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Morphine Sulfate 4mg/ml Inj, 1ml

Manufacturer FRESENIUS KABI USA 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 high doses at term)
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FDA Approved
Jan 1941
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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 to change how your body feels and responds to pain. It is used for moderate to severe pain, especially after surgery or for serious injuries.
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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 instructions carefully. This medication is administered via injection into a muscle, vein, or the fatty layer 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 drive or operate heavy machinery until you know how this medicine affects you, as it can cause drowsiness and dizziness.
  • Avoid alcohol and other sedating medications (like sleeping pills or anxiety medications) unless specifically instructed by your doctor, as this can increase the risk of serious breathing problems.
  • Report any difficulty breathing, extreme drowsiness, or feeling faint immediately.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and ask your doctor about stool softeners or laxatives.
  • Do not share this medication with anyone else, as it can be dangerous and is illegal.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Acute Pain (IV/IM/SC): 2-10 mg every 3-4 hours as needed.
Dose Range: 2 - 10 mg

Condition-Specific Dosing:

postoperativePain: IV: 1-4 mg every 1-4 hours as needed, titrated to effect.
myocardialInfarction: IV: 2-4 mg initially, then 2-8 mg every 5-15 minutes as needed.
epidural: Initial: 5 mg in lumbar region. Max: 10 mg/24 hours.
intrathecal: Initial: 0.2-1 mg. Max: 1 mg/24 hours.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and reduced doses if used (e.g., 0.03-0.05 mg/kg/dose IV/IM/SC every 4-8 hours).
Infant: IV/IM/SC: 0.05-0.2 mg/kg/dose every 2-4 hours as needed (max 15 mg/dose).
Child: IV/IM/SC: 0.05-0.2 mg/kg/dose every 2-4 hours as needed (max 15 mg/dose).
Adolescent: IV/IM/SC: 0.05-0.2 mg/kg/dose every 2-4 hours as needed (max 15 mg/dose), or adult dosing if weight appropriate.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor for increased effects.
Moderate: Reduce dose by 25-50% and/or extend dosing interval. Monitor for accumulation of active metabolites (morphine-6-glucuronide).
Severe: Reduce dose by 50-75% and/or extend dosing interval. Avoid if possible. Monitor closely for respiratory depression and sedation.
Dialysis: Morphine and its active metabolites are dialyzable. Administer after dialysis. Significant dose reduction required (e.g., 25% of normal dose).

Hepatic Impairment:

Mild: No specific adjustment, but monitor for increased effects.
Moderate: Reduce dose by 25-50% and/or extend dosing interval. Monitor for increased effects.
Severe: Reduce dose by 50-75% and/or extend dosing interval. Avoid if possible. Monitor closely for respiratory depression and sedation.

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 perception of pain, and generalized CNS depression.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable for IV/IM/SC injection (100% for IV). Oral bioavailability is low (20-40%) due to significant first-pass metabolism.
Tmax: IV: 1-2 minutes; IM: 30-60 minutes; SC: 60-90 minutes.
FoodEffect: Not applicable for injection.

Distribution:

Vd: 3-4 L/kg (adults)
ProteinBinding: 20-35%
CnssPenetration: Yes, readily crosses the blood-brain barrier.

Elimination:

HalfLife: 2-4 hours (parent drug); M6G half-life is longer, especially in renal impairment.
Clearance: 15-30 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10% (parent drug)
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Pharmacodynamics

OnsetOfAction: IV: within minutes; IM: 10-30 minutes; SC: 15-60 minutes.
PeakEffect: IV: 20 minutes; IM: 30-60 minutes; SC: 60-90 minutes.
DurationOfAction: 4-5 hours (for single dose).

