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Morphine Sul 50mg/ml Inj , 20ml

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 (prolonged use or high doses in 3rd trimester: 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 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) to help with 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, as this can increase the risk of serious side effects like extreme drowsiness or trouble breathing.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • Report any signs of severe constipation to your healthcare provider, as this is a common side effect and may require treatment.
  • If you are receiving this medication at home, ensure it is stored securely and out of reach of children and pets to prevent accidental ingestion.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

postoperative_pain: IV: 1-5 mg every 2-4 hours as needed, titrated to effect
severe_chronic_pain: Individualized titration based on patient response and tolerance, often starting with lower doses and increasing gradually.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and reduced doses if used for severe pain (e.g., 0.01-0.03 mg/kg/dose IV/IM/SC every 4-6 hours).
Infant: 0.05-0.2 mg/kg/dose IV/IM/SC every 2-4 hours as needed, maximum 15 mg/dose.
Child: 0.05-0.2 mg/kg/dose IV/IM/SC every 2-4 hours as needed, maximum 15 mg/dose.
Adolescent: 0.05-0.2 mg/kg/dose IV/IM/SC every 2-4 hours as needed, maximum 15 mg/dose (or adult dosing if appropriate weight/size).
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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 closely for respiratory depression and sedation.
Severe: Reduce dose by 50-75% and/or extend dosing interval significantly (e.g., every 6-8 hours or longer). Avoid if possible.
Dialysis: Morphine and its active metabolites (M3G, M6G) are dialyzable. Administer after dialysis. Significant dose reduction required (e.g., 25% of normal dose).

Hepatic Impairment:

Mild: No specific adjustment, but monitor for increased effects.
Moderate: Reduce dose by 25-50% and/or extend dosing interval. Monitor closely.
Severe: Reduce dose by 50-75% and/or extend dosing interval. Avoid if possible due to impaired metabolism and increased risk of adverse effects.

Pharmacology

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Mechanism of Action

Morphine is a potent opioid analgesic that acts primarily as an agonist at mu (ΞΌ) opioid receptors in the central nervous system (CNS). It also has weaker agonist activity at kappa (ΞΊ) and delta (Ξ΄) opioid receptors. Activation of these receptors leads to inhibition of pain transmission, altered pain perception, and various other effects including respiratory depression, sedation, euphoria, and gastrointestinal motility reduction.
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Pharmacokinetics

Absorption:

Bioavailability: 20-40% (oral, due to first-pass metabolism); 100% (IV)
Tmax: IV: 1-2 minutes; IM: 30-60 minutes; SC: 60-90 minutes
FoodEffect: Not applicable for injectable forms; oral bioavailability can be affected by food.

Distribution:

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

Elimination:

HalfLife: 2-4 hours (parent drug); M6G: 3-5 hours; M3G: 4-6 hours
Clearance: 15-30 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10% (urine)
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Pharmacodynamics

OnsetOfAction: IV: <5 minutes; IM: 10-30 minutes; SC: 15-60 minutes
PeakEffect: IV: 20 minutes; IM: 30-60 minutes; SC: 60-90 minutes
DurationOfAction: 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; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. Morphine exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Serious, life-threatening, or fatal respiratory depression may occur. Accidental ingestion of even one dose can result in a fatal overdose. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome. Concomitant use with benzodiazepines or other CNS depressants may result in profound sedation, respiratory depression, coma, and death.
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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 immediately or seek emergency medical attention:

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
+ Weakness, shaking, or a rapid heartbeat
+ Confusion, hunger, or sweating
Severe dizziness or fainting
 Chest pain or pressure, or a rapid heartbeat
Confusion or disorientation
 Breathing difficulties, including:
+ 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 that 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
+ Seizures or shivering
+ Excessive sweating, diarrhea, 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
+ Irregular 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 movement or muscle spasms
 Difficulty controlling body movements
Urination problems

Other Possible Side Effects

Most people taking this medication will not experience severe side effects. However, some may encounter mild or moderate side effects, including:

 Dizziness, drowsiness, or fatigue
Dry mouth
 Constipation, diarrhea, stomach pain, or decreased appetite
Headache or anxiety
 Excessive sweating

If you experience any of these side effects or have concerns about your medication, contact your doctor for guidance. 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 when standing up
  • Confusion or disorientation
  • Severe constipation or abdominal pain
  • 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 signs.
 Existing 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 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 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 issues. Verify that it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

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

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 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 complications. Before decreasing the dose or discontinuing this medication, consult your doctor and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.

