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Morphine Sul 20mg 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
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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 is a strong pain medicine (an opioid) that works in your brain and nervous system to change how your body feels and responds to pain. The 'extended-release' part means it's designed to release the medicine slowly over 24 hours, so you only take it once a day for continuous pain relief. It's used for severe, ongoing pain that needs around-the-clock treatment and can't be managed by other 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 the information provided below.

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 lead to severe side effects, including trouble breathing and death from overdose.
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.

Special Administration Instructions

Do not use this medication for fast pain relief or on an as-needed basis.
 If you have not been taking medications like this one, do not use it for pain relief after surgery.
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 contents have been swallowed.
 Certain brands of this medication may be administered through a specific type of feeding tube, while others should not be given through a feeding tube. Consult your pharmacist to determine if your brand can be given through a feeding tube.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
 Keep your medication in a safe and secure location, out of the reach of children and pets, and inaccessible to others. Consider using a locked box or area to store your medication.

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 dangerous side effects, including severe drowsiness and breathing problems.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • 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 rapid release of a potentially fatal dose.
  • Discuss all other medications, including over-the-counter drugs, herbal supplements, and illicit drugs, with your doctor to avoid dangerous interactions.
  • Maintain adequate hydration and fiber intake, and use stool softeners/laxatives as directed to prevent constipation.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose for opioid-naïve patients: 15 mg or 30 mg orally every 24 hours. For opioid-tolerant patients, convert from previous opioid regimen.
Dose Range: 15 - 1600 mg

Condition-Specific Dosing:

opioid_naïve: Initial: 15 mg or 30 mg orally every 24 hours. Titrate slowly, no more frequently than every 3-4 days.
opioid_tolerant_conversion: Calculate total daily oral morphine equivalent (OME) of current opioid. Administer the calculated OME as morphine extended-release once daily. Reduce initial dose by 25-50% to account for incomplete cross-tolerance. Titrate based on patient response and tolerability.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not generally recommended for routine use due to lack of established safety and efficacy for all age groups and high risk of respiratory depression. Use only in highly specialized settings for severe chronic pain, with extreme caution and individualized titration.
Adolescent: Not generally recommended for routine use due to lack of established safety and efficacy for all age groups and high risk of respiratory depression. Use only in highly specialized settings for severe chronic pain, with extreme caution and individualized titration.
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Dose Adjustments

Renal Impairment:

Mild: Monitor closely for increased effects; dose adjustment may be needed.
Moderate: Reduce initial dose by 50% and titrate cautiously. Monitor for increased effects and adverse reactions.
Severe: Reduce initial dose by 75% or more and titrate cautiously. Avoid if possible. Monitor for increased effects and adverse reactions.
Dialysis: Morphine and its active metabolites are partially dialyzable. Administer after dialysis. Significant dose reduction and close monitoring are required.

Hepatic Impairment:

Mild: Monitor closely for increased effects; dose adjustment may be needed.
Moderate: Reduce initial dose by 50% and titrate cautiously. Monitor for increased effects and adverse reactions.
Severe: Reduce initial dose by 75% or more and titrate cautiously. Avoid if possible. Monitor for increased effects and adverse reactions.

Pharmacology

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Mechanism of Action

Morphine is an opioid agonist. It acts primarily as an agonist at the mu-opioid receptors in the central nervous system (CNS), peripheral tissues, and gastrointestinal tract. 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: Variable (20-40% for oral immediate-release; extended-release formulations may have different relative bioavailability but overall oral bioavailability is low due to first-pass metabolism)
Tmax: Approximately 6-12 hours for extended-release capsules (e.g., Kadian)
FoodEffect: Food may increase the rate and extent of absorption for some extended-release formulations; consult specific product labeling.

Distribution:

Vd: Approximately 3-5 L/kg
ProteinBinding: Approximately 20-35%
CnssPenetration: Yes

Elimination:

HalfLife: Terminal half-life of morphine is 2-4 hours (for IR); for ER formulations, the effective half-life for sustained release is longer, allowing once-daily dosing.
Clearance: Approximately 15-30 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: Less than 10% (renal)
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Pharmacodynamics

OnsetOfAction: Not applicable for ER formulation for acute pain relief. For steady-state, analgesic effects are sustained over 24 hours.
PeakEffect: Approximately 6-12 hours for extended-release capsules (e.g., Kadian)
DurationOfAction: 24 hours

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 (Note: Morphine is not a primary CYP3A4 substrate, but this warning is common for opioids and may apply to specific formulations or co-administered drugs); RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
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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
+ Difficulty 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 or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
 Chest pain or pressure, or a rapid heartbeat
Confusion
 Breathing difficulties, including:
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Seizures
 Severe constipation or stomach pain, which may indicate a 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
+ Balance problems
+ Confusion
+ Hallucinations
+ Fever
+ Rapid or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, nausea, or vomiting
+ Severe headache
Adrenal gland problems, which may occur with long-term opioid use. Symptoms include:
+ Extreme fatigue or weakness
+ Fainting
+ Severe dizziness
+ Nausea and vomiting
+ Decreased appetite
 Hormonal changes, which may occur with long-term opioid use. Symptoms include:
+ Decreased sex drive
+ Fertility problems
+ Irregular menstrual periods
+ Ejaculation problems

Other Possible Side Effects

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 any other unusual symptoms, contact your doctor or seek medical attention if they persist or bother you.

