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Morphine Sul 15mg Imm Rel Tab

Manufacturer ROXANE Active Ingredient Morphine Immediate-Release Tablets and Capsules(MOR feen) Pronunciation MOR-feen SUL-fate
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. @ COMMON USES: It is used to manage pain 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
Not available
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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 is a strong pain medicine that works in your brain and spinal cord to change how your body feels and responds to pain. It is used for moderate to severe pain that is not controlled by other pain medicines. This is an immediate-release tablet, meaning it starts working quickly but only lasts for a few hours.
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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 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 discomfort.

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.

Storing and Disposing of Your Medication

Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. To prevent accidental ingestion, store it in a secure location where children and pets cannot access it. Consider using a locked box or area to keep the medication safe. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and explore local drug take-back programs.

Managing Missed Doses

If you take this medication regularly, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Avoid taking two doses at the same time or taking extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Do not drink alcohol or use other sedating medications (like benzodiazepines, sleeping pills, or other pain medications) while taking morphine, as this can cause dangerous breathing problems or extreme drowsiness.
  • Avoid driving or operating heavy machinery until you know how morphine affects you, as it can cause dizziness and drowsiness.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and use a stool softener or laxative as recommended by your doctor.
  • Store morphine securely away from children and pets, and dispose of unused medication properly (e.g., drug take-back programs).
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 15-30 mg orally every 4 hours as needed for pain
Dose Range: 10 - 30 mg

Condition-Specific Dosing:

opioidNaive: Initial dose typically 10-15 mg every 4 hours, titrated to effect.
opioidTolerant: Dose should be individualized based on previous opioid exposure and titrated to effect.
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Pediatric Dosing

Neonatal: Not established for routine use; highly individualized and generally avoided due to risk of respiratory depression and prolonged half-life.
Infant: Not established for routine use; highly individualized and generally avoided.
Child: 0.2-0.5 mg/kg/dose orally every 4 hours as needed for pain, maximum 15 mg/dose. Titrate carefully.
Adolescent: Similar to adult dosing, 0.2-0.5 mg/kg/dose orally every 4 hours as needed for pain, maximum 30 mg/dose. Titrate carefully.
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Dose Adjustments

Renal Impairment:

Mild: Consider dose reduction and/or extended dosing interval due to accumulation of active metabolites (morphine-6-glucuronide).
Moderate: Reduce initial dose by 25-50% and extend dosing interval. Monitor closely for sedation and respiratory depression.
Severe: Reduce initial dose by 50-75% and extend dosing interval significantly (e.g., every 6-8 hours or longer). Avoid if possible. Monitor very closely.
Dialysis: Morphine and its active metabolites are dialyzable. Administer after dialysis. Significant dose reduction required.

Hepatic Impairment:

Mild: No specific dose adjustment typically required, but monitor for increased sensitivity.
Moderate: Reduce initial dose by 25-50%. Monitor closely for adverse effects.
Severe: Reduce initial dose by 50-75%. Avoid if possible. Monitor very closely for sedation and respiratory depression.

Pharmacology

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Mechanism of Action

Morphine is a full opioid agonist that binds to and activates mu-opioid receptors in the central nervous system (CNS) and other tissues. This binding leads to inhibition of ascending pain pathways, altering the perception of and emotional response to pain. It also produces generalized CNS depression, including respiratory depression, sedation, and antitussive effects.
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Pharmacokinetics

Absorption:

Bioavailability: 20-40%
Tmax: 30-60 minutes (oral IR)
FoodEffect: Food may slightly delay Tmax but generally does not significantly affect the extent of absorption for immediate-release formulations.

Distribution:

Vd: 3-5 L/kg
ProteinBinding: 30-35%
CnssPenetration: Yes, but limited by P-glycoprotein efflux

Elimination:

HalfLife: 2-4 hours
Clearance: Not available
ExcretionRoute: Renal (primarily as glucuronide metabolites)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: 15-60 minutes (oral IR)
PeakEffect: 60 minutes (oral IR)
DurationOfAction: 4-5 hours

Safety & Warnings

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BLACK BOX WARNING

Addiction, Abuse, and Misuse: Morphine exposes 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, 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. Monitor for respiratory depression, especially during initiation of morphine or following a dose increase.
Accidental Ingestion: Accidental ingestion of morphine, especially by children, can result in a fatal overdose.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of morphine 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 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.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction, such as:
+ Rash
+ 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 Rare but Serious Condition

If you take this medication with certain other drugs, you may be at risk for a rare but potentially life-threatening condition called serotonin syndrome. 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:

Feeling very tired or weak
 Passing out
Severe dizziness
 Very upset stomach
Vomiting
 Decreased appetite

Hormonal Changes: A Potential Side Effect

Long-term use of an opioid medication may lead to lower sex hormone levels. If you experience any of the following symptoms, contact your doctor:

Decreased interest in sex
 Fertility problems
No menstrual period
 Ejaculation problems

Other Side Effects: Less Severe but Still Important

While many people do not experience side effects or only have minor ones, it is essential to be aware of the following less severe 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 bother you or do not go away, contact your doctor or seek medical attention. Remember to report any 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 (less than 10 breaths per minute)
  • Extreme drowsiness or difficulty waking up
  • Severe dizziness or confusion
  • Blue-tinged lips or skin
  • Severe constipation or inability to have a bowel movement
  • Signs of allergic reaction (rash, itching, swelling of face/tongue/throat, 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 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

Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to inform your doctor and pharmacist about:

All prescription and over-the-counter medications you are taking
 Any natural products or vitamins you are using
* Your complete medical history

Before starting, stopping, or adjusting the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
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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.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.

