Morphine Sul 60mg ER Tabs (12h)
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.
Drug Class
Opioid Analgesic
Pharmacologic Class
Opioid Agonist
Pregnancy Category
Not available
FDA Approved
May 1996
DEA Schedule
Schedule II
Overview
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 the medicine slowly over 12 hours, providing continuous pain relief. It's used for severe, ongoing pain that needs around-the-clock treatment, and it's not for pain that comes and goes or for immediate relief.
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 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, without chewing, breaking, crushing, or dissolving it. Altering the tablet in any way 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.
If you have not been taking medications like this one, do not use it for pain relief after surgery.
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 a full glass of water immediately after placing it in your mouth.
If you have trouble swallowing, consult your doctor for guidance.
Storage and Disposal
Store this medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Keep this 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.
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 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, without chewing, breaking, crushing, or dissolving it. Altering the tablet in any way 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.
If you have not been taking medications like this one, do not use it for pain relief after surgery.
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 a full glass of water immediately after placing it in your mouth.
If you have trouble swallowing, consult your doctor for guidance.
Storage and Disposal
Store this medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Keep this 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.
Lifestyle & Tips
- Do not crush, chew, or dissolve the tablet. This can cause a rapid release of a potentially fatal dose of morphine.
- Take exactly as prescribed, typically every 12 hours. Do not take more often than prescribed.
- Do not stop taking this medication suddenly without talking to your doctor, as this can cause withdrawal symptoms.
- Avoid alcohol and other sedating medications (e.g., benzodiazepines, sleeping pills) unless specifically approved by your doctor, as this can lead to dangerous breathing problems or extreme drowsiness.
- Be careful when driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Store this medication securely away from children and pets, as accidental ingestion can be fatal.
- Maintain a regular bowel regimen (e.g., fiber, fluids, stool softeners, laxatives) to prevent opioid-induced constipation.
Available Forms & Alternatives
Available Strengths:
- Morphine Sulf Rect 20mg Suppository
- Morphine Sul 10mg Rect Suppository
- Morphine Sulf Rect 30mg Suppository
- Morphine Sulf Rect 5mg Suppository
- Morphine Sul 15mg ER Tabs (12h)
- Morphine Sul 30mg ER Tabs (12h)
- Morphine Sul 60mg ER Tabs (12h)
- Morphine Sulf 100mg ER Tabs (12h)
- Morphine Sulf 200mg ER Tabs (12h)
- Morphine Sul 50mg/ml Inj , 20ml
- Morphine Sul 50mg/ml Inj, 50ml
- Morphine Sul 1mg/ml Inj 10ml
- Morphine Sul 30mg Imm Rel Tab
- Morphine Sul 15mg Imm Rel Tab
- Morphine Sul 10mg/5ml(2mg/ml) Sol
- Morphine Sul 20mg/5ml(4mg/ml) Sol
- Morphine Sulf 100mg/5ml(20mg/ml)sol
- Morphine Sul 10mg/ml Inj, 1ml
- Morphine Sul 10mg ER Caps (24h)
- Morphine Sul 30mg ER Caps (24h)
- Morphine Sul 60mg ER Caps (24h)
- Morphine Sul 45mg ER Caps (24h)
- Morphine Sul 75mg ER Caps (24h)
- Morphine Sul 90mg ER Caps (24h)
- Morphine Sulf 120mg ER Caps (24h)
- Morphine Sul 80mg ER Caps (24h)
- Morphine Sul 30mg ER Caps (24h)
- Morphine Sul 20mg ER Caps(24h)
- Morphine Sul 50mg ER Caps(24h)
- Morphine Sulf 100mg ER Caps (24h)
- Morphine Sul 4mg/ml Inj, 1ml
- Morphine Sulf 100mg/5ml(20mg/ml)sol
- Morphine Sulfate 2mg/ml Inj 1ml
- Morphine Sulf Inj 4mg/ml 1ml Syr
- Morphine Sul 2mg/ml Inj 1ml
- Morphine Sul 8mg/ml Inj, 1ml
- Morphine Sul 30mg ER Tabs
- Morphine Sulfate 4mg/ml Inj, 1ml
- Morphine Sulfate 10mg/ml Inj, 1ml
- Morphine Sul 0.5mg/ml Inj, 5ml
- Morphine Sul 8mg/ml Inj, 1ml Vial
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized, typically 15 mg to 200 mg every 12 hours for opioid-tolerant patients.
