Morphine Sul 45mg 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 follow the instructions closely.
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 breathing difficulties and overdose, which can be fatal.
Take your medication at the same time every day to establish a routine.
Swallow the medication whole; do not chew, break, crush, or dissolve it before swallowing, as this can cause severe side effects and death.
Important Usage Guidelines
This medication is not intended for fast pain relief or for use 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 you have difficulty swallowing the medication whole, you may sprinkle the contents on applesauce. If you do this, swallow the mixture immediately without chewing, and then rinse your mouth to ensure all the contents have been swallowed.
Administration via Feeding Tube
Some brands of this medication can be given through a specific type of feeding tube, while others cannot. Consult your pharmacist to determine if your brand can be administered this way.
Storage and Disposal
Store the medication at room temperature, protected from light and in a dry place. Avoid storing it in a bathroom.
Keep the medication in a safe location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or secure area.
Keep all medications away from 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.
Lifestyle & Tips
- Take exactly as prescribed; do not crush, chew, or dissolve the capsules as this can lead to a rapid release of a potentially fatal dose.
- Do not drink alcohol or use other sedating medications (like benzodiazepines, sleeping pills, or other pain medications) while taking this medicine, as it can cause severe breathing problems, coma, or death.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Store this medication securely away from children and pets, as accidental ingestion can be fatal.
- Discuss all other medications, supplements, and herbal products you are taking with your doctor to avoid dangerous interactions.
- Be prepared for and manage constipation, which is a common side effect. Your doctor may recommend laxatives or stool softeners.
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 regularly for the development of these behaviors and conditions.
Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Extended-Release Capsules. 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.
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 immediately or seek emergency medical attention:
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 fast 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 serious bowel problem
Depression or other 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 abnormal heartbeat
+ Flushing or muscle twitching or stiffness
+ Seizures or shivering and shaking
+ 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 or irregular menstrual periods
+ Ejaculation problems
Other Possible Side Effects
Most people experience few or no side effects while taking this medication. However, some common side effects may occur, including:
Dizziness, drowsiness, or fatigue
Dry mouth
Constipation, diarrhea, stomach pain, or decreased appetite
Headache
Anxiety
Excessive sweating
If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Slow, shallow, or difficult breathing (signs of respiratory depression)
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion or disorientation
- Severe constipation or abdominal pain
- Signs of allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
- Symptoms of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea)
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, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
If you are currently taking any 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 if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.
Interactions with Other Medications
Do not take this medication with other strong pain medications or use a pain patch without first consulting your doctor.
Monitoring Your Pain
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, contact your doctor immediately. Do not exceed the prescribed dose.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses are needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not take more than the prescribed dose. Additionally, regular use of opioid medications like this one can cause dependence. If you need to lower your dose or stop taking this medication, consult your doctor to avoid withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Allergies and Interactions
If you are allergic to sulfites, discuss this with your doctor, as some products contain sulfites. Do not consume alcohol or use products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal effects.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
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
- 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, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
- Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of MAOI discontinuation can result in severe, unpredictable, and potentially fatal reactions (e.g., serotonin syndrome, respiratory depression, coma).
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, fentanyl, lithium, St. John's Wort): Increased risk of serotonin syndrome.
- Mixed agonist/antagonist opioids (e.g., butorphanol, nalbuphine, pentazocine): May reduce the analgesic effect of morphine and/or precipitate withdrawal symptoms.
- Partial agonist opioids (e.g., buprenorphine): May reduce the analgesic effect of morphine and/or precipitate withdrawal symptoms.
Moderate Interactions
- Anticholinergics (e.g., atropine, scopolamine, TCAs, antihistamines): Increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
- Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May increase morphine exposure and effects, though morphine is not primarily metabolized by CYP2D6, its active metabolite M6G is not affected.
- CYP3A4 inhibitors/inducers: Less relevant for morphine as it is primarily metabolized by glucuronidation, not CYP3A4.
Minor Interactions
- Antihypertensives: May cause additive hypotensive effects.
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 neurological status and identify risk for excessive sedation.
Timing: Prior to initiation of therapy
Rationale: To assess baseline and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy
Rationale: To identify impairment that may necessitate dose adjustment.
Timing: Prior to initiation of therapy
Rationale: To identify patients at higher risk and implement appropriate monitoring strategies.
Timing: Prior to initiation of therapy
Routine Monitoring
Frequency: Regularly, at least daily during titration, then periodically (e.g., weekly/monthly) during maintenance.
Target: Acceptable pain control with tolerable side effects.
Action Threshold: Uncontrolled pain or intolerable side effects warrant dose adjustment or alternative strategies.
Frequency: Frequently during initiation/titration (e.g., every 1-4 hours), then periodically during maintenance (e.g., daily or as clinically indicated).
Target: >10-12 breaths/min, regular rhythm.
Action Threshold: <10 breaths/min, shallow breathing, or signs of respiratory distress warrant immediate intervention (e.g., naloxone, respiratory support).
Frequency: Frequently during initiation/titration, then periodically during maintenance.
Target: Alert and oriented, or easily aroused.
Action Threshold: Excessive sedation (e.g., somnolence, difficult to arouse) warrants dose reduction or discontinuation.
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-3 days).
Action Threshold: Constipation (e.g., no bowel movement for >3 days) warrants laxative intervention.
Frequency: At every visit
Target: Absence of aberrant drug-related behaviors.
Action Threshold: Presence of aberrant behaviors warrants re-evaluation of treatment plan, referral to addiction specialist, or discontinuation.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/drowsiness
- Dizziness/lightheadedness
- Nausea/vomiting
- Constipation
- Pruritus
- Urinary retention
- Confusion/disorientation
- 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. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
Lactation
Morphine is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, and poor feeding. Consider alternative analgesics or temporary discontinuation of breastfeeding.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Morphine ER is not recommended for use in children. Accidental ingestion by children can be fatal.
Geriatric Use
Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, 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 around-the-clock pain management and is NOT for as-needed (PRN) pain relief or acute pain.
- Do not crush, chew, or dissolve the capsules; this can lead to rapid release of a potentially fatal dose.
- Always assess for opioid tolerance before initiating Morphine ER. Opioid-naive patients should start with the lowest available dose (e.g., 15 mg every 24 hours).
- Titrate dose slowly and carefully, typically no more frequently than every 3-4 days, based on patient response and tolerability.
- Be vigilant for signs of respiratory depression, especially during initiation or dose escalation. Have naloxone readily available.
- Manage opioid-induced constipation proactively with a bowel regimen.
- Educate patients and caregivers thoroughly on safe storage, administration, and disposal to prevent accidental ingestion and diversion.
- Consider the risk of drug-drug interactions, especially with other CNS depressants, and avoid concomitant use whenever possible.
Alternative Therapies
- Other extended-release opioids (e.g., oxycodone ER, hydromorphone ER, fentanyl transdermal, tapentadol ER)
- Other strong opioid analgesics (e.g., oxycodone, hydromorphone, fentanyl, methadone)
- Non-opioid analgesics for severe pain (e.g., NSAIDs, acetaminophen, gabapentinoids, antidepressants) as adjuncts or for specific pain types.
- Interventional pain management techniques (e.g., nerve blocks, spinal cord stimulation)
- Physical therapy, occupational therapy, psychological therapies (e.g., CBT)
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 counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If an overdose is suspected, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.