Morphine Sulf 200mg 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 Sulfate Extended-Release is a strong pain medicine (an opioid) used to treat severe, ongoing pain that requires around-the-clock treatment. It works by changing how your brain and nervous system respond to pain. Because it's extended-release, it slowly releases the medicine over 12 hours, providing continuous pain relief.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. Take this medication by mouth only, with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
Important Safety Precautions
Do not inject or snort this medication, as this can lead to severe side effects, including breathing difficulties and overdose, which can be fatal. Additionally, do not chew, break, crush, or dissolve the tablet before swallowing, as this can also cause serious side effects and death.
Dosage and Administration
Take this medication at the same time every day. Swallow the tablet whole with plenty of water immediately after placing it in your mouth. If your dose requires more than one tablet, take them one at a time. Avoid licking or wetting the tablet before swallowing.
If you have trouble swallowing, consult your doctor for guidance. Do not put this medication down a feeding tube.
Using This Medication Safely
Do not use this medication for rapid pain relief or on an as-needed basis. Also, do not use it for pain relief after surgery if you have not been taking similar medications.
Storage and Disposal
Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. Store it in a secure location where children and pets cannot access it, such as a locked box or area. This will help prevent accidental ingestion or misuse.
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 the missed one.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. Take this medication by mouth only, with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
Important Safety Precautions
Do not inject or snort this medication, as this can lead to severe side effects, including breathing difficulties and overdose, which can be fatal. Additionally, do not chew, break, crush, or dissolve the tablet before swallowing, as this can also cause serious side effects and death.
Dosage and Administration
Take this medication at the same time every day. Swallow the tablet whole with plenty of water immediately after placing it in your mouth. If your dose requires more than one tablet, take them one at a time. Avoid licking or wetting the tablet before swallowing.
If you have trouble swallowing, consult your doctor for guidance. Do not put this medication down a feeding tube.
Using This Medication Safely
Do not use this medication for rapid pain relief or on an as-needed basis. Also, do not use it for pain relief after surgery if you have not been taking similar medications.
Storage and Disposal
Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. Store it in a secure location where children and pets cannot access it, such as a locked box or area. This will help prevent accidental ingestion or misuse.
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 the missed one.
Lifestyle & Tips
- Do not crush, chew, or dissolve the tablet. This can cause a rapid release of morphine, leading to a potentially fatal overdose.
- Swallow the tablet whole.
- Take exactly as prescribed; do not take more or less than directed, and do not take it 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) while taking morphine, as this can increase the risk of serious side effects like severe drowsiness and breathing problems.
- Be aware that this medication can cause constipation. Discuss strategies with your doctor to manage constipation (e.g., increased fiber, fluids, laxatives).
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- Store this medication securely, out of reach of children and pets, to prevent accidental ingestion.
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:
Initial dose for opioid-naive patients: 15 mg orally every 12 hours. For patients converting from other opioids, the dose should be individualized based on prior opioid exposure and calculated total daily dose.
Dose Range:
15 - 200 mg
Condition-Specific Dosing:
chronic_severe_pain:
Individualize dose based on patient's response and tolerability. Titrate slowly, no more frequently than every 3-4 days, to achieve adequate analgesia with acceptable side effects. Doses up to 200 mg every 12 hours are available, but higher doses require careful consideration and monitoring.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; consider dose reduction.
Moderate:
Reduce initial dose by 50% or extend dosing interval. Titrate slowly.
Severe:
Reduce initial dose by 75% or extend dosing interval significantly (e.g., every 24 hours or longer). Avoid if possible. Close monitoring for respiratory depression and sedation is crucial.
Dialysis:
Morphine and its active metabolite (M6G) are dialyzable. Administer after dialysis. Significant dose reduction is required, and close monitoring is essential.
Hepatic Impairment:
Mild:
Use with caution; consider dose reduction.
Moderate:
Reduce initial dose by 50%. Titrate slowly.
Severe:
Reduce initial dose by 75%. Avoid if possible. Close monitoring for respiratory depression and sedation is crucial.
Pharmacology
Mechanism of Action
Morphine is an opioid agonist that acts primarily at mu-opioid receptors in the central nervous system (CNS) and other tissues. Its analgesic effects are mediated by binding to these receptors, leading to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces generalized CNS depression, including respiratory depression, sedation, and euphoria.
