Morphine Sul 90mg ER Caps (24h)

Manufacturer ACTAVIS Active Ingredient Morphine Extended-Release Capsules(MOR feen) Pronunciation MOR-feen
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
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 (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 with your prescription 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 breathing difficulties and overdose, which can be fatal.
Take your medication at the same time every day to establish a routine.
Swallow the tablet whole; do not chew, break, crush, or dissolve it before swallowing, as this can cause severe side effects 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 tablet 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.

Administration via Feeding Tube

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 brand can be given through a feeding tube.

Storage and Disposal

Store your medication at room temperature, protected from light and in a dry place. Avoid storing it in a bathroom.
Keep your medication in a safe and secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to store your medication.
* Keep all medications away from pets.

Missing a Dose

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

  • Do not drink alcohol while taking this medicine, as it can cause dangerous side effects, including overdose and death.
  • Do not drive or operate heavy machinery until you know how this medicine affects you, as it can cause drowsiness and dizziness.
  • 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 a rapid release of a potentially fatal dose of morphine.
  • Discuss all other medications, including over-the-counter drugs, herbal supplements, and illicit drugs, with your doctor to avoid dangerous interactions.
  • Maintain a regular bowel regimen (e.g., fiber, fluids, laxatives) to prevent constipation, a common side effect.

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized, typically initiated at lower doses for opioid-naive patients. For opioid-tolerant patients, conversion from other opioids or immediate-release morphine is necessary. 90mg ER is a high dose, usually for chronic, severe pain in opioid-tolerant patients. Administer once every 24 hours.
Dose Range: 15 - 1600 mg

Condition-Specific Dosing:

chronic_severe_pain: Initial dose for opioid-naive patients: 15 mg orally every 24 hours. Titrate slowly based on patient response and tolerability. For conversion from other opioids, use established equianalgesic tables and reduce the calculated dose by 25-50% to account for incomplete cross-tolerance.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor for increased adverse effects.
Moderate: Reduce initial dose by 50% and titrate slowly; monitor for increased adverse effects and accumulation of active metabolites (morphine-6-glucuronide).
Severe: Contraindicated or significantly reduce dose (e.g., 75% reduction) and extend dosing interval; close monitoring for respiratory depression and sedation is essential. Consider alternative analgesics.
Dialysis: Morphine and its metabolites are partially dialyzable. Administer after dialysis. Significant dose reduction and extended intervals are required. Close monitoring is critical.

Hepatic Impairment:

Mild: Use with caution; monitor for increased adverse effects.
Moderate: Reduce initial dose by 50% and titrate slowly; monitor for increased adverse effects.
Severe: Reduce initial dose by 75% or more and extend dosing interval; close monitoring for respiratory depression and sedation is essential. Consider alternative analgesics.

Pharmacology

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Mechanism of Action

Morphine is an opioid agonist that binds to mu-opioid receptors in the central nervous system (CNS), gastrointestinal tract, and other tissues. Activation of these receptors 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% (oral, due to significant first-pass metabolism)
Tmax: Approximately 6-12 hours (for ER formulations)
FoodEffect: Food may increase the extent of absorption (AUC) and peak plasma concentrations (Cmax) for some ER formulations; consult specific product labeling.

Distribution:

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

Elimination:

HalfLife: Approximately 8-12 hours (terminal half-life for ER formulations, reflecting absorption phase)
Clearance: Not available (highly variable due to first-pass metabolism)
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Not applicable for ER formulation for acute pain relief; provides continuous pain control.
PeakEffect: Approximately 6-12 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; RISK EVALUATION AND MITIGATION STRATEGY (REMS); RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; ALCOHOL INTERACTION.
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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 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
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

Serotonin Syndrome: A Rare but Serious Condition

If you take this medication with certain other drugs, you may be at risk for a severe and potentially life-threatening condition called serotonin syndrome. Seek medical help 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

Adrenal Gland Problems: A Rare but Serious Condition

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

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

Hormonal Changes: A Potential Side Effect

Long-term use of an opioid medication may lead to lower sex hormone levels. Contact your doctor if you experience:

Lowered interest in sex
Fertility problems
No menstrual period
Ejaculation problems

Other Side Effects

Most people do not experience severe side effects, and many have only minor side effects or none at all. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

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

Reporting Side Effects

If you have questions about side effects or want to report a side effect, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects 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 inability to pass urine
  • Signs of allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as 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 problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or modify the dosage of any medication without consulting your doctor.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution When Performing Daily Activities

Until you understand how this medication affects you, avoid driving and engaging in other activities that require your full attention. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when navigating stairs.

Interactions with Other Medications

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

Monitoring Your Pain

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 dosage.

Tolerance and Dependence

Prolonged or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses are 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 amount.

Additionally, long-term or regular use of opioid medications like this one may result in dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as abruptly stopping or lowering the dose may increase the risk of withdrawal or other severe complications. 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 using products that contain alcohol, as this may lead to unsafe and potentially fatal consequences.