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); RESPIRATORY DEPRESSION; 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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
 Signs of low blood sugar, including:
+ Dizziness or lightheadedness
+ Headache or feeling sleepy or weak
+ Shaking or fast heartbeat
+ Confusion, hunger, or sweating
Severe dizziness or fainting
 Chest pain or pressure, or a rapid heartbeat
Confusion or disorientation
 Breathing difficulties, such as:
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Seizures
 Severe constipation or stomach pain, which may indicate a bowel problem
Depression or mood changes
 Swelling in the arms or legs
Fever, chills, or sore throat
 Painful urination
Abnormal sensations, such as burning, numbness, or tingling
 Serotonin syndrome, a potentially life-threatening condition, which may occur when taking this medication with certain other drugs. Symptoms include:
+ Agitation or changes in balance
+ Confusion or hallucinations
+ Fever or rapid heartbeat
+ Flushing or muscle twitching or stiffness
+ Seizures or shivering
+ Excessive sweating or 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 or severe dizziness
+ Nausea, vomiting, or decreased appetite
 Hormonal changes, which may occur with long-term opioid use. Symptoms include:
+ Decreased libido or fertility problems
+ Irregular menstrual periods or ejaculation problems

Additional Side Effects (Injection Only)

If you receive this medication via injection into the spine, you may experience:

Loss of motor function
 Muscle spasms
Difficulty controlling body movements
 Urination problems

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following symptoms, contact your doctor if they bother you or persist:

Dizziness, drowsiness, fatigue, or weakness
 Dry mouth
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
 Headache
Anxiety
 Excessive sweating

This is not an exhaustive list of possible side effects. If you have concerns or questions, consult your doctor. 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 inability to have a bowel movement
  • Hives, rash, or swelling of the face, lips, tongue, or throat (signs of allergic reaction)
  • Confusion or hallucinations
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Before Using This Medicine

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

To ensure your safety while taking this medication, it is crucial that you inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Describe the allergic reactions you have 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
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
 Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

If you are receiving this medication via spinal injection, also inform your doctor if you:
Have an infection at the injection site
 Experience bleeding problems
* Are taking anticoagulant (blood-thinning) medications

This list is not exhaustive, and it is essential to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

Important Warnings and Precautions

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 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 cause dependence. If you need to lower your dose or stop taking this medication, consult your doctor to avoid withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

Allergies and Interactions
If you are allergic to sulfites, discuss this with your doctor, as some products contain sulfites. 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 in some individuals, particularly those 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. Inform your doctor if you are breastfeeding, as this medication passes into breast milk and may 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
  • Extreme drowsiness or unresponsiveness
  • Slow, shallow, or stopped breathing
  • Bluish discoloration of lips or fingernails
  • Cold, clammy skin
  • Limp muscles
  • Low blood pressure
  • Slow heart rate
  • Coma

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. Administer naloxone if available and trained to do so. Call 1-800-222-1222 (Poison Control Center) for further guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI use (risk of serotonin syndrome, respiratory depression, coma, death)
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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, fentanyl): Risk of serotonin syndrome.
  • Mixed agonist/antagonist and partial agonist opioids (e.g., buprenorphine, nalbuphine, pentazocine): May precipitate withdrawal symptoms or reduce analgesic effect.
  • Diuretics: May reduce the efficacy of diuretics due to ADH release.
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Moderate Interactions

  • Anticholinergics (e.g., atropine, scopolamine): Increased risk of severe constipation and/or urinary retention.
  • Antihypertensives: May cause additive hypotensive effects.
  • Cimetidine: May increase morphine levels due to inhibition of metabolism (minor effect).
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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 first dose and regularly throughout therapy.

Vital signs (respiratory rate, heart rate, blood pressure)

Rationale: To assess baseline cardiorespiratory status and identify contraindications or risk factors for adverse effects.

Timing: Prior to first dose.

Level of consciousness/sedation score

Rationale: To assess baseline neurological status and risk of oversedation.

Timing: Prior to first dose.

Renal and hepatic function tests (BUN, creatinine, LFTs)

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

Timing: Prior to initiation, especially in patients with known or suspected impairment.

