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Morphine Sulf 100mg ER Tabs (12h)

Manufacturer MALLINCKRODT PHARM Active Ingredient Morphine Extended-Release Tablets(MOR feen) Pronunciation MOR-feen SUL-fayt
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. Make sure you have the right drug; there is more than one strength. A lower strength may not ease pain well enough. A higher strength could lead to accidental overdose and death.Certain strengths of this drug may only be used by people who have been taking drugs like this drug and are used to their effects. The use of these strengths by people who have not been taking drugs like this drug may cause very bad and sometimes deadly breathing problems. Talk with the doctor. @ COMMON USES: It is used to manage pain when daily pain treatment is needed for a long time. It is for use when non-opioid pain drugs do not treat your pain well enough or you cannot take them.
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Drug Class
Opioid analgesic
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Pharmacologic Class
Opioid agonist
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Pregnancy Category
C
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FDA Approved
Jan 1970
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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 that works in your brain to change how your body feels and responds to pain. It is designed to release slowly over 12 hours to provide continuous pain relief. It is only for severe, ongoing pain that needs around-the-clock treatment and is not for occasional or 'as needed' pain. Because it is a strong opioid, it carries serious risks, including addiction and breathing problems.
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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 breathing difficulties and overdose, which can be fatal.
Take your medication at the same time every day. Swallow the tablet whole, without chewing, breaking, crushing, or dissolving it. Altering the tablet in any way can cause severe side effects and death.
 Do not use this medication for quick pain relief or on an as-needed basis. Additionally, do not use it for pain relief after surgery if you have not been taking medications like this one.
If your prescribed dose is more than one tablet, take one tablet at a time. Do not lick or wet the tablet before putting it in your mouth. Swallow the tablet with a full glass of water immediately after placing it in your mouth.
 If you have difficulty swallowing, consult your doctor.
Do not administer this medication 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.
 Keep all medications away from pets.

Missing a 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.
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Lifestyle & Tips

  • Do not drink alcohol while taking this medication, as it can lead to dangerous side effects, including severe breathing problems and death.
  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
  • Store this medication securely, out of reach of children and pets, in a locked cabinet or safe. Accidental ingestion can be fatal.
  • Do not crush, chew, or dissolve the tablets, as this can lead to a rapid release of a potentially fatal dose of morphine.
  • Take this medication exactly as prescribed, typically every 12 hours. Do not take more than prescribed or take it more often.
  • Discuss a bowel regimen with your doctor to prevent or manage constipation, a common side effect.
  • Inform your doctor or pharmacist about all other medications you are taking, especially sedatives, tranquilizers, or other pain medications.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized, based on patient's prior opioid exposure and tolerance. Typically initiated with a low dose (e.g., 15-30 mg every 12 hours) for opioid-tolerant patients, then titrated.
Dose Range: 15 - 200 mg

Condition-Specific Dosing:

opioid_tolerant: Patients who have been taking, for 1 week or longer, at least 60 mg/day of oral morphine, 25 mcg/hour of transdermal fentanyl, 30 mg/day of oral oxycodone, 8 mg/day of oral hydromorphone, 25 mg/day of oral oxymorphone, or an equianalgesic dose of another opioid.
conversion_from_other_opioids: Use equianalgesic conversion tables carefully, reducing the calculated dose by 25-50% to account for incomplete cross-tolerance.
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Pediatric Dosing

Neonatal: Not established (contraindicated due to risk of respiratory depression)
Infant: Not established (contraindicated due to risk of respiratory depression)
Child: Not established (safety and efficacy not established for ER formulations)
Adolescent: Not established (safety and efficacy not established for ER formulations)
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Dose Adjustments

Renal Impairment:

Mild: Initiate with caution, consider lower starting dose and longer dosing interval.
Moderate: Reduce initial dose by 50% and/or extend dosing interval to every 18-24 hours. Monitor closely for adverse effects.
Severe: Contraindicated or use with extreme caution and significant dose reduction (e.g., 75% reduction) and extended interval (e.g., every 24 hours or longer). Accumulation of active metabolites (morphine-6-glucuronide) is significant.
Dialysis: Morphine and its metabolites are dialyzable to some extent, but accumulation can still occur. Avoid or use with extreme caution and significant dose reduction. Administer after dialysis.

