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Morphine Sulfate 10mg/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 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 (shot) 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 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 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 (e.g., tranquilizers, sleeping pills) unless specifically approved by your doctor, as this can increase the risk of serious side effects like severe 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: Initial: 2-10 mg IV/IM/SC every 3-4 hours as needed for pain. Titrate to effect.
Dose Range: 2 - 15 mg

Condition-Specific Dosing:

acutePain_IV: 2-10 mg IV every 3-4 hours PRN
postoperativePain_IV: 1-5 mg IV every 2-4 hours PRN, or continuous infusion 0.8-10 mg/hr
chronicPain_IV_infusion: Individualized, often starting at 0.8-10 mg/hr, titrating to effect. Higher doses may be required for opioid-tolerant patients.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution. 0.05-0.1 mg/kg/dose IV/IM/SC every 2-4 hours, max 0.2 mg/kg/dose. Monitor closely.
Infant: 0.05-0.1 mg/kg/dose IV/IM/SC every 2-4 hours, max 0.2 mg/kg/dose. Max single dose 15 mg. Monitor closely.
Child: 0.05-0.1 mg/kg/dose IV/IM/SC every 2-4 hours, max 0.2 mg/kg/dose. Max single dose 15 mg. Monitor closely.
Adolescent: 0.05-0.1 mg/kg/dose IV/IM/SC every 2-4 hours, max 0.2 mg/kg/dose. Max single dose 15 mg. Monitor closely.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Morphine is a full opioid agonist that binds to and activates mu (Îŧ), kappa (Îē), and delta (δ) opioid receptors in the central nervous system (CNS) and other tissues. Its primary analgesic effects are mediated through the mu-opioid receptor, leading to inhibition of pain transmission, alteration of pain perception, and induction of euphoria. It also causes respiratory depression, miosis, constipation, and sedation.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable for IV/IM/SC injection (100% for IV)
Tmax: IV: 1-2 minutes; IM: 30-60 minutes; SC: 60-90 minutes
FoodEffect: Not applicable for injection

Distribution:

Vd: 3-4.7 L/kg
ProteinBinding: 30-35%
CnssPenetration: Yes

Elimination:

HalfLife: 2-4 hours (parent drug); M6G: 3-7 hours (can be significantly prolonged in renal impairment)
Clearance: Not available (highly variable)
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

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION (not directly applicable to morphine, but a general opioid class warning); and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction, 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
Confusion
 Breathing difficulties, including:
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Seizures
 Severe constipation or stomach pain, which may indicate a severe bowel problem
Depression or other 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
+ Balance problems
+ 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 can be rare but severe. Symptoms include:
+ Extreme fatigue or weakness
+ Fainting
+ Severe dizziness
+ Nausea and vomiting
+ Decreased appetite
 Low sex hormone levels, which may occur with long-term use of this medication. Symptoms include:
+ Decreased interest in sex
+ Fertility problems
+ Absence of menstrual period
+ Ejaculation problems

Additional Side Effects

Most people taking this medication do not experience side effects or only have mild side effects. However, if you experience any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

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
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness when standing up
  • Confusion or disorientation
  • Severe constipation or inability to have a bowel movement
  • 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 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 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 Injection Administration (Spinal):

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

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 assess potential interactions and ensure it is safe for you to take this medication with your other treatments. Never initiate, terminate, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

Important Information About Your Medication

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

Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in other activities that require your full attention. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.

Interactions with Other Medications
Do not take this medication with other strong pain medications or use a pain patch without first consulting your doctor.

Monitoring Your Pain
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not exceed the prescribed dose.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses are required to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not take more than the prescribed dose. Additionally, regular use of opioid medications like this one can result in dependence. If you need to reduce the dose or stop taking this medication, consult your doctor to avoid withdrawal or other severe problems. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

Allergies and Interactions
If you are allergic to sulfites, discuss this with your doctor, as some products contain sulfites. Avoid consuming alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal consequences.