Interactions with Other Medications
Do not take this medication with other strong pain medications or use a pain patch without first consulting your doctor.

Monitoring Your Pain
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, contact your doctor immediately. Do not exceed the prescribed dose.

Tolerance and Dependence
Long-term or high-dose use of this medication can lead to tolerance, where the medication may not work as well, and you may require higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not take more than the prescribed dose.

Additionally, long-term or regular use of opioid medications like this one can cause dependence. If you need to lower your dose or stop taking this medication, consult your doctor first, as suddenly stopping or reducing 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.

Interactions with Alcohol
Do not consume alcohol or 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. Discuss your risk with your doctor.

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

Breastfeeding
If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
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Overdose Information

Overdose Symptoms:

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

What to Do:

If you suspect an overdose, call 911 immediately. Administer naloxone if available and trained to do so. Call 1-800-222-1222 (Poison Control Center) for further guidance.

Drug Interactions

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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).
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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 opioids (e.g., butorphanol, nalbuphine, pentazocine) or partial agonist opioids (e.g., buprenorphine): 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 severe constipation.
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Moderate Interactions

  • Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
  • P-glycoprotein (P-gp) inhibitors (e.g., quinidine, amiodarone, verapamil): May increase morphine plasma concentrations.
  • P-glycoprotein (P-gp) inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease morphine plasma concentrations.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pain intensity and characteristics

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 plan for constipation prophylaxis.

Timing: Prior to initiation of therapy

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Routine Monitoring

Pain intensity and relief

Frequency: Regularly, especially after dose adjustments and before subsequent doses (e.g., every 2-4 hours for IR)

Target: Patient-specific pain goal (e.g., 3/10 or less)

Action Threshold: Pain uncontrolled or worsening; consider dose adjustment or alternative therapy.

Respiratory rate and depth

Frequency: Regularly, especially during initial titration and with dose increases (e.g., every 1-4 hours)

Target: >10-12 breaths/minute (adults)

Action Threshold: <10 breaths/minute, shallow breathing, or signs of hypoventilation; intervene immediately.

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

Frequency: Regularly, especially during initial titration and with dose increases (e.g., every 1-4 hours)

Target: Alert or mildly drowsy, easily aroused

Action Threshold: Difficult to arouse, somnolent, or unresponsive; intervene immediately.

Bowel function

Frequency: Daily

Target: Regular bowel movements (e.g., every 1-2 days)

Action Threshold: No bowel movement for 2-3 days; initiate or escalate laxative regimen.

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation/drowsiness
  • Constipation
  • Nausea and vomiting
  • Pruritus (itching)
  • Urinary retention
  • Dizziness/lightheadedness
  • Signs of opioid use disorder (e.g., drug-seeking behavior, escalating doses, loss of control)

Special Patient Groups

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Pregnancy

Prolonged use of morphine during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which can be life-threatening if not recognized and treated. Morphine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Advise pregnant patients of the risk of NOWS.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations with first-trimester opioid exposure cannot be ruled out.
Second Trimester: Risk of NOWS increases with prolonged exposure.
Third Trimester: Highest risk of NOWS with prolonged exposure. Risk of respiratory depression in the neonate if administered close to delivery.
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Lactation

Morphine is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. 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 alternative analgesics.

Infant Risk: Risk of sedation, respiratory depression, and withdrawal in the infant. Risk is higher with higher maternal doses, prolonged use, and in preterm or ill infants.
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Pediatric Use

Use with extreme caution. Pediatric patients, especially neonates and infants, are more sensitive to the respiratory depressant effects of opioids. Dosing must be individualized and carefully titrated. Not recommended for routine use in neonates/infants due to prolonged half-life and increased risk of adverse effects.

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of morphine, particularly respiratory depression and constipation. Start with lower doses and titrate slowly. Monitor closely for CNS and respiratory depression.

Clinical Information

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Clinical Pearls

  • Always assess pain level and patient's opioid history before administering morphine.
  • Start low and go slow, especially in opioid-naive, elderly, or renally/hepatically impaired patients.
  • Proactive management of opioid-induced constipation is crucial; initiate a bowel regimen (e.g., stimulant laxative plus stool softener) at the start of therapy.
  • Educate patients and caregivers about the risks of respiratory depression, sedation, and accidental ingestion, and the importance of safe storage.
  • Have naloxone readily available, especially for patients at high risk of overdose (e.g., concomitant CNS depressants, history of overdose).
  • Morphine-6-glucuronide (M6G), an active metabolite, accumulates in renal impairment, leading to prolonged and enhanced opioid effects. Adjust dose accordingly.
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Alternative Therapies

  • Other immediate-release opioid analgesics (e.g., oxycodone IR, hydromorphone IR, hydrocodone/acetaminophen)
  • Non-opioid analgesics for moderate pain (e.g., NSAIDs, acetaminophen)
  • Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
  • Regional anesthesia or nerve blocks
  • Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (15mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues 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, 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.