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Morphine Sulf Rect 30mg Suppository

Manufacturer PERRIGO Active Ingredient Morphine Suppositories(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. @ 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 (D if used for prolonged periods or near term in opioid-dependent women)
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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. This medicine is given as a suppository, which is inserted into the rectum.
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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. When using the suppository rectally, make sure to:

Wash your hands before and after handling the suppository
 Chill the suppository in the refrigerator or run it under cold water if it becomes soft
Remove the foil wrapper and insert the suppository into the rectum, pointed end first, taking care not to handle it excessively
 Wet the suppository before insertion to facilitate ease of use

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication:

Store it at room temperature, protected from light and moisture
 Keep it in a dry place, away from the bathroom
Store it in a secure location, out of reach of children and pets, such as a locked box or area
 Dispose of unused or expired medication by throwing it away, but do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist
Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in local drug take-back programs

Managing Missed Doses

If you take this medication on a regular schedule and miss a dose:

 Take the missed dose as soon as you remember
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule
 Do not take two doses at the same time or take extra doses
* If you take this medication on an as-needed basis, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Do not drive or operate heavy machinery until you know how this medicine affects you, as it can cause drowsiness and dizziness.
  • Avoid alcohol and other medications that can make you sleepy (like tranquilizers, sleeping pills, or other pain relievers) while taking morphine, as this can lead to dangerous breathing problems or extreme drowsiness.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and use a stool softener or laxative as recommended by your doctor.
  • Store this medicine securely away from children and pets, as accidental ingestion can be fatal.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mg to 30 mg rectally every 4 hours as needed for pain
Dose Range: 10 - 30 mg

Condition-Specific Dosing:

acute_pain: Initial dose 10-20 mg rectally every 4 hours, titrate to effect.
chronic_pain: Titrate slowly based on patient response and tolerability, often used for breakthrough pain or when oral route is not feasible.
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Pediatric Dosing

Neonatal: Not established (Use with extreme caution, if at all, and only under specialist supervision)
Infant: Not established (Use with extreme caution, if at all, and only under specialist supervision)
Child: Not established (Rectal suppositories generally not recommended for routine pediatric use; consult specialist for specific cases)
Adolescent: Not established (Rectal suppositories generally not recommended for routine pediatric use; consult specialist for specific cases)
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Dose Adjustments

Renal Impairment:

Mild: Reduce dose by 25-50% or extend dosing interval.
Moderate: Reduce dose by 50-75% or extend dosing interval significantly.
Severe: Avoid or use with extreme caution; significant dose reduction (e.g., 75% or more) and extended intervals are necessary 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: Reduce initial dose by 25-50%.
Moderate: Reduce initial dose by 50-75%.
Severe: Avoid or use with extreme caution; significant dose reduction (e.g., 75% or more) and extended intervals are necessary due to impaired metabolism.
Confidence: High

Pharmacology

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Mechanism of Action

Morphine is a potent opioid analgesic that acts primarily as an agonist at mu-opioid receptors in the central nervous system (CNS). Its analgesic effects are mediated by binding to these receptors, which are coupled to G-proteins. This binding leads to inhibition of adenylate cyclase, decreased intracellular cAMP, and modulation of ion channel activity (e.g., opening of potassium channels, closing of calcium channels), resulting in hyperpolarization of neurons and inhibition of neurotransmitter release, thereby reducing pain transmission.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (20-70% rectally, due to first-pass metabolism in rectal mucosa and liver)
Tmax: Approximately 20-60 minutes (rectal)
FoodEffect: Not applicable for rectal administration

Distribution:

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

Elimination:

HalfLife: Approximately 2-4 hours (parent drug); M6G has a longer half-life (3-5 hours) and can accumulate in renal impairment.
Clearance: Approximately 15-30 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: Less than 10% (parent drug)
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Pharmacodynamics

OnsetOfAction: Approximately 15-60 minutes (rectal)
PeakEffect: Approximately 60-90 minutes (rectal)
DurationOfAction: Approximately 3-7 hours (rectal)

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and 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. Assess each patient’s risk prior to prescribing morphine, 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, especially by children, can result in a fatal overdose. Prolonged use of morphine 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
 Chest pain or pressure, or a rapid heartbeat
Confusion
 Breathing difficulties, including:
+ Slow 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
+ Missed menstrual periods
+ Ejaculation problems

Other Possible Side Effects

Most people experience few or no side effects while taking this medication. However, some individuals may encounter the following:

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. Not all possible side effects are listed here. If you have questions or concerns about side effects, consult your doctor.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on reporting side effects.
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Seek Immediate Medical Attention If You Experience:

  • Difficulty breathing, slow or shallow breathing
  • Extreme drowsiness, dizziness, or feeling like you might pass out
  • Confusion or disorientation
  • Bluish lips or fingernails
  • Pinpoint pupils
  • Severe constipation or abdominal pain
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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. Be sure to describe the allergic reaction and its symptoms.
 Certain health conditions, such as:
+ Respiratory problems, including 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, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
 Current use of certain medications, such as 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 your medications, including prescription and over-the-counter drugs, natural products, and vitamins
 Discuss all your health problems with your doctor
Verify that it is safe to take this medication with your existing medications and health conditions
 Avoid starting, stopping, or changing the dose of any medication without consulting your doctor first
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Precautions & Cautions

Important Warnings and Cautions

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

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, rise 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 lower your dose or stop taking this medication, consult your doctor to avoid withdrawal or other severe problems. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

Interactions with Alcohol
Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal effects.

Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.

Special Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Breastfeeding
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 leading to stupor or coma
  • Pinpoint pupils
  • Cold, clammy skin
  • Limp muscles
  • Low blood pressure
  • Slowed heart rate

What to Do:

If you suspect an overdose, 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. Stay with the person until emergency help arrives. Call 1-800-222-1222 for Poison Control.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation due to risk of serotonin syndrome or severe respiratory depression)
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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, alcohol) - increased risk of profound sedation, respiratory depression, coma, and death.
  • Mixed agonist/antagonist opioids (e.g., buprenorphine, nalbuphine, pentazocine) - may precipitate withdrawal symptoms or reduce analgesic effect.
  • Anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, antipsychotics) - increased risk of urinary retention and severe constipation.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - increased risk of serotonin syndrome.
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Moderate Interactions

  • Diuretics - reduced efficacy of diuretics due to ADH release.
  • Antihypertensives - additive hypotensive effects.
  • Cimetidine - may increase morphine levels.
  • Rifampin - may decrease morphine levels.
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Minor Interactions

  • Not specifically identified as minor, but general caution with any drug affecting CNS or GI motility.

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 (frequency, consistency)

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

Timing: Prior to initiation of therapy

Renal and hepatic function tests (CrCl, LFTs)

Rationale: To assess organ function and guide dose adjustments.

Timing: Prior to initiation of therapy, especially in patients with suspected impairment

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Routine Monitoring

Pain assessment

Frequency: Regularly (e.g., every 2-4 hours initially, then as needed based on pain control and dose adjustments)

Target: Acceptable pain level as defined by patient

Action Threshold: Uncontrolled pain or excessive sedation/adverse effects

Respiratory rate and depth

Frequency: Regularly (e.g., every 1-4 hours initially, then as clinically indicated)

Target: 12-20 breaths/min (adults)

Action Threshold: <10 breaths/min, shallow breathing, or signs of respiratory distress

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

Frequency: Regularly (e.g., every 1-4 hours initially, then as clinically indicated)

Target: Alert or mildly drowsy, easily aroused

Action Threshold: Difficult to arouse, somnolent, or unarousable

Bowel function

Frequency: Daily

Target: Regular bowel movements (e.g., every 1-2 days)

Action Threshold: No bowel movement for >2-3 days, severe straining, or abdominal distension

Blood pressure and heart rate

Frequency: As clinically indicated, especially with dose changes

Target: Within patient's normal range

Action Threshold: Significant hypotension or bradycardia

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation/somnolence
  • Dizziness, lightheadedness
  • Nausea, vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Confusion, disorientation
  • Pinpoint pupils (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), which is a life-threatening condition requiring specialized management.

Trimester-Specific Risks:

First Trimester: Potential for congenital malformations (though data are mixed and not definitively linked to morphine alone).
Second Trimester: Risk of fetal growth restriction and potential for NOWS with prolonged exposure.
Third Trimester: High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically, and risk of respiratory depression in the neonate if used near delivery.
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Lactation

Morphine is excreted into breast milk. While levels are generally low, infants should be monitored for signs of sedation, respiratory depression, poor feeding, and poor weight gain. Short-term, low-dose use may be considered with close infant monitoring; however, alternative analgesics are often preferred.

Infant Risk: Moderate to High (L3-L4) - Risk of sedation, respiratory depression, and withdrawal symptoms in the infant if mother is taking high doses or for prolonged periods.
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Pediatric Use

Rectal suppositories are generally not a preferred route for routine pediatric pain management due to variable absorption and difficulty in precise dosing. Use in pediatric patients should be under the guidance of a pain specialist, with extreme caution, and only when other routes are not feasible. Dosing must be individualized and based on weight, age, and clinical condition, with careful monitoring for respiratory depression.

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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 closely for CNS and respiratory depression, and ensure adequate bowel regimen. Reduced renal and hepatic function are common in the elderly, necessitating dose adjustments.

Clinical Information

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Clinical Pearls

  • Rectal absorption of morphine can be variable; monitor patient response closely and adjust dose accordingly.
  • Opioid-induced constipation is a common and often severe side effect; prophylactic bowel regimen (stimulant laxative plus stool softener) should be initiated concurrently with morphine therapy.
  • Tolerance and physical dependence can develop with prolonged use. Do not discontinue abruptly; taper dose gradually to prevent withdrawal symptoms.
  • Educate patients and caregivers on the signs of respiratory depression and the importance of naloxone availability.
  • Morphine-6-glucuronide (M6G), an active metabolite, accumulates in renal impairment, leading to prolonged and enhanced opioid effects. Dose reduction is crucial in these patients.
  • The 30mg suppository is a relatively high dose for initial opioid-naïve patients; careful consideration and titration are essential.
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Alternative Therapies

  • Other opioid analgesics (e.g., oxycodone, hydromorphone, fentanyl, tramadol - oral, IV, transdermal)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
  • Adjuvant analgesics (e.g., gabapentin, pregabalin for neuropathic pain; antidepressants)
  • Regional anesthesia/nerve blocks
  • Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: Price varies widely by pharmacy and quantity per suppository
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (depending on insurance plan and formulary)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, do not share your medication with others, and never take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe and effective use. It is essential to read this guide carefully and review it again each time you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for personalized guidance.

In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss the availability and use of naloxone with your doctor or pharmacist to ensure you are prepared in case of an emergency. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. When seeking medical help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.