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Morphine Sul 8mg/ml Inj, 1ml

Manufacturer HIKMA 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 (shot) for severe pain.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This medication is administered via injection into a muscle, vein, or the fatty tissue under the skin.

For proper storage and disposal of this medication, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store it at home.

If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Avoid alcohol and other sedating medications (e.g., benzodiazepines, sleeping pills) unless specifically approved by your doctor, as this can lead to dangerous breathing problems or extreme drowsiness.
  • Do not drive or operate heavy machinery until you know how morphine affects you, as it can cause dizziness and drowsiness.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and use a stool softener or laxative as directed by your doctor.
  • Change positions slowly to avoid dizziness or lightheadedness, especially when getting up from a sitting or lying position.
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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: 2-10 mg IV/IM/SC every 3-4 hours
chronicPain: Individualized titration, often higher doses or continuous infusion
postoperativePain: 1-4 mg IV every 1-4 hours as needed
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution, 0.01-0.03 mg/kg/dose IV/IM/SC every 4-8 hours, titrate carefully.
Infant: 0.05-0.2 mg/kg/dose IV/IM/SC every 2-4 hours, max 15 mg/dose. Titrate carefully.
Child: 0.05-0.2 mg/kg/dose IV/IM/SC every 2-4 hours, max 15 mg/dose. Titrate carefully.
Adolescent: 0.05-0.2 mg/kg/dose IV/IM/SC every 2-4 hours, max 15 mg/dose. Titrate carefully.
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Dose Adjustments

Renal Impairment:

Mild: Monitor for increased effects; consider lower initial dose.
Moderate: Reduce initial dose by 25-50%; extend dosing interval. Monitor closely for accumulation of parent drug and active metabolites (M6G).
Severe: Reduce initial dose by 50-75%; extend dosing interval. Avoid if possible. Monitor closely for accumulation of parent drug and active metabolites (M6G).
Dialysis: Morphine and its active metabolite (M6G) are dialyzable. Administer after dialysis. Significant dose reduction required.

Hepatic Impairment:

Mild: Monitor for increased effects; consider lower initial dose.
Moderate: Reduce initial dose by 25-50%; extend dosing interval. Monitor closely.
Severe: Reduce initial dose by 50-75%; extend dosing interval. Avoid if possible. Monitor closely.

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), gastrointestinal tract, and other peripheral tissues. Binding to these receptors leads to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces generalized CNS depression, respiratory depression, euphoria, and physical dependence.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV/IM/SC)
Tmax: IV: 1-2 minutes (onset), 20 minutes (peak); IM: 30-60 minutes; SC: 60-90 minutes
FoodEffect: Not applicable for injection

Distribution:

Vd: 3-4 L/kg
ProteinBinding: Approximately 30-35%
CnssPenetration: Limited (due to P-glycoprotein efflux), but sufficient for therapeutic effect

Elimination:

HalfLife: 2-4 hours (parent drug); M6G half-life is longer, especially in renal impairment
Clearance: Approximately 10-20 mL/min/kg
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: Approximately 10% (renal)
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Pharmacodynamics

OnsetOfAction: IV: Rapid (within minutes); IM: 10-30 minutes; SC: 15-60 minutes
PeakEffect: IV: 20 minutes; IM: 30-60 minutes; SC: 60-90 minutes
DurationOfAction: 3-5 hours

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH OTHER CNS DEPRESSANTS; and CYTOCHROME P450 3A4 INTERACTION (not primary for morphine, but for other opioids). Morphine Sulfate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors and conditions. Serious, life-threatening, or fatal respiratory depression may occur. Neonatal opioid withdrawal syndrome may occur with prolonged maternal use during pregnancy. Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
 Signs of low blood sugar, including:
+ Dizziness or lightheadedness
+ Headache or feeling sleepy or weak
+ Shaking or rapid heartbeat
+ Confusion, hunger, or sweating
Severe dizziness or fainting
 Chest pain or pressure, or a rapid heartbeat
Confusion or disorientation
 Breathing difficulties, such as:
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Seizures
 Severe constipation or stomach pain, which may indicate a bowel problem
Depression or mood changes
 Swelling in the arms or legs
Fever, chills, or sore throat
 Painful urination
Abnormal sensations, such as burning, numbness, or tingling
 Serotonin syndrome, a potentially life-threatening condition, characterized by:
+ Agitation or changes in balance
+ Confusion or hallucinations
+ Fever or rapid heartbeat
+ Flushing or muscle twitching or stiffness
+ Seizures or shivering
+ Excessive sweating, 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 spinal injection, watch for:

Loss of muscle movement
 Muscle spasms
Difficulty controlling body movements
 Urination problems

Other Possible Side Effects

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

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

Reporting Side Effects

If you have questions or concerns about side effects, 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
  • Severe dizziness or lightheadedness
  • Confusion
  • Bluish lips or fingernails
  • Pinpoint pupils
  • Severe constipation or abdominal pain
  • Signs of 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, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
 Existing health conditions, such as:
+ Respiratory problems (e.g., asthma, breathing difficulties, 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, including 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. 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 medication 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 become more sensitive to pain, or experience new pain after taking this medication, contact your doctor immediately. Adhere to the prescribed dosage and do not exceed it.

