Morphine Sulf 100mg ER Caps (24h)
Overview
What is this medicine?
How to Use This Medicine
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines below.
Take this medication by mouth only, with or without food. If it causes stomach upset, take it with food to help minimize discomfort.
Do not inject or snort this medication, as this can lead to severe side effects, including respiratory problems and overdose, which can be fatal.
Take your medication at the same time every day to establish a routine.
Swallow the tablet whole; do not chew, break, crush, or dissolve it before swallowing, as this can cause serious side effects and potentially be fatal.
This medication is not intended for fast pain relief or for use on an as-needed basis. Additionally, it should not be used for post-surgical pain relief if you have not previously been taking similar medications.
If you have difficulty swallowing the tablet whole, you may sprinkle the contents onto applesauce. If you choose this method, swallow the mixture immediately without chewing. Then, rinse your mouth to ensure all the contents have been swallowed.
Administration via Feeding Tube
Some brands of this medication can be administered through a specific type of feeding tube, while others cannot. Consult your pharmacist to determine if your brand can be given via a feeding tube.
Storage and Disposal
Store your medication at room temperature, protected from light and in a dry place. Avoid storing it in a bathroom. Keep the medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to safeguard your medication. Also, keep all medications out of reach of pets.
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 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 use stool softeners or laxatives as recommended by your doctor.
- Store this medication securely away from children and pets, as accidental ingestion can be fatal.
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
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Addiction, Abuse, and Misuse: Morphine Sulfate Extended-Release Capsules expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientβs risk prior to prescribing Morphine Sulfate Extended-Release Capsules, and monitor all patients receiving Morphine Sulfate Extended-Release Capsules for the development of these behaviors or conditions.
REMS: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make available to healthcare providers REMS-compliant education programs for pain management, and must counsel patients on safe use, serious risks, storage, and disposal of opioid analgesics.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of Morphine Sulfate Extended-Release Capsules or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose of Morphine Sulfate Extended-Release Capsules, especially by children, can result in a fatal overdose of morphine.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of Morphine Sulfate Extended-Release Capsules 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 Capsules with all cytochrome P450 3A4 inhibitors may result in increased plasma concentrations of morphine, leading to increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of CYP3A4 inhibitors and Morphine Sulfate Extended-Release Capsules, particularly when an inhibitor is added after a stable dose of Morphine Sulfate Extended-Release Capsules is achieved. If concomitant use is necessary, consider dose reduction of Morphine Sulfate Extended-Release Capsules and monitor patients closely for respiratory depression and sedation.
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
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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ 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 or vomiting
+ Decreased appetite
Hormonal changes, which may occur with long-term opioid use. Symptoms include:
+ Decreased interest in sex
+ Fertility problems
+ Absence of menstrual period
+ Ejaculation problems
Other Possible Side Effects
Most people experience few or no side effects while taking this medication. However, some individuals may encounter mild or moderate side effects, including:
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 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, shallow, or difficult breathing (signs of respiratory depression)
- Extreme drowsiness or difficulty waking up
- Severe dizziness or lightheadedness
- Confusion or disorientation
- Blue-tinged lips or skin
- Pinpoint pupils
- Severe constipation or abdominal pain
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
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 whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor.
Precautions & Cautions
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution When Performing Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in other activities that require your full attention. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
Interactions with Other Medications
Do not take this medication concurrently 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 dosage.
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 find that this medication is no longer working as well as it should, consult your doctor. Do not take more than the prescribed amount.
Additionally, prolonged or regular use of opioid medications like this one can result in dependence. If you need to reduce your dose or stop taking this medication, consult your doctor first, as abruptly stopping or lowering the dose 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.
Allergies and Interactions
If you are allergic to sulfites, discuss this with your doctor, as some products contain sulfites. Avoid consuming alcohol or using products that contain alcohol, as this can lead to unsafe and potentially fatal consequences.
