ml vial (0.2mg/ml)
Generic Available: Yes
Insurance Coverage: Generally covered by most prescription drug plans, often as a Tier 1 or Tier 2 generic.
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General Drug Facts

It is essential to monitor your symptoms and health problems while taking this medication. If you notice no improvement or a worsening of your condition, contact your doctor promptly.

To ensure safe use, keep the following guidelines in mind:
- Do not share your medication with others, and never take someone else's medication.
- Store all medications in a secure location, out of reach of children and pets.
- Properly dispose of unused or expired medications. Unless instructed to do so, avoid flushing them down the toilet or pouring 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 and review it each time you receive a refill. 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 administered to help treat the condition. 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 used. Be prepared to provide information about the overdose, including the substance taken, the amount, and the time it occurred.

If you believe an overdose has occurred, contact your local poison control center or seek medical care immediately. When seeking help, be prepared to provide details about the overdose, including what was taken, the quantity, and the time of the incident.