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Morphine Sulf Rect 5mg 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 (prolonged use or high doses near term may be 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 by changing how your brain and nervous system respond to pain. The suppository form is inserted into the rectum to relieve moderate to 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. Use the suppository rectally, as directed. Before and after handling the suppository, wash your hands thoroughly. If the suppository is soft, you can chill it in the refrigerator or run it under cold water to firm it up. To insert the suppository, remove the foil wrapper and gently push it into your rectum, pointed end first. Avoid handling the suppository excessively. To make insertion easier, wet the suppository with water before putting it in your rectum.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. To prevent accidental ingestion, store your medication in a safe and secure location where children and pets cannot access it. Consider using a locked box or cabinet to keep your medication out of reach. When you no longer need your medication or it has expired, dispose of it properly. 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 ask about potential drug take-back programs in your area.

Missing a Dose

If you take this medication on a regular schedule and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose. If you take this medication as needed, 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 sedating medications while taking morphine, as this can increase the risk of serious side effects like severe drowsiness and breathing problems.
  • To prevent constipation, which is a common side effect, drink plenty of fluids, eat fiber-rich foods, and consider taking 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: 5 mg to 30 mg rectally every 4 hours as needed for pain
Dose Range: 5 - 30 mg

Condition-Specific Dosing:

acutePain: Initial dose 10-20 mg every 4 hours, adjust as needed based on response and tolerability.
chronicPain: Individualize dose based on patient's prior opioid exposure and pain severity. May be used for breakthrough pain in patients on chronic opioid therapy.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, if at all, due to high risk of respiratory depression)
Infant: Not established (use with extreme caution, individualized dosing by specialist only, typically 0.1-0.2 mg/kg/dose, max 0.5 mg/kg/dose)
Child: Not established (use with extreme caution, individualized dosing by specialist only, typically 0.1-0.2 mg/kg/dose, max 0.5 mg/kg/dose)
Adolescent: Not established (use with extreme caution, individualized dosing by specialist only, typically 0.1-0.2 mg/kg/dose, max 0.5 mg/kg/dose)
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Dose Adjustments

Renal Impairment:

Mild: Consider dose reduction or extended dosing interval due to accumulation of active metabolites (morphine-6-glucuronide, M6G).
Moderate: Significant dose reduction (e.g., 25-50% of usual dose) and/or extended dosing interval (e.g., every 6-8 hours) required. Monitor closely for sedation and respiratory depression.
Severe: Avoid use if possible. If necessary, use very low doses (e.g., 10-25% of usual dose) with extended intervals and close monitoring. Consider alternative analgesics.
Dialysis: Morphine and M6G are dialyzable. Administer after dialysis. Significant dose reduction required. Monitor closely.

Hepatic Impairment:

Mild: No specific adjustment, but monitor for increased sensitivity.
Moderate: Reduce initial dose by 25-50%. Titrate slowly based on response and tolerability. Monitor for increased sedation and respiratory depression.
Severe: Reduce initial dose by 50-75%. Avoid if possible. Monitor closely for adverse effects.

Pharmacology

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Mechanism of Action

Morphine is an opioid agonist that primarily interacts with mu-opioid receptors in the central nervous system (CNS). Binding to these receptors produces analgesia, sedation, euphoria, and respiratory depression. It also affects gastrointestinal motility, causing constipation.
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Pharmacokinetics

Absorption:

Bioavailability: 20-70% (highly variable via rectal route due to first-pass metabolism and incomplete absorption)
Tmax: 30-60 minutes (rectal)
FoodEffect: Not applicable for rectal administration.

Distribution:

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

Elimination:

HalfLife: 2-4 hours (parent drug); M6G has a longer half-life, especially in renal impairment.
Clearance: Not readily quantifiable as a single value due to complex metabolism and excretion.
ExcretionRoute: Primarily renal (90% as metabolites, 7-10% as unchanged drug).
Unchanged: 7-10%
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Pharmacodynamics

OnsetOfAction: 15-60 minutes (rectal)
PeakEffect: 30-90 minutes (rectal)
DurationOfAction: 3-7 hours (rectal)

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE: 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 receiving morphine for the development of these behaviors and conditions.

RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use of morphine. Monitor for respiratory depression, especially during initiation of morphine or following a dose increase.

ACCIDENTAL INGESTION: Accidental ingestion of even one dose of morphine, especially by children, can result in a fatal overdose of morphine.

NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of morphine during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

CYTOCHROME P450 3A4 INTERACTION: The concomitant use of morphine with all cytochrome P450 3A4 inhibitors may result in increased plasma concentrations of morphine, leading to increased opioid effects. The concomitant use of morphine with all cytochrome P450 3A4 inducers may result in decreased plasma concentrations of morphine, leading to decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to morphine. Discuss the potential for serious interactions with patients and advise them on the signs and symptoms of opioid overdose and withdrawal syndrome.

RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
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Side Effects

Important Side Effects to Report to Your Doctor 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, seek medical attention immediately:

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 passing out
 Chest pain or pressure, or a fast heartbeat
Feeling confused
 Trouble breathing, slow breathing, or shallow breathing
Noisy breathing
 Breathing problems during sleep (sleep apnea)
Seizures
 Severe constipation or stomach pain, which may be signs of a severe bowel problem
Depression or other mood changes
 Swelling in the arms or legs
Fever, chills, or sore throat
 Pain when passing urine
A burning, numbness, or tingling feeling that is not normal

Serotonin Syndrome: A Rare but Serious Condition

If you take this medication with certain other drugs, you may be at risk for a rare but potentially life-threatening condition called serotonin syndrome. Seek medical attention immediately if you experience any of the following symptoms:

 Agitation
Change in balance
 Confusion
Hallucinations
 Fever
Fast or abnormal heartbeat
 Flushing
Muscle twitching or stiffness
 Seizures
Shivering or shaking
 Sweating a lot
Severe diarrhea, upset stomach, or throwing up
 Severe headache

Adrenal Gland Problems: A Rare but Serious Condition

Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Seek medical attention immediately if you experience any of the following symptoms:

Feeling very tired or weak
 Passing out
Severe dizziness
 Very upset stomach
Throwing up
 Decreased appetite

Hormonal Changes: A Potential Side Effect

Long-term use of an opioid medication may lead to lower sex hormone levels. If you experience any of the following symptoms, contact your doctor:

Lowered interest in sex
 Fertility problems
No menstrual period
 Ejaculation problems

Other Possible Side Effects

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

Feeling dizzy, sleepy, tired, or weak
 Dry mouth
Constipation, diarrhea, stomach pain, upset stomach, throwing up, or decreased appetite
 Headache
Anxiety
 Sweating a lot

If any of these side effects bother you or do not go away, contact your doctor for medical advice. You may 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)
  • Extreme drowsiness or difficulty waking up
  • Bluish lips or fingernails
  • Severe dizziness or lightheadedness
  • Confusion or disorientation
  • 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 crucial 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 you experienced, including any symptoms that occurred.
 Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Recent use of specific medications for depression or Parkinson's disease within the last 14 days, 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. It is essential to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

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

When starting this medication, be cautious and avoid driving or engaging in activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be careful when climbing stairs.

Do not combine this medication with other strong pain relievers or use a pain patch without first consulting your doctor. If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Adhere to the prescribed dosage and do not exceed it.

Long-term or high-dose use of this medication can lead to tolerance, where the medication may not provide adequate pain relief. If you experience reduced effectiveness, consult your doctor and do not increase the dosage on your own.

Additionally, prolonged or regular use of opioid medications like this one can result in dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as abruptly stopping or lowering the dose can increase the risk of withdrawal or other severe complications. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

Avoid consuming alcohol or products containing alcohol while taking this medication, as it can lead to unsafe and potentially fatal interactions.

