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Morphine Sul 30mg ER Tabs (12h)

Manufacturer MALLINCKRODT Active Ingredient Morphine Extended-Release Tablets(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. 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 (single dose/short-term), Category D (prolonged use/high doses at term)
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FDA Approved
May 1987
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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 used for severe, ongoing pain that needs around-the-clock treatment, not for pain that comes and goes. Because it's extended-release, it slowly releases the medicine over many hours.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines below.

Take this medication by mouth only, with or without food. If it causes stomach upset, take it with food to help minimize discomfort.
 Do not inject or snort this medication, as this can lead to severe side effects, including respiratory problems and overdose, which can be fatal.
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 potentially be fatal.
This medication is not intended for fast pain relief or for use on an as-needed basis. Additionally, it should not be used for post-surgical pain relief if you have not previously been taking similar medications.
 If your prescribed dose is more than one tablet, take one tablet at a time. Avoid licking or wetting the tablet before placing it in your mouth. Swallow the tablet with a generous amount of water immediately after putting it in your mouth.
If you experience difficulty swallowing, consult your doctor for guidance.
 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 in a dry place. Avoid storing it in a bathroom.
 Keep your medication in a secure location where children cannot see or access it, and where others cannot easily obtain it. Consider using a locked box or secure area to safeguard your medication.
Keep all medications out of reach of 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 to compensate for the missed dose.
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Lifestyle & Tips

  • Do not drink alcohol while taking this medication, as it can increase the risk of serious side effects like breathing problems.
  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and use stool softeners/laxatives as recommended 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 tablets, as this can lead to 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: Not recommended. For patients converting from other opioids or immediate-release morphine: Individualized based on prior opioid use and pain severity. Typical starting dose for conversion is 15 mg every 8-12 hours, adjusted as needed.
Dose Range: 15 - 200 mg

Condition-Specific Dosing:

chronic_severe_pain: Administer every 8 or 12 hours, depending on the specific product formulation (e.g., MS Contin is 12h, Kadian/Avinza can be 24h). Titrate slowly to effect, monitoring for adverse events.
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Pediatric Dosing

Neonatal: Not established (contraindicated due to risk of respiratory depression and neonatal opioid withdrawal syndrome).
Infant: Not established (contraindicated).
Child: Not established (contraindicated for opioid-naive children; use in opioid-tolerant children requires extreme caution and specialized expertise, generally not recommended for routine use).
Adolescent: Not established (contraindicated for opioid-naive adolescents; use in opioid-tolerant adolescents requires extreme caution and specialized expertise, generally not recommended for routine use).
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; consider dose reduction and extended dosing interval.
Moderate: Significant dose reduction (e.g., 50%) and/or extended dosing interval (e.g., every 12-24 hours) recommended due to accumulation of active metabolite (morphine-6-glucuronide).
Severe: Contraindicated or extreme caution with significant dose reduction (e.g., 75%) and extended dosing interval (e.g., every 24-48 hours). Close monitoring for respiratory depression and sedation is essential.
Dialysis: Morphine and its metabolites are dialyzable. Administer after dialysis. Significant dose reduction and extended intervals are necessary.

Hepatic Impairment:

Mild: Use with caution; consider dose reduction.
Moderate: Significant dose reduction (e.g., 50%) and/or extended dosing interval recommended due to reduced clearance.
Severe: Contraindicated or extreme caution with significant dose reduction (e.g., 75%) and extended dosing interval. Close monitoring for respiratory depression and sedation is essential.

Pharmacology

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Mechanism of Action

Morphine is a full opioid agonist that acts primarily at the mu-opioid receptor, but also has affinity for kappa and delta opioid receptors. Its analgesic effects are mediated by binding to these receptors in the central nervous system (CNS), leading to inhibition of pain transmission, alteration of pain perception, and induction of euphoria.
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Pharmacokinetics

Absorption:

Bioavailability: 20-40% (oral, due to significant first-pass metabolism)
Tmax: 2-4 hours (extended-release formulations)
FoodEffect: Food may increase the rate and extent of absorption for some ER formulations (e.g., MS Contin), leading to higher peak concentrations. Should be taken consistently with or without food.

Distribution:

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

Elimination:

HalfLife: 2-4 hours (parent drug, but ER formulations provide sustained release over 8-24 hours); M6G half-life is longer, especially in renal impairment.
Clearance: 15-30 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10% (in urine)
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Pharmacodynamics

OnsetOfAction: Not applicable for ER formulation for acute pain relief. For sustained analgesia, onset of steady-state effect is achieved after several doses.
PeakEffect: 4-8 hours (for sustained analgesia with ER formulations)
DurationOfAction: 8-12 hours (for 12-hour formulations), up to 24 hours (for 24-hour formulations)

Safety & Warnings

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BLACK BOX WARNING

ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION (for some formulations, but generally applicable to opioids); 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 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
+ 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
+ Rapid 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, which 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 or 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 mild ones, it's essential to be aware of the following potential side effects:

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 symptoms that concern you, contact your doctor for guidance. Not all side effects are listed here, so if you have questions or concerns, don't hesitate to reach out to your doctor.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
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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
  • Severe constipation or inability to have a bowel movement
  • Signs of an allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
  • Signs of serotonin syndrome (agitation, hallucinations, fast heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea)
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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 you determine the safety of taking 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 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 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, regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking this medication, consult your doctor to avoid withdrawal or other severe problems. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

Tablet Shell in Stool
For certain brands of this medication, you may notice the tablet shell in your stool. This is a normal occurrence 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 it may lead to unsafe and potentially fatal effects.

