Morphine Sulf 120mg ER Caps (24h)

Manufacturer ACTAVIS Active Ingredient Morphine Extended-Release Capsules(MOR feen) Pronunciation MOR-feen SUL-fayt
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.Do not take more than what your doctor told you to take. Do not take more often or for longer than you were told. Doing any of these things may raise the chance of severe side effects.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.Swallow whole. Do not chew, break, crush, or dissolve before swallowing. Doing these things can cause very bad side effects and death.If you open this drug and sprinkle the contents on applesauce, do not crush or chew the pellets before swallowing. Doing so can cause severe side effects and death.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 daily pain treatment is needed for a long time. It is for use when non-opioid pain drugs do not treat your pain well enough or you cannot take them.
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Drug Class
Opioid Analgesic
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Pharmacologic Class
Opioid Agonist
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Pregnancy Category
Category C
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FDA Approved
May 1996
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Morphine extended-release capsules are a strong pain medicine (opioid) used to treat severe, ongoing pain that needs around-the-clock treatment. It works by changing how your brain and nervous system respond to pain. Because it's extended-release, it releases the medicine slowly over 24 hours.
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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 carefully. Read all the information provided to you and adhere to the guidelines below.

Take this medication by mouth only, with or without food. If it causes stomach upset, take it with food to help alleviate discomfort.
Do not inject or snort this medication, as this can lead to severe side effects, including respiratory problems and overdose, which can be fatal.
Establish a routine by taking this medication at the same time every day. Swallow the tablet whole, without chewing, breaking, crushing, or dissolving it, as this can also cause severe side effects and death.
This medication is not intended for fast pain relief or as-needed use. Additionally, it should not be used for post-surgical pain relief if you have not previously taken similar medications.
If you have difficulty swallowing the tablet whole, you may sprinkle the contents onto applesauce. If you choose this method, swallow the mixture immediately without chewing. Rinse your mouth to ensure all the contents have been swallowed.
Certain brands of this medication can be administered through a specific type of feeding tube, while others cannot. Consult your pharmacist to determine if your brand can be given via a feeding tube.

Storing and Disposing of Your Medication

Store this medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep this medication in a secure location, out of the reach of children and pets, and inaccessible to others. Consider using a locked box or area to prevent unauthorized access.
Keep all medications away from pets.

Missing a Dose

If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or extra doses to make up for the missed one.
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Lifestyle & Tips

  • Do not drink alcohol while taking this medicine.
  • Avoid driving or operating heavy machinery until you know how this medicine affects you, as it can cause drowsiness and dizziness.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and use a stool softener or laxative as directed by your doctor.
  • Store this medicine securely away from children and pets, as accidental ingestion can be fatal.
  • Do not crush, chew, or dissolve the capsules, as this can lead to rapid release and a fatal overdose.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose for opioid-tolerant patients: 15 mg to 30 mg orally every 24 hours. For conversion from other opioids, calculate total daily oral morphine equivalent and administer once daily.
Dose Range: 15 - 1600 mg

Condition-Specific Dosing:

opioidTolerant: Patients receiving at least 60 mg/day oral morphine, 25 mcg/hour transdermal fentanyl, 30 mg/day oral oxycodone, 8 mg/day oral hydromorphone, 25 mg/day oral oxymorphone, or an equianalgesic dose of another opioid for 1 week or longer.
chronicPain: For management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and effectiveness not established in pediatric patients. Use in pediatric patients <18 years of age is not recommended.)
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; consider dose reduction and/or extended dosing interval.
Moderate: Significant dose reduction (e.g., 50%) and/or extended dosing interval (e.g., every 36-48 hours) recommended due to accumulation of active metabolites (morphine-3-glucuronide, morphine-6-glucuronide).
Severe: Contraindicated or significant dose reduction (e.g., 75%) and/or extended dosing interval (e.g., every 48 hours or longer) recommended. Close monitoring for respiratory depression and sedation is essential.
Dialysis: Morphine and its metabolites are partially dialyzable. Administer after dialysis. Significant dose reduction and extended interval required.

Hepatic Impairment:

Mild: Use with caution; consider dose reduction.
Moderate: Significant dose reduction (e.g., 50%) and/or extended dosing interval recommended due to reduced clearance.
Severe: Significant dose reduction (e.g., 75%) and/or extended dosing interval recommended. Close monitoring for respiratory depression and sedation is essential.

Pharmacology

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Mechanism of Action

Morphine is an opioid agonist. It acts primarily as an agonist at the mu-opioid receptors in the central nervous system (CNS) and gastrointestinal tract. Activation of these receptors produces analgesia, sedation, euphoria, and respiratory depression. It also affects the limbic system, thalamus, hypothalamus, and spinal cord.
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Pharmacokinetics

Absorption:

Bioavailability: 20-40% (oral, due to significant first-pass metabolism)
Tmax: Approximately 6-12 hours for extended-release capsules
FoodEffect: Food may increase the extent of absorption (AUC) and peak plasma concentrations (Cmax) of morphine extended-release capsules. Administer consistently with or without food.

