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Morphine Sul 10mg/5ml(2mg/ml) Sol

Manufacturer ROXANE Active Ingredient Morphine Oral Solution(MOR feen) Pronunciation MOR-feen
WARNING: 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.Make sure you have the right drug; there is more than one strength. A lower strength may not ease pain well enough. A higher strength could lead to accidental overdose and death.Certain strengths of this drug may only be used by people who have been taking drugs like this drug and are used to their effects. The use of these strengths by people who have not been taking drugs like this drug may cause very bad and sometimes deadly breathing problems. Talk with the doctor.Be sure that you know how to measure your dose. Dosing errors can lead to accidental overdose and death. If you have any questions, talk with your doctor or pharmacist. @ 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: 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 nervous system to change how your body feels and responds to pain. It is used to treat moderate to severe pain.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. Take this medication by mouth only, with or without food. If it causes stomach upset, take it with food to help minimize discomfort.

Important Administration Instructions

Do not inject or snort this medication, as this can lead to severe side effects, including breathing difficulties and overdose, which can be fatal.
 When taking the liquid form, measure your dose carefully using the device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring tool.
* Avoid using household teaspoons or tablespoons to measure your dose, as this can result in taking too much medication.

Storing and Disposing of Your Medication

Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. To ensure safety, store the medication in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area to store your medication.

When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs.

Managing Missed Doses

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.

If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Do not drink alcohol while taking morphine, as it can increase the risk of serious side effects like extreme drowsiness and breathing problems.
  • Avoid driving or operating 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 consider taking a stool softener or laxative as recommended by your doctor.
  • Store morphine in a secure place, 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: Initial dose: 10-30 mg every 4 hours as needed for pain. Titrate to effect.
Dose Range: 10 - 30 mg

Condition-Specific Dosing:

acutePain: 10-30 mg every 4 hours as needed
chronicPain: Individualized titration, often starting with lower doses and increasing gradually based on response and tolerability.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution if used (0.05-0.2 mg/kg/dose IV/SC/IM, oral not well-established for neonates).
Infant: 0.2-0.5 mg/kg/dose every 4-6 hours as needed (oral solution). Max 15 mg/dose.
Child: 0.2-0.5 mg/kg/dose every 4-6 hours as needed (oral solution). Max 15 mg/dose.
Adolescent: 0.2-0.5 mg/kg/dose every 4-6 hours as needed (oral solution) or adult dosing (10-30 mg every 4 hours) if appropriate weight/age.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Reduce initial dose by 25-50%; extend dosing interval. Monitor for increased sedation/respiratory depression.
Severe: Reduce initial dose by 50-75%; extend dosing interval. Avoid if possible due to accumulation of active metabolites (morphine-6-glucuronide).
Dialysis: Morphine and its metabolites are dialyzable to some extent, but accumulation can still occur. Administer after dialysis. Significant dose reduction required.

Hepatic Impairment:

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

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) and other tissues. Activation of these receptors leads to analgesia, sedation, euphoria, and respiratory depression. It also affects gastrointestinal motility, causing constipation.
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Pharmacokinetics

Absorption:

Bioavailability: 20-40% (oral, due to significant first-pass metabolism)
Tmax: 30-60 minutes (oral solution)
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption.

Distribution:

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

Elimination:

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

OnsetOfAction: 15-60 minutes (oral solution)
PeakEffect: 60-90 minutes (oral solution)
DurationOfAction: 3-5 hours (oral solution)

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 RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. Morphine oral solution 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 morphine oral solution, and monitor all patients regularly for the development of these behaviors and conditions. Serious, life-threatening, or fatal respiratory depression may occur. Accidental ingestion of even one dose of morphine oral solution, especially by children, can result in a fatal overdose. Prolonged use of morphine oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Concomitant use of opioids with benzodiazepines or other 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 immediate medical attention:

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
+ Difficulty 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 or weak
+ Shaking
+ Rapid heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
 Chest pain or pressure, or a rapid heartbeat
Feeling confused
 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 serious 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 that 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 may occur with long-term opioid use. Symptoms include:
+ Extreme fatigue or weakness
+ Fainting
+ Severe dizziness
+ Nausea and vomiting
+ Decreased appetite
 Hormonal changes, which may occur with long-term opioid use. Symptoms include:
+ Decreased sex drive
+ Fertility problems
+ Irregular menstrual periods
+ Ejaculation problems

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:

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

If you experience any of these side effects or any other symptoms that concern you, 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
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness when standing up
  • Confusion
  • Pinpoint pupils
  • Severe constipation or inability to have a bowel movement
  • Signs of an allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to 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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
 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
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure
 If you are currently taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to inform your doctor and pharmacist about:

All prescription and over-the-counter medications you are taking
 Any natural products or vitamins you are using
* Your complete medical history, including all health problems

Before starting, stopping, or changing the dosage of any medication, including this one, consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
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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 When Performing Daily Activities

Until you understand how this medication affects you, avoid driving and other tasks that require your full attention. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious 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 become more sensitive to pain, or you experience 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 you may require higher doses 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 cause dependence. If you need to reduce your dose or stop taking this medication, consult your doctor first, as suddenly stopping or lowering the dose can increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

Special Warnings

Do not consume alcohol or products containing alcohol while taking this medication, as it can cause unsafe and potentially fatal effects.
 This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.
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 medical attention immediately 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
  • Loss of consciousness
  • Coma

What to Do:

Call 911 immediately. Administer naloxone if available and trained to do so. Stay with the person until emergency medical help arrives. Provide rescue breathing if necessary.

