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Morphine Sul 50mg/ml Inj, 50ml

Manufacturer HOSPIRA Active Ingredient Morphine Injection(MOR feen) Pronunciation MOR-feen
WARNING: For all injections: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.Injection (if given into the spine):You will be watched closely for breathing problems and other severe effects for at least 24 hours after getting this drug. @ 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 C (short-term), Category D (prolonged use or near 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 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 severe pain that other medicines cannot control.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the dosage instructions carefully. This medication is administered via injection into a muscle, vein, or the fatty tissue under the skin.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.

Missing a Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Do not drink alcohol while taking this medication, as it can increase the risk of serious side effects like extreme drowsiness and breathing problems.
  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause dizziness, drowsiness, and impaired judgment.
  • To prevent severe constipation, drink plenty of fluids, eat fiber-rich foods, and use a stool softener or laxative as recommended by your doctor.
  • Do not share this medication with anyone else, as it can be dangerous and is illegal.
  • Store this medication securely to prevent accidental ingestion, especially by children or pets.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized. For severe pain, initial IV bolus 2-10 mg, then titrated. For continuous infusion (often in palliative care with this concentration), rates vary widely, e.g., 0.8-10 mg/hr or higher, adjusted to patient response and tolerance. Subcutaneous/Intramuscular: 5-20 mg every 4 hours as needed.
Dose Range: 2 - 20 mg

Condition-Specific Dosing:

acuteSeverePain: IV: 2-10 mg every 3-4 hours PRN, or continuous infusion titrated to effect.
chronicSeverePain: Continuous IV/SC infusion, titrated to effect, often starting at 0.8-10 mg/hr and adjusted based on prior opioid exposure and pain control.
palliativeCare: Often used as concentrated SC/IV infusion or bolus for breakthrough pain, highly individualized based on patient's opioid tolerance.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and specialized protocols required if used (e.g., 0.01-0.03 mg/kg/dose IV, titrate slowly).
Infant: IV: 0.05-0.1 mg/kg/dose every 2-4 hours PRN; Max 0.2 mg/kg/dose. Continuous IV infusion: 0.01-0.04 mg/kg/hr.
Child: IV: 0.05-0.1 mg/kg/dose every 2-4 hours PRN; Max 0.2 mg/kg/dose. Continuous IV infusion: 0.01-0.04 mg/kg/hr.
Adolescent: Similar to adult dosing, but start with lower doses and titrate carefully (e.g., IV 2-5 mg every 3-4 hours PRN).
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Dose Adjustments

Renal Impairment:

Mild: Consider dose reduction or extended dosing interval.
Moderate: Reduce dose by 25-50% or extend dosing interval. Monitor closely for sedation and respiratory depression.
Severe: Reduce dose by 50-75% or extend dosing interval significantly. Avoid if possible. Monitor closely for accumulation of active metabolites (M6G).
Dialysis: Morphine and its active metabolites are partially dialyzable. Administer after dialysis. Significant dose reduction required.

Hepatic Impairment:

Mild: Consider dose reduction.
Moderate: Reduce dose by 25-50%. Monitor closely for increased effects.
Severe: Reduce dose by 50-75%. Avoid if possible. Monitor closely for increased effects and prolonged duration of action.

Pharmacology

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Mechanism of Action

Morphine is a potent opioid analgesic that acts primarily as an agonist at mu (Îŧ) opioid receptors in the central nervous system (CNS). It also has weaker agonist activity at kappa (Îē) and delta (δ) opioid receptors. Activation of these receptors leads to inhibition of pain transmission, altered pain perception, and effects on mood and reward pathways.
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Pharmacokinetics

Absorption:

Bioavailability: IV: 100%; Oral: 20-40% (due to significant first-pass metabolism)
Tmax: IV: 10-20 minutes; IM: 30-60 minutes; SC: 60-90 minutes
FoodEffect: Not applicable for injection; for oral forms, food may delay absorption but not significantly affect extent.

Distribution:

Vd: 3-4 L/kg
ProteinBinding: Approximately 30-35%
CnssPenetration: Yes, readily crosses the blood-brain barrier, but slower than some other opioids.

