Morphine Sul 60mg ER Caps (24h)

Manufacturer UPSHER-SMITH 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 (first/second trimester); Category D (prolonged use or near term)
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FDA Approved
Mar 1987
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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 (an 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 slowly releases the medicine over 24 hours to provide continuous pain relief.
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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 minimize 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 medication whole; do not chew, break, crush, or dissolve it before swallowing, as this can cause severe side effects and potentially be fatal.
This medication is not intended for fast pain relief or for use on an as-needed basis. Additionally, it should not be used for post-surgical pain relief if you have not previously been taking similar medications.
If you have difficulty swallowing the medication whole, you may sprinkle its 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.

Special Administration Instructions

Some formulations of this medication can be administered through a specific type of feeding tube, while others cannot. Consult your pharmacist to determine if your medication can be given via a feeding tube.

Storage and Disposal

Store this medication at room temperature, protected from light and in a dry place. Avoid storing it in a bathroom.
Keep this medication in a secure location where it is not visible or accessible to children, and where others cannot easily obtain it. Consider using a locked box or secure area.
* Keep all medications out of reach of pets.

Missed Dose Instructions

If you miss a dose, skip it and continue with your regular dosing schedule. Do not take two doses at once or take extra doses to compensate for the missed dose.
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Lifestyle & Tips

  • Do NOT crush, chew, or dissolve the capsules. Swallow them whole. Crushing or chewing can lead to a rapid release of a potentially fatal dose of morphine.
  • Do NOT consume alcohol while taking this medication, as it can lead to dangerous side effects, including severe breathing problems and death.
  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
  • Store this medication securely away from children and pets, as accidental ingestion can be fatal.
  • Discuss a bowel regimen with your doctor to prevent constipation, a common side effect.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can cause withdrawal symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: For opioid-tolerant patients: Initial dose based on prior opioid regimen, typically 15-30 mg every 8-12 hours for ER capsules (e.g., Kadian, Avinza) or 15-60 mg every 12-24 hours for ER capsules (e.g., MorphaBond ER). The specific 60mg ER capsule (24h) implies a once-daily formulation.
Dose Range: 15 - 1600 mg

Condition-Specific Dosing:

opioid_naive: Not for opioid-naive patients. Use immediate-release morphine to titrate to an appropriate dose before converting to extended-release.
conversion_from_other_opioids: Consult opioid conversion tables. Dose should be individualized and carefully titrated.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for extended-release capsules. Safety and efficacy not established in pediatric patients under 18 years of age for most ER formulations.
Adolescent: Not established for extended-release capsules. Safety and efficacy not established in pediatric patients under 18 years of age for most ER formulations.
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Dose Adjustments

Renal Impairment:

Mild: Monitor closely for increased effects; consider dose reduction.
Moderate: Reduce initial dose by 25-50%; titrate carefully. Monitor for accumulation of active metabolites (morphine-3-glucuronide, morphine-6-glucuronide).
Severe: Reduce initial dose by 50-75% or more; titrate very carefully. Avoid if possible. Monitor for accumulation of active metabolites.
Dialysis: Morphine and its metabolites are dialyzable, but clinical effects may persist. Administer after dialysis. Close monitoring required.

Hepatic Impairment:

Mild: Monitor closely for increased effects; consider dose reduction.
Moderate: Reduce initial dose by 25-50%; titrate carefully. Monitor for increased effects.
Severe: Reduce initial dose by 50-75% or more; titrate very carefully. Avoid if possible. Monitor for increased effects.
Confidence: Medium

Pharmacology

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Mechanism of Action

Morphine is an opioid agonist that acts primarily at the mu-opioid receptors in the central nervous system (CNS) and other tissues. Its analgesic effects are mediated by binding to these receptors, leading to inhibition of pain transmission, alteration of pain perception, and induction of euphoria.
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Pharmacokinetics

Absorption:

Bioavailability: Variable, approximately 20-40% (oral, due to first-pass metabolism). Extended-release formulations are designed for slower, sustained absorption.
Tmax: Extended-release capsules: 3-12 hours (highly variable depending on specific ER formulation).
FoodEffect: Some ER formulations (e.g., Kadian) are not significantly affected by food. Others (e.g., Avinza) may have increased Cmax and AUC with high-fat meals. Always refer to specific product labeling.

