Dilaudid 8mg Tablets

Manufacturer PURDUE PHARMA L.P. Active Ingredient Hydromorphone Tablets(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. @ 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
Aug 1984
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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's important to take it exactly as prescribed because it can be habit-forming and cause serious side effects like very slow breathing.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, but if it causes stomach upset, take it with food. It's essential to take this medication by mouth only. Do not inject or snort this medication, as this can lead to severe side effects, including breathing difficulties and overdose, which can be fatal.

Storing and Disposing of Your Medication

Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. To prevent accidental ingestion, store this medication in a secure location where children and pets cannot access it. Consider using a locked box or area to keep it safe. 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. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.

What to Do If You Miss a Dose

If you take this medication regularly, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than prescribed by your doctor.
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Lifestyle & Tips

  • Avoid alcohol and other sedating medications (e.g., tranquilizers, sleeping pills) while taking this medication, as this can increase the risk of serious side effects like extreme drowsiness and breathing problems.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and consider using stool softeners or laxatives as recommended by your doctor.
  • Store this medication securely away from children and pets, as accidental ingestion can be fatal.
  • Do not share this medication with anyone else, even if they have similar pain.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose 2-4 mg orally every 4-6 hours as needed for pain.
Dose Range: 2 - 8 mg

Condition-Specific Dosing:

moderateToSeverePain: Initial dose 2-4 mg orally every 4-6 hours. May be titrated based on patient response and tolerability. For opioid-tolerant patients, higher initial doses may be considered, but always with caution.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and specialized monitoring if used.
Infant: Not established for routine use; extreme caution and specialized monitoring if used.
Child: Not established for routine use; extreme caution and specialized monitoring if used. Limited data for children >6 months: 0.03-0.08 mg/kg/dose every 4-6 hours, max 5 mg/dose.
Adolescent: Not established for routine use; extreme caution and specialized monitoring if used. Dosing should be individualized and started at the lowest effective dose.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but monitor for increased effects.
Moderate: Reduce initial dose by 50% and/or extend dosing interval. Monitor closely.
Severe: Reduce initial dose by 75% and/or extend dosing interval. Avoid if possible. Monitor closely.
Dialysis: Hydromorphone is not significantly removed by hemodialysis. Dose adjustment needed based on renal function.

Hepatic Impairment:

Mild: No specific dose adjustment required, but monitor for increased effects.
Moderate: Reduce initial dose by 50% and/or extend dosing interval. Monitor closely.
Severe: Reduce initial dose by 75% and/or extend dosing interval. Avoid if possible. Monitor closely.
Confidence: Medium

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, and reduced gastrointestinal motility.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 30-35% (oral)
Tmax: 0.5-1 hour (oral solution/tablet)
FoodEffect: Food may delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

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

Elimination:

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

OnsetOfAction: 15-30 minutes (oral)
PeakEffect: 30-90 minutes (oral)
DurationOfAction: 3-5 hours (oral)

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION (less relevant for hydromorphone's primary metabolism); and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. 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. Accidental ingestion of hydromorphone, especially by children, can result in a fatal overdose. 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.
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Side Effects

Serious 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 be signs of 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
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 right away 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, or vomiting
Severe headache

Long-Term Use and Hormonal Changes

Long-term use of an opioid medication 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
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 do not go away, contact your doctor or seek medical attention. 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
  • Bluish lips or fingernails
  • Severe constipation or abdominal pain
  • Difficulty urinating
  • Signs of allergic reaction (rash, itching, swelling of face/tongue/throat, 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. Be sure to describe the allergic reaction you experienced, including any 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
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 medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss all your health problems with your doctor
Verify that it is safe to take this medication with your existing medications and health conditions
Never start, stop, or adjust the dose of any medication without first 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 duration, may increase the risk of severe side effects.

Interactions with Other Medications
Do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.

Monitoring and Follow-up
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.

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

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 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 avoid withdrawal or other severe problems. 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 excessively sleepy, limp, or has breathing difficulties.
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Overdose Information

Overdose Symptoms:

  • Pinpoint pupils
  • Slowed or stopped breathing
  • Extreme drowsiness or unresponsiveness
  • Limp muscles
  • Cold, clammy skin
  • Bluish discoloration of lips and fingernails
  • Slowed heart rate
  • Low blood pressure
  • Coma

What to Do:

If you suspect an overdose, call 911 immediately. Administer naloxone (Narcan) if available and you are trained to do so. Stay with the person until emergency medical help arrives. Call 1-800-222-1222 (Poison Control Center) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Concurrent use with monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI discontinuation (risk of serotonin syndrome or severe respiratory depression).
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Major Interactions

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

  • CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole, ritonavir): May increase hydromorphone plasma concentrations (though CYP3A4 is a minor pathway for hydromorphone).
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease hydromorphone plasma concentrations.
  • Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
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Minor Interactions

  • Not available

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 initiation of therapy

Respiratory rate and depth

Rationale: To assess baseline respiratory function and identify risk for respiratory depression.

