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Morphine Sul 8mg/ml Inj, 1ml Vial

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
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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 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 to you. It is essential to follow the 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 to determine the proper 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 sedating medications unless approved by your doctor, as this can increase the risk of serious side effects like extreme drowsiness and breathing problems.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and discuss a bowel regimen (e.g., stool softeners, laxatives) with your healthcare provider.
  • 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: IV: 2-10 mg every 3-4 hours as needed, titrated to effect.
Dose Range: 2 - 15 mg

Condition-Specific Dosing:

acutePain: IV: 2-10 mg every 3-4 hours, titrated. SC/IM: 5-20 mg every 3-4 hours.
chronicPain: Individualized titration, often starting with lower doses and increasing gradually. May use extended-release formulations.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and reduced doses if used (e.g., 0.05 mg/kg/dose IV, titrate).
Infant: IV: 0.05-0.1 mg/kg/dose every 2-4 hours, max 0.2 mg/kg/dose. Titrate carefully.
Child: IV: 0.05-0.1 mg/kg/dose every 2-4 hours, max 0.2 mg/kg/dose. Titrate carefully.
Adolescent: IV: 0.05-0.1 mg/kg/dose every 2-4 hours, max 0.2 mg/kg/dose or adult dose. Titrate carefully.
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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.
Severe: Reduce dose by 75% or more, or extend dosing interval significantly. Avoid if possible due to accumulation of active metabolite (morphine-6-glucuronide).
Dialysis: Supplemental dose after hemodialysis may be needed. Monitor closely for prolonged effects.

Hepatic Impairment:

Mild: Reduce initial dose by 25-50%.
Moderate: Reduce initial dose by 50-75%.
Severe: Reduce initial dose by 75% or more. Monitor closely for increased effects and prolonged duration.

Pharmacology

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Mechanism of Action

Morphine is an opioid agonist that acts primarily at the mu-opioid receptors in the central nervous system (CNS). Binding to these receptors mimics the action of endogenous opioid peptides, leading to inhibition of pain transmission, alteration of pain perception, and production of analgesia. It also produces respiratory depression, euphoria, sedation, and decreased gastrointestinal motility.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable for IV injection (100% for IV). Oral bioavailability is 20-40%.
Tmax: IV: 10-20 minutes; IM: 30-60 minutes; SC: 60-90 minutes.
FoodEffect: Not applicable for injection. Oral absorption may be affected by food.

Distribution:

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

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: Rapid (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 immediate-release formulations).

Safety & Warnings

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BLACK BOX WARNING

WARNING: ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.

ADDICTION, ABUSE, AND MISUSE: Morphine Sulfate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Morphine Sulfate Injection, and monitor all patients regularly for the development of these behaviors and conditions.

RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Injection. Monitor for respiratory depression, especially during initiation of Morphine Sulfate Injection or following a dose increase.

ACCIDENTAL INGESTION: Accidental ingestion of even one dose of Morphine Sulfate Injection, especially by children, can result in a fatal overdose of morphine.

NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of Morphine Sulfate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction, such as:
+ Rash 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 rapid 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, characterized by:
+ 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 cause:
+ Extreme fatigue or weakness
+ Fainting or severe dizziness
+ Upset stomach, vomiting, or decreased appetite
 Hormonal changes, including:
+ Decreased sex drive
+ Fertility problems
+ Missed menstrual periods or ejaculation problems

Additional Side Effects (Injection into the Spine)

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

While many people may not experience side effects, some may encounter mild or moderate symptoms. If you notice any of the following, contact your doctor or seek medical attention if they persist or bother you:

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

Reporting Side Effects

If you have questions or concerns about side effects, contact 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 (less than 10 breaths per minute for adults)
  • Extreme drowsiness or difficulty waking up
  • Bluish lips or fingernails
  • Severe dizziness or lightheadedness
  • Confusion or disorientation
  • Severe constipation or inability to pass urine
  • 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 reaction you experienced, such as symptoms and severity.
 Existing health conditions, including:
+ Respiratory problems 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, such as 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, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to verify the safety of taking this medication. Do not initiate, discontinue, 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.

Safety Precautions

To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. When rising from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

Interactions and Contraindications

Do not take this medication with other strong pain medications or use a pain patch without first consulting your doctor. If you experience worsening pain, increased sensitivity to pain, or new pain after taking this medication, contact your doctor immediately. Do not exceed the prescribed dosage.

Tolerance and Dependence

Long-term or high-dose use of this medication may lead to tolerance, where the medication 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, contact your doctor. Do not increase your dosage without consulting your doctor.

Additionally, regular use of opioid medications like this one can result in dependence. If you need to reduce your dosage or stop taking this medication, consult your doctor first, as sudden changes can increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, or suicidal thoughts.

Allergies and Interactions

If you are allergic to sulfites, discuss this with your doctor, as some products contain sulfites. Avoid consuming alcohol or using products that contain alcohol, as this can lead to unsafe and potentially deadly effects.

Seizure Risk

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.

