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Morphine Sul 30mg ER Tabs

Manufacturer MAJOR PHARMACEUTICALS Active Ingredient Morphine Extended-Release Tablets(MOR feen) Pronunciation MOR feen
WARNING: This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing. Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Do not take more than what your doctor told you to take. Do not take more often or for longer than you were told. Doing any of these things may raise the chance of severe side effects.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life-threatening if not treated.Swallow whole. Do not chew, break, crush, or dissolve before swallowing. Doing these things can cause very bad side effects and death. Make sure you have the right drug; there is more than one strength. A lower strength may not ease pain well enough. A higher strength could lead to accidental overdose and death.Certain strengths of this drug may only be used by people who have been taking drugs like this drug and are used to their effects. The use of these strengths by people who have not been taking drugs like this drug may cause very bad and sometimes deadly breathing problems. Talk with the doctor. @ COMMON USES: It is used to manage pain when daily pain treatment is needed for a long time. It is for use when non-opioid pain drugs do not treat your pain well enough or you cannot take them.
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Drug Class
Opioid analgesic
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Pharmacologic Class
Opioid agonist
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Pregnancy Category
Category C (first trimester), Category D (prolonged use or high doses at term)
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FDA Approved
Jan 1970
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Morphine extended-release is a strong pain medicine (an opioid) that works in your brain to change how your body feels and responds to pain. The 'extended-release' part means it's designed to release the medicine slowly over many hours, so you take it less often, usually once or twice a day, for ongoing pain.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.

Take this medication by mouth only, with or without food. If it causes stomach upset, take it with food.
 Do not inject or snort this medication, as this can lead to severe side effects, including respiratory problems and overdose, which can be fatal.
Take your medication at the same time every day. Swallow the tablet whole, without chewing, breaking, crushing, or dissolving it first, as this can also cause severe side effects and death.
 Do not use this medication for rapid pain relief or on an as-needed basis. Additionally, do not use it for post-surgical pain relief if you have not been taking similar medications.
If your prescribed dose is more than one tablet, take one tablet at a time. Do not lick or wet the tablet before placing it in your mouth. Swallow the tablet with a large amount of water immediately after putting it in your mouth.
 If you have difficulty swallowing, consult your doctor for guidance.
Do not administer this medication through a feeding tube.

Storing and Disposing of Your Medication

 Store your medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep your 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.
 Keep all medications away from pets.

Missing a Dose

* If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Do not drink alcohol while taking this medication, as it can cause dangerous side effects, including severe drowsiness and breathing problems.
  • Do not drive or operate 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.
  • Do not crush, chew, or dissolve the tablets, as this can lead to rapid release of a potentially fatal dose.
  • Maintain a regular bowel regimen (e.g., fiber, fluids, laxatives) to prevent constipation, a common side effect.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: For opioid-tolerant patients, initial dose is typically 15 mg or 30 mg orally every 8 to 12 hours, titrated based on patient response and tolerability.
Dose Range: 15 - 200 mg

Condition-Specific Dosing:

opioid_naive: Morphine ER is NOT for opioid-naive patients. Use immediate-release morphine for titration.
chronic_pain: Administer on a fixed schedule, not on an as-needed basis. Titrate slowly to minimize adverse effects and achieve adequate analgesia.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for extended-release formulations. Safety and efficacy not established.
Adolescent: Not established for extended-release formulations. Safety and efficacy not established.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; consider dose reduction and extended dosing interval.
Moderate: Significant dose reduction (e.g., 50%) and/or extended dosing interval (e.g., every 12-24 hours) recommended due to accumulation of active metabolites (morphine-6-glucuronide).
Severe: Contraindicated or significant dose reduction (e.g., 75%) and extended dosing interval (e.g., every 24 hours or longer) required. Close monitoring for respiratory depression and sedation.
Dialysis: Morphine and its metabolites are partially dialyzable. Administer after dialysis. Significant dose reduction and extended interval required.

Hepatic Impairment:

Mild: Use with caution; consider dose reduction.
Moderate: Significant dose reduction (e.g., 50%) and/or extended dosing interval recommended due to impaired metabolism.
Severe: Contraindicated or significant dose reduction (e.g., 75%) and extended dosing interval required. Close monitoring for respiratory depression and sedation.

