Morphine Sul 50mg ER Caps(24h)

Manufacturer UPSHER-SMITH 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 C (older classification, risk cannot be ruled out); FDA has moved to narrative system, stating risk of neonatal opioid withdrawal syndrome.
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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 is a strong pain medicine (an opioid) that works in your brain to change how your body feels and responds to pain. It's designed to release slowly over 24 hours to provide continuous pain relief for severe, ongoing pain. It's only for people who are already used to taking opioid pain medicines.
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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 and read all the information provided. Take this medication by mouth only, with or without food. If it causes stomach upset, take it with food to help minimize discomfort.

Important Administration Instructions

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 maintain a consistent level in your system.
Swallow the medication whole; do not chew, break, crush, or dissolve it before swallowing, as this can also cause severe side effects and death.

Special Considerations

This medication is not intended for fast pain relief or for use on an as-needed basis.
If you are scheduled for surgery, do not use this medication for pain relief after the procedure unless you have been taking it regularly before surgery.

Alternative Administration Methods

If you have difficulty swallowing the medication whole, you may sprinkle the contents onto applesauce. If you choose this method, swallow the mixture immediately without chewing.
Rinse your mouth to ensure all the medication has been swallowed.
Certain brands of this medication can be administered through a specific type of feeding tube, while others cannot. Consult your pharmacist to determine if your brand can be given via a feeding tube.

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 secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area.
Keep all medications away from pets.

Missing a Dose

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

  • Do not drink alcohol while taking this medication, as it can cause a dangerous overdose.
  • Do not drive or operate 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.
  • Take this medication exactly as prescribed; do not crush, chew, or dissolve the capsules, as this can lead to a rapid release of the drug and a fatal overdose.
  • Discuss a bowel regimen with your doctor to prevent constipation, a common side effect.
  • Inform your doctor about all other medications you are taking, especially sedatives, tranquilizers, or other pain medications.
  • Do not stop taking this medication suddenly without consulting your doctor, as this can cause withdrawal symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: For opioid-tolerant patients, convert from previous opioid. Initial dose of extended-release morphine should be based on the patient's total daily oral morphine equivalent (OME) requirement. For 24-hour formulations, the total daily OME is given once daily.
Dose Range: 15 - 200 mg

Condition-Specific Dosing:

opioid_naive: Not recommended for opioid-naive patients due to risk of fatal respiratory depression. If used, initial dose should be very low (e.g., 15 mg every 24 hours) and titrated cautiously.
chronic_pain: Individualized titration to achieve adequate analgesia with acceptable side effects. Doses above 160 mg/day or 200 mg/day should be prescribed with caution and only for patients who have demonstrated tolerance to lower doses and require higher doses for pain control.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and efficacy of extended-release morphine in pediatric patients under 18 years of age have not been established. Use is generally not recommended.)
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Dose Adjustments

Renal Impairment:

Mild: Use with caution, consider dose reduction.
Moderate: Reduce initial dose by 50% and titrate cautiously. Monitor closely for respiratory depression and sedation.
Severe: Contraindicated or significantly reduced dose (e.g., 25% of usual dose) and extended dosing interval. Close monitoring is essential.
Dialysis: Morphine is dialyzable, but its active metabolite (M6G) is not. Avoid or use with extreme caution and significant dose reduction. Monitor closely for prolonged effects.

Hepatic Impairment:

Mild: Use with caution, consider dose reduction.
Moderate: Reduce initial dose by 50% and titrate cautiously. Monitor closely for respiratory depression and sedation.
Severe: Reduce initial dose by 75% or more and extend dosing interval. Close monitoring is essential due to impaired metabolism and increased bioavailability.

Pharmacology

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Mechanism of Action

Morphine is an opioid agonist. It acts primarily as an agonist at mu-opioid receptors in the central nervous system (CNS), including the brain, spinal cord, and peripheral tissues. Activation of these receptors leads to inhibition of pain transmission, resulting in analgesia. It also produces other effects such as respiratory depression, euphoria, sedation, and decreased gastrointestinal motility.
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Pharmacokinetics

Absorption:

Bioavailability: 20-40% (oral, highly variable due to first-pass metabolism)
Tmax: 3-12 hours (for extended-release formulations)
FoodEffect: Food may increase the extent of absorption (AUC) and peak plasma concentrations (Cmax) for some extended-release formulations. Consult specific product labeling.

Distribution:

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

Elimination:

HalfLife: 2-4 hours (parent drug, but effective half-life for ER formulations is longer due to sustained absorption)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Not applicable for ER (designed for sustained release)
PeakEffect: Not applicable for ER (designed for sustained release)
DurationOfAction: 24 hours (for 24-hour extended-release 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; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL. Morphine extended-release exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Life-threatening respiratory depression may occur. Accidental ingestion of even one dose can result in a fatal overdose. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome. Concomitant use with CYP3A4 inhibitors or discontinuation of CYP3A4 inducers may result in increased opioid plasma concentrations. Concomitant use with benzodiazepines or other CNS depressants may result in profound sedation, respiratory depression, coma, and death. Concomitant use with alcohol can result in an overdose 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 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 Potentially Life-Threatening Condition

If you take this medication with certain other drugs, you may be at risk for a severe and potentially deadly condition called serotonin syndrome. Seek medical help right away 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. Contact your doctor immediately if you:

Feel very tired or weak
Pass out
Experience severe dizziness
Have a very upset stomach, throwing up, or decreased appetite

Hormonal Changes: A Potential Long-Term Effect

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

Lowered interest in sex
Fertility problems
No menstrual period
Ejaculation problems

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following:

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

If any of these side effects bother you or do not go away, contact your doctor or seek medical attention. 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
  • 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 of face/tongue/throat, 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, 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 if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

Important Information to Share with Your Healthcare Team

Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Safety Precautions

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

Interactions and Contraindications

Do not take this medication with other strong pain medications or use a pain patch without first consulting your doctor. If you experience worsening pain, increased sensitivity to pain, or 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, regular use of opioid medications like this one can result in 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 adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.

