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Morphine Sul 10mg 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
Not available
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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's designed to work for 24 hours with one dose.
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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.
 Do not inject or snort this medication, as this can cause severe side effects, including trouble breathing and death from overdose.
Take this medication at the same time every day. Swallow the tablet whole; do not chew, break, crush, or dissolve it before swallowing, as this can also cause severe side effects and death.

Important Usage Guidelines

 Do not use this medication for fast pain relief or on an as-needed basis.
Do not use this medication 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 on 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 may be given through a specific type of feeding tube, while others should not be. Check with your pharmacist to determine if your medication can be administered through a feeding tube.

Storing and Disposing of Your Medication

Store this medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
 Keep this medication in a safe place, out of the reach of children and pets, and where others cannot access it. Consider using a locked box or secure 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.
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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.
  • To prevent constipation, increase fluid intake, eat fiber-rich foods, and use a stool softener or laxative as directed by your doctor.
  • Store this medication 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.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose for opioid-naive patients: 15 mg orally every 24 hours. For opioid-tolerant patients, convert from previous opioid regimen.
Dose Range: 15 - 1600 mg

Condition-Specific Dosing:

opioidNaive: Initial dose: 15 mg orally every 24 hours. Titrate slowly, no more frequently than every 3-4 days, in increments of 15-30 mg.
opioidTolerantConversion: Refer to product-specific conversion tables from other opioids. Generally, calculate 24-hour oral morphine equivalent and administer once daily. Reduce 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% or extend dosing interval. Titrate slowly.
Severe: Avoid use if possible. If necessary, reduce initial dose by 75% or more and extend dosing interval. Monitor closely for respiratory depression and sedation.
Dialysis: Morphine and its active metabolites are dialyzable. Administer after dialysis. Significant dose reduction and extended interval required. Monitor closely.

Hepatic Impairment:

Mild: Use with caution. Monitor for increased adverse effects.
Moderate: Reduce initial dose by 50%. Titrate slowly.
Severe: Reduce initial dose by 75% or more. Monitor closely for respiratory depression and sedation.

Pharmacology

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Mechanism of Action

Morphine is a full opioid agonist that acts primarily on the mu-opioid receptors in the central nervous system (CNS). Its analgesic effects are mediated by binding to these receptors, leading to inhibition of ascending pain pathways, altering the perception of and emotional response to pain. It also produces respiratory depression, miosis, euphoria, and physical dependence.
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Pharmacokinetics

Absorption:

Bioavailability: 20-40% (oral, due to significant first-pass metabolism)
Tmax: Approximately 3-4 hours (for ER capsules)
FoodEffect: Food may increase the rate and extent of absorption, but the clinical significance is generally not considered to be dose-limiting for ER formulations. Should be taken consistently with or without food.

Distribution:

Vd: Approximately 3-5 L/kg
ProteinBinding: Approximately 30-35%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 2-4 hours (for immediate release); 8-12 hours (apparent half-life for ER due to sustained release)
Clearance: Approximately 15-30 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Approximately 1-2 hours (for ER capsules)
PeakEffect: Approximately 3-6 hours (for ER capsules)
DurationOfAction: 24 hours (for ER capsules)
Confidence: High

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; 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 immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ 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
Burning, numbness, or tingling sensations that are not normal

Serotonin Syndrome: A Potentially Life-Threatening Condition

If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a severe and potentially deadly condition. 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
 Excessive sweating
Severe diarrhea, upset stomach, or vomiting
 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 right away if you:

Feel extremely tired or weak
 Pass out
Experience severe dizziness
 Have a severely upset stomach
Vomit
 Have 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:

Decreased 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, vomiting, or decreased appetite
 Headache
Anxiety
 Excessive sweating

If any of these side effects or other symptoms bother you or do not go away, contact your doctor or seek medical help. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Slow or shallow breathing
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness when standing up
  • Confusion or disorientation
  • Blue lips or fingernails
  • Severe constipation or inability to have a bowel movement
  • Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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Before Using This Medicine

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

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
 Certain health conditions, such as:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Recent use of 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
 Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
* If you are breastfeeding, as you should not breastfeed while taking this medication

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

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

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and be cautious when climbing stairs.

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

Monitoring Your Pain
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, contact your doctor immediately. Do not exceed the prescribed dose.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses are needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not take more than the prescribed dose.

Additionally, long-term or regular use of opioid medications like this one may cause dependence. If you need to lower your dose or stop taking this medication, consult your doctor first, as suddenly stopping or reducing the dose 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. Avoid consuming alcohol or using products that contain alcohol, as this may lead to unsafe and potentially fatal effects.

Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.

Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
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Overdose Information

Overdose Symptoms:

  • Pinpoint pupils
  • Slowed or stopped breathing
  • Extreme drowsiness or unresponsiveness
  • Limp muscles
  • Cold, clammy skin
  • Loss of consciousness
  • Blue discoloration of lips or fingernails

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 Center) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Concomitant use with alcohol (risk of dose dumping)
  • 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)
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Major Interactions

  • Other CNS depressants (e.g., sedatives, hypnotics, anxiolytics, general anesthetics, phenothiazines, other opioids, tricyclic antidepressants, muscle relaxants, gabapentinoids): 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., butorphanol, nalbuphine, pentazocine): May reduce analgesic effect and/or precipitate withdrawal symptoms.
  • Monoamine Oxidase Inhibitors (MAOIs): Potentiation of opioid effects (respiratory depression, hypotension, profound sedation, coma). Do not use within 14 days of MAOI discontinuation.
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Moderate Interactions

  • Anticholinergic drugs (e.g., atropine, scopolamine): Increased risk of urinary retention and/or severe constipation.
  • Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
  • P-glycoprotein (P-gp) inhibitors (e.g., quinidine, verapamil, amiodarone): May increase morphine exposure.
  • P-glycoprotein (P-gp) inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease morphine exposure.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pain assessment (intensity, character, location)

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

Timing: Prior to initiation of therapy

Respiratory rate and depth

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

Timing: Prior to initiation of therapy

Sedation level

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

Timing: Prior to initiation of therapy

Bowel function

Rationale: To assess baseline bowel habits and anticipate opioid-induced constipation.

Timing: Prior to initiation of therapy

Renal and hepatic function tests (e.g., BUN, creatinine, 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 condition (e.g., daily or as needed)

Target: Acceptable pain control with tolerable side effects

Action Threshold: Uncontrolled pain or unacceptable side effects

Respiratory rate and depth

Frequency: Regularly, especially during initiation and dose titration (e.g., daily or as needed)

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

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

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

Frequency: Regularly, especially during initiation and dose titration (e.g., daily or as needed)

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 (e.g., no bowel movement for >3 days)

Signs of opioid abuse, misuse, or addiction

Frequency: Periodically, at each visit

Target: Not applicable

Action Threshold: Any signs of aberrant drug-taking behavior

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing, cyanosis)
  • Excessive sedation/somnolence
  • Dizziness, lightheadedness
  • Nausea, vomiting
  • Constipation
  • Pruritus
  • Urinary retention
  • Signs of opioid withdrawal (if abruptly 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 the risk of neonatal opioid withdrawal syndrome (NOWS) and potential for respiratory depression in the neonate. Benefits must outweigh risks.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations cannot be ruled out. Avoid if possible.
Second Trimester: Risk of NOWS increases with prolonged use. Monitor for fetal growth restriction.
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. Use is generally not recommended due to potential for serious adverse reactions in the breastfed infant (e.g., sedation, respiratory depression). If use is necessary, monitor infant closely for signs of sedation and respiratory depression. Consider alternative analgesics.

Infant Risk: High (L3 - Moderately Safe, but significant risk of adverse effects in infant)
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Not recommended for use in children.

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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 capsules are for opioid-tolerant patients or opioid-naive patients requiring around-the-clock pain management. They are NOT for as-needed (PRN) pain relief.
  • Do not crush, chew, or dissolve the capsules. This can lead to rapid release of a potentially fatal dose.
  • Patients should be educated on the risks of addiction, abuse, and misuse, and proper storage and disposal.
  • Always have naloxone readily available for patients at high risk of overdose (e.g., those on high doses, or with concomitant CNS depressant use).
  • Opioid-induced constipation is a common and persistent side effect; prophylactic bowel regimen should be initiated concurrently with opioid therapy.
  • Careful titration is essential, especially in opioid-naive, elderly, or renally/hepatically impaired patients.
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Alternative Therapies

  • Other strong opioid analgesics (e.g., hydromorphone, oxycodone, fentanyl, oxymorphone)
  • Non-opioid analgesics for less severe pain (e.g., NSAIDs, acetaminophen)
  • Adjuvant analgesics (e.g., gabapentin, pregabalin for neuropathic pain; antidepressants)
  • Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: Varies widely, e.g., $50-$200+ per 30 capsules (10mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (generic); Tier 3 or 4 (brand)
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General Drug Facts

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

This medication is accompanied by a Medication Guide, which is 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 it. 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.