Reporting Side Effects

If you have questions or concerns about side effects, consult your doctor. 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 inability to wake up
  • Dizziness or lightheadedness when standing up
  • Confusion or disorientation
  • Pinpoint pupils
  • Cold, clammy skin
  • Blue lips or fingernails
  • Severe constipation or abdominal pain
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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, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
 If you are currently taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
* If you are breastfeeding, as you should not breastfeed while taking this medication

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dose 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 tasks that require alertness. 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 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 lower your 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 products containing alcohol while taking this medication, as this can 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
  • Respiratory depression (slowed or stopped breathing)
  • Extreme drowsiness or sedation
  • Limp muscles
  • Cold, clammy skin
  • Loss of consciousness
  • Coma
  • 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. Call 1-800-222-1222 (Poison Control Center) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome, severe respiratory depression, coma, 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

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, alcohol): 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, tricyclic antidepressants): Increased risk of urinary retention and severe constipation/paralytic ileus.
  • Mixed agonist/antagonist and partial agonist opioids (e.g., butorphanol, nalbuphine, pentazocine, buprenorphine): May precipitate withdrawal symptoms or reduce analgesic effect.
  • Diuretics: Opioids may reduce the efficacy of diuretics by causing the release of antidiuretic hormone.
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Moderate Interactions

  • CYP3A4 inhibitors/inducers (morphine is not primarily metabolized by CYP3A4, but some formulations or other opioids may be, leading to complex interactions if switching or co-administering).
  • P-glycoprotein (P-gp) inhibitors (e.g., quinidine, verapamil): May increase morphine exposure.
  • Cimetidine: May inhibit morphine metabolism, increasing plasma concentrations.
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Minor Interactions

  • Not specifically identified for minor interactions with significant clinical impact for morphine ER.

Monitoring

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Baseline Monitoring

Pain assessment (intensity, character, location, duration)

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 neurological status and identify risk for excessive sedation.

Timing: Prior to initiation of therapy

Bowel function

Rationale: To assess baseline bowel habits 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 potential need for dose adjustment in patients with organ impairment.

Timing: Prior to initiation of therapy

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Routine Monitoring

Pain assessment

Frequency: Regularly, at least daily during titration, then periodically (e.g., weekly to monthly) once stable.

Target: Acceptable pain control with tolerable side effects.

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

Respiratory rate and depth

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

Target: Typically >10-12 breaths/min, regular rhythm, adequate depth.

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

Level of consciousness/sedation

Frequency: Frequently during initiation and titration, then periodically.

Target: Alert and oriented, or easily arousable.

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

Bowel function

Frequency: Daily

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

Action Threshold: Constipation (e.g., no bowel movement for >3 days) requires intervention (laxatives, stool softeners, etc.).

Signs of opioid-induced hyperalgesia or tolerance

Frequency: Periodically, especially with dose escalation or prolonged use.

Target: Not applicable

Action Threshold: Increased pain despite dose escalation, or pain in new areas, may indicate hyperalgesia and require re-evaluation of therapy.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS).

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations cannot be ruled out. Risk of NOWS if continued.
Second Trimester: Risk of NOWS if prolonged use. Fetal growth restriction and preterm birth have been reported.
Third Trimester: High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. 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 the risk of serious adverse reactions in breastfed infants, including sedation, respiratory depression, and withdrawal symptoms. If use is unavoidable, monitor the infant closely for signs of sedation and respiratory depression.

Infant Risk: Risk L3 (Moderate risk). Monitor for drowsiness, difficulty breathing, poor feeding, and developmental delay.
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Pediatric Use

Safety and effectiveness of morphine extended-release capsules have not been established in pediatric patients. Use is generally not recommended due to the risk of respiratory depression and lack of established dosing guidelines for most pediatric populations. If used in highly specialized settings for severe chronic pain, extreme caution, individualized titration, and close monitoring are essential.

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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 around-the-clock, continuous pain management, not for as-needed (PRN) pain relief or acute pain.
  • Do NOT crush, chew, or dissolve the capsules. This can lead to rapid release of a potentially fatal dose of morphine.
  • Always start opioid-naïve patients on the lowest effective dose and titrate slowly to minimize adverse effects.
  • Opioid-induced constipation is a common and persistent side effect; proactive bowel regimen (stool softeners, laxatives) should be initiated concurrently with opioid therapy.
  • Educate patients and caregivers on the signs of respiratory depression and the importance of having naloxone readily available.
  • Due to the risk of addiction, abuse, and misuse, assess patient risk factors before prescribing and monitor throughout therapy.
  • Taper slowly when discontinuing to avoid opioid withdrawal symptoms.
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Alternative Therapies

  • Other extended-release opioid analgesics (e.g., oxycodone ER, hydromorphone ER, fentanyl transdermal)
  • Other strong opioid analgesics (e.g., oxycodone IR, hydromorphone IR, oxymorphone IR)
  • Non-opioid analgesics for chronic pain (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants, SNRIs)
  • Non-pharmacological pain management (e.g., physical therapy, occupational therapy, cognitive behavioral therapy, acupuncture, massage, interventional pain procedures)
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Cost & Coverage

Average Cost: Highly variable, typically $100 - $500+ per 30 capsules (20mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (often requires prior authorization or step therapy due to opioid class)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information for patients. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.