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 life-threatening 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 loss of consciousness
  • Slowed or stopped breathing
  • Limp muscles
  • Cold, clammy skin
  • Blue discoloration of lips and fingernails
  • Slowed heart rate
  • Low blood pressure
  • Coma

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. If naloxone (Narcan) is available and you are trained to use it, administer it as directed. Stay with the person until emergency help arrives. Call 1-800-222-1222 (Poison Control) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Concomitant use with alcohol (risk of rapid release and fatal overdose)
  • Concomitant use with benzodiazepines or other CNS depressants in patients for whom alternative treatment options are inadequate (risk of profound sedation, respiratory depression, coma, and death)
  • 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, phenothiazines, other opioids): Increased risk of respiratory depression, hypotension, profound sedation, coma, and death.
  • Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of MAOI discontinuation can result in unpredictable, severe, or fatal reactions (e.g., serotonin syndrome, respiratory depression, coma).
  • Mixed Agonist/Antagonist Opioid Analgesics (e.g., butorphanol, nalbuphine, pentazocine): May reduce the analgesic effect of morphine and/or precipitate withdrawal symptoms.
  • CYP3A4 Inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors): May increase morphine plasma concentrations, leading to increased or prolonged opioid effects.
  • CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease morphine plasma concentrations, leading to reduced efficacy or withdrawal symptoms.
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Moderate Interactions

  • Anticholinergics (e.g., atropine, scopolamine): Increased risk of urinary retention and/or severe constipation.
  • Diuretics: Opioids may reduce the efficacy of diuretics by causing the release of antidiuretic hormone.
  • Antihypertensives: Increased hypotensive effects.
  • Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans): Increased risk of serotonin syndrome, especially with higher doses or in combination with other serotonergic agents.
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Minor Interactions

  • Not available (most interactions are clinically significant)

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 factors 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

Bowel function

Rationale: To assess baseline and plan for opioid-induced constipation prevention.

Timing: Prior to initiation of therapy

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

Rationale: To identify impairment that may require dose adjustment.

Timing: Prior to initiation of therapy

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Routine Monitoring

Pain assessment

Frequency: Regularly, especially during titration and with dose changes (e.g., daily to weekly initially, then monthly)

Target: Patient-specific, aiming for acceptable pain control with minimal side effects

Action Threshold: Inadequate pain control or unacceptable side effects warrant dose adjustment or alternative strategies.

Respiratory rate and depth

Frequency: Frequently during initiation and titration (e.g., every 1-2 hours initially), then periodically (e.g., daily) once stable.

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

Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation require immediate intervention (e.g., naloxone, respiratory support).

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

Frequency: Frequently during initiation and titration, then periodically.

Target: Alert or mildly drowsy, easily aroused

Action Threshold: Difficult to arouse, somnolent, or unarousable requires immediate intervention.

Bowel function

Frequency: Daily

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

Action Threshold: No bowel movement for 3 days or severe straining/discomfort requires intervention for opioid-induced constipation.

Signs of opioid abuse, misuse, or addiction

Frequency: Ongoing, at every patient encounter

Target: Absence of aberrant drug-related behaviors

Action Threshold: Evidence of diversion, dose escalation without clinical need, or other concerning behaviors requires reassessment of treatment plan and potential referral.

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation/drowsiness
  • Dizziness
  • Nausea/vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Confusion
  • Hypotension
  • Signs of opioid withdrawal (if abruptly discontinued)

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

Trimester-Specific Risks:

First Trimester: Potential for congenital malformations, though data are mixed and not definitively linked to morphine.
Second Trimester: Risk of NOWS increases with prolonged exposure.
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 in breast milk. While generally considered moderately safe (L3), monitor infants for signs of sedation, respiratory depression, poor feeding, and poor weight gain. Consider alternative analgesics or pump and dump if high doses are required.

Infant Risk: Risk of sedation, respiratory depression, constipation, and poor feeding in the breastfed infant. Risk is higher with higher maternal doses, prolonged use, or in preterm/neonatal infants.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Extended-release formulations are generally not recommended for use in children due to the risk of overdose and respiratory depression, especially in opioid-naive children.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Morphine ER is for opioid-tolerant patients only. Never use in opioid-naive patients unless specifically indicated and with extreme caution at very low doses.
  • Counsel patients extensively on the risks of addiction, abuse, misuse, and accidental ingestion, especially by children.
  • Emphasize the importance of not crushing, chewing, or dissolving the capsules to avoid dose dumping and fatal overdose.
  • Always co-prescribe a stimulant laxative and/or stool softener to prevent opioid-induced constipation.
  • Educate patients and caregivers on the signs of respiratory depression and the availability of naloxone.
  • Be aware of the significant drug interactions, especially with CNS depressants and alcohol.
  • Titrate doses slowly and individually based on pain relief and tolerability, not just pain scores.
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Alternative Therapies

  • Other extended-release opioid analgesics (e.g., oxycodone ER, hydromorphone ER, fentanyl transdermal, tapentadol ER)
  • Non-opioid analgesics for chronic pain (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, duloxetine, tricyclic antidepressants)
  • Interventional pain management (e.g., nerve blocks, spinal cord stimulation)
  • Physical therapy, occupational therapy, psychological therapies (e.g., CBT)
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Cost & Coverage

Average Cost: Varies widely, typically $100-$500+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often requires prior authorization and/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, 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 with your doctor or pharmacist how to obtain or use naloxone. 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.