Dose Range:
15 - 200 mg
Condition-Specific Dosing:
opioidNaive:
Morphine ER is NOT for opioid-naive patients. Initial opioid therapy should be with immediate-release formulations.
conversionFromOtherOpioids:
Requires careful calculation of total daily oral morphine equivalent (TDOME) and reduction by 25-50% to account for incomplete cross-tolerance. Administer half of the calculated TDOME every 12 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
Monitor closely for increased effects. Consider dose reduction.
Moderate:
Reduce initial dose by 25-50%. Titrate cautiously. Monitor for respiratory depression and sedation.
Severe:
Reduce initial dose by 50-75%. Titrate very cautiously. Avoid if possible due to accumulation of morphine and active metabolites (M3G, M6G).
Dialysis:
Morphine is dialyzable, but metabolites are not. Administer after dialysis. Significant dose reduction required. Avoid if possible.
Hepatic Impairment:
Mild:
Monitor closely for increased effects. Consider dose reduction.
Moderate:
Reduce initial dose by 25-50%. Titrate cautiously. Monitor for respiratory depression and sedation.
Severe:
Reduce initial dose by 50-75%. Titrate very cautiously. Avoid if possible due to impaired metabolism and clearance.
Pharmacology
Mechanism of Action
Morphine is an opioid agonist primarily acting at the mu-opioid receptors in the central nervous system (CNS). It produces analgesia, respiratory depression, euphoria, and physical dependence. Its actions are mediated by binding to G-protein coupled receptors, leading to inhibition of adenylate cyclase, decreased intracellular cAMP, and modulation of ion channel activity (e.g., opening of potassium channels, closing of calcium channels), which hyperpolarizes neurons and inhibits neurotransmitter release.
Pharmacokinetics
Absorption:
Bioavailability:
20-40% (oral, due to significant first-pass metabolism)
Tmax:
3-4 hours (extended-release)
FoodEffect:
Food may increase absorption and Cmax, but the extent varies by formulation. Generally, ER formulations can be taken with or without food, but consistency is advised.
Distribution:
Vd:
3-4 L/kg
ProteinBinding:
30-35%
CnssPenetration:
Yes
Elimination:
HalfLife:
2-4 hours (parent drug); 3-5 hours (extended-release formulation apparent half-life); M6G has a longer half-life, especially in renal impairment.
Clearance:
Not available
ExcretionRoute:
Renal (primarily as glucuronide conjugates)
Unchanged:
Less than 10%
Pharmacodynamics
OnsetOfAction:
Not applicable for ER formulation (designed for sustained release, not rapid onset)
PeakEffect:
4-8 hours (extended-release)
DurationOfAction:
12 hours (extended-release)
Safety & Warnings
BLACK BOX WARNING
WARNING: 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.
ADDICTION, ABUSE, AND MISUSE: 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.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Extended-Release Tablets. Monitor for respiratory depression, especially during initiation of Morphine Sulfate Extended-Release Tablets or following a dose increase.
ACCIDENTAL INGESTION: Accidental ingestion of even one dose of Morphine Sulfate Extended-Release Tablets, especially by children, can result in a fatal overdose of morphine.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of Morphine Sulfate Extended-Release Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
CYTOCHROME P450 3A4 INTERACTION: The concomitant use of Morphine Sulfate Extended-Release Tablets with all cytochrome P450 3A4 inhibitors may result in increased plasma concentrations of morphine, 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 Sulfate Extended-Release Tablets and any CYP3A4 inhibitor or inducer.
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
ADDICTION, ABUSE, AND MISUSE: 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.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Extended-Release Tablets. Monitor for respiratory depression, especially during initiation of Morphine Sulfate Extended-Release Tablets or following a dose increase.
ACCIDENTAL INGESTION: Accidental ingestion of even one dose of Morphine Sulfate Extended-Release Tablets, especially by children, can result in a fatal overdose of morphine.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of Morphine Sulfate Extended-Release Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
CYTOCHROME P450 3A4 INTERACTION: The concomitant use of Morphine Sulfate Extended-Release Tablets with all cytochrome P450 3A4 inhibitors may result in increased plasma concentrations of morphine, 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 Sulfate Extended-Release Tablets and any CYP3A4 inhibitor or inducer.
