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Morphine Sul 30mg Imm Rel Tab

Manufacturer ROXANE Active Ingredient Morphine Immediate-Release Tablets and Capsules(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. @ 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
Category D
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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's used for moderate to severe pain that other medicines haven't helped. It's important to take it exactly as prescribed because it can be habit-forming.
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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 this side effect. It is essential to use this medication as directed and avoid injecting or snorting it, as these methods 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, avoiding storage in a bathroom. To ensure safety, store this medication in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area to store your medication. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or look into local drug take-back programs.

Managing Missed Doses

If you take this medication on a regular schedule, take a missed dose as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Do not drink alcohol while taking this medicine, as it can increase side effects like drowsiness and breathing problems.
  • Avoid driving or operating heavy machinery until you know how this medicine 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 this medicine securely away from children and pets, as accidental ingestion can be fatal.
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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: 15 - 30 mg

Condition-Specific Dosing:

opioid_naive_initial_dose: 15 mg orally every 4 hours as needed
severe_pain: May require higher initial doses or more frequent administration based on patient response and tolerance
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, often IV route preferred)
Infant: Not established (use with extreme caution, often IV route preferred)
Child: 0.2-0.5 mg/kg/dose orally every 4-6 hours as needed (max 15 mg/dose for immediate release)
Adolescent: 15-30 mg orally every 4 hours as needed for pain
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor for increased effects
Moderate: Reduce dose by 25-50% and/or extend dosing interval; monitor closely for respiratory depression and sedation due to accumulation of active metabolites (morphine-6-glucuronide)
Severe: Reduce dose by 50-75% and/or extend dosing interval; monitor closely for respiratory depression and sedation
Dialysis: Morphine and its metabolites are dialyzable to some extent; administer after dialysis, monitor closely

Hepatic Impairment:

Mild: No specific adjustment, monitor for increased effects
Moderate: Reduce dose by 25-50% and/or extend dosing interval; monitor closely
Severe: Reduce dose by 50-75% and/or extend dosing interval; monitor closely

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 response to pain. It also produces generalized CNS depression, including respiratory depression, sedation, and euphoria.
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Pharmacokinetics

Absorption:

Bioavailability: 20-40% (highly variable due to significant first-pass metabolism)
Tmax: 30-60 minutes (oral solution), 60 minutes (oral tablet)
FoodEffect: Food may delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

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

Elimination:

HalfLife: 2-4 hours (parent drug), 3-15 hours (M6G)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: Approximately 10% (renal)
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Pharmacodynamics

OnsetOfAction: 15-60 minutes (oral)
PeakEffect: 60-120 minutes (oral)
DurationOfAction: 3-5 hours (oral)

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION (for some formulations); and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
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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 immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy 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 and vomiting
+ Decreased appetite
 Hormonal changes, which may occur with long-term opioid use. 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 or seek medical attention. 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 (respiratory depression)
  • Extreme drowsiness or difficulty waking up
  • Severe dizziness or lightheadedness
  • Confusion or disorientation
  • Blue-tinged lips or skin
  • Severe constipation that doesn't improve with laxatives
  • 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
 Certain health conditions, including:
+ Respiratory problems, such as asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Recent use of specific medications for depression or Parkinson's disease within the last 14 days, 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

Please note that this is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss all your medications (prescription and over-the-counter), natural products, vitamins, and health problems with your doctor and pharmacist to ensure safe use. Do not initiate, stop, or adjust the dosage of any medication without first 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.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks 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 may lead to tolerance, where the medication becomes less effective, 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 may 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 may 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.

Special Warnings

Do not consume alcohol or products containing alcohol while taking this medication, as it may cause unsafe and potentially fatal effects.
 This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
 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
  • Slowed heart rate
  • Low blood pressure
  • Coma

What to Do:

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

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of serotonin syndrome or severe CNS depression)
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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines): 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): May precipitate withdrawal symptoms or reduce analgesic effect.
  • Opioid antagonists (e.g., naltrexone, naloxone): Precipitate withdrawal.
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Moderate Interactions

  • Anticholinergic drugs (e.g., antihistamines, tricyclic antidepressants, antipsychotics, muscle relaxants): Increased risk of urinary retention and/or severe constipation.
  • Diuretics: Reduced efficacy of diuretics due to ADH release.
  • P-glycoprotein (P-gp) inhibitors/inducers: May alter morphine exposure.
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Minor Interactions

  • Antihypertensives: May cause additive hypotensive effects.

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 plan for opioid-induced constipation prevention.

Timing: Prior to initiation of therapy

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Routine Monitoring

Pain assessment

Frequency: Regularly, typically before each dose or every 2-4 hours initially, then as needed

Target: Acceptable pain level as defined by patient

Action Threshold: Uncontrolled pain, requiring dose adjustment or alternative therapy

Respiratory rate and depth

Frequency: Every 1-4 hours initially, then as clinically indicated

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

Action Threshold: <10 breaths/minute, shallow breathing, or signs of respiratory distress (e.g., cyanosis, somnolence)

Level of consciousness/sedation

Frequency: Every 1-4 hours initially, then as clinically indicated

Target: Alert, easily aroused

Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolent, stuporous)

Bowel function

Frequency: Daily

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

Action Threshold: Constipation (e.g., no bowel movement for 3 days, straining, hard stools)

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Morphine can cause fetal harm when administered to a pregnant woman. 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:

First Trimester: Potential for congenital malformations (limited human data, some animal studies suggest risk).
Second Trimester: Risk of neonatal opioid withdrawal syndrome with prolonged use.
Third Trimester: High risk of neonatal opioid withdrawal syndrome (NOWS) with prolonged use; risk of respiratory depression in the neonate if used close to delivery.
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Lactation

Morphine is excreted in breast milk. Infants exposed to morphine through breast milk should be monitored for signs of sedation and respiratory depression. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Moderate risk (L3). Potential for sedation, poor feeding, and respiratory depression in the infant. Monitor for signs of opioid effects.
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Pediatric Use

Use with caution. Dosing is weight-based and requires careful titration. Neonates and infants are particularly sensitive to respiratory depressant effects. Not recommended for routine use in very young children without specialized pain management expertise.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Morphine immediate-release is suitable for acute pain or for titration to determine an appropriate daily dose before converting to an extended-release formulation.
  • Always prescribe and advise on a bowel regimen (e.g., stimulant laxative plus stool softener) concurrently with opioid therapy to prevent opioid-induced constipation.
  • Educate patients and caregivers on the signs of respiratory depression and the availability of naloxone.
  • Due to its abuse potential, prescribe the smallest effective dose for the shortest duration consistent with treatment goals.
  • Monitor for signs of tolerance and hyperalgesia, which may indicate a need for dose adjustment or alternative pain management strategies.
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Alternative Therapies

  • Other opioid analgesics (e.g., oxycodone, hydromorphone, fentanyl)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
  • Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
  • Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (30mg)
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 each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss with your doctor or pharmacist how to obtain or use naloxone. 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.