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Routine Monitoring

Pain assessment

Frequency: Every 1-4 hours (acute pain) or as clinically indicated.

Target: Patient-specific pain goal (e.g., reduction by 2 points on 0-10 scale, or tolerable pain level).

Action Threshold: Pain not adequately controlled, or pain score increasing.

Respiratory rate and depth

Frequency: Every 15-30 minutes initially after IV dose, then every 1-4 hours or as clinically indicated.

Target: 12-20 breaths/minute (adults), age-appropriate for pediatrics.

Action Threshold: <10-12 breaths/minute (adults), shallow breathing, or signs of respiratory distress.

Sedation level (e.g., Pasero Opioid-Induced Sedation Scale)

Frequency: Every 15-30 minutes initially after IV dose, then every 1-4 hours or as clinically indicated.

Target: Alert or mildly drowsy, easily aroused.

Action Threshold: Difficult to arouse, somnolent, or unarousable.

Blood pressure and heart rate

Frequency: Every 1-4 hours or as clinically indicated.

Target: Within patient's normal range.

Action Threshold: Significant hypotension or bradycardia.

Bowel function

Frequency: Daily

Target: Regular bowel movements.

Action Threshold: Constipation (no bowel movement for >2-3 days).

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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
  • Confusion/disorientation

Special Patient Groups

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Pregnancy

Use during pregnancy, especially prolonged use or near term, can lead to neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening if not recognized and treated. Morphine crosses the placenta. Short-term use for acute pain may be considered if benefits outweigh risks, but careful monitoring of the neonate is essential.

Trimester-Specific Risks:

First Trimester: Limited data on teratogenicity, but generally avoided unless clearly needed.
Second Trimester: Risk of fetal respiratory depression and potential for NOWS with prolonged exposure.
Third Trimester: High risk of neonatal opioid withdrawal syndrome (NOWS) and respiratory depression in the newborn if used near term. Prolonged use may lead to physical dependence in the fetus.
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Lactation

Morphine is excreted into breast milk. While generally considered compatible with breastfeeding for short-term, single-dose use, caution is advised. Monitor the infant for signs of sedation, poor feeding, and respiratory depression. Long-term or high-dose use is generally not recommended.

Infant Risk: L3 (Moderately Safe) - Risk of infant sedation, respiratory depression, constipation, and poor feeding. Risk is higher in neonates and premature infants.
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Pediatric Use

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

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of morphine, including respiratory depression, sedation, and constipation, due to decreased renal and hepatic function, reduced lean body mass, and polypharmacy. Lower initial doses and slower titration are recommended. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Always have naloxone readily available when administering morphine, especially in opioid-naive patients or those at high risk of respiratory depression.
  • Titrate dose slowly to effect, especially in opioid-naive, elderly, or renally/hepatically impaired patients.
  • Monitor respiratory rate and sedation level frequently, particularly during the first hour after IV administration.
  • Prophylactic bowel regimen (stool softener + stimulant laxative) should be initiated with regular opioid use to prevent opioid-induced constipation.
  • Morphine is a potent histamine releaser, which can cause pruritus, flushing, and urticaria, especially with rapid IV administration. This is not a true allergic reaction unless accompanied by other anaphylactic symptoms.
  • Consider alternative analgesics or multimodal pain management strategies to minimize opioid use and side effects.
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Alternative Therapies

  • Other opioid analgesics (e.g., hydromorphone, fentanyl, oxycodone, codeine)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
  • Regional anesthesia (e.g., nerve blocks, epidural analgesia)
  • Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
  • Non-pharmacological pain management (e.g., physical therapy, heat/cold therapy, massage, acupuncture)
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Cost & Coverage

Average Cost: $5 - $20 per 1ml vial (4mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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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, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Additionally, you may want to inquire about potential drug take-back programs in your area.

This medication is accompanied by a Medication Guide, which provides crucial information for patients. It is essential 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, 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 administered to help treat the condition. 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred, to ensure prompt and effective treatment.