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Morphine Sul 4mg/ml Inj, 1ml

Manufacturer WEST-WARD 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
C
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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 belongs to a group of drugs called opioids. It works in your brain and spinal cord to change how your body feels and responds to pain. It is given by injection, usually into a vein, muscle, or under the skin, to provide fast relief for severe pain.
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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 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 to determine the best storage method.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on what to do next.
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Lifestyle & Tips

  • Avoid alcohol and other sedatives (e.g., benzodiazepines) while taking morphine, as this can lead to dangerous breathing problems and extreme drowsiness.
  • Do not drive or operate heavy machinery until you know how morphine affects you, as it can cause dizziness and drowsiness.
  • Report any difficulty breathing, extreme sleepiness, or confusion immediately to your healthcare provider.
  • 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, and keep it in a secure place to prevent misuse.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: IV: 2-10 mg every 3-4 hours as needed; IM/SC: 5-20 mg every 3-4 hours as needed
Dose Range: 2 - 20 mg

Condition-Specific Dosing:

acutePain_IV: Initial 2-4 mg, titrate in 1-2 mg increments every 5-15 minutes until pain relief or adverse effects occur.
postoperativePain_PCA: Loading dose 2-5 mg, then 0.5-2 mg demand dose with 5-10 minute lockout interval.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution, consider alternative. If used, 0.01-0.03 mg/kg/dose IV/IM/SC every 4-6 hours.
Infant: 0.05-0.2 mg/kg/dose IV/IM/SC every 2-4 hours as needed (max 15 mg/dose).
Child: 0.05-0.2 mg/kg/dose IV/IM/SC every 2-4 hours as needed (max 15 mg/dose).
Adolescent: Similar to adult dosing, 0.05-0.2 mg/kg/dose IV/IM/SC every 2-4 hours as needed (max 15 mg/dose).
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Dose Adjustments

Renal Impairment:

Mild: Reduce dose by 25-50% or extend dosing interval.
Moderate: Reduce dose by 50-75% or extend dosing interval significantly.
Severe: Avoid or use with extreme caution; significant dose reduction (e.g., 75% or more) and extended intervals (e.g., every 6-8 hours or longer). Monitor closely for accumulation of active metabolites (M6G).
Dialysis: Supplemental dose after hemodialysis may be needed; monitor closely. Morphine and its metabolites are dialyzable to some extent.

Hepatic Impairment:

Mild: No specific adjustment, but monitor for increased sensitivity.
Moderate: Reduce initial dose by 25-50%; titrate carefully.
Severe: Reduce initial dose by 50-75%; titrate very carefully and monitor for prolonged effects.

Pharmacology

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Mechanism of Action

Morphine is a full opioid agonist that acts primarily on the mu-opioid receptors in the central nervous system (CNS) and gastrointestinal tract. Its analgesic effects are mediated by binding to these receptors, leading to inhibition of pain signal transmission, altered pain perception, and induction of euphoria. It also causes respiratory depression, miosis, and reduced gastrointestinal motility.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV); 20-40% (oral, due to extensive 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 alter extent.

Distribution:

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

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: Renal (primarily as glucuronide conjugates)
Unchanged: <10% (parent drug)
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Pharmacodynamics

OnsetOfAction: IV: <5 minutes; IM: 10-30 minutes; SC: 15-60 minutes
PeakEffect: IV: 20 minutes; IM: 30-60 minutes; SC: 60-90 minutes
DurationOfAction: 3-5 hours (for immediate-release injection)

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; INTERACTIONS WITH OTHER CNS DEPRESSANTS; ACCIDENTAL INGESTION.
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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 fainting
 Chest pain or pressure, or a fast heartbeat
Confusion
 Breathing difficulties, slow breathing, or shallow breathing
Noisy breathing or sleep apnea (breathing problems during sleep)
 Seizures
Severe constipation or stomach pain, which may be signs of a severe bowel problem
 Depression or other mood changes
Swelling in the arms or legs
 Fever, chills, or sore throat
Pain when urinating
 Abnormal sensations, such as burning, numbness, or tingling
Serotonin syndrome, a potentially life-threatening condition, may occur when taking this medication with certain other drugs. Symptoms include agitation, balance problems, confusion, hallucinations, fever, fast or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, upset stomach, or vomiting, and severe headache

Additional Serious Side Effects

 Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Seek medical help immediately if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.
Long-term use of an opioid medication may cause lower sex hormone levels. Contact your doctor if you experience decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems.

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

 Loss of muscle movement
Muscle spasms
 Difficulty controlling body movements
Urination problems

Other Possible Side Effects

While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:

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

If you experience any of these side effects or have concerns about others, contact your doctor or seek medical attention. You can also report side effects to the FDA at 1-800-332-1088 or 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
  • Bluish lips or fingernails
  • Severe dizziness or lightheadedness
  • Confusion or hallucinations
  • Pinpoint pupils
  • Severe constipation or abdominal pain
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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Before Using This Medicine

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

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

Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced.
 Existing 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 certain 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 blood thinners

This list is not exhaustive. It is essential to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to verify the safety of taking this medication with your existing regimen. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

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

When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.

Do not combine this medication with other strong pain relievers or use it with a pain patch without first consulting your doctor. If your pain worsens, you become more sensitive to pain, or experience new pain after taking this medication, contact your doctor immediately. Do not exceed the prescribed dose.

