Morphine Sul 75mg ER Caps (24h)

Manufacturer ACTAVIS ELIZABETH 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
Category D
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FDA Approved
Sep 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 used to treat severe, ongoing pain that needs around-the-clock treatment. It's not for pain that comes and goes or for use 'as needed'. This medicine works by changing how your brain and nervous system respond to pain.
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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 medication 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 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.

Administration via Feeding Tube

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 of medication is compatible with feeding tube administration.

Storage and Disposal

Store this medication at room temperature, protected from light and in a dry place. Avoid storing it in a bathroom. Keep the medication in a secure location where it is out of sight and reach of children, and inaccessible to others. Consider using a locked box or area to safeguard the medication. Also, keep all medications away from pets.

Missed 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 compensate 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 consume alcohol or use other CNS depressants (e.g., tranquilizers, sleeping pills) while taking this medication, as it can cause severe drowsiness, breathing problems, and death.
  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and use a stool softener or laxative as recommended by your doctor.
  • Store this medication securely away from children and pets, and dispose of any unused medication properly (e.g., drug take-back program or flushing down the toilet if no other option is available and instructed by FDA).

Dosing & Administration

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Adult Dosing

Standard Dose: 75 mg orally once daily for opioid-tolerant patients requiring around-the-clock opioid analgesia. Not for opioid-naive patients.
Dose Range: 10 - 1600 mg

Condition-Specific Dosing:

chronic_severe_pain: Individualized titration based on patient response and tolerability. Initial dose for opioid-naive patients is typically 15-30 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for extended-release formulations in opioid-naive patients. Use only if benefits outweigh risks in opioid-tolerant children under strict medical supervision.
Adolescent: Not established for extended-release formulations in opioid-naive patients. Use only if benefits outweigh risks in opioid-tolerant adolescents under strict medical supervision.
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Dose Adjustments

Renal Impairment:

Mild: Initiate with caution, consider lower starting dose and longer dosing interval.
Moderate: Significant dose reduction (e.g., 50% or more) and/or increased dosing interval (e.g., every 48 hours) may be necessary due to accumulation of active metabolites (morphine-6-glucuronide).
Severe: Contraindicated or extreme caution with significant dose reduction and extended dosing intervals. Close monitoring for respiratory depression and sedation is essential.
Dialysis: Morphine and its metabolites are dialyzable, but accumulation can still occur. Administer after dialysis and monitor closely.

Hepatic Impairment:

Mild: Initiate with caution, consider lower starting dose.
Moderate: Significant dose reduction (e.g., 50% or more) and/or increased dosing interval may be necessary due to impaired metabolism.
Severe: Contraindicated or extreme caution with significant dose reduction and extended dosing intervals. Close monitoring for respiratory depression and sedation is essential.

Pharmacology

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Mechanism of Action

Morphine is a full opioid agonist, primarily acting at the mu-opioid receptors in the central nervous system (CNS). 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: 20-40% (oral, due to significant first-pass metabolism)
Tmax: 6-12 hours (for extended-release formulations)
FoodEffect: Food may increase the rate and extent of absorption for some ER formulations; consult specific product labeling.

Distribution:

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

Elimination:

HalfLife: 8-12 hours (effective half-life for 24-hour ER formulations)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Delayed (several hours for ER formulations)
PeakEffect: 6-12 hours (for ER formulations)
DurationOfAction: 24 hours

Safety & Warnings

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BLACK BOX WARNING

WARNING: ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; and ALCOHOL INTERACTION.

ADDICTION, ABUSE, AND MISUSE: Morphine Sulfate Extended-Release Capsules expose 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 and conditions.

RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.

ACCIDENTAL INGESTION: Accidental ingestion of even one dose of Morphine Sulfate Extended-Release Capsules, especially by children, can result in a fatal overdose of morphine.

NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of Morphine Sulfate Extended-Release Capsules 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.

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.

ALCOHOL INTERACTION: Concomitant use of alcohol with Morphine Sulfate Extended-Release Capsules can result in an increase in morphine plasma levels and a potentially fatal overdose of morphine. Instruct patients not to consume alcoholic beverages or use alcohol-containing prescription or non-prescription products while taking Morphine Sulfate Extended-Release Capsules.
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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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness or lightheadedness
+ Headache or feeling sleepy or weak
+ Shaking, fast heartbeat, confusion, hunger, or sweating
Severe dizziness or fainting
Chest pain or pressure, or a rapid heartbeat
Confusion or disorientation
Breathing difficulties, such as:
+ 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 or changes in balance
+ Confusion, hallucinations, or fever
+ Rapid or abnormal heartbeat, flushing, or muscle twitching or stiffness
+ Seizures, shivering or shaking, or excessive sweating
+ Severe diarrhea, nausea, vomiting, or headache
Adrenal gland problems, which may cause:
+ Extreme fatigue or weakness
+ Fainting or severe dizziness
+ Upset stomach, vomiting, or decreased appetite
Low sex hormone levels, which may lead to:
+ Decreased interest in sex
+ Fertility problems or irregular 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 have concerns about other symptoms, 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 or shallow breathing (less than 10 breaths per minute)
  • Extreme drowsiness or difficulty waking up
  • Blue lips or fingernails
  • Severe dizziness or lightheadedness
  • Confusion or disorientation
  • Pinpoint pupils
  • Cold, clammy skin
  • Unresponsiveness or fainting
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Before Using This Medicine