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness or lightheadedness
+ Headache or feeling sleepy
+ Weakness, shaking, or a rapid heartbeat
+ Confusion, hunger, or sweating
Severe dizziness or fainting
Chest pain or pressure, or a rapid heartbeat
Confusion or disorientation
Breathing difficulties, such as:
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Seizures
Severe constipation or stomach pain, which may indicate a bowel problem
Depression or 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 or changes in balance
+ Confusion or hallucinations
+ Fever or rapid heartbeat
+ Flushing or muscle twitching
+ Seizures or shivering
+ Excessive sweating, diarrhea, or vomiting
+ Severe headache
Adrenal gland problems, which may occur with long-term opioid use. Symptoms include:
+ Extreme fatigue or weakness
+ Fainting or severe dizziness
+ Upset stomach, vomiting, or decreased appetite
Hormonal changes, which may occur with long-term opioid use. Symptoms include:
+ Decreased sex drive
+ Fertility problems
+ Irregular menstrual periods or ejaculation problems
Other Possible Side Effects
While many people may not experience side effects or may only have mild symptoms, it's essential to be aware of the following potential side effects:
Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Headache
Anxiety
Excessive sweating
If you experience any of these side effects or have concerns about other symptoms, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness or lightheadedness
+ Headache or feeling sleepy
+ Weakness, shaking, or a rapid heartbeat
+ Confusion, hunger, or sweating
Severe dizziness or fainting
Chest pain or pressure, or a rapid heartbeat
Confusion or disorientation
Breathing difficulties, such as:
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Seizures
Severe constipation or stomach pain, which may indicate a bowel problem
Depression or 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 or changes in balance
+ Confusion or hallucinations
+ Fever or rapid heartbeat
+ Flushing or muscle twitching
+ Seizures or shivering
+ Excessive sweating, diarrhea, or vomiting
+ Severe headache
Adrenal gland problems, which may occur with long-term opioid use. Symptoms include:
+ Extreme fatigue or weakness
+ Fainting or severe dizziness
+ Upset stomach, vomiting, or decreased appetite
Hormonal changes, which may occur with long-term opioid use. Symptoms include:
+ Decreased sex drive
+ Fertility problems
+ Irregular menstrual periods or ejaculation problems
Other Possible Side Effects
While many people may not experience side effects or may only have mild symptoms, it's essential to be aware of the following potential side effects:
Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Headache
Anxiety
Excessive sweating
If you experience any of these side effects or have concerns about other symptoms, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 abdominal pain
- Signs of an allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
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 the safety of taking this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting 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 the safety of taking this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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 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 can lead to tolerance, where the medication may not work as well, 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, long-term or 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 first, as sudden changes can increase the risk of withdrawal or other severe problems.
Potential Side Effects and Risks
Some brands of this medication may cause you to see the tablet shell in your stool, which is normal and not a cause for concern. However, if you have any questions or concerns, discuss them with your doctor. Do not consume alcohol or products containing alcohol while taking this medication, as it can lead to unsafe and potentially deadly effects. This medication may also 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.
Special Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Certain brands of this medication may be more likely to cause choking, gagging, or swallowing difficulties, and must be taken with a full glass of water. Consult your pharmacist to determine if your specific product requires a full glass of water.
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 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 can lead to tolerance, where the medication may not work as well, 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, long-term or 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 first, as sudden changes can increase the risk of withdrawal or other severe problems.
Potential Side Effects and Risks
Some brands of this medication may cause you to see the tablet shell in your stool, which is normal and not a cause for concern. However, if you have any questions or concerns, discuss them with your doctor. Do not consume alcohol or products containing alcohol while taking this medication, as it can lead to unsafe and potentially deadly effects. This medication may also 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.
Special Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Certain brands of this medication may be more likely to cause choking, gagging, or swallowing difficulties, and must be taken with a full glass of water. Consult your pharmacist to determine if your specific product requires a full glass of water.
Overdose Information
Overdose Symptoms:
- Pinpoint pupils
- Slow, shallow, or stopped breathing
- Extreme drowsiness or inability to wake up
- Limp body
- Cold, clammy skin
- Blue lips or fingernails
- Profound sedation or 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
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines): Increased risk of respiratory depression, profound sedation, coma, and death.
- Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of MAOI discontinuation can result in severe, unpredictable reactions including serotonin syndrome or opioid toxicity (CNS excitation, rigidity, hyperpyrexia, respiratory depression, circulatory collapse).
- Mixed Agonist/Antagonist Opioid Analgesics (e.g., butorphanol, nalbuphine, pentazocine): May reduce the analgesic effect of morphine and/or precipitate withdrawal symptoms.
Moderate Interactions
- Anticholinergics (e.g., tricyclic antidepressants, antihistamines, antipsychotics): Increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
- Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid): Increased risk of serotonin syndrome.
- Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
- CYP3A4 Inhibitors (e.g., clarithromycin, ketoconazole, ritonavir): May increase morphine plasma concentrations, leading to increased or prolonged opioid effects. (Note: Morphine is primarily metabolized by glucuronidation, not CYP3A4, but some formulations or other opioids may be affected).
- CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease morphine plasma concentrations, leading to reduced efficacy or withdrawal symptoms.
Minor Interactions
- Antihypertensives: May cause additive hypotensive effects.
Monitoring
Baseline Monitoring
Pain assessment (intensity, character, location)
Rationale: To establish baseline pain level and guide initial dosing.
Timing: Prior to initiation of therapy
Respiratory rate and depth
Rationale: To assess baseline respiratory function and identify risk for respiratory depression.
Timing: Prior to initiation of therapy
Sedation level (e.g., Pasero Opioid-Induced Sedation Scale)
Rationale: To assess baseline CNS depression and guide safe dosing.
Timing: Prior to initiation of therapy
Bowel function (frequency, consistency)
Rationale: To assess baseline and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy
Renal and hepatic function tests (CrCl, LFTs)
Rationale: To identify impairment that necessitates dose adjustment.
Timing: Prior to initiation of therapy
Psychosocial assessment (history of substance abuse, mental health)
Rationale: To identify risk factors for addiction, abuse, and misuse.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain assessment
Frequency: Regularly, as clinically indicated (e.g., daily, weekly during titration, monthly during maintenance)
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: Regularly, especially during initiation and titration, or with changes in concomitant medications.
Target: Normal for patient, typically >10-12 breaths/min
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoventilation require immediate intervention (e.g., naloxone, respiratory support).
Sedation level
Frequency: Regularly, especially during initiation and titration.
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolent) 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 initiation or adjustment of bowel regimen.
Signs of abuse, misuse, or diversion
Frequency: At each visit
Target: Absence of aberrant drug-related behaviors
Action Threshold: Evidence of abuse or diversion requires re-evaluation of treatment plan and potential referral to addiction specialist.
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
Pregnancy
Prolonged use 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:
Limited data on specific risks, but generally, opioid exposure in early pregnancy is associated with a small increased risk of certain birth defects (e.g., neural tube defects, cardiac defects).
Second Trimester:
Risk of NOWS increases with prolonged exposure.
Third Trimester:
High risk of NOWS with prolonged exposure. Monitor neonate for signs of withdrawal (irritability, hyperactivity, abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, poor feeding, sweating, yawning, sneezing, fever).
Lactation
Morphine is excreted into breast milk. While levels are generally low, there is a risk of serious adverse reactions in breastfed infants, including sedation and respiratory depression. Monitor infants for increased sleepiness, difficulty breathing, or limpness. Consider alternative analgesics or advise against breastfeeding, especially with high doses or prolonged use. The L3 risk category suggests moderate concern.
Infant Risk:
Risk of sedation, respiratory depression, poor feeding, and withdrawal symptoms if maternal opioid use is prolonged.
Pediatric Use
Safety and effectiveness of morphine extended-release tablets have not been established in pediatric patients. Not recommended for use in children.
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, requiring further dose adjustments.
Clinical Information
Clinical Pearls
- Morphine ER is for chronic, severe pain requiring continuous, around-the-clock opioid analgesia, not for PRN use or acute pain.
- Never crush, chew, or dissolve ER tablets due to the risk of rapid release and fatal overdose.
- Always assess for opioid tolerance before initiating ER morphine. It is contraindicated in opioid-naive patients.
- Careful titration is crucial, especially when converting from other opioids, due to incomplete cross-tolerance.
- Prophylactic treatment for opioid-induced constipation should be initiated concurrently with opioid therapy.
- Educate patients and caregivers thoroughly on safe storage, administration, and disposal to prevent accidental ingestion, especially by children.
- Monitor for signs of respiratory depression and sedation, particularly during initiation and dose escalation, and when co-administered with other CNS depressants.
- Be aware of the potential for neonatal opioid withdrawal syndrome if used during pregnancy.
Alternative Therapies
- Other extended-release opioid analgesics (e.g., oxycodone ER, hydromorphone ER, fentanyl transdermal, tapentadol ER, buprenorphine transdermal)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts
- Adjuvant analgesics (e.g., gabapentin, pregabalin for neuropathic pain; antidepressants for chronic pain)
- Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
$50 - $300+ per 30 tablets (60mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization due to opioid class and ER formulation)
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 or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss with your doctor or pharmacist how to obtain or use naloxone. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss with your doctor or pharmacist how to obtain or use naloxone. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.