Long-term or high-dose use of this medication can lead to tolerance, where the drug becomes less effective, and higher doses may be required to achieve the same effect. If you find that this medication is no longer working as well as it should, consult your doctor. Do not increase your dose without medical guidance.

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

If you have a sulfite allergy, discuss this with your doctor, as some products contain sulfites. Avoid consuming alcohol or using products that contain alcohol while taking this medication, as this can lead to unsafe and potentially fatal consequences.

This medication may increase the risk of seizures in certain individuals, including those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are breastfeeding, as this medication can pass into breast milk and harm your baby. Seek immediate medical attention if your baby appears excessively sleepy, limp, or has breathing difficulties.
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Overdose Information

Overdose Symptoms:

  • Severe respiratory depression (slowed or stopped breathing)
  • Extreme somnolence progressing to stupor or coma
  • Skeletal muscle flaccidity
  • Cold, clammy skin
  • Pinpoint pupils (miosis)
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Circulatory collapse
  • Cardiac arrest
  • 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. Provide respiratory support (e.g., rescue breathing) if breathing is severely depressed. Call 1-800-222-1222 (Poison Control Center).

Drug Interactions

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Contraindicated Interactions

  • Not typically contraindicated with specific drugs, but extreme caution/avoidance with certain classes.
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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 respiratory depression, profound sedation, coma, and death.
  • Mixed opioid agonist/antagonists (e.g., nalbuphine, butorphanol, pentazocine): May precipitate withdrawal symptoms or reduce analgesic effect.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, MAOIs): Risk of serotonin syndrome (especially with MAOIs).
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Moderate Interactions

  • Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and/or severe constipation.
  • Diuretics: Opioids may reduce the efficacy of diuretics by inducing ADH release.
  • Muscle relaxants: Enhanced neuromuscular blockade.
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Minor Interactions

  • Cimetidine: May increase morphine levels (minor effect).

Monitoring

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Baseline Monitoring

Pain assessment (intensity, character, location)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to first dose

Respiratory rate and depth

Rationale: To assess baseline respiratory function and risk of depression.

Timing: Prior to first dose

Level of consciousness/sedation

Rationale: To assess baseline neurological status and risk of over-sedation.

Timing: Prior to first dose

Renal and hepatic function tests (CrCl, LFTs)

Rationale: To identify impairment that may require dose adjustment.

Timing: Prior to initiation, especially in at-risk patients

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Routine Monitoring

Pain assessment

Frequency: Every 1-4 hours (acute pain); as needed (chronic pain)

Target: Patient-specific pain goal (e.g., 0-3/10)

Action Threshold: Pain uncontrolled, or pain score increasing

Respiratory rate and depth

Frequency: Every 15-30 minutes (initial IV/acute); every 1-4 hours (stable); as needed

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

Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation

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

Frequency: Every 15-30 minutes (initial IV/acute); every 1-4 hours (stable); as needed

Target: Alert to mildly drowsy (S1-S2)

Action Threshold: Difficult to arouse, somnolent, or unarousable (S3-S4)

Oxygen saturation (SpO2)

Frequency: Continuous or intermittent, especially with high doses or risk factors

Target: >92-94%

Action Threshold: <90% or significant drop from baseline

Bowel function

Frequency: Daily

Target: Regular bowel movements

Action Threshold: Constipation, abdominal distension

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Use during pregnancy may cause neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening if not recognized and treated. Prolonged use during pregnancy is not recommended. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data on teratogenicity; some studies suggest a possible association with neural tube defects and cardiac defects, but evidence is not conclusive.
Second Trimester: Risk of fetal growth restriction and premature birth 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 close to 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 potential for infant sedation, respiratory depression, and withdrawal symptoms. Monitor infants for signs of sedation, poor feeding, and breathing difficulties.

Infant Risk: L3 (Moderately Safe) for single doses or short-term use; L4 (Potentially Hazardous) for chronic or high-dose use.
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Pediatric Use

Pediatric patients are more sensitive to the respiratory depressant effects of opioids. Dosing must be carefully calculated based on weight and titrated to effect. Close monitoring for respiratory depression and sedation is crucial. Not recommended for routine use in neonates.

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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, due to decreased renal and hepatic function, reduced lean body mass, and polypharmacy. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Always have naloxone readily available when administering morphine, especially in opioid-naïve patients or with higher doses.
  • Titrate dose slowly to effect, especially in opioid-naïve, elderly, or renally/hepatically impaired patients.
  • Monitor respiratory rate and sedation level frequently, particularly during the first few hours after administration.
  • Prophylactic laxatives should be initiated with chronic opioid therapy to prevent opioid-induced constipation.
  • Be aware of the potential for tolerance, physical dependence, and opioid use disorder with prolonged use.
  • Consider alternative pain management strategies for chronic non-cancer pain to minimize opioid exposure.
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Alternative Therapies

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

Average Cost: $5 - $20 per 1ml vial (4mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or 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; do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. You can also inquire about drug take-back programs in your area, which may offer 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 use. It is crucial 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 used as an emergency treatment. Discuss with your doctor or pharmacist how to obtain or use naloxone, and be prepared to seek immediate medical attention if you suspect an overdose has occurred, even if naloxone has been administered. When seeking medical help, 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.