Pharmacology

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Mechanism of Action

Morphine is an opioid agonist that acts primarily at the mu-opioid receptors in the central nervous system (CNS) and gastrointestinal tract. Activation of these receptors leads to analgesia, sedation, euphoria, respiratory depression, miosis, and decreased gastrointestinal motility.
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Pharmacokinetics

Absorption:

Bioavailability: 20-40% (oral, highly variable due to first-pass metabolism)
Tmax: 3-6 hours (extended-release formulations)
FoodEffect: Variable depending on specific ER formulation; some formulations may have increased absorption with high-fat meals, others are unaffected. Refer to specific product labeling.

Distribution:

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

Elimination:

HalfLife: 2-4 hours (immediate-release); 8-12 hours (extended-release, due to formulation characteristics)
Clearance: Approximately 15-30 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Not applicable for acute pain; extended-release formulations are designed for continuous pain control, not rapid onset.
PeakEffect: 4-8 hours (extended-release formulations)
DurationOfAction: 8-12 hours (extended-release formulations)
Confidence: High

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION (for some opioids, less direct for morphine); RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
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Side Effects

Important Side Effects to Report to Your Doctor Right Away

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

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling 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 be signs of a severe 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
+ Changes in balance
+ 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 use of opioid medications like this one. Symptoms include:
+ Extreme fatigue or weakness
+ Fainting
+ Severe dizziness
+ Nausea and vomiting
+ Decreased appetite
 Hormonal changes, which may occur with long-term use of opioid medications like this one. Symptoms include:
+ Decreased interest in sex
+ Fertility problems
+ Missed menstrual periods
+ Ejaculation problems

Other Possible Side Effects

Most people experience few or no side effects while taking this medication. However, some common side effects may occur, including:

Dizziness
 Drowsiness
Fatigue
 Weakness
Dry mouth
 Constipation
Diarrhea
 Stomach pain
Nausea and vomiting
 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.
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Seek Immediate Medical Attention If You Experience:

  • Slow or shallow breathing
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness when standing up
  • Severe constipation or abdominal pain
  • Confusion or unusual thoughts
  • Pinpoint pupils
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, 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 obstruction 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 problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

Do not take this medication with other strong pain medications or use a pain patch without first consulting your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not exceed the prescribed dose.

Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required 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.

Prolonged or regular use of opioid medications like this one can result in dependence. Suddenly lowering the dose or stopping the medication may increase the risk of withdrawal or other severe problems. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.

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.

Avoid consuming alcohol or products containing alcohol while taking this medication, as it may lead to unsafe and potentially fatal effects.

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.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Some brands of this medication may pose a choking hazard or cause difficulty swallowing. To minimize this risk, take these products with a full glass of water. Consult your pharmacist to determine if your specific product requires administration with a full glass of water.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Call 911 immediately. Administer naloxone if available and trained to do so. Stay with the person until emergency medical help arrives. Call 1-800-222-1222 (Poison Control) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI discontinuation (risk of serotonin syndrome, severe respiratory depression, coma, death).
  • Patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, or known or suspected paralytic ileus.
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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, fentanyl): Risk of serotonin syndrome.
  • Mixed agonist/antagonist and partial agonist opioids (e.g., buprenorphine, nalbuphine, butorphanol, pentazocine): May reduce the analgesic effect of morphine or precipitate withdrawal symptoms.
  • Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
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Moderate Interactions

  • Diuretics: Opioids may reduce the efficacy of diuretics by causing the release of antidiuretic hormone.
  • Antihypertensives: May cause additive hypotensive effects.
  • P-glycoprotein (P-gp) inhibitors/inducers: May alter morphine exposure, though morphine is not a major P-gp substrate.
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Minor Interactions

  • Cimetidine: May slightly increase morphine levels.

Monitoring

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Baseline Monitoring

Pain assessment (intensity, character, location)

Rationale: To establish baseline pain level and guide initial dosing.

Timing: Prior to initiation of therapy

Respiratory rate and depth

Rationale: To assess baseline respiratory function and identify risk for respiratory depression.