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

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

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are breastfeeding, as this medication can pass into breast milk and 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:

  • Pinpoint pupils
  • Extreme drowsiness or unresponsiveness
  • Slow, shallow, or stopped breathing
  • Bluish skin, especially around the lips and fingertips
  • Limp muscles
  • Cold, clammy skin
  • Loss of consciousness

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. Administer naloxone if available and trained to do so. Provide rescue breathing if necessary. Call 1-800-222-1222 (Poison Control Center).

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of MAOI discontinuation due to risk of severe, unpredictable reactions including serotonin syndrome or respiratory depression.
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Major Interactions

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

  • Diuretics: Opioids may reduce the efficacy of diuretics by inducing ADH release.
  • Antihypertensives: May cause additive hypotensive effects.
  • Cimetidine: May inhibit morphine metabolism, leading to increased 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 risk of respiratory depression.

Timing: Prior to first dose

Level of consciousness/sedation

Rationale: To assess baseline mental status and risk of excessive 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

Renal and hepatic function tests (e.g., BUN, creatinine, LFTs)

Rationale: To identify potential impairment that may require dose adjustment.

Timing: Prior to initiation, especially in patients with known or suspected impairment

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Routine Monitoring

Pain assessment

Frequency: Every 1-2 hours initially after IV/IM/SC dose, then as clinically indicated (e.g., every 3-4 hours or before each dose)

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

Action Threshold: Pain score above goal, requiring additional dose or intervention

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; Pediatrics: Age-appropriate normal range

Action Threshold: Respiratory rate <10 breaths/min (adults), shallow breathing, or signs of hypoventilation

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

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: Difficult to arouse, somnolent, or unarousable

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

Bowel function (e.g., last bowel movement, abdominal distension)

Frequency: Daily

Target: Regular bowel movements

Action Threshold: Constipation, abdominal distension, or absence of bowel sounds

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation/somnolence
  • Nausea and vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Dizziness/lightheadedness
  • Hypotension
  • Pupil constriction (miosis)

Special Patient Groups

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Pregnancy

Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS).

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations cannot be ruled out. Avoid if possible.
Second Trimester: Risk of NOWS increases with prolonged use. 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 close to delivery.
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Lactation

Morphine is excreted into breast milk. While generally considered compatible with breastfeeding for short-term, single-dose use, chronic use or high doses are not recommended due to risk of infant sedation, respiratory depression, and withdrawal.

Infant Risk: L3 (Moderately Safe) - Monitor infant for sedation, poor feeding, and respiratory depression. Consider alternative if chronic use is needed.
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Pediatric Use

Use with extreme caution, especially in neonates and infants, due to increased sensitivity to respiratory depression and variable metabolism. Dosing must be weight-based and carefully titrated. 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

  • Always have naloxone readily available when administering morphine, especially in opioid-naΓ―ve patients or when titrating doses.
  • Rapid IV administration can lead to histamine release, causing flushing, itching, and hypotension. Administer IV doses slowly (over 4-5 minutes).
  • Morphine-6-glucuronide (M6G), an active metabolite, accumulates in renal impairment, leading to prolonged and enhanced opioid effects. Dose reduction is crucial in kidney disease.
  • Tolerance and physical dependence can develop with prolonged use. Do not abruptly discontinue after chronic use to avoid withdrawal symptoms.
  • Assess patient's pain, sedation level, and respiratory status frequently, especially during the first few hours after initiation or dose escalation.
  • Prophylactic laxatives (stimulant and stool softener) should be initiated with chronic opioid therapy to prevent opioid-induced constipation.
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Alternative Therapies

  • Other strong opioid analgesics (e.g., hydromorphone, fentanyl, oxycodone)
  • Moderate opioid analgesics (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: Varies widely based on dosage, formulation, and supplier. Typically ranges from $5 - $50 per 20ml vial (50mg/ml). per 20ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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, 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. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. 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 whenever 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred, to facilitate prompt and effective treatment.