Hepatic Impairment:

Mild: Initiate with caution, consider lower starting dose.
Moderate: Reduce initial dose by 25-50%. Monitor closely for adverse effects.
Severe: Reduce initial dose by 50-75%. Monitor closely for adverse effects. Accumulation of parent drug and metabolites may occur.

Pharmacology

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Mechanism of Action

Morphine is an opioid agonist, primarily acting at mu-opioid receptors in the central nervous system (CNS) and other tissues. 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 2-4 hours for extended-release formulations (range 1.5-12 hours depending on specific ER product)
FoodEffect: Food may increase the extent of absorption (AUC) and/or delay Tmax for some ER formulations. Refer to specific product labeling.

Distribution:

Vd: Approximately 3-5 L/kg
ProteinBinding: Approximately 20-35%
CnssPenetration: Yes (readily crosses blood-brain barrier)

Elimination:

HalfLife: Approximately 2-4 hours (for immediate-release morphine); for extended-release formulations, the effective half-life for maintaining therapeutic concentrations is longer, supporting 12-hour dosing.
Clearance: Approximately 15-30 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10% (renal)
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Pharmacodynamics

OnsetOfAction: Not applicable for ER formulation for acute pain relief; for steady-state analgesia, it takes several doses.
PeakEffect: Approximately 4-8 hours (for ER formulations)
DurationOfAction: Approximately 12 hours (for ER formulations)
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; and ALCOHOL INTERACTION. Morphine Sulfate Extended-Release Tablets 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 Morphine Sulfate Extended-Release Tablets, and monitor all patients regularly for the development of these behaviors and conditions. Serious, life-threatening, or fatal respiratory depression may occur. Accidental ingestion of even one dose of Morphine Sulfate Extended-Release Tablets, especially by children, can result in a fatal overdose. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Concomitant use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, 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 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 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
 Pain while urinating
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
+ Upset stomach
+ Vomiting
+ Decreased appetite
 Hormonal changes, which may occur with long-term opioid use. Symptoms include:
+ Decreased interest in sex
+ Fertility problems
+ Missed menstrual periods
+ 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 potential side effects:

Dizziness
 Drowsiness
Fatigue
 Weakness
Dry mouth
 Constipation
Diarrhea
 Stomach pain
Nausea
 Vomiting
Decreased appetite
 Headache
Anxiety
 Excessive sweating

If you experience any of these side effects or any other unusual symptoms, contact your doctor for guidance. They can help you determine the best course of action.

Reporting Side Effects

If you have questions or concerns about side effects, you can:

Contact your doctor for medical advice
 Report side effects to the FDA at 1-800-332-1088
* Submit a report 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 or disorientation
  • Severe constipation or abdominal pain
  • Signs of an 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. 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
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, 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

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 whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

Important Information About Your Medication

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

Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and other tasks that require your full attention. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, 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 can lead to tolerance, where the medication may not work as effectively, and you may require higher doses to achieve the same effect. If you experience this, 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 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.

Administration and Potential Side Effects
With certain brands of this medication, you may notice the tablet shell in your stool, which is normal and not a cause for concern. If you have questions, discuss them with your doctor.

Alcohol Interaction
Do not consume 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.

Swallowing Precautions
Some brands of this medication may pose a choking hazard or cause difficulty swallowing. To minimize this risk, take these products with a full glass of water. Consult your pharmacist to determine if your specific product requires a full glass of water.
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Overdose Information

Overdose Symptoms:

  • Pinpoint pupils
  • Extreme drowsiness or unresponsiveness
  • Slowed or stopped breathing (respiratory depression)
  • Bluish lips or fingernails (cyanosis)
  • Cold, clammy skin
  • Limp muscles
  • 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).

