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Morphine Sulf Inj 4mg/ml 1ml Syr

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
Not available
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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 as an injection, usually in a hospital 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 instructions carefully. This medication is administered via injection into a muscle, vein, or the fatty layer under the skin.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.

Missing a Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Avoid alcohol and other sedating medications unless approved by your doctor.
  • Do not drive or operate heavy machinery until you know how morphine affects you, as it can cause drowsiness and dizziness.
  • Report any difficulty breathing, extreme drowsiness, or severe constipation immediately.
  • If you are receiving morphine for chronic pain, discuss a bowel regimen with your healthcare provider to prevent constipation.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: IV: Initial 2-10 mg, administered slowly over 4-5 minutes. May repeat every 3-4 hours as needed.
Dose Range: 2 - 15 mg

Condition-Specific Dosing:

acutePain: IV: 2-10 mg every 3-4 hours PRN. SC/IM: 5-20 mg every 3-4 hours PRN.
chronicPain: Individualized titration, often starting with lower doses and increasing gradually. Extended-release formulations are preferred for chronic pain.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and individualized dosing if used (e.g., for post-surgical pain in NICU, 0.01-0.03 mg/kg/dose IV every 2-4 hours).
Infant: IV/SC/IM: 0.05-0.2 mg/kg/dose every 2-4 hours PRN (max 15 mg/dose).
Child: IV/SC/IM: 0.05-0.2 mg/kg/dose every 2-4 hours PRN (max 15 mg/dose).
Adolescent: IV/SC/IM: 0.05-0.2 mg/kg/dose every 2-4 hours PRN (max 15 mg/dose) or adult dose if weight appropriate.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor for increased effects.
Moderate: Reduce dose by 25-50% and/or extend dosing interval. Monitor for accumulation of active metabolites (M6G).
Severe: Reduce dose by 50-75% and/or extend dosing interval. Avoid if possible. Monitor closely for respiratory depression and sedation.
Dialysis: Morphine and its metabolites are dialyzable to some extent. Administer after dialysis. Significant dose reduction required. Monitor closely.

Hepatic Impairment:

Mild: No specific adjustment, but monitor for increased effects.
Moderate: Reduce dose by 25-50%. Monitor for increased effects and prolonged duration.
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 an opioid agonist that primarily interacts with mu-opioid receptors in the central nervous system (CNS). Binding to these receptors produces analgesia, sedation, euphoria, and respiratory depression. It also affects the gastrointestinal tract, causing decreased motility and constipation.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: 1-4 L/kg
ProteinBinding: 20-40%
CnssPenetration: Limited (due to P-glycoprotein efflux), but sufficient for therapeutic effect.

Elimination:

HalfLife: 2-4 hours (parent drug); M6G has a longer half-life (3-7 hours)
Clearance: Not readily available as a single rate, highly variable.
ExcretionRoute: Renal (primarily as glucuronide metabolites)
Unchanged: <10% (in urine)
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Pharmacodynamics

OnsetOfAction: IV: 5-10 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 (variable)

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

Additional Side Effects (Injection Only)

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

Paralysis or inability to move
 Muscle spasms
Difficulty controlling body movements
 Urination problems

Other Possible Side Effects

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

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

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Slow or shallow breathing
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness when standing up
  • Confusion or disorientation
  • Pinpoint pupils
  • Severe constipation
  • Hives or rash (signs of allergic reaction)
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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 medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
 Certain health conditions, including:
+ 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 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. It is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to verify the safety of taking this medication in conjunction with your other treatments. Do not initiate, cease, or adjust the dosage of any medication without first 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 down position. Be cautious when climbing stairs.

Do not combine this medication with other strong pain relievers or use 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. Adhere to the prescribed dosage and avoid taking more than ordered.

Long-term or high-dose use of this medication can lead to tolerance, where the drug may not be as 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 prescribed 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 issues. Before changing your dosage 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, 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 breathing difficulties.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. Naloxone (Narcan) may be administered to reverse the effects of an opioid overdose. Call 1-800-222-1222 (Poison Control) for advice.