Seizure Risk
This medication may increase the risk of seizures in some individuals, including 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 Precautions 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
Certain brands of this medication may be more likely to cause choking, gagging, or swallowing difficulties. 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
  • Slowed or stopped breathing (respiratory depression)
  • Extreme drowsiness or unresponsiveness
  • Limp muscles
  • Cold, clammy skin
  • Bluish discoloration of lips and fingernails (cyanosis)
  • Loss of consciousness
  • Coma

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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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, MAOIs, mirtazapine, tramadol, fentanyl): Risk of serotonin syndrome.
  • Mixed agonist/antagonist opioids (e.g., butorphanol, nalbuphine, pentazocine): May reduce the analgesic effect of morphine and/or precipitate withdrawal symptoms.
  • MAOIs: Concomitant use or within 14 days of MAOI discontinuation is contraindicated due to potential for severe, unpredictable reactions including serotonin syndrome or respiratory depression.
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Moderate Interactions

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

  • Antihypertensives: May cause additive hypotensive effects.

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 risk of respiratory depression.

Timing: Prior to initiation of therapy

Level of consciousness/sedation

Rationale: To assess baseline neurological status and risk of excessive sedation.

Timing: Prior to initiation of therapy

Bowel function

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

Timing: Prior to initiation of therapy

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

Rationale: To identify potential impairment requiring 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 dose; at least daily during stable therapy.

Target: Acceptable pain control with minimal 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); periodically during stable therapy (e.g., daily).

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

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

Level of consciousness/sedation

Frequency: Frequently during initiation and titration; periodically during stable therapy.

Target: Alert, easily aroused.

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

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) requires intervention (e.g., laxatives).

Signs of opioid abuse, misuse, or addiction

Frequency: At every visit

Target: Absence of aberrant drug-related behaviors.

Action Threshold: Presence of such signs requires reassessment of therapy and potential referral.

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • 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, hyperthermia, rapid blood pressure changes, hyperreflexia, incoordination, nausea, vomiting, diarrhea)

Special Patient Groups

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Pregnancy

Use during pregnancy is generally not recommended, especially prolonged use or near term, due to risks of neonatal opioid withdrawal syndrome (NOWS) and respiratory depression in the neonate. Category C for single dose/short-term, Category D for prolonged use/high doses at term.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations cannot be entirely ruled out, though not consistently demonstrated.
Second Trimester: Risk of NOWS increases with prolonged exposure. Fetal growth restriction may occur.
Third Trimester: High risk of NOWS if used chronically. Risk of respiratory depression in the neonate if used near term. Prolonged labor may occur.
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Lactation

Morphine is excreted into breast milk. While generally considered compatible with caution for single doses, chronic use is not recommended due to potential for infant sedation, respiratory depression, and withdrawal symptoms upon discontinuation. Monitor infants for increased sleepiness, difficulty breathing, or limpness.

Infant Risk: L3 (Moderate risk). Monitor for sedation, poor feeding, respiratory depression, and withdrawal symptoms.
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Pediatric Use

Morphine extended-release is generally not recommended for use in opioid-naive pediatric patients due to the risk of respiratory depression. Use in opioid-tolerant pediatric patients requires extreme caution, specialized expertise, and careful titration. Not for acute pain.

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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 adverse effects, especially respiratory and CNS depression. Renal and hepatic impairment are more common in the elderly, requiring dose adjustments.

Clinical Information

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Clinical Pearls

  • Morphine ER is for chronic, severe pain requiring continuous, around-the-clock opioid analgesia, not for PRN use or acute pain.
  • Do not crush, chew, or dissolve ER tablets; this can lead to rapid release of a potentially fatal dose.
  • Patients should be stable on immediate-release opioids before converting to ER morphine to establish opioid tolerance.
  • Always have naloxone readily available for patients at high risk of overdose (e.g., those on high doses, concomitant CNS depressants, or with respiratory compromise).
  • Aggressively manage opioid-induced constipation with prophylactic bowel regimens.
  • Educate patients and caregivers on safe storage and disposal to prevent accidental ingestion, especially by children.
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Alternative Therapies

  • Other extended-release opioid analgesics (e.g., oxycodone ER, hydromorphone ER, fentanyl transdermal, tapentadol ER, oxymorphone 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: $50 - $300+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often requires prior authorization)
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General Drug Facts

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

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

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