Pharmacokinetics
Absorption:
Bioavailability:
20-40% (oral, due to first-pass metabolism)
Tmax:
3-4 hours (extended-release)
FoodEffect:
Food may increase the extent of absorption (AUC) and peak plasma concentrations (Cmax) of extended-release morphine. 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); M6G has a longer half-life, especially in renal impairment.
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (primarily as glucuronide conjugates)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Not available (ER formulation, gradual onset)
PeakEffect:
Not available (ER formulation, sustained effect)
DurationOfAction:
12 hours
Safety & Warnings
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.
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. 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.
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. 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.
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 immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Chest pain or pressure, or a fast heartbeat
Feeling confused
Trouble breathing, slow breathing, or shallow breathing
Noisy breathing
Breathing problems during sleep (sleep apnea)
Seizures
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Depression or other mood changes
Swelling in the arms or legs
Fever, chills, or sore throat
Pain when passing urine
Burning, numbness, or tingling sensations that are not normal
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:
Extreme tiredness or weakness
Passing out
Severe dizziness
Very upset stomach
Vomiting
Decreased appetite
Hormonal Changes: A Potential Long-Term Effect
Long-term use of an opioid medication may lead to lower sex hormone levels. If you notice any of the following symptoms, contact your doctor:
Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Headache
Anxiety
Excessive sweating
If any of these side effects or other symptoms bother you or do not go away, contact your doctor or seek medical help. 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 immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Chest pain or pressure, or a fast heartbeat
Feeling confused
Trouble breathing, slow breathing, or shallow breathing
Noisy breathing
Breathing problems during sleep (sleep apnea)
Seizures
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Depression or other mood changes
Swelling in the arms or legs
Fever, chills, or sore throat
Pain when passing urine
Burning, numbness, or tingling sensations that are not normal
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:
Extreme tiredness or weakness
Passing out
Severe dizziness
Very upset stomach
Vomiting
Decreased appetite
Hormonal Changes: A Potential Long-Term Effect
Long-term use of an opioid medication may lead to lower sex hormone levels. If you notice any of the following symptoms, contact your doctor:
Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Headache
Anxiety
Excessive sweating
If any of these side effects or other symptoms bother you or do not go away, contact your doctor or seek medical help. 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
- Bluish lips or fingernails
- Severe constipation or abdominal pain
- Signs of allergic reaction (rash, itching, swelling, 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. Describe the allergic reaction and its symptoms.
Existing health conditions, such as:
+ Respiratory problems (e.g., asthma, breathing difficulties, sleep apnea)
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Recent use (within the last 14 days) of certain 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 the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
* If you are breastfeeding, as you should not breastfeed while taking this medication
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
Existing health conditions, such as:
+ Respiratory problems (e.g., asthma, breathing difficulties, sleep apnea)
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Recent use (within the last 14 days) of certain 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 the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
* If you are breastfeeding, as you should not breastfeed while taking this medication
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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 this, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of opioid medications like this one can result in 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. 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 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 can lead to unsafe and potentially fatal effects.
Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly 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 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
Certain 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 if you are unsure whether 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 this, contact your doctor. Do not take more than the prescribed dose. Additionally, regular use of opioid medications like this one can result in 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. 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 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 can lead to unsafe and potentially fatal effects.
Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly 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 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
Certain 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 if you are unsure whether your specific product requires a full glass of water.
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
- Coma
What to Do:
If you suspect an overdose, 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
Contraindicated Interactions
- Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOIs (risk of serotonin syndrome, severe respiratory depression, coma, death).
- 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.
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, fentanyl, St. John's Wort): Risk of serotonin syndrome.
- Mixed agonist/antagonist opioids (e.g., butorphanol, nalbuphine, pentazocine): May reduce analgesic effect and/or precipitate withdrawal symptoms.
- Opioid antagonists (e.g., naltrexone, naloxone): May precipitate acute opioid withdrawal.
- Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
Moderate Interactions
- Anticholinergics (e.g., atropine, scopolamine): Increased risk of urinary retention and/or severe constipation.
- CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole, ritonavir): 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 opioid efficacy or withdrawal symptoms.
- Muscle relaxants: Enhanced neuromuscular blocking effects.
- Antihypertensives: May cause additive hypotensive effects.
Minor Interactions
- Not available
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
Level of consciousness/sedation
Rationale: To assess baseline neurological status and identify risk for excessive sedation.