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

It is crucial 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 essential 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. Do not initiate, stop, or modify the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Precautions

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 position, and exercise caution 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 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 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 using products that contain alcohol, as this can 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
  • Respiratory depression (slowed or stopped breathing)
  • Extreme drowsiness leading to stupor or coma
  • Limp muscles
  • Cold, clammy skin
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Circulatory collapse
  • Death

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. Administer naloxone if available and trained to do so. Provide rescue breathing if the person is not breathing. Call 1-800-222-1222 (Poison Control Center) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of serotonin syndrome or severe respiratory depression)
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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, alcohol, sedatives, hypnotics, anxiolytics, general anesthetics, phenothiazines, tricyclic antidepressants): 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.
  • Anticholinergic drugs (e.g., atropine, scopolamine, some antihistamines): Increased risk of urinary retention and/or severe constipation.
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Moderate Interactions

  • Muscle relaxants: Enhanced neuromuscular blocking effects and increased risk of respiratory depression.
  • Diuretics: May reduce the efficacy of diuretics due to ADH release.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pain assessment (intensity, location, quality)

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

Sedation level (e.g., Pasero Opioid-Induced Sedation Scale)

Rationale: To assess baseline CNS depression and identify risk for over-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

Mental status and cognitive function

Rationale: To assess baseline and identify potential for impairment.

Timing: Prior to initiation of therapy

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Routine Monitoring

Pain assessment

Frequency: Regularly, at least daily or as clinically indicated, especially during titration

Target: Acceptable pain control with tolerable side effects

Action Threshold: Uncontrolled pain or intolerable side effects

Respiratory rate and depth

Frequency: Regularly, especially during initiation and dose escalation; less frequently once stable

Target: 12-20 breaths/minute (adults), regular rhythm

Action Threshold: <10 breaths/minute, shallow breathing, or signs of distress

Sedation level

Frequency: Regularly, especially during initiation and dose escalation; less frequently once stable

Target: Alert or mildly drowsy, easily aroused

Action Threshold: Difficult to arouse, somnolent, or unarousable

Bowel function

Frequency: Daily

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

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

Signs of opioid-induced hyperalgesia

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

Target: Not applicable

Action Threshold: Increased pain sensitivity, pain spreading beyond original site, or pain worsening despite dose increase

Signs of abuse, misuse, or addiction

Frequency: Ongoing, at every visit

Target: Not applicable

Action Threshold: Aberrant drug-related behaviors, escalating use, seeking drugs from multiple providers

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation or somnolence
  • Constipation
  • Nausea and vomiting
  • Pruritus (itching)
  • Urinary retention
  • Dizziness or lightheadedness
  • Confusion or disorientation
  • Hypotension
  • Miosis (pinpoint pupils)
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, overactive reflexes, nausea, vomiting, diarrhea, incoordination)

Special Patient Groups

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Pregnancy

Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome, which may be life-threatening. Use only if the potential benefit justifies the potential risk to the fetus. Advise pregnant patients of the risk.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations cannot be ruled out with early exposure.
Second Trimester: Risk of neonatal opioid withdrawal syndrome increases with prolonged use.
Third Trimester: High risk of neonatal opioid withdrawal syndrome if used for prolonged periods or near term. Respiratory depression in the neonate may also occur.
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Lactation

Morphine is excreted into breast milk and can cause serious adverse reactions in breastfed infants, including sedation and respiratory depression. Not recommended for use during breastfeeding. If necessary, monitor infants closely for signs of sedation and respiratory depression.

Infant Risk: High (L4 - Possibly Hazardous)
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Pediatric Use

Safety and effectiveness in pediatric patients under 18 years of age have not been established for opioid-naive patients. Use in opioid-tolerant pediatric patients should be done with extreme caution and under specialist supervision, with careful 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.

Clinical Information

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Clinical Pearls

  • Morphine ER is for chronic, severe pain requiring continuous, around-the-clock opioid analgesia. It is NOT for as-needed (PRN) pain relief.
  • Do not crush, chew, or dissolve extended-release capsules, as this can lead to rapid release of a potentially fatal dose of morphine.
  • Always assess for risk factors for addiction, abuse, and misuse before initiating therapy and monitor regularly.
  • Opioid-induced constipation is a common and often persistent side effect; proactive management with a stimulant laxative and stool softener is usually necessary.
  • Patients should be educated on the signs of respiratory depression and how to administer naloxone if prescribed.
  • Proper storage and disposal of unused medication are crucial to prevent accidental ingestion, especially by children.
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Alternative Therapies

  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
  • Adjuvant analgesics (e.g., gabapentinoids, tricyclic antidepressants, SNRIs)
  • Interventional pain management (e.g., nerve blocks, spinal cord stimulation)
  • Physical therapy and rehabilitation
  • Cognitive behavioral therapy and other psychological interventions
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Cost & Coverage

Average Cost: $100 - $500+ per 30 capsules (75mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 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 an overdose is suspected, 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.