Drug Interactions

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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, other opioids): Increased risk of profound sedation, respiratory depression, coma, and death.
  • Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of MAOI discontinuation can result in severe, unpredictable reactions including serotonin syndrome or opioid overdose symptoms.
  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir): May increase morphine plasma concentrations, leading to increased or prolonged opioid effects.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease morphine plasma concentrations, leading to reduced efficacy or withdrawal symptoms.
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Moderate Interactions

  • Anticholinergics (e.g., atropine, scopolamine): Increased risk of severe constipation and/or urinary retention.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans): Increased risk of serotonin syndrome.
  • Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
  • Muscle relaxants: Enhanced neuromuscular blockade.
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Minor Interactions

  • Antihypertensives: May cause additive hypotensive effects.

Monitoring

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Baseline Monitoring

Pain assessment (e.g., pain scale)

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

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

Timing: Prior to first dose

Blood pressure and heart rate

Rationale: To assess baseline cardiovascular status, as opioids can cause hypotension and bradycardia.

Timing: Prior to first dose

Bowel function

Rationale: To assess baseline bowel habits due to risk of opioid-induced constipation.

Timing: Prior to first dose

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Routine Monitoring

Pain assessment

Frequency: Every 1-2 hours initially after IV dose, then every 3-4 hours or as clinically indicated.

Target: Patient-specific, aiming for acceptable pain relief with minimal side effects.

Action Threshold: Inadequate pain relief may require dose adjustment; excessive pain relief may indicate over-sedation.

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: Typically >10-12 breaths/minute (adults), regular rhythm.

Action Threshold: Respiratory rate <10 breaths/minute (adults), shallow breathing, or signs of respiratory distress require immediate intervention (e.g., naloxone, respiratory support).

Level of consciousness/sedation score

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

Target: Awake and alert or mildly drowsy, easily aroused.

Action Threshold: Somnolent, difficult to arouse, or unarousable requires immediate intervention.

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 may require intervention.

Bowel function

Frequency: Daily

Target: Regular bowel movements.

Action Threshold: Constipation (no bowel movement for >3 days) requires laxative intervention.

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Symptom Monitoring

  • Sedation
  • Respiratory depression (slow, shallow breathing)
  • Nausea and vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Dizziness
  • Confusion
  • Pinpoint pupils (miosis)

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 on teratogenicity, but generally avoided unless clearly needed.
Second Trimester: Risk of NOWS increases with prolonged exposure.
Third Trimester: High risk of NOWS with prolonged exposure. Risk of neonatal respiratory depression if used close to delivery.
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Lactation

Morphine is excreted into breast milk. While single, low doses may be compatible with breastfeeding, repeated or high doses can cause sedation, respiratory depression, and poor feeding in the infant. Monitor infants for signs of sedation, difficulty breathing, or poor feeding. Consider alternative analgesics or temporary cessation of breastfeeding.

Infant Risk: Risk of sedation, respiratory depression, and poor feeding, especially with repeated or high doses. Risk is higher in neonates and preterm infants.
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Pediatric Use

Pediatric patients may be more sensitive to the respiratory depressant effects of opioids. Dosing must be carefully individualized based on weight, age, and clinical condition. Close monitoring for respiratory depression and sedation is crucial.

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Geriatric Use

Elderly patients are generally more sensitive to the adverse effects of opioids, including respiratory depression, sedation, 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 to effect, especially in opioid-naive patients.
  • Respiratory depression is the most serious adverse effect; monitor respiratory rate and sedation level closely, especially within the first hour after IV administration.
  • Naloxone should be readily available when administering morphine.
  • Opioid-induced constipation is common; prophylactic bowel regimen (stool softener + stimulant laxative) should be considered for patients on regular opioid therapy.
  • Tolerance and physical dependence can develop with prolonged use. Do not abruptly discontinue in dependent patients to avoid withdrawal symptoms.
  • Caution in patients with head injury, increased intracranial pressure, severe respiratory disease, or acute asthma exacerbation.
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Alternative Therapies

  • Fentanyl (for rapid onset, shorter duration, less histamine release)
  • Hydromorphone (Dilaudid) (more potent, shorter duration than morphine)
  • Oxycodone
  • Hydrocodone
  • Tramadol (weaker opioid)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts.
  • Regional anesthesia/nerve blocks
  • Non-pharmacological pain management (e.g., physical therapy, heat/cold, massage)
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Cost & Coverage

Average Cost: Varies widely per 1ml syringe
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 persist or worsen, it is essential to contact your doctor promptly. 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. 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 when you first receive your medication and again with each refill. If you have any questions or concerns about your 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred, to ensure you receive appropriate care.