Morphine Sul 30mg ER Caps (24h)

Manufacturer UPSHER-SMITH Active Ingredient Morphine Extended-Release Capsules(MOR feen) Pronunciation MOR-feen SUL-fate
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
D
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FDA Approved
May 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 releases the medicine slowly 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 follow the instructions closely.

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.
Take your medication at the same time every day to maintain a consistent routine.
Swallow the medication whole; do not chew, break, crush, or dissolve it before swallowing, as this can cause severe side effects and increase the risk of overdose and death.
This medication is not intended for fast pain relief or for use on an as-needed basis. Additionally, it should not be used for pain relief after surgery if you have not been taking similar medications.
If you have difficulty swallowing the medication whole, you may sprinkle the contents onto applesauce. If you do this, swallow the mixture immediately without chewing. Rinse your mouth to ensure all the contents have been swallowed.

Special Administration Instructions

Some brands 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 through a feeding tube.

Storage and Disposal

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

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 take extra doses to make up for the missed dose.
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Lifestyle & Tips

  • Take exactly as prescribed; do not crush, chew, or dissolve the capsules, as this can lead to a rapid release of a potentially fatal dose.
  • Do not drink alcohol while taking this medicine, as it can increase the risk of serious side effects like breathing problems and extreme sleepiness.
  • Avoid driving or operating heavy machinery until you know how this medicine affects you, as it can cause dizziness and drowsiness.
  • To prevent severe constipation, drink plenty of fluids, eat fiber-rich foods, and use a stool softener or laxative as recommended by your doctor.
  • Store this medicine securely away from children and pets, as accidental ingestion can be fatal.
  • Do not share this medication with anyone else, as it can be dangerous and is against the law.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose for opioid-naive patients: 15 mg orally every 24 hours. For patients converting from other opioids or IR morphine, the dose should be individualized based on prior opioid exposure and titrated to effect.
Dose Range: 15 - 200 mg

Condition-Specific Dosing:

chronic_pain: Titrate slowly to achieve adequate analgesia with acceptable side effects. Doses above 200 mg/day should be used with caution and only in patients who have demonstrated tolerance to lower doses.
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Pediatric Dosing

Neonatal: Not established (contraindicated due to risk of respiratory depression and neonatal opioid withdrawal syndrome)
Infant: Not established
Child: Not established (safety and efficacy not established for opioid-naive children)
Adolescent: Not established (safety and efficacy not established for opioid-naive adolescents)
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; consider dose reduction and 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-6-glucuronide).
Severe: Contraindicated or significant dose reduction (e.g., 75%) and extended dosing interval (e.g., every 48 hours or longer) with close monitoring. Consider alternative analgesics.
Dialysis: Morphine and its metabolites are dialyzable, but accumulation can still occur. Administer after dialysis and monitor closely. Significant dose reduction required.

Hepatic Impairment:

Mild: Use with caution; consider dose reduction.
Moderate: Significant dose reduction (e.g., 50%) and close monitoring recommended.
Severe: Significant dose reduction (e.g., 75%) and extended dosing interval with close monitoring. Consider alternative analgesics.

Pharmacology

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Mechanism of Action

Morphine is a full opioid agonist that binds to and activates mu-opioid receptors in the central nervous system (CNS) and other tissues. This binding leads to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces generalized CNS depression, including respiratory depression, sedation, and euphoria.
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Pharmacokinetics

Absorption:

Bioavailability: 20-40% (highly variable due to first-pass metabolism)
Tmax: 4-8 hours (for extended-release formulations)
FoodEffect: Minimal to no significant effect on overall absorption for most ER formulations, but may slightly delay Tmax.

Distribution:

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

Elimination:

HalfLife: 2-4 hours (for parent drug, but ER formulations provide sustained release over 24 hours; effective half-life for ER is longer)
Clearance: Approximately 15-30 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10% (in urine)
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Pharmacodynamics

OnsetOfAction: Delayed (for ER formulations, typically 1-2 hours to initial effect)
PeakEffect: 4-8 hours (for ER formulations)
DurationOfAction: 24 hours (for 24-hour ER formulations)

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; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.

Addiction, Abuse, and Misuse: Morphine extended-release 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 and monitor all patients regularly for the development of these behaviors or conditions.

Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of morphine extended-release or following a dose increase.

Accidental Ingestion: Accidental ingestion of even one dose of morphine extended-release, especially by children, can result in a fatal overdose of morphine.

Neonatal Opioid Withdrawal Syndrome: Prolonged use of morphine extended-release 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. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: 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. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
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Side Effects

Important Side Effects to Report to Your Doctor 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, 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 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 severe 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
+ Changes in balance
+ 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
+ Irregular menstrual periods
+ Ejaculation problems

Other Possible Side Effects

While many people may not experience any side effects or only mild side effects, it is essential to report any concerns to your doctor. Common side effects include:

Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Nausea and vomiting
Decreased appetite
Headache
Anxiety
* Excessive sweating

If you experience any of these side effects or any other concerns, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Slow, shallow, or difficult breathing (signs of respiratory depression)
  • Extreme drowsiness, dizziness, or feeling like you might pass out
  • Confusion or disorientation
  • Bluish lips or fingernails
  • Severe constipation or inability to have a bowel movement
  • Signs of an allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
  • Seizures
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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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
If you are currently taking any of the following medications: 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 modify 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 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 consulting your doctor first. 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.