Distribution:

Vd: Approximately 3-5 L/kg.
ProteinBinding: Low, approximately 20-35%.
CnssPenetration: Yes, readily crosses the blood-brain barrier.

Elimination:

HalfLife: Immediate-release: 2-4 hours. Extended-release: 8-12 hours (terminal half-life can be longer, up to 15-45 hours for some 24h formulations, reflecting absorption phase).
Clearance: Approximately 15-30 mL/min/kg.
ExcretionRoute: Primarily renal (approximately 90% as metabolites, 7-10% as unchanged drug). A small amount is excreted in bile/feces.
Unchanged: Approximately 7-10% (renal excretion).
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Pharmacodynamics

OnsetOfAction: Extended-release: Not applicable for acute pain relief; designed for sustained pain control. Onset of significant pain relief is gradual, typically within 1-2 hours, reaching steady state over several days.
PeakEffect: Extended-release: 3-12 hours (variable by formulation).
DurationOfAction: Extended-release: 12-24 hours (depending on specific formulation, e.g., 24h for this product).

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. Morphine extended-release capsules expose 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 even one dose, 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

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 immediately or seek emergency 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
+ Difficulty 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
+ Rapid heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Chest pain or pressure, or a rapid heartbeat
Confusion
Breathing difficulties, including:
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Seizures
Severe constipation or stomach pain, which may indicate a serious bowel problem
Depression or other mood changes
Swelling in the arms or legs
Fever, chills, or sore throat
Painful urination
Abnormal sensations, such as burning, numbness, or tingling
Serotonin syndrome, a potentially life-threatening condition that may occur when taking this medication with certain other drugs. Symptoms include:
+ Agitation
+ Balance problems
+ Confusion
+ Hallucinations
+ Fever
+ Rapid or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, nausea, or vomiting
+ Severe headache
Adrenal gland problems, which may occur with long-term opioid use. Symptoms include:
+ Extreme fatigue or weakness
+ Fainting
+ Severe dizziness
+ Nausea and vomiting
+ Decreased appetite
Hormonal changes, which may occur with long-term opioid use. Symptoms include:
+ Decreased sex drive
+ Fertility problems
+ Missed menstrual periods
+ Ejaculation problems

Other Possible Side Effects

Most people experience few or no side effects while taking this medication. However, some individuals may encounter mild or moderate side effects, including:

Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Headache
Anxiety
Excessive sweating

If you experience any of these side effects or any other unusual symptoms, contact your doctor for 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
  • Confusion
  • Blue lips or fingernails
  • Severe constipation or abdominal pain
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction 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 lead to severely high blood pressure
Current use of certain medications, such as 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 inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to ensure safe use. Do not initiate, 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 alertness. 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 you 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 higher doses are needed 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 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 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
  • Slowed or stopped breathing (respiratory depression)
  • Extreme drowsiness or loss of consciousness
  • Limp muscles
  • Cold, clammy skin
  • Blue discoloration of lips or fingernails
  • Slowed heart rate
  • Low blood pressure
  • Coma

What to Do:

If you suspect an overdose, seek immediate emergency medical attention. Call 911 or your local emergency number. Administer naloxone if available and trained to do so. Call 1-800-222-1222 (Poison Control) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome or severe respiratory depression)
  • Patients with significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected paralytic ileus
  • Hypersensitivity to morphine
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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 reduce analgesic effect and/or precipitate withdrawal symptoms.
  • Opioid antagonists (e.g., naltrexone, naloxone): May precipitate acute opioid withdrawal.
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Moderate Interactions

  • Anticholinergic drugs (e.g., antihistamines, tricyclic antidepressants, antipsychotics, muscle relaxants): Increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
  • Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
  • Muscle relaxants: Enhanced neuromuscular blocking action, leading to increased respiratory depression.
  • CYP3A4 inhibitors/inducers: While morphine is primarily metabolized by glucuronidation, some minor CYP pathways exist. Monitor for altered effects if co-administered with strong CYP3A4 modulators.
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Minor Interactions

  • Cimetidine: May inhibit morphine metabolism, leading to increased morphine levels (clinical significance often minor).

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 factors for respiratory depression.