Timing: Prior to initiation of therapy

Level of consciousness/sedation

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

Timing: Prior to initiation of therapy

Bowel function

Rationale: To assess baseline bowel habits and anticipate opioid-induced constipation.

Timing: Prior to initiation of therapy

Renal and hepatic function tests (CrCl, LFTs)

Rationale: To identify impairment that may necessitate dose adjustment.

Timing: Prior to initiation of therapy

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Routine Monitoring

Pain assessment

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 re-evaluation.

Respiratory rate and depth

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 (e.g., cyanosis, somnolence) require immediate intervention (e.g., naloxone, respiratory support).

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

Frequency: Frequently during initiation/titration, then periodically during maintenance.

Target: Alert or mildly drowsy, easily aroused.

Action Threshold: Difficult to arouse, somnolent, or unarousable requires immediate intervention.

Bowel function

Frequency: Daily

Target: Regular bowel movements (e.g., every 1-3 days).

Action Threshold: Constipation (e.g., no bowel movement for >3 days) requires intervention (e.g., laxatives, stool softeners).

Signs of abuse, misuse, or addiction

Frequency: At each visit

Target: Absence of aberrant drug-related behaviors.

Action Threshold: Evidence of diversion, dose escalation without clinical need, or other concerning behaviors requires re-evaluation of treatment plan.

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation/drowsiness
  • Nausea and vomiting
  • Constipation
  • Pruritus (itching)
  • Dizziness/lightheadedness
  • Urinary retention
  • Confusion
  • Miosis (pinpoint pupils)

Special Patient Groups

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Pregnancy

Use during pregnancy is generally not recommended due to potential for neonatal opioid withdrawal syndrome (NOWS) and respiratory depression in the neonate. Category C for first trimester, Category D for prolonged use or high doses at term.

Trimester-Specific Risks:

First Trimester: Limited human data, but animal studies suggest potential for developmental toxicity. Generally Category C.
Second Trimester: Risk of neonatal opioid withdrawal syndrome increases with prolonged use.
Third Trimester: High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Risk of respiratory depression in the neonate if used near delivery. Generally Category D.
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Lactation

Morphine is excreted into breast milk. Use is generally discouraged due to potential for infant sedation, respiratory depression, and withdrawal. If used, monitor infant closely for signs of sedation, poor feeding, and breathing difficulties.

Infant Risk: Moderate risk (L3). Potential for sedation, respiratory depression, and withdrawal in the infant. Consider alternative analgesics or pump and dump if short-term use is necessary and infant monitoring is not feasible.
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Pediatric Use

Safety and efficacy of extended-release morphine have not been established in pediatric patients. Not recommended for use in children. Immediate-release morphine may be used in specific pediatric populations under strict medical supervision.

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Geriatric Use

Start with lower doses and titrate slowly due to increased sensitivity to opioid effects, decreased renal/hepatic function, and increased risk of adverse effects (e.g., respiratory depression, constipation, falls). Monitor closely.

Clinical Information

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Clinical Pearls

  • Morphine ER is for opioid-tolerant patients requiring continuous, around-the-clock pain management. It is NOT for as-needed (PRN) pain relief or acute pain.
  • Do not crush, chew, or dissolve extended-release tablets due to the risk of rapid release of a potentially fatal dose.
  • Always assess for respiratory depression and sedation, especially during initiation and dose titration.
  • Prophylactic treatment for opioid-induced constipation should be initiated concurrently with morphine ER therapy.
  • Educate patients and caregivers on the safe storage and disposal of opioids to prevent accidental ingestion and diversion.
  • Consider the use of naloxone co-prescription for patients at high risk of overdose.
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Alternative Therapies

  • Other extended-release opioid analgesics (e.g., oxycodone ER, hydromorphone ER, fentanyl transdermal)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for mild to moderate pain or as adjuncts
  • Adjuvant analgesics (e.g., gabapentin, pregabalin for neuropathic pain; antidepressants for chronic pain)
  • Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: $50 - $300+ per 30 tablets (30mg ER)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (often requires prior authorization)
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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 provides crucial information for patients. 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 for guidance.

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 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, to facilitate prompt and effective treatment.