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 may be required 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, long-term or 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 first, as sudden changes may 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.

Allergies and Interactions
If you are allergic to sulfites, discuss this with your doctor, as some products contain sulfites. Do not consume alcohol or use products containing alcohol while taking this medication, as this may lead to unsafe and potentially fatal effects.

Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those 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 unresponsiveness
  • Slow, shallow, or stopped breathing
  • Limp muscles
  • Cold, clammy skin
  • Bluish discoloration of lips and fingernails
  • Loss of consciousness

What to Do:

If you suspect an overdose, call 911 immediately. Administer naloxone if available and trained to do so. Stay with the person until emergency medical help arrives. Provide rescue breathing if necessary.

Drug Interactions

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Contraindicated Interactions

  • Concomitant use with benzodiazepines or other CNS depressants (unless benefits outweigh risks, then use lowest effective dose and shortest duration)
  • 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

  • Other CNS depressants (e.g., sedatives, hypnotics, anxiolytics, general anesthetics, phenothiazines, other opioids, alcohol): Increased risk of respiratory depression, profound sedation, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, MAOIs): Risk of serotonin syndrome.
  • Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol): May reduce analgesic effect and/or precipitate withdrawal symptoms.
  • Muscle relaxants: Enhanced neuromuscular blocking effects and increased risk of respiratory depression.
  • Anticholinergic drugs: Increased risk of urinary retention and/or severe constipation that may lead to paralytic ileus.
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Moderate Interactions

  • Diuretics: Opioids may reduce the efficacy of diuretics by causing the release of antidiuretic hormone.
  • Antihypertensives: May cause additive hypotensive effects.
  • P-glycoprotein (P-gp) inhibitors/inducers: May alter morphine plasma concentrations (morphine is a P-gp substrate).
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Minor Interactions

  • Not typically categorized as minor for morphine due to its potent effects and significant interaction profile.

Monitoring

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Baseline Monitoring

Pain assessment (intensity, quality, location)

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

Timing: Prior to initiation of therapy

Respiratory rate and depth, oxygen saturation

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

Timing: Prior to initiation of therapy

Mental status (level of consciousness, sedation)

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

Timing: Prior to initiation of therapy

Bowel function (frequency, consistency)

Rationale: To establish baseline and anticipate opioid-induced constipation.

Timing: Prior to initiation of therapy

Renal and hepatic function tests (CrCl, LFTs)

Rationale: To identify 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 for chronic therapy.

Target: Individualized, aiming for acceptable pain control with minimal side effects.

Action Threshold: Inadequate pain control or unacceptable side effects warrant dose adjustment or re-evaluation.

Respiratory rate and depth, sedation level (e.g., Pasero Opioid-Induced Sedation Scale)

Frequency: Frequently during initiation and titration (e.g., every 1-4 hours), then periodically (e.g., daily) for stable patients.

Target: Respiratory rate >10 breaths/min, sedation score <3 (awake, slightly drowsy, easily aroused).

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or sedation score β‰₯3 (difficult to arouse, somnolent) requires immediate intervention (e.g., naloxone, stopping opioid).

Bowel function

Frequency: Daily

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

Action Threshold: No bowel movement for 2-3 days, straining, or hard stools requires intervention (e.g., laxatives, stool softeners, opioid-induced constipation specific agents).

Signs of opioid abuse, misuse, or addiction

Frequency: Regularly throughout therapy, at each visit.

Target: Absence of aberrant drug-related behaviors.

Action Threshold: Evidence of diversion, dose escalation without clinical justification, or other concerning behaviors requires re-evaluation of treatment plan and potential referral.

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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

Special Patient Groups

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Pregnancy

Prolonged use 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 only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations with first-trimester opioid exposure is suggested by some studies, though not definitively established for morphine.
Second Trimester: Risk of NOWS increases with prolonged exposure. Fetal growth restriction may occur.
Third Trimester: High risk of NOWS if used chronically. Risk of respiratory depression in the neonate if used near delivery.
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Lactation

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

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

Safety and efficacy have not been established in opioid-naive pediatric patients. Extended-release formulations are generally not recommended for children due to the risk of accidental overdose and difficulty in precise dose titration.

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of morphine, 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 further dose adjustments.

Clinical Information

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Clinical Pearls

  • Extended-release morphine is for chronic, severe pain requiring continuous, around-the-clock opioid analgesia, not for as-needed pain relief.
  • Emphasize the critical importance of not crushing, chewing, or dissolving ER capsules due to the risk of rapid, potentially fatal, opioid release.
  • Always have naloxone readily available for patients prescribed high-dose opioids or those with risk factors for overdose.
  • Opioid-induced constipation is a common and persistent side effect; proactive management with a bowel regimen (stimulant laxative plus stool softener) should be initiated at the start of therapy.
  • Titrate slowly and individually to the lowest effective dose to minimize adverse effects and reduce the risk of addiction.
  • Regularly assess for signs of abuse, misuse, and addiction, and consider urine drug screens and prescription drug monitoring program (PDMP) checks.
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Alternative Therapies

  • Other opioid analgesics (e.g., oxycodone, hydrocodone, hydromorphone, fentanyl, tramadol)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
  • Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
  • Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy, interventional pain procedures)
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Cost & Coverage

Average Cost: $50 - $200+ per 30 capsules (30mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (often requires prior authorization or step therapy due to opioid class)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication.

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.