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 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 can pass into breast milk and harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
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Overdose Information

Overdose Symptoms:

  • Pinpoint pupils
  • Slowed or stopped breathing (respiratory depression)
  • Extreme drowsiness or unresponsiveness
  • Limp muscles
  • Cold, clammy skin
  • Bluish discoloration of lips and fingernails (cyanosis)
  • Slowed heart rate
  • Low blood pressure
  • Coma

What to Do:

Seek immediate emergency medical attention. Administer naloxone if available and trained. Call 911 or 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

  • Concomitant use with benzodiazepines or other CNS depressants (unless benefits outweigh risks, then reduce dose and duration)
  • MAO inhibitors (within 14 days)
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Major Interactions

  • Other CNS depressants (e.g., alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, other opioids)
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, fentanyl, St. John's Wort) - risk of serotonin syndrome
  • Anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, antiemetics) - risk of paralytic ileus, urinary retention
  • Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol) - may precipitate withdrawal
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Moderate Interactions

  • Diuretics - may reduce diuretic effect
  • Antihypertensives - additive hypotensive effects
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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 and assess treatment efficacy.

Timing: Prior to first dose

Respiratory rate and depth

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

Timing: Prior to first dose

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

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

Timing: Prior to first dose

Blood pressure and heart rate

Rationale: To assess baseline cardiovascular status and risk of hypotension/bradycardia.

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 guide dose adjustments in patients with organ impairment.

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

Target: Acceptable pain level (patient-specific)

Action Threshold: Uncontrolled pain, requiring dose adjustment or alternative therapy

Respiratory rate and depth

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

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

Action Threshold: <10 breaths/min, shallow breathing, or signs of respiratory distress (e.g., cyanosis, hypoxemia)

Level of consciousness/sedation

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

Target: Awake and 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 needed

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
  • Dizziness, lightheadedness
  • Nausea, vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Confusion, disorientation
  • Miosis (pinpoint pupils)

Special Patient Groups

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Pregnancy

Morphine crosses the placenta. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Use during labor may cause respiratory depression in the neonate. Use 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 early exposure (Category C).
Second Trimester: Risk of NOWS increases with prolonged exposure (Category C).
Third Trimester: High risk of NOWS with prolonged use. Risk of neonatal respiratory depression if used during labor (Category D).
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Lactation

Morphine is excreted into breast milk. While generally considered compatible with breastfeeding for short-term, single-dose use, prolonged or high-dose use carries a risk of infant sedation, respiratory depression, and withdrawal. Monitor infants for increased sleepiness, difficulty breathing, or limpness. Consult a healthcare professional.

Infant Risk: Risk of sedation, respiratory depression, and withdrawal symptoms in the infant. L3 (Moderately Safe) - use with caution, monitor infant.
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Pediatric Use

Pediatric patients may be 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, especially in neonates and infants.

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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. Start with lower doses and titrate slowly. Monitor closely for CNS and respiratory depression.

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.
  • The active metabolite, M6G, accumulates in renal impairment, leading to prolonged and enhanced opioid effects. Dose reduction is crucial in these patients.
  • Opioid-induced constipation is a common and often persistent side effect; prophylactic bowel regimen should be initiated concurrently with morphine therapy.
  • Naloxone should be readily available when administering morphine, especially in higher doses or to at-risk patients.
  • Tolerance and physical dependence can develop with prolonged use; discuss strategies for tapering and managing withdrawal symptoms if long-term use is anticipated.
  • Educate patients and caregivers on the signs of respiratory depression and overdose, and the importance of safe storage to prevent accidental ingestion.
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Alternative Therapies

  • Other opioid analgesics (e.g., hydromorphone, oxycodone, fentanyl, 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: Varies widely by supplier and contract per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic), Tier 3 (Brand) - varies by insurance plan
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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 a healthcare professional. If you are unsure about the correct disposal method, consult 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 for safe use. 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 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 information about the overdose, including the substance taken, the amount, and the time it occurred, to ensure prompt and effective treatment.