Distribution:

Vd: 3-4 L/kg
ProteinBinding: Approximately 30-35%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 8-12 hours for extended-release formulation (terminal half-life of morphine itself is 2-4 hours, but release from ER formulation extends apparent half-life)
Clearance: Approximately 10-20 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: Approximately 7-10% (renal)
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Pharmacodynamics

OnsetOfAction: Not applicable for ER formulation for acute pain relief; designed for sustained release.
PeakEffect: Approximately 6-12 hours for extended-release capsules
DurationOfAction: 24 hours for the specific formulation (Morphine Sulf 120mg ER Caps (24h))
Confidence: Medium

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; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; RISK EVALUATION AND MITIGATION STRATEGY (REMS).
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Side Effects

Important Side Effects to Report to Your Doctor Right Away

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, 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
Chest pain or pressure, or a fast heartbeat
Feeling confused
Trouble breathing, slow breathing, or shallow breathing
Noisy breathing
Breathing problems during sleep (sleep apnea)
Seizures
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Depression or other mood changes
Swelling in the arms or legs
Fever, chills, or sore throat
Pain when passing urine
A burning, numbness, or tingling feeling that is not normal

Serious and Potentially Life-Threatening Conditions

If you take this medication with certain other drugs, you may be at risk for a condition called serotonin syndrome. Seek medical attention immediately if you experience:

Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Sweating a lot
Severe diarrhea, upset stomach, or throwing up
Severe headache

Additionally, taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Seek medical attention immediately if you experience:

Feeling very tired or weak
Passing out
Severe dizziness
Very upset stomach
Throwing up
Decreased appetite

Long-term use of an opioid medication may also lead to lower sex hormone levels. If you experience any of the following symptoms, contact your doctor:

Lowered 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 side effects, it's essential to be aware of the following possible side effects:

Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation, diarrhea, stomach pain, upset stomach, throwing up, or decreased appetite
Headache
Anxiety
Sweating a lot

If any of these side effects or any other side effects bother you or do not go away, contact your doctor for medical advice. 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
  • Severe constipation or abdominal pain
  • Confusion or hallucinations
  • Signs of an allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
  • Signs of serotonin syndrome (agitation, fast heartbeat, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea)
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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.
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 lead to severely high blood pressure
Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
* If you are breastfeeding, as you should not breastfeed while taking this medication

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

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
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and be cautious when climbing stairs.

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

Monitoring Your Pain
If your pain worsens, you become more sensitive to pain, or experience new pain after taking this medication, contact your doctor immediately. Do not exceed the prescribed dose.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and you may require higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not take more than the prescribed dose. Additionally, regular use of opioid medications like this one can cause dependence. If you need to lower your 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 increased pain, mood changes, suicidal thoughts, or other adverse effects.

Allergies and Interactions
If you are allergic to sulfites, discuss this with your doctor, as some products contain sulfites. Avoid consuming alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal effects.

Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.

Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
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Overdose Information

Overdose Symptoms:

  • Pinpoint pupils
  • Extreme drowsiness or loss of consciousness
  • Slow, shallow, or stopped breathing
  • Limp muscles
  • Cold, clammy skin
  • Blue lips or fingernails
  • Slowed heart rate
  • Low blood pressure

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 Center) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Concomitant use with benzodiazepines or other CNS depressants (unless benefits outweigh risks, and only with reduced doses and close monitoring)
  • Concomitant use with alcohol
  • Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs
  • Patients with significant respiratory depression
  • Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Patients with known or suspected paralytic ileus
  • Patients with hypersensitivity to morphine
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Major Interactions

  • Other opioid analgesics (additive CNS depression, respiratory depression)
  • Sedatives, hypnotics, anxiolytics, tranquilizers (e.g., benzodiazepines, barbiturates) - increased risk of respiratory depression, profound sedation, coma, death
  • Muscle relaxants (e.g., cyclobenzaprine, baclofen) - increased risk of respiratory depression
  • General anesthetics (additive CNS depression)
  • Phenothiazines (additive CNS depression)
  • Antiemetics (e.g., promethazine, metoclopramide - additive CNS depression)
  • Anticholinergics (e.g., atropine, scopolamine) - increased risk of urinary retention and/or severe constipation, paralytic ileus
  • Diuretics (opioids may reduce efficacy of diuretics by inducing ADH release)
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - potential for serotonin syndrome (rare but serious)
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Moderate Interactions

  • Cimetidine (may inhibit morphine metabolism, increasing levels)
  • Ritonavir (may increase morphine levels)
  • Rifampin (may decrease morphine levels)
  • Certain antifungals (e.g., ketoconazole, itraconazole) - potential for altered morphine metabolism
  • Gabapentin/Pregabalin (additive CNS depression)
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Minor Interactions

  • Not specifically categorized as minor for morphine; most interactions are significant due to CNS effects.

Monitoring

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Baseline Monitoring

Pain assessment (intensity, character, location)

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

Timing: Prior to 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

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

Rationale: To identify potential impairment requiring dose adjustment.