Special Considerations

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 potentially harm your baby. If your baby appears excessively sleepy, limp, or has breathing difficulties, seek medical attention immediately.
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Overdose Information

Overdose Symptoms:

  • Pinpoint pupils
  • Extreme drowsiness or unresponsiveness
  • Slow, shallow, or stopped breathing
  • Bluish skin, especially around the lips and fingertips
  • Limp body
  • Cold, clammy skin
  • Slowed heart rate
  • Low blood pressure
  • Coma

What to Do:

If you suspect an overdose, call 911 immediately. If naloxone (Narcan) is available and you are trained to use it, administer it as directed. Stay with the person until emergency medical help arrives. Provide rescue breathing if the person is not breathing.

Drug Interactions

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Contraindicated Interactions

  • Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI discontinuation (risk of serotonin syndrome or severe respiratory depression).
  • Patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
  • Known or suspected paralytic ileus.
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Major Interactions

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

  • Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
  • Antihypertensives: May cause additive hypotensive effects.
  • P-glycoprotein (P-gp) inhibitors/inducers: May alter morphine concentrations, though morphine is not a major P-gp substrate.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pain level (e.g., NRS, VAS)

Rationale: To establish baseline pain intensity and guide initial dosing.

Timing: Prior to first dose

Respiratory rate and depth

Rationale: To assess baseline respiratory function and identify risk for respiratory depression.

Timing: Prior to first dose

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

Rationale: To assess baseline CNS depression and guide initial dosing.

Timing: Prior to first dose

Blood pressure and heart rate

Rationale: To assess baseline cardiovascular status.

Timing: Prior to first dose

Bowel function

Rationale: To assess baseline bowel habits and anticipate opioid-induced constipation.

Timing: Prior to first dose

Renal and hepatic function tests (CrCl, LFTs)

Rationale: To identify impairment that may necessitate dose adjustment.

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

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Routine Monitoring

Pain level

Frequency: Every 1-2 hours initially, then every 2-4 hours or as needed based on patient response and stability.

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

Action Threshold: Uncontrolled pain, or pain score above patient's goal; consider dose adjustment or alternative analgesia.

Respiratory rate and depth

Frequency: Every 15-30 minutes for 1-2 hours after IV dose, then every 1-4 hours or as clinically indicated.

Target: Adults: >10-12 breaths/min, regular rhythm, adequate depth. Pediatrics: Age-appropriate normal range.

Action Threshold: Respiratory rate <10 breaths/min (adults), shallow breathing, irregular rhythm, or signs of hypoventilation; administer naloxone, provide respiratory support.

Sedation level

Frequency: Every 15-30 minutes for 1-2 hours after IV dose, then every 1-4 hours or as clinically indicated.

Target: Alert or mildly drowsy, easily aroused.

Action Threshold: Somnolent, difficult to arouse, or unarousable; administer naloxone, reduce dose, or hold next dose.

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; consider dose reduction or supportive measures.

Bowel function

Frequency: Daily

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

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

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Symptom Monitoring

  • Nausea/vomiting
  • Pruritus
  • Urinary retention
  • Dizziness/lightheadedness
  • Confusion/delirium
  • Signs of opioid withdrawal (if abruptly discontinued after prolonged use)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations with first-trimester opioid exposure is suggested by some studies, though not definitively established for morphine.
Second Trimester: Risk of NOWS increases with prolonged use. Fetal growth restriction may occur.
Third Trimester: High risk of NOWS if used chronically. Risk of respiratory depression in the neonate if administered shortly before delivery.
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Lactation

Morphine is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. A single dose is generally considered low risk, but chronic use is not recommended. Consider alternative analgesics or pump and dump if chronic use is necessary.

Infant Risk: Moderate risk (L3). Risk of sedation, respiratory depression, and withdrawal in the infant.
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Pediatric Use

Use with extreme caution and individualized dosing based on weight and age. Neonates and infants are particularly sensitive to respiratory depressant effects. Close monitoring for respiratory depression and sedation is crucial.

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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 and hepatic function. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Morphine is a potent opioid; always start with the lowest effective dose and titrate slowly, especially in opioid-naive patients.
  • Monitor respiratory rate and sedation level frequently, particularly during initiation and dose escalation.
  • Have naloxone readily available when administering morphine, especially in high-risk patients.
  • Opioid-induced constipation is a common and persistent side effect; proactive bowel regimen is essential.
  • The active metabolite, morphine-6-glucuronide (M6G), accumulates in renal impairment, leading to prolonged and enhanced opioid effects. Dose reduction is critical in these patients.
  • Tolerance and physical dependence can develop with prolonged use; do not discontinue abruptly after chronic use to avoid withdrawal symptoms.
  • Educate patients and caregivers on safe storage to prevent accidental ingestion, especially by children.
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Alternative Therapies

  • Other strong opioid agonists (e.g., hydromorphone, fentanyl, oxycodone)
  • Moderate opioid agonists (e.g., codeine, tramadol)
  • 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 (8mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic), Tier 3 (Brand)
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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 medication prescribed for someone else. 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 dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so by a healthcare professional. If you are unsure about the best method for disposing of your medication, consult with your pharmacist. Many communities have drug take-back programs that provide a safe and environmentally friendly way to dispose of unused medications.

This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides important information about its 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, 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. 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 information about what was taken, the amount, and the time it happened to healthcare professionals.