Timing: Prior to initiation of therapy.

Level of consciousness/sedation

Rationale: To assess baseline neurological status and identify risk factors 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., SCr, BUN, LFTs)

Rationale: To identify potential impairment that may necessitate dose adjustment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Pain assessment

Frequency: Regularly, especially during titration and with any change in dose; at least daily once stable.

Target: Acceptable pain level as defined by patient and clinician.

Action Threshold: Uncontrolled pain or significant increase in pain.

Respiratory rate and depth

Frequency: Frequently during initiation and titration (e.g., every 1-4 hours); less frequently once stable (e.g., daily or as clinically indicated).

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

Action Threshold: <10 breaths/min, shallow breathing, or signs of respiratory distress.

Level of consciousness/sedation

Frequency: Frequently during initiation and titration; less frequently once stable.

Target: Alert, easily aroused, or mildly sedated.

Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolence), confusion, or disorientation.

Bowel function (frequency of bowel movements, consistency)

Frequency: Daily.

Target: Regular bowel movements (e.g., every 1-3 days).

Action Threshold: Constipation (e.g., no bowel movement for >3 days, straining, hard stools).

Signs of opioid-induced adverse effects (nausea, vomiting, pruritus, dizziness)

Frequency: Daily or as reported by patient.

Target: Minimal or manageable side effects.

Action Threshold: Intolerable or severe adverse effects.

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation/somnolence
  • Dizziness/lightheadedness
  • Nausea and vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Confusion/disorientation
  • Hypotension

Special Patient Groups

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Pregnancy

Prolonged use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Morphine crosses the placenta. Use during labor may cause respiratory depression in the neonate. Category C (first/second trimester); Category D (prolonged use or near term). Weigh potential benefits against risks.

Trimester-Specific Risks:

First Trimester: Potential for congenital malformations (limited data, some studies suggest increased risk of neural tube defects, heart defects, gastroschisis).
Second Trimester: Risk of neonatal opioid withdrawal syndrome with prolonged use.
Third Trimester: High risk of neonatal opioid withdrawal syndrome (NOWS) with prolonged use. Risk of respiratory depression in the neonate if used during labor.
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Lactation

Morphine is excreted into breast milk. Monitor breastfed infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. The American Academy of Pediatrics considers morphine to be compatible with breastfeeding with caution and close infant monitoring. Consider lowest effective dose and short-term use if possible.

Infant Risk: Risk of sedation, respiratory depression, constipation, and withdrawal symptoms in the infant. L3 (Moderately safe).
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Pediatric Use

Safety and efficacy of morphine extended-release capsules have not been established in pediatric patients under 18 years of age. Not recommended for opioid-naive pediatric patients. Use with extreme caution and only if benefits outweigh risks in specific situations, under expert guidance.

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, including respiratory depression. Start with lower doses and titrate slowly. Monitor closely for sedation, respiratory depression, and constipation. Increased risk of falls.

Clinical Information

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Clinical Pearls

  • Morphine extended-release capsules are for opioid-tolerant patients only. Do NOT use in opioid-naive patients.
  • Emphasize to patients that capsules must be swallowed whole. Crushing, chewing, or dissolving can lead to rapid release of a potentially fatal dose.
  • Some ER formulations (e.g., Kadian) can be opened and sprinkled on soft food (like applesauce) for patients with swallowing difficulties, but the beads must not be chewed. Always verify specific product instructions.
  • Opioid-induced constipation is a common and persistent side effect; proactive management with a stimulant laxative and stool softener is often necessary.
  • Educate patients and caregivers about the signs of opioid overdose and the availability of naloxone.
  • Due to the risk of addiction, abuse, and misuse, assess patient risk factors before prescribing and monitor for signs of abuse and addiction during therapy.
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Alternative Therapies

  • Other extended-release opioid analgesics (e.g., oxycodone ER, hydromorphone ER, fentanyl transdermal, tapentadol ER, buprenorphine transdermal)
  • Immediate-release opioid analgesics (for breakthrough pain or titration)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, duloxetine)
  • Adjuvant analgesics (e.g., antidepressants, anticonvulsants)
  • Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: Highly variable, typically $50-$500+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for generic); Tier 3 or Tier 4 (for 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, 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 important 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 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.