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Morphine Sulfate 2mg/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 (prolonged use or high doses at term: Category D)
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FDA Approved
Jan 1970
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Morphine is a strong pain medicine that works in your brain and spinal cord to change how your body feels and responds to pain. It is given by injection, usually in a hospital or clinic setting, 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 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

  • Avoid alcohol and other sedating medications unless approved by your doctor.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
  • Report any difficulty breathing, extreme drowsiness, or confusion immediately.
  • To prevent constipation, increase fluid intake, eat fiber-rich foods, and use stool softeners or laxatives as directed by your healthcare provider.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose for moderate to severe pain: 2-10 mg IV/IM/SC every 3-4 hours as needed.
Dose Range: 2 - 15 mg

Condition-Specific Dosing:

postoperativePain: 1-5 mg IV every 2-4 hours as needed, or continuous infusion 0.8-10 mg/hr.
myocardialInfarction: 2-4 mg IV, may repeat with 2-8 mg at 5-15 minute intervals.
cancerPain: Individualized, often higher doses or continuous infusions based on patient's opioid tolerance.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution if used (0.05 mg/kg/dose IV/IM/SC every 4-8 hours, max 0.1 mg/kg/dose).
Infant: 0.05-0.1 mg/kg/dose IV/IM/SC every 2-4 hours as needed (max 0.2 mg/kg/dose).
Child: 0.05-0.1 mg/kg/dose IV/IM/SC every 2-4 hours as needed (max 0.2 mg/kg/dose).
Adolescent: Similar to adult dosing, but individualized based on weight and pain severity.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Reduce initial dose by 25-50%; extend dosing interval. Monitor for increased sedation and respiratory depression.
Severe: Reduce initial dose by 50-75%; extend dosing interval. Avoid if possible. Monitor for increased sedation and respiratory depression.
Dialysis: Morphine and its active metabolite (M6G) are dialyzable. Administer after dialysis. Reduce dose significantly (e.g., 25% of normal dose) and extend interval.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Morphine is an opioid agonist that primarily acts on mu-opioid receptors in the central nervous system (CNS) and gastrointestinal tract. Activation of these receptors leads to inhibition of pain transmission, altered perception of pain, and various other effects including respiratory depression, euphoria, sedation, and decreased gastrointestinal motility.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (IV/IM/SC injection)
Tmax: IV: 1-2 minutes; IM: 30-60 minutes; SC: 60-90 minutes
FoodEffect: Not applicable (parenteral)

Distribution:

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

Elimination:

HalfLife: 2-4 hours (parent drug); M6G has a longer half-life (3-7 hours) especially in renal impairment.
Clearance: Not available
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10%
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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: 3-5 hours

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 or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
 Chest pain or pressure, or a rapid heartbeat
Feeling confused
 Breathing difficulties, including:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ 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 while urinating
Abnormal sensations, such as burning, numbness, or tingling
 Serotonin syndrome, a potentially life-threatening condition that may occur when taking this medication with certain other drugs. Symptoms include:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Rapid or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, nausea, or vomiting
+ Severe headache
Adrenal gland problems, which may occur with long-term use of opioid medications like this one. Symptoms include:
+ Feeling extremely tired or weak
+ Fainting
+ Severe dizziness
+ Upset stomach
+ Vomiting
+ Decreased appetite
 Hormonal changes, which may occur with long-term use of opioid medications like this one. Symptoms include:
+ Decreased interest in sex
+ Fertility problems
+ Missed menstrual periods
+ Ejaculation problems

Additional Side Effects:

Most people do not experience significant side effects, but some may occur. If you notice 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, 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.

Important Information for Injection (Spinal) Administration:

If you receive this medication via spinal injection, be aware of the following potential side effects:

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

Contact your doctor or seek medical attention if you experience any of these symptoms.
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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
  • Confusion or disorientation
  • Blue-tinged lips or fingernails
  • Severe constipation or inability to pass urine
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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.
 Certain health conditions, including:
+ Respiratory problems such as asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Recent use (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

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 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

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you.

To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position. Be cautious when climbing stairs.

Do not combine this medication with other potent pain relievers or use a pain patch without first consulting your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Adhere to the prescribed dosage and do not take more than instructed.

Long-term or high-dose use of this medication can lead to tolerance, where the drug becomes less effective, and you may require higher doses 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 exceed the recommended dosage.

Prolonged or regular use of opioid medications like this one can result in dependence. Suddenly reducing the dose or stopping the medication altogether may increase the risk of withdrawal or other severe complications. Before adjusting your dose or discontinuing this medication, consult your doctor and follow their instructions. Inform your doctor if you experience increased pain, mood changes, suicidal thoughts, or any other adverse effects.

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, 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. If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and potentially harm your baby. Seek immediate medical attention if your baby appears excessively sleepy, limp, or has difficulty breathing.
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Overdose Information

Overdose Symptoms:

  • Pinpoint pupils
  • Extreme drowsiness or unresponsiveness
  • Slow, shallow, or stopped breathing
  • 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. Naloxone (Narcan) may be administered by trained personnel. Call 1-800-222-1222 (Poison Control) for advice.