Seizure Risk

This medication may increase the risk of seizures in certain individuals, including 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
  • Slowed or stopped breathing
  • Extreme drowsiness or unresponsiveness
  • Limp muscles
  • Cold, clammy skin
  • Bluish discoloration of lips and fingernails
  • Loss of consciousness
  • Coma

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) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Concomitant use with benzodiazepines or other CNS depressants (unless benefits outweigh risks, and then with extreme caution and reduced dosages)
  • 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, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol): Increased risk of respiratory depression, profound sedation, coma, and death.
  • Monoamine Oxidase Inhibitors (MAOIs): May potentiate opioid effects (respiratory depression, hypotension, profound sedation, coma). Avoid concomitant use or use with extreme caution and reduced opioid dose.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans): Risk of serotonin syndrome.
  • Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol): May reduce analgesic effect or precipitate withdrawal symptoms.
  • Opioid antagonists (e.g., naltrexone, naloxone): May precipitate acute withdrawal.
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Moderate Interactions

  • Anticholinergics: Increased risk of urinary retention and/or severe constipation.
  • Diuretics: Opioids may reduce the efficacy of diuretics by inducing ADH release.
  • P-glycoprotein (P-gp) inhibitors/inducers: May alter morphine plasma concentrations.
  • Cimetidine: May inhibit morphine metabolism, increasing plasma levels.
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Minor Interactions

  • Not available

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

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 mental status and identify risk for excessive sedation.

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

Concomitant medications review

Rationale: To identify potential drug interactions, especially with CNS depressants.

Timing: Prior to initiation of therapy

Risk assessment for opioid use disorder

Rationale: To identify patients at higher risk for abuse, misuse, or addiction.

Timing: Prior to initiation of therapy

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Routine Monitoring

Pain assessment

Frequency: Regularly, especially during titration and with any change in pain or dose (e.g., daily to weekly during titration, then monthly to quarterly for stable patients)

Target: Acceptable pain control with tolerable side effects

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

Respiratory rate and depth

Frequency: Regularly, especially during initiation and dose titration (e.g., daily for first few days, then as clinically indicated)

Target: Normal respiratory rate (12-20 breaths/min) and adequate depth

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoventilation require immediate intervention.

Level of consciousness/sedation

Frequency: Regularly, especially during initiation and dose titration (e.g., daily for first few days, then as clinically indicated)

Target: Alert and oriented, or easily aroused

Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolence) requires dose reduction or discontinuation.

Bowel function

Frequency: Daily

Target: Regular bowel movements

Action Threshold: Constipation requires prophylactic laxative regimen and/or treatment.

Signs of opioid use disorder (e.g., aberrant drug-related behaviors)

Frequency: Ongoing, at every visit

Target: Absence of aberrant behaviors

Action Threshold: Suspicion of misuse/abuse requires further assessment and intervention.

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation/somnolence
  • Dizziness
  • Nausea/vomiting
  • Constipation
  • Pruritus
  • Urinary retention
  • Hypotension
  • Signs of opioid withdrawal (if dose reduced too quickly or discontinued)
  • Signs of serotonin syndrome (agitation, hallucinations, tachycardia, fever, hyperreflexia, incoordination, nausea, vomiting, diarrhea)

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, but some studies suggest a possible increased risk of birth defects with opioid use early in pregnancy.
Second Trimester: Risk of fetal respiratory depression and potential for NOWS if used chronically.
Third Trimester: High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Risk of respiratory depression in the neonate at delivery.
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Lactation

Morphine is excreted into breast milk. Use is generally not recommended due to potential for infant sedation, respiratory depression, and withdrawal symptoms. If use is unavoidable, monitor the infant closely for signs of sedation and respiratory depression.

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

Safety and efficacy of morphine extended-release capsules have not been established in pediatric patients. Use is generally not recommended.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Morphine ER 90mg is a high dose and should only be used in opioid-tolerant patients with severe chronic pain.
  • Never crush, chew, or dissolve extended-release morphine capsules due to the risk of rapid release of a fatal dose.
  • Educate patients and caregivers thoroughly on safe storage, administration, and disposal to prevent accidental ingestion, especially by children.
  • Always assess for risk factors for opioid use disorder and implement appropriate monitoring strategies.
  • Prophylactic treatment for opioid-induced constipation should be initiated concurrently with morphine therapy.
  • Be vigilant for signs of respiratory depression, especially during initiation, dose titration, or with concomitant use of other CNS depressants.
  • Renal impairment significantly increases the risk of morphine and M6G accumulation, leading to prolonged and exaggerated opioid effects; dose adjustments are critical.
  • Consider the patient's overall pain management plan, including non-pharmacological and non-opioid therapies, as part of a comprehensive approach.
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Alternative Therapies

  • Other extended-release opioids (e.g., oxycodone ER, hydromorphone ER, fentanyl transdermal, buprenorphine transdermal)
  • Other strong short-acting opioids (e.g., immediate-release morphine, oxycodone, hydromorphone) for breakthrough pain or initial titration
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts
  • Adjuvant analgesics (e.g., gabapentin, pregabalin for neuropathic pain; tricyclic antidepressants)
  • Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: $100 - $500+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often requires prior authorization)
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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 each time 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.