Elimination:

HalfLife: 2-4 hours (parent drug); M6G half-life can be longer, especially in renal impairment.
Clearance: Approximately 15-30 mL/min/kg
ExcretionRoute: Primarily renal (90% as glucuronide conjugates, 7-10% as unchanged drug); small amount in feces/bile.
Unchanged: Approximately 7-10%
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Pharmacodynamics

OnsetOfAction: IV: 5-10 minutes; IM: 10-30 minutes; SC: 15-30 minutes
PeakEffect: IV: 20 minutes; IM: 30-60 minutes; SC: 60-90 minutes
DurationOfAction: IV/IM/SC: 3-5 hours (analgesia)

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; 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
 Signs of low blood sugar: dizziness, headache, feeling sleepy, feeling weak, shaking, fast heartbeat, confusion, hunger, or 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 or 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
 A burning, numbness, or tingling feeling that is not normal

Serotonin Syndrome: A Potentially Life-Threatening Condition

If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help right away if you experience:
Agitation
 Change in balance
Confusion
 Hallucinations
Fever
 Fast or abnormal heartbeat
Flushing
 Muscle twitching or stiffness
Seizures
 Shivering or shaking
Sweating a lot
 Severe diarrhea, upset stomach, or throwing up
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
 Throwing up
Decreased appetite

Hormonal Changes: A Potential Long-Term Effect

Long-term use of an opioid medication may lead to lower sex hormone levels. If you experience:
 Lowered interest in sex
Fertility problems
 No menstrual period
Ejaculation problems
contact your doctor.

Injection-Specific Side Effects (if given into the spine)

If you receive this medication via injection into the spine, seek medical help right away if you experience:
 Inability to move
Muscle spasm
 Trouble controlling body movements
Trouble passing urine

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
 Feeling dizzy, sleepy, tired, or weak
Dry mouth
 Constipation, diarrhea, stomach pain, upset stomach, throwing up, or decreased appetite
Headache
 Anxiety
* Sweating a lot

Reporting Side Effects

If you have questions about side effects or want to report a side effect, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Difficulty breathing or very slow, shallow breathing
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness when standing up
  • Confusion or disorientation
  • Severe constipation or abdominal pain
  • Signs of an 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

To ensure safe treatment, inform your doctor about the following:

Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reactions you've experienced.
 Certain health conditions, such as:
+ Respiratory issues like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
 Current use of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

Additional Considerations for Spinal Injection:

Presence of an infection at the injection site
 Bleeding disorders
* Use of anticoagulant medications (blood thinners)

This list is not exhaustive. It is crucial to inform your doctor and pharmacist about all prescription and over-the-counter medications, natural products, and vitamins you are taking, as well as any health issues you have. This will help determine the safety of using this medication in conjunction with your other treatments. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of 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 experience increased sensitivity to pain, or you develop 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, regular use of opioid medications like this one can result in dependence. If you need to reduce the 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. Avoid consuming 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. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.

Special Precautions
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 (miosis)
  • Profound respiratory depression (slow, shallow, or absent breathing)
  • Extreme drowsiness leading to stupor or coma
  • Limp muscles (flaccidity)
  • Cold, clammy skin
  • Low blood pressure
  • Slow heart rate
  • Circulatory collapse
  • Death

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) for further guidance.

Drug Interactions

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Contraindicated Interactions

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

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): Risk of serotonin syndrome.
  • Anticholinergic drugs (e.g., antihistamines, TCAs, antipsychotics): Increased risk of urinary retention and severe constipation, paralytic ileus.
  • Mixed agonist/antagonist opioids (e.g., buprenorphine, nalbuphine, pentazocine): May precipitate withdrawal symptoms or reduce analgesic effect.
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Moderate Interactions

  • Diuretics: May reduce the efficacy of diuretics due to opioid-induced ADH release.
  • Antihypertensives: May cause additive hypotensive effects.
  • Cimetidine: May inhibit morphine metabolism, leading to increased morphine levels.
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Minor Interactions

  • Not available

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 neurological status and identify risk for excessive sedation.