Timing: Prior to initiation of therapy

Level of consciousness/sedation

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

Timing: Prior to initiation of therapy

Bowel function

Rationale: To assess baseline bowel habits and anticipate opioid-induced constipation.

Timing: Prior to initiation of therapy

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

Rationale: To identify potential impairment requiring dose adjustment.

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

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Routine Monitoring

Pain assessment

Frequency: Regularly, especially after dose changes and before subsequent doses

Target: Acceptable pain control with minimal side effects

Action Threshold: Uncontrolled pain or excessive side effects warrant dose adjustment or alternative therapy.

Respiratory rate and depth

Frequency: Frequently during initiation and titration, then periodically

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

Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation (e.g., cyanosis, somnolence) require immediate intervention (e.g., naloxone, respiratory support).

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

Frequency: Frequently during initiation and titration, then periodically

Target: Awake and alert or mildly drowsy, easily aroused

Action Threshold: Difficult to arouse, somnolent, or unarousable requires immediate intervention.

Bowel function

Frequency: Daily

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

Action Threshold: Constipation (e.g., no bowel movement for >3 days) requires intervention (e.g., laxatives, stool softeners).

Signs of opioid-induced hyperalgesia or tolerance

Frequency: Periodically, especially with long-term use or dose escalation

Target: Not applicable

Action Threshold: Increased pain despite dose escalation, or pain in new areas, may indicate hyperalgesia or tolerance requiring re-evaluation of pain management strategy.

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Symptom Monitoring

  • Excessive sedation
  • Dizziness
  • Nausea
  • Vomiting
  • Constipation
  • Pruritus
  • Urinary retention
  • Confusion
  • Respiratory depression (shallow breathing, slow breathing)
  • Signs of opioid withdrawal (in case of abrupt discontinuation)

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: Potential for congenital malformations, though data are limited and inconsistent for opioids in general.
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 chronically. Risk of respiratory depression in the neonate if used close to delivery.
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Lactation

Hydromorphone is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. Use with caution, or consider alternative analgesics. The American Academy of Pediatrics considers hydromorphone to be a drug for which the effect on a nursing infant is unknown but may be of concern.

Infant Risk: Moderate risk (L3). Potential for sedation, respiratory depression, and withdrawal symptoms in the infant.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Use with extreme caution and individualized dosing, if at all, due to increased risk of respiratory depression and other adverse effects. Not recommended for routine use in children.

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of hydromorphone (e.g., respiratory depression, sedation, constipation) due to decreased renal and hepatic function, and polypharmacy. Start with lower doses and titrate slowly. Monitor closely.

Clinical Information

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Clinical Pearls

  • Hydromorphone is approximately 5-7 times more potent than oral morphine. Always ensure correct dose conversion when switching from other opioids.
  • Oral hydromorphone has a relatively rapid onset and short duration of action, making it suitable for acute pain or breakthrough pain in opioid-tolerant patients.
  • The 8mg tablet is a high dose for opioid-naive patients and should be used with extreme caution, if at all, as an initial dose.
  • Educate patients and caregivers on the safe storage and disposal of hydromorphone to prevent accidental ingestion and diversion.
  • Always have naloxone readily available when prescribing opioids, especially for patients at high risk of overdose.
  • Opioid-induced constipation is a common and persistent side effect; proactive management with bowel regimens is crucial.
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Alternative Therapies

  • Other strong opioid agonists (e.g., morphine, oxycodone, fentanyl)
  • Tramadol (for moderate pain)
  • NSAIDs (e.g., ibuprofen, naproxen, celecoxib - for mild to moderate pain, often used as adjuncts)
  • Acetaminophen (for mild to moderate pain, often used as adjunct)
  • Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy, nerve blocks)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (8mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (generic usually Tier 2, brand Tier 3)
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General Drug Facts

If your symptoms or health problems do not improve or worsen, contact your doctor immediately. It is essential to use your prescribed medication responsibly: do not share it with others, and never take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be administered to help counteract its effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.

In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When seeking help, be prepared to provide information about what was taken, the quantity, and the time of the incident.