Timing: Prior to initiation of therapy
Bowel function
Rationale: To assess baseline bowel habits and 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
Risk assessment for opioid abuse, addiction, or diversion
Rationale: To identify patients at higher risk and implement appropriate monitoring strategies.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain assessment
Frequency: Regularly, especially during dose titration and with changes in pain.
Target: Acceptable pain control with tolerable side effects.
Action Threshold: Inadequate pain control or intolerable side effects warrant dose adjustment or alternative strategies.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration; less frequently once stable.
Target: Typically >10-12 breaths/min, regular rhythm.
Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation warrant immediate intervention (e.g., naloxone, respiratory support).
Level of consciousness/sedation (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Regularly, especially during initiation and dose titration.
Target: Alert or mildly drowsy, easily aroused.
Action Threshold: Difficult to arouse, somnolent, or unarousable warrants immediate intervention.
Bowel function
Frequency: Daily or every other day.
Target: Regular bowel movements (e.g., every 1-2 days).
Action Threshold: Constipation (e.g., no bowel movement for >3 days) warrants intervention with laxatives/stool softeners.
Signs of opioid abuse, misuse, or addiction
Frequency: At each visit or refill.
Target: Adherence to prescribed regimen, no aberrant drug-taking behaviors.
Action Threshold: Signs of abuse/misuse (e.g., early refills, lost prescriptions, multiple prescribers) warrant re-evaluation of therapy and potential referral.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing, cyanosis)
- Excessive sedation/somnolence
- Dizziness, lightheadedness
- Nausea, vomiting
- Constipation
- Pruritus (itching)
- Urinary retention
- Signs of opioid withdrawal (if abruptly discontinued or dose reduced too rapidly): restlessness, lacrimation, rhinorrhea, yawning, sweating, chills, myalgia, arthralgia, abdominal cramps, nausea, vomiting, diarrhea, anxiety, irritability.
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 major birth defects. Animal studies show some developmental toxicity.
Second Trimester:
Risk of NOWS increases with prolonged exposure.
Third Trimester:
High risk of NOWS if used chronically. May cause respiratory depression in the neonate if used close to delivery.
Lactation
Morphine is excreted into breast milk. Infants exposed to morphine through breast milk should be monitored for signs of sedation and respiratory depression. Consider alternative analgesics or temporary discontinuation of breastfeeding. The American Academy of Pediatrics considers morphine to be a drug for which the effect on the nursing infant is unknown but may be of concern.
Infant Risk:
L3 (Moderate concern) - Risk of sedation, respiratory depression, poor feeding, and withdrawal symptoms in the infant.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.
Geriatric Use
Elderly patients may be more sensitive to the analgesic and adverse effects of morphine, particularly respiratory depression. Start with lower doses and titrate slowly. Monitor closely for sedation, respiratory depression, and constipation. Renal impairment is more common in the elderly, requiring dose adjustments.
Clinical Information
Clinical Pearls
- Morphine ER is for chronic, severe pain requiring continuous, around-the-clock opioid analgesia, not for as-needed (PRN) pain relief.
- Emphasize to patients the critical importance of swallowing the tablet whole and not crushing, chewing, or dissolving it, due to the risk of fatal overdose.
- Always assess for risk factors for opioid abuse, addiction, and misuse before initiating therapy and monitor regularly.
- Proactive management of opioid-induced constipation is essential, as it is a nearly universal side effect.
- Educate patients and caregivers on the signs of respiratory depression and how to respond, including the availability and use of naloxone.
- Due to the risk of neonatal opioid withdrawal syndrome, avoid prolonged use during pregnancy if possible. If necessary, ensure appropriate neonatal care is planned.
- Careful dose titration is crucial, especially in opioid-naive, elderly, or renally/hepatically impaired patients.
Alternative Therapies
- Other extended-release opioid analgesics (e.g., oxycodone ER, hydromorphone ER, fentanyl transdermal)
- Other strong opioid analgesics (e.g., hydromorphone, oxycodone, oxymorphone, fentanyl)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts
- Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants) for neuropathic pain
- Interventional pain management techniques
- Physical therapy, occupational therapy, psychological therapies
Cost & Coverage
Average Cost:
Varies widely by strength and pharmacy; e.g., $50-$500+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again 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.
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 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.