Timing: Prior to initiation of therapy.

Renal and hepatic function tests (CrCl, LFTs)

Rationale: To identify potential impairment that may necessitate dose adjustment due to altered metabolism or excretion.

Timing: Prior to initiation of therapy, especially in elderly or patients with comorbidities.

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Routine Monitoring

Pain assessment

Frequency: Regularly (e.g., every 1-4 hours initially, then as needed based on stability and route)

Target: Acceptable pain level as defined by patient goals.

Action Threshold: Uncontrolled pain or significant increase in pain; requires dose adjustment or alternative intervention.

Respiratory rate and depth

Frequency: Regularly (e.g., every 1-4 hours initially, then as needed based on stability)

Target: Typically >10-12 breaths/min, unlabored.

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoventilation; requires immediate intervention (e.g., naloxone, respiratory support).

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

Frequency: Regularly (e.g., every 1-4 hours initially, then as needed based on stability)

Target: Alert or mildly drowsy, easily aroused.

Action Threshold: Difficult to arouse, somnolent, or unarousable; requires immediate intervention (e.g., naloxone, reduce dose).

Bowel function (frequency of bowel movements)

Frequency: Daily

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

Action Threshold: Constipation (no bowel movement for >3 days, straining, hard stools); requires laxative regimen adjustment.

Blood pressure and heart rate

Frequency: Regularly (e.g., every 4-8 hours initially)

Target: Within patient's normal range.

Action Threshold: Significant hypotension or bradycardia; requires intervention.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS).

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations cannot be ruled out. Generally avoided.
Second Trimester: Risk of fetal growth restriction and other adverse outcomes 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.
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Lactation

Morphine is excreted into breast milk. While generally considered compatible with breastfeeding for short-term, single-dose use, chronic use or high doses are not recommended due to risk of infant sedation, respiratory depression, and withdrawal.

Infant Risk: Moderate risk. Monitor infants for increased sleepiness, difficulty breathing, poor feeding, and developmental delay. Consider alternative analgesics or pump and dump for a period after high doses.
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Pediatric Use

Dosing must be carefully calculated based on weight and age, and titrated to effect. Pediatric patients, especially neonates and infants, are more sensitive to the respiratory depressant effects of opioids. Close monitoring is essential.

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of morphine (e.g., respiratory depression, sedation, constipation) due to decreased renal and hepatic function, reduced lean body mass, and polypharmacy. Start with lower doses and titrate slowly. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Morphine 50mg/ml is a highly concentrated formulation, typically reserved for patients with high opioid tolerance, severe pain, or for use in continuous infusions (e.g., palliative care, PCA pumps). Extreme caution is needed to prevent dosing errors.
  • Always have naloxone readily available when administering morphine, especially in opioid-naive patients or when titrating doses.
  • Prophylactic bowel regimen (stool softener plus stimulant laxative) should be initiated at the start of opioid therapy to prevent opioid-induced constipation.
  • Tolerance to the analgesic effects of morphine can develop over time, requiring dose escalation. Physical dependence and psychological addiction are risks with chronic use.
  • Monitor for signs of opioid-induced hyperalgesia, which can manifest as increasing pain despite escalating opioid doses.
  • The active metabolite, M6G, accumulates in renal impairment, leading to prolonged and enhanced opioid effects. Dose adjustments are crucial in these patients.
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Alternative Therapies

  • Other strong opioid analgesics (e.g., hydromorphone, fentanyl, oxycodone)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts
  • Adjuvant analgesics (e.g., gabapentin, pregabalin for neuropathic pain; antidepressants for chronic 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: Check current market data per 50ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 for generic formulations, depending on insurance plan.
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your medication with others, and do not take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs that provide a safe and environmentally friendly way to dispose of unwanted medications.

This medication is accompanied by a Medication Guide, which provides important information about its safe and effective use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be used as part of the treatment. Consult your doctor or pharmacist about obtaining and using naloxone. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate care.