Seizure Risk
This medication may increase the risk of seizures in certain 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.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing
- Extreme drowsiness or unresponsiveness
- Pinpoint pupils
- Cold, clammy skin
- Limp muscles
- Low blood pressure
- Slowed heart rate
- Coma
What to Do:
Seek immediate emergency medical attention. Call 911 or your local emergency number. Naloxone (Narcan) is an antidote for opioid overdose and may be administered by emergency personnel. Inform them of the medication taken. Call 1-800-222-1222 (Poison Control Center) for additional guidance.
Drug Interactions
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
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): Risk of serotonin syndrome.
- Mixed agonist/antagonist and partial agonist opioids (e.g., butorphanol, nalbuphine, pentazocine, buprenorphine): May reduce analgesic effect or precipitate withdrawal symptoms.
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir): May increase morphine plasma concentrations, leading to increased or prolonged opioid effects.
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease morphine plasma concentrations, leading to reduced efficacy or withdrawal symptoms.
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.
Minor Interactions
- Not specifically categorized as minor for morphine, but general caution with any drug affecting CNS or GI motility.
Confidence Interactions
Monitoring
Baseline Monitoring
Rationale: To establish baseline pain level and guide initial dosing.
Timing: Prior to initiation of therapy
Rationale: To assess baseline respiratory function and identify risk for respiratory depression.
Timing: Prior to initiation of therapy
Rationale: To assess baseline mental status and identify risk for excessive sedation.
Timing: Prior to initiation of therapy
Rationale: To assess baseline bowel habits and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy
Rationale: To identify impairment that may require dose adjustment.
Timing: Prior to initiation of therapy
Routine Monitoring
Frequency: Regularly, at least daily during titration, then periodically (e.g., weekly to monthly) during maintenance.
Target: Patient-specific, aiming for acceptable pain control with minimal side effects.
Action Threshold: Uncontrolled pain or unacceptable side effects warrant dose adjustment or alternative strategies.
Frequency: Frequently during initiation/titration (e.g., every 1-4 hours), then periodically during maintenance.
Target: >10-12 breaths/min, regular rhythm, adequate depth.
Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation require immediate intervention (e.g., naloxone, respiratory support).
Frequency: Frequently during initiation/titration, then periodically during maintenance.
Target: Alert or mildly drowsy, easily aroused.
Action Threshold: Moderately to excessively sedated (difficult to arouse, somnolent) requires intervention.
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-3 days).
Action Threshold: Constipation (no bowel movement for >3 days) requires laxative intervention.
Frequency: Ongoing, at every patient encounter.
Target: Absence of aberrant drug-related behaviors.
Action Threshold: Presence of aberrant behaviors (e.g., requesting early refills, lost prescriptions, multiple prescribers) requires further assessment and intervention.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/drowsiness
- Dizziness
- Nausea and vomiting
- Constipation
- Pruritus (itching)
- Urinary retention
- Confusion
- Hypotension
- Signs of opioid withdrawal (if dose reduced too quickly or 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:
Lactation
Morphine is excreted into breast milk. While levels are generally low, infants should be monitored for signs of sedation and respiratory depression. 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. Use with caution, or consider alternatives.
Pediatric Use
Safety and efficacy of morphine extended-release capsules have not been established in pediatric patients under 18 years of age. Use is generally not recommended due to the risk of serious adverse events, including respiratory depression and death, especially in opioid-naive 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 impairment is more common in the elderly, requiring dose adjustments.
Clinical Information
Clinical Pearls
- Morphine ER capsules are designed for once-daily dosing and should not be crushed, chewed, or dissolved, as this can lead to rapid release and absorption of a potentially fatal dose of morphine.
- Patients should be educated on the signs of respiratory depression and how to respond, including the availability of naloxone.
- Opioid-induced constipation is a common and persistent side effect; a bowel regimen (stimulant laxative plus stool softener) should be initiated proactively.
- Due to the risk of addiction, abuse, and misuse, careful patient selection, risk assessment, and ongoing monitoring are crucial.
- Conversion from other opioids to morphine ER requires careful calculation using equianalgesic tables to avoid over- or under-dosing.
Alternative Therapies
- Other strong opioid analgesics (e.g., oxycodone, hydromorphone, fentanyl, methadone)
- 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 (e.g., nerve blocks, spinal cord stimulation)
- Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
General Drug Facts
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever 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.