Drug Interactions

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Contraindicated Interactions

  • Concomitant use with benzodiazepines or other CNS depressants (unless benefits outweigh risks, then use lowest dose and shortest duration)
  • MAO inhibitors (within 14 days) - risk of serotonin syndrome or severe respiratory depression
  • Patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, or known or suspected paralytic ileus.
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Major Interactions

  • Other CNS depressants (e.g., sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol) - increased risk of profound sedation, respiratory depression, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol) - risk of serotonin syndrome.
  • Mixed agonist/antagonist opioids (e.g., butorphanol, nalbuphine, pentazocine) - may precipitate withdrawal symptoms or reduce analgesic effect.
  • Anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, antipsychotics, muscle relaxants) - increased risk of urinary retention and/or severe constipation.
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Moderate Interactions

  • Diuretics - opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
  • Antihypertensives - additive hypotensive effects.
  • Cimetidine - may inhibit morphine metabolism, increasing morphine levels.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pain assessment (intensity, quality, location)

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

Timing: Prior to initiation of therapy

Respiratory rate and depth

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

Timing: Prior to initiation of therapy

Level of consciousness/sedation

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

Timing: Prior to initiation of therapy

Renal and hepatic function tests (CrCl, LFTs)

Rationale: To identify impairment that may require dose adjustment.

Timing: Prior to initiation of therapy

Bowel function

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

Timing: Prior to initiation of therapy

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Routine Monitoring

Pain assessment

Frequency: Regularly, especially during titration and with any change in dose; at least daily once stable.

Target: Acceptable pain control with tolerable side effects.

Action Threshold: Inadequate pain control or excessive side effects warrant dose adjustment or re-evaluation.

Respiratory rate and depth

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

Target: Normal for patient, typically >10-12 breaths/min.

Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation (e.g., cyanosis, somnolence).

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

Frequency: Frequently during initiation and titration, then regularly 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: No bowel movement for >2-3 days, severe straining, or abdominal discomfort.

Signs of opioid misuse, abuse, or addiction

Frequency: Periodically and at each visit

Target: Adherence to prescribed regimen.

Action Threshold: Requests for early refills, lost/stolen prescriptions, multiple prescribers, escalating doses without clinical justification.

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing, cyanosis)
  • Excessive sedation/somnolence
  • Dizziness, lightheadedness
  • Nausea, vomiting
  • Constipation
  • Pruritus
  • Urinary retention
  • Confusion, disorientation
  • 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 (e.g., neural tube defects, cardiac defects) if used early in pregnancy, though data are mixed and causality not definitively established.
Second Trimester: Risk of fetal growth restriction and premature birth.
Third Trimester: High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Risk of respiratory depression in the neonate if used close to delivery.
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Lactation

Morphine is excreted into breast milk. While levels are generally low, infants, especially neonates, are highly susceptible to adverse effects. Monitor infants for signs of sedation, respiratory depression, and poor feeding. Use with caution, consider alternative analgesics, or advise against breastfeeding, especially for prolonged use or high doses.

Infant Risk: L3 (Moderate risk) - Potential for sedation, respiratory depression, poor feeding, and withdrawal symptoms in the infant. Risk is higher in preterm infants or those with respiratory compromise.
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Pediatric Use

Safety and efficacy of extended-release morphine have not been established in pediatric patients. Use is generally not recommended due to the risk of serious adverse events, including fatal respiratory depression, especially in opioid-naïve children. Accidental ingestion by children is a significant risk.

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, including respiratory depression, sedation, and constipation. Start with lower doses and titrate slowly. Monitor closely for CNS and respiratory depression. 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. Prescribing to opioid-naïve patients can result in fatal respiratory depression.
  • Do not crush, chew, or dissolve ER tablets. This destroys the extended-release mechanism and can lead to rapid absorption of a potentially fatal dose.
  • Always counsel patients on the risks of respiratory depression, sedation, and concomitant use with alcohol or other CNS depressants.
  • Proactive management of opioid-induced constipation is essential from the start of therapy.
  • Titrate dose slowly and carefully, monitoring for both pain relief and adverse effects. Steady-state concentrations are reached after 2-3 days of regular dosing.
  • Have naloxone readily available for patients at increased risk of overdose (e.g., those on high doses, concomitant CNS depressants, history of substance use disorder).
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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 techniques (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 $50 - $500+ per 30 tablets (100mg)
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 problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never 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 whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

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, to ensure you receive appropriate care.