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Morphine Sul 15mg ER Tabs (12h)

Manufacturer MALLINCKRODT 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
Not available
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FDA Approved
May 1995
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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. The 'extended-release' part means it's designed to release slowly over 12 hours to provide continuous pain relief, so you take it less often. It's used for severe, ongoing pain that needs around-the-clock treatment.
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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 to maintain a consistent routine.
 Swallow the tablet whole; do not chew, break, crush, or dissolve it before swallowing, as this can 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 your 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 plenty of water immediately after placing it in your mouth.
If you have trouble swallowing, consult your doctor for guidance.

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

Missing a Dose

If you miss a dose, skip it and return to your regular 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 increase the risk of serious side effects like extreme drowsiness and breathing problems.
  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and consider using a stool softener or laxative 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 and absorption of a potentially fatal dose of morphine.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized, typically 15 mg every 12 hours for opioid-naive patients, or based on conversion from other opioids.
Dose Range: 15 - 200 mg

Condition-Specific Dosing:

opioidNaive: Initial dose 15 mg every 12 hours. Titrate slowly.
conversionFromOtherOpioids: Calculate total daily oral morphine equivalent (TDOME) and divide by 2 for every 12-hour dosing. 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 (safety and efficacy not established for pediatric patients under 18 years of age)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor for increased effects.
Moderate: Reduce initial dose by 25-50%, extend dosing interval, and titrate cautiously. Monitor for increased sedation and respiratory depression.
Severe: Reduce initial dose by 50-75%, extend dosing interval, and titrate very cautiously. Avoid if possible. Monitor closely for accumulation of morphine and its active metabolite (morphine-6-glucuronide).
Dialysis: Morphine and its metabolites are dialyzable. Administer after dialysis. Significant dose reduction required. Monitor closely.

Hepatic Impairment:

Mild: No specific adjustment, monitor for increased effects.
Moderate: Reduce initial dose by 25-50% and titrate cautiously. Monitor for increased sedation and respiratory depression.
Severe: Reduce initial dose by 50-75% and titrate very cautiously. Avoid if possible. Monitor closely.

Pharmacology

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Mechanism of Action

Morphine is an opioid agonist that acts primarily at the mu-opioid receptors in the central nervous system (CNS) 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: 20-40% (oral, due to significant first-pass metabolism)
Tmax: 2-4 hours (for ER formulations)
FoodEffect: Food may increase absorption and Cmax, but generally does not significantly alter AUC for ER formulations. Administer consistently with or without food.

Distribution:

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

Elimination:

HalfLife: 2-4 hours (for immediate release); 8-12 hours (for extended release, reflecting release rate)
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; designed for sustained release.
PeakEffect: 4-8 hours (for ER formulation)
DurationOfAction: 12 hours (for ER formulation)

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; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. 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 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 can result in a fatal overdose. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome. Concomitant use with benzodiazepines or other CNS depressants may result in profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough medications in patients taking benzodiazepines or other CNS depressants. The concomitant use of morphine with all cytochrome P450 3A4 inhibitors may result in increased morphine plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in increased morphine plasma concentration. Monitor patients receiving morphine and any CYP3A4 inhibitor or inducer.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy 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
+ Nausea and 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

Most people experience few or no side effects while taking this medication. However, some individuals may encounter the following 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 advice. 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
  • Severe constipation or inability to have a bowel movement
  • Hives, rash, or itching (signs of allergic reaction)
  • Swelling of face, lips, tongue, or throat
  • Seizures
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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 blockage 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 if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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 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, get up slowly from a sitting or lying 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 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.

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 Interactions
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
  • Slowed or stopped breathing
  • Extreme drowsiness or unresponsiveness
  • Limp muscles
  • Cold, clammy skin
  • Bluish discoloration of lips and fingernails
  • Loss of consciousness

What to Do:

Seek immediate emergency medical attention. Call 911. 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

  • 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
  • Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOIs
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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, linezolid, St. John's Wort): Risk of serotonin syndrome.
  • Mixed agonist/antagonist and partial agonist opioids (e.g., butorphanol, nalbuphine, pentazocine, buprenorphine): May precipitate withdrawal symptoms or reduce analgesic effect.
  • CYP3A4 inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors): May increase morphine plasma concentrations, leading to increased opioid effects.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease morphine plasma concentrations, leading to reduced efficacy or withdrawal symptoms.
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Moderate Interactions

  • Anticholinergics (e.g., atropine, scopolamine): Increased risk of urinary retention and/or severe constipation.
  • Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
  • Antihypertensives: May cause additive hypotensive effects.
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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

Level of consciousness/sedation

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

Timing: Prior to initiation of therapy

Bowel function

Rationale: To assess baseline 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 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 condition (e.g., daily or as needed)

Target: Acceptable pain level as defined by patient

Action Threshold: Uncontrolled pain or adverse effects

Respiratory rate and depth

Frequency: Regularly, especially during initiation and dose titration (e.g., every 4-8 hours initially, then daily)

Target: Typically >10-12 breaths/min, unlabored

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoventilation

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

Frequency: Regularly, especially during initiation and dose titration (e.g., every 4-8 hours initially, then daily)

Target: Alert or mildly drowsy, easily aroused

Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolent)

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, straining, hard stools)

Signs of opioid-induced hyperalgesia

Frequency: Periodically, especially with high doses or long-term use

Target: Not applicable

Action Threshold: Worsening pain despite increasing opioid dose, or pain spreading to new areas

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • 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 preterm 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. Infants exposed to morphine through breast milk should be monitored for signs of sedation and respiratory depression. A single dose is generally considered low risk, but chronic use is not recommended due to potential for accumulation and adverse effects in the infant.

Infant Risk: L3 (Moderate risk) - Monitor for sedation, poor feeding, respiratory depression. Consider alternative or pump and dump if chronic use is necessary.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients under 18 years of age. Use is generally not recommended.

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, including 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 and require dose adjustments.

Clinical Information

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Clinical Pearls

  • Morphine ER is for around-the-clock pain management, not for as-needed (PRN) pain relief. Patients should have an immediate-release opioid available for breakthrough pain.
  • Do not crush, chew, or dissolve extended-release tablets. 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 of unused medication.
  • Opioid-induced constipation is a common and persistent side effect; a bowel regimen (stimulant laxative plus stool softener) should be initiated prophylactically.
  • Titrate dose slowly and carefully, especially in opioid-naive, elderly, or renally/hepatically impaired patients, to minimize adverse effects and achieve optimal pain control.
  • Always assess for signs of respiratory depression and excessive sedation, especially during initiation and dose escalation.
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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)
  • Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: Varies widely, e.g., $50 - $300+ per 30 tablets (15mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or higher (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, 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 essential 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 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.