Drug Interactions

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Contraindicated Interactions

  • Concurrent use with MAO inhibitors or within 14 days of discontinuing MAO inhibitors (risk of serotonin syndrome or severe CNS depression).
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Major Interactions

  • Other CNS depressants (e.g., benzodiazepines, barbiturates, alcohol, general anesthetics, other opioids, sedatives/hypnotics, tricyclic antidepressants): Increased risk of respiratory depression, profound sedation, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, linezolid): Risk of serotonin syndrome.
  • Mixed agonist/antagonist opioids (e.g., buprenorphine, nalbuphine, butorphanol): May precipitate withdrawal symptoms or reduce analgesic effect.
  • Muscle relaxants: Enhanced neuromuscular blockade and increased risk of respiratory depression.
  • Diuretics: Reduced efficacy of diuretics due to ADH release.
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Moderate Interactions

  • Anticholinergic drugs (e.g., atropine, scopolamine, some antihistamines): Increased risk of urinary retention and severe constipation.
  • Antihypertensives: Additive hypotensive effects.
  • Cimetidine: May increase morphine levels.
  • Ritonavir: May increase 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 first dose

Respiratory rate and depth

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

Timing: Prior to first dose

Level of consciousness/sedation score

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

Timing: Prior to first dose

Blood pressure and heart rate

Rationale: To assess baseline cardiovascular status.

Timing: Prior to first dose

Renal and hepatic function tests (CrCl, LFTs)

Rationale: To identify potential need for dose adjustment in patients with organ impairment.

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

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Routine Monitoring

Pain assessment

Frequency: Every 2-4 hours initially, then as needed based on patient response and pain control.

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

Action Threshold: Pain score above target, or inadequate pain relief

Respiratory rate and depth

Frequency: Every 15-30 minutes for 1-2 hours after IV dose, then every 1-4 hours depending on stability and route.

Target: Respiratory rate >10-12 breaths/min, regular rhythm, adequate depth

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, irregular rhythm, or signs of hypoventilation

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

Frequency: Every 15-30 minutes for 1-2 hours after IV dose, then every 1-4 hours depending on stability and route.

Target: Alert or mildly drowsy, easily aroused

Action Threshold: Difficult to arouse, somnolent, or unarousable

Blood pressure and heart rate

Frequency: Periodically, especially with initial doses or dose escalations.

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 >3 days)

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Symptom Monitoring

  • Sedation
  • Respiratory depression (slow, shallow breathing)
  • Nausea and vomiting
  • Constipation
  • Pruritus
  • Dizziness
  • Hypotension
  • Urinary retention
  • Confusion

Special Patient Groups

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Pregnancy

Use during pregnancy should be avoided if possible, especially prolonged use or high doses near term, due to risk of neonatal opioid withdrawal syndrome (NOWS) and respiratory depression in the neonate. Category C for general use, Category D for prolonged use or high doses at term.

Trimester-Specific Risks:

First Trimester: Limited human data, but animal studies show some developmental toxicity. Risk of congenital malformations is generally low with short-term use.
Second Trimester: Risk of NOWS increases with prolonged exposure. Monitor for fetal growth restriction.
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. Monitor infants for signs of sedation, respiratory depression, and poor feeding. Short-term, low-dose use may be acceptable with close infant monitoring. Avoid prolonged use or high doses. Consider alternative analgesics if possible.

Infant Risk: Risk level L3 (Moderate Concern)
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Pediatric Use

Use with caution, especially in neonates and infants, due to increased sensitivity to respiratory depression and variable pharmacokinetics. Dosing must be carefully calculated based on weight and age. Close monitoring is essential.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Always have naloxone readily available when administering morphine, especially in opioid-naive patients or during dose titration.
  • Monitor respiratory rate and sedation level frequently, particularly during the first few hours after administration and with dose increases.
  • Prophylactic bowel regimen (stool softener plus stimulant laxative) should be initiated with regular opioid use to prevent opioid-induced constipation.
  • Be aware of the potential for opioid-induced hyperalgesia with chronic high-dose use.
  • In patients with renal impairment, accumulation of the active metabolite M6G can lead to prolonged and exaggerated opioid effects; dose reduction and extended intervals are crucial.
  • Morphine can cause histamine release, leading to pruritus, flushing, and urticaria, which are not true allergic reactions but rather pharmacologic 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/nerve blocks
  • Non-pharmacological pain management (e.g., physical therapy, heat/cold therapy, TENS, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: Varies widely per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 or 4 (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, 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. Properly dispose of unused or expired medications by throwing them away. However, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by your pharmacist or healthcare provider. If you are unsure about the best method for disposing of your medication, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. 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, 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 with 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 what was taken, the amount, and the time it happened to healthcare providers.