Timing: Prior to initiation of therapy

Opioid tolerance status

Rationale: Morphine ER is for opioid-tolerant patients only; essential to confirm to prevent overdose.

Timing: Prior to initiation of therapy

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Routine Monitoring

Pain assessment

Frequency: Regularly, as clinically indicated (e.g., daily, weekly, or at each visit) to assess efficacy and need for dose adjustment.

Target: Acceptable pain control with minimal side effects.

Action Threshold: Uncontrolled pain or unacceptable side effects warranting dose adjustment or alternative strategies.

Respiratory rate and depth, oxygen saturation (if available)

Frequency: Regularly, especially during dose titration or initiation of therapy; less frequently once stable.

Target: Normal respiratory rate (e.g., 12-20 breaths/min), SpO2 > 92%.

Action Threshold: Respiratory rate < 10 breaths/min, shallow breathing, or SpO2 < 90% (consider naloxone, medical emergency).

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

Frequency: Regularly, especially during dose titration or initiation of therapy; less frequently once stable.

Target: Alert or mildly drowsy, easily aroused.

Action Threshold: Difficult to arouse, somnolent, or unresponsive (consider naloxone, medical emergency).

Bowel function (constipation)

Frequency: Daily or as needed.

Target: Regular bowel movements.

Action Threshold: No bowel movement for > 3 days, severe straining, or abdominal discomfort (initiate/adjust bowel regimen).

Signs of opioid abuse, misuse, or addiction

Frequency: At each visit.

Target: Adherence to prescribed regimen, no aberrant drug-seeking behaviors.

Action Threshold: Evidence of diversion, escalating use, or other concerning behaviors (consider urine drug screen, referral to addiction specialist).

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation/somnolence
  • Dizziness, lightheadedness
  • Nausea, vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Confusion, disorientation
  • Hypotension
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart beat, fever, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination)

Special Patient Groups

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Pregnancy

Use during pregnancy is generally not recommended due to potential for neonatal opioid withdrawal syndrome (NOWS) and respiratory depression in the neonate. Benefits must clearly outweigh risks.

Trimester-Specific Risks:

First Trimester: Limited data on teratogenicity; some studies suggest increased risk of congenital malformations (e.g., neural tube defects, cardiac defects) with first-trimester opioid exposure, but causality is not definitively established.
Second Trimester: Risk of fetal growth restriction and potential for NOWS if exposure continues.
Third Trimester: High risk of neonatal opioid withdrawal syndrome (NOWS) in infants born to mothers physically dependent on opioids. NOWS can be life-threatening and requires prolonged hospitalization. Risk of respiratory depression in the neonate at delivery.
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Lactation

Morphine is excreted into breast milk. Not recommended for use during breastfeeding due to potential for serious adverse reactions in the infant, including sedation, respiratory depression, and withdrawal symptoms. If used, monitor infant closely for signs of sedation and respiratory depression.

Infant Risk: L3 (Moderate risk) - Monitor infant for sedation, poor feeding, respiratory depression, and withdrawal symptoms if maternal use is necessary. Consider alternative analgesics or temporary cessation of breastfeeding.
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients. Use in pediatric patients <18 years of age is not recommended due to the risks of respiratory depression, accidental ingestion, and lack of established dosing.

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, particularly respiratory depression. Start with lower doses and titrate slowly. Monitor closely for sedation, respiratory depression, and constipation. Renal and hepatic impairment are more common in the elderly, requiring dose adjustments.

Clinical Information

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Clinical Pearls

  • Morphine ER capsules are for opioid-tolerant patients only. Initiating in opioid-naΓ―ve patients can cause fatal respiratory depression.
  • Do not crush, chew, or dissolve the capsules. This can lead to rapid release of a potentially fatal dose of morphine.
  • Educate patients and caregivers on the risks of accidental ingestion, especially by children, which can be fatal.
  • Always have naloxone available for patients at increased risk of overdose (e.g., those on higher doses, concomitant CNS depressants, or with a history of substance use disorder).
  • Constipation is a universal side effect of opioids; proactively manage with a bowel regimen (stimulant laxative + stool softener).
  • Titrate dose slowly and monitor for signs of respiratory depression and excessive sedation, especially during initiation or dose escalation.
  • Consider the 24-hour dosing interval carefully; some patients may require a different ER formulation or supplemental short-acting opioid for breakthrough pain.
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Alternative Therapies

  • Other extended-release opioid analgesics (e.g., oxycodone ER, hydromorphone ER, fentanyl transdermal, tapentadol ER)
  • Other strong opioid analgesics (e.g., hydromorphone, oxymorphone, fentanyl, methadone)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants, SNRIs) for chronic pain management, often as adjuncts or for less severe pain.
  • Non-pharmacological therapies (e.g., physical therapy, occupational therapy, cognitive behavioral therapy, interventional pain procedures).
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Cost & Coverage

Average Cost: $100 - $500+ per 30 capsules (120mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often requires prior authorization for brand or higher doses)
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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, do not share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be administered to help treat the condition. 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.