Drug Interactions

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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, MAOIs): Increased risk of serotonin syndrome.
  • Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol): May reduce analgesic effect and/or precipitate withdrawal symptoms.
  • Opioid antagonists (e.g., naltrexone, naloxone): Precipitate withdrawal.
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Moderate Interactions

  • Anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, antipsychotics): Increased risk of urinary retention and severe constipation.
  • Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
  • P-glycoprotein (P-gp) inhibitors/inducers: May alter morphine exposure.
  • CYP3A4 inhibitors/inducers: While morphine is not primarily metabolized by CYP3A4, some drug interactions may indirectly affect its metabolism or the metabolism of co-administered drugs.
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Minor Interactions

  • Antihypertensives: May cause additive hypotensive effects.

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 initiation of therapy

Respiratory rate and depth

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

Timing: Prior to initiation of therapy

Level of consciousness/sedation

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

Timing: Prior to initiation of therapy

Bowel function

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

Timing: Prior to initiation of therapy

Renal and hepatic function tests (CrCl, LFTs)

Rationale: To guide dose adjustments in patients with organ impairment.

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

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Routine Monitoring

Pain assessment

Frequency: Regularly, based on clinical need (e.g., before each dose, daily for chronic pain)

Target: Acceptable pain level as defined by patient

Action Threshold: Uncontrolled pain: consider dose increase or alternative; excessive pain relief/sedation: consider dose decrease.

Respiratory rate and depth

Frequency: Regularly, especially during initiation and dose titration (e.g., every 1-4 hours initially, then daily)

Target: >10-12 breaths/min (adults), normal for age (pediatrics)

Action Threshold: <10 breaths/min (adults) or significant decrease: hold dose, consider naloxone, notify provider.

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

Frequency: Regularly, especially during initiation and dose titration (e.g., every 1-4 hours initially, then daily)

Target: Alert or mildly drowsy, easily aroused

Action Threshold: Difficult to arouse or unarousable: hold dose, consider naloxone, notify provider.

Bowel function

Frequency: Daily

Target: Regular bowel movements (at least every 2-3 days)

Action Threshold: Constipation: initiate or escalate bowel regimen.

Signs of opioid withdrawal (if discontinuing or rapidly tapering)

Frequency: Daily during taper

Target: Absence of withdrawal symptoms

Action Threshold: Presence of withdrawal symptoms: slow taper, consider symptomatic treatment.

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Symptom Monitoring

  • Sedation
  • Dizziness
  • Nausea
  • Vomiting
  • Constipation
  • Pruritus
  • Urinary retention
  • Respiratory depression (slow, shallow breathing)
  • Pinpoint pupils
  • Confusion
  • Hypotension

Special Patient Groups

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Pregnancy

Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS), which is life-threatening if not treated. Use only if the potential benefit justifies the potential risk to the fetus. Short-term use for acute pain may be considered under strict medical supervision.

Trimester-Specific Risks:

First Trimester: Limited data on major birth defects; some studies suggest a possible increased risk of neural tube defects and cardiac defects, but evidence is not conclusive.
Second Trimester: Risk of NOWS increases with prolonged exposure.
Third Trimester: High risk of NOWS if used near term. Risk of respiratory depression in the neonate if used during labor and delivery.
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Lactation

Morphine is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, and poor feeding. Use with caution, or consider alternative analgesics, especially in preterm or young infants.

Infant Risk: L3 (Moderate risk). Potential for sedation, respiratory depression, and constipation in the infant. Risk is higher with higher maternal doses, prolonged use, or in neonates/preterm infants.
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Pediatric Use

Dosing must be carefully calculated based on weight and age. Infants and young children are more sensitive to the respiratory depressant effects of opioids. Close monitoring is essential. Not recommended for routine use in neonates.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Morphine oral solution is particularly useful for rapid titration of pain, especially in patients who have difficulty swallowing tablets or capsules.
  • Always start with the lowest effective dose and titrate slowly to minimize adverse effects, especially respiratory depression.
  • Educate patients and caregivers about the risks of addiction, abuse, and accidental ingestion, and the importance of safe storage.
  • Prophylactic treatment for opioid-induced constipation (e.g., stool softener plus stimulant laxative) should be initiated concurrently with morphine therapy.
  • Be aware of the accumulation of the active metabolite (morphine-6-glucuronide) in patients with renal impairment, which can lead to prolonged and exaggerated opioid effects.
  • Naloxone should be readily available for patients at high risk of overdose or for emergency use.
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Alternative Therapies

  • Other opioid analgesics (e.g., oxycodone, hydromorphone, fentanyl, hydrocodone)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for mild to moderate pain
  • Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants) for neuropathic pain
  • Regional anesthesia or nerve blocks
  • Non-pharmacological pain management techniques (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 100ml bottle (2mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information for patients. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult 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. Discuss obtaining and using naloxone with your doctor or pharmacist. If an overdose is suspected, 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.