Prolonged 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 find that this medication is no longer working as well as it should, consult your doctor. Do not increase your dosage without medical guidance.

Long-term or regular use of opioid medications like this one can cause dependence. Suddenly reducing the dose or stopping the medication may increase the risk of withdrawal or other severe complications. Before changing your dosage or discontinuing the 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 interactions.

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 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 or unresponsiveness
  • Pinpoint pupils
  • Cold, clammy skin
  • Limp muscles
  • Bluish discoloration of lips and fingernails
  • Slowed heart rate
  • Low blood pressure
  • Coma

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. If naloxone (Narcan) is available and you are trained to use it, administer it as directed while waiting for emergency help. Stay with the person and monitor their breathing until help arrives. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

  • Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOIs (risk of serotonin syndrome, severe respiratory depression, coma, death)
  • Patients with significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected paralytic ileus
  • Hypersensitivity to morphine
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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
  • Mixed opioid agonist/antagonists (e.g., butorphanol, nalbuphine, pentazocine): May reduce the analgesic effect of morphine or precipitate withdrawal symptoms.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, fentanyl): Risk of serotonin syndrome.
  • Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
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Moderate Interactions

  • Anticholinergics (e.g., atropine, scopolamine): Increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
  • Muscle relaxants: Enhanced neuromuscular blocking action, leading to increased respiratory depression.
  • Cimetidine: May inhibit morphine metabolism, leading to increased morphine levels and effects.
  • Rifampin: May induce morphine metabolism, leading to decreased morphine levels and effects.
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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

Vital signs (respiratory rate, heart rate, blood pressure)

Rationale: To assess baseline cardiorespiratory status and identify contraindications or risk factors for adverse effects.

Timing: Prior to first dose

Level of consciousness/sedation score

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

Timing: Prior to first dose

Bowel function history

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

Timing: Prior to first dose

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

Rationale: To identify impairment that may necessitate dose adjustment due to altered metabolism or excretion.

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

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Routine Monitoring

Pain assessment

Frequency: Every 1-4 hours (acute pain); as needed or per protocol (chronic pain)

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

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

Respiratory rate and depth

Frequency: Every 15-30 minutes initially after IV dose, then every 1-4 hours or per protocol

Target: >10-12 breaths/min (adults), age-appropriate for pediatric

Action Threshold: <10 breaths/min (adults), shallow breathing, or signs of respiratory distress; administer naloxone, provide respiratory support

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

Frequency: Every 15-30 minutes initially after IV dose, then every 1-4 hours or per protocol

Target: Alert or mildly drowsy, easily aroused

Action Threshold: Difficult to arouse, somnolent, or unarousable; hold dose, administer naloxone, provide respiratory support

Blood pressure and heart rate

Frequency: Every 1-4 hours or per protocol

Target: Within patient's normal range

Action Threshold: Significant hypotension or bradycardia

Bowel function

Frequency: Daily

Target: Regular bowel movements

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

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Pruritus
  • Dizziness
  • Constipation
  • Urinary retention
  • Confusion
  • Miosis (pinpoint pupils)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Limited data on specific risks, but generally avoided unless clearly necessary due to potential for congenital malformations (though not definitively linked to morphine).
Second Trimester: Risk of NOWS increases with prolonged exposure.
Third Trimester: High risk of NOWS with prolonged exposure. Risk of respiratory depression in the neonate if administered close to delivery.
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Lactation

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

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

Use with extreme caution, especially in neonates and infants, due to increased sensitivity to respiratory depression and variable pharmacokinetics. Dosing must be individualized and carefully titrated based on weight, age, and clinical response. Close monitoring for adverse effects is crucial.

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of morphine, particularly respiratory depression, sedation, and constipation. Start with lower doses and titrate slowly. Monitor renal function closely as clearance may be reduced.

Clinical Information

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Clinical Pearls

  • Always have naloxone readily available when administering morphine, especially in opioid-naive patients or when titrating doses.
  • Opioid-induced constipation is a common and persistent side effect; prophylactic bowel regimen (stimulant laxative + stool softener) should be initiated with chronic use.
  • Titrate dose slowly to achieve adequate pain relief while minimizing adverse effects, especially respiratory depression and sedation.
  • Assess pain and sedation levels frequently, particularly after initial doses or dose adjustments.
  • Be aware of the potential for tolerance and physical dependence with prolonged use; do not abruptly discontinue after chronic use to avoid withdrawal symptoms.
  • In patients with renal impairment, accumulation of the active metabolite (M6G) can lead to prolonged and exaggerated opioid effects; dose reduction and extended dosing intervals are crucial.
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Alternative Therapies

  • Other strong opioid analgesics (e.g., hydromorphone, fentanyl, oxycodone)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin)
  • Regional anesthesia (e.g., nerve blocks, epidural analgesia)
  • Adjuvant analgesics (e.g., antidepressants, muscle relaxants)
  • Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: $5 - $20 per 1ml vial (8mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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 someone else's medication. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which can be a safe and responsible way to dispose of unwanted medications.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information about its use. It is crucial to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be used as an emergency treatment. Discuss with your doctor or pharmacist how to obtain or use naloxone, as it can help reverse the effects of an overdose. 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 medication taken, the amount, and the time it occurred, to help healthcare providers deliver appropriate care.