Some individuals, particularly those with a history of seizures, may be at a higher risk of experiencing seizures while taking this medication. 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.

Breastfeeding mothers should inform their doctor, as this medication can pass into breast milk and potentially harm the baby. If your baby appears excessively sleepy, limp, or has breathing difficulties, seek medical attention immediately.
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Overdose Information

Overdose Symptoms:

  • Pinpoint pupils
  • Slowed or stopped breathing
  • Extreme drowsiness or unresponsiveness
  • Limp muscles
  • Cold, clammy skin
  • Bluish discoloration of lips and fingernails
  • Loss of consciousness
  • 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 awaiting emergency medical help. Call 1-800-222-1222 (Poison Control) for further guidance.

Drug Interactions

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Contraindicated Interactions

  • Concomitant use with benzodiazepines or other CNS depressants (unless benefits outweigh risks, then use lowest dose and shortest duration, monitor closely)
  • Concomitant use with alcohol
  • 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

  • Other CNS depressants (e.g., sedatives, hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, other opioids, alcohol): Increased risk of respiratory depression, profound sedation, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, MAOIs): Risk of serotonin syndrome.
  • Mixed agonist/antagonist opioids (e.g., buprenorphine, nalbuphine, pentazocine): May precipitate withdrawal symptoms or reduce analgesic effect.
  • Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of MAOI discontinuation is contraindicated due to risk of severe, unpredictable reactions including serotonin syndrome or opioid overdose symptoms.
  • Anticholinergic drugs: Increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
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Moderate Interactions

  • Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
  • Cimetidine: May inhibit morphine metabolism, leading to increased morphine levels.
  • Rifampin: May induce morphine metabolism, leading to decreased morphine levels and reduced efficacy.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pain assessment (intensity, quality, 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 identify risk for respiratory depression.

Timing: Prior to first dose

Level of consciousness/sedation

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

Timing: Prior to first dose

Bowel function/history of constipation

Rationale: To anticipate and proactively manage opioid-induced constipation.

Timing: Prior to first dose

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Routine Monitoring

Pain assessment

Frequency: Regularly (e.g., 30-60 minutes after dose, then every 2-4 hours or as needed)

Target: Acceptable pain level as defined by patient

Action Threshold: Uncontrolled pain or unacceptable side effects warrant dose adjustment or alternative therapy.

Respiratory rate and depth

Frequency: Every 1-2 hours initially, then every 4 hours or as clinically indicated

Target: Typically >10-12 breaths/min, regular rhythm

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoventilation (e.g., cyanosis, somnolence) require immediate intervention (e.g., naloxone, respiratory support).

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

Frequency: Every 1-2 hours initially, then every 4 hours or as clinically indicated

Target: Alert or mildly drowsy, easily aroused

Action Threshold: Difficult to arouse, somnolent, or unarousable requires immediate intervention (e.g., naloxone, respiratory support).

Bowel movements

Frequency: Daily

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

Action Threshold: No bowel movement for 2-3 days despite prophylactic laxatives requires intervention (e.g., stimulant laxatives, stool softeners, opioid-induced constipation specific agents).

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation/somnolence
  • Nausea and vomiting
  • Constipation
  • Pruritus (itching)
  • Dizziness/lightheadedness
  • Urinary retention
  • Confusion/disorientation

Special Patient Groups

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Pregnancy

Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening. Use only if the potential benefit justifies the potential risk to the fetus. Monitor neonates for signs of NOWS.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations with first-trimester opioid exposure is suggested by some studies, though not definitively established for morphine.
Second Trimester: Risk of NOWS increases with prolonged use. Fetal growth restriction may occur.
Third Trimester: High risk of NOWS if used chronically. Risk of respiratory depression in the neonate if used shortly before delivery.
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Lactation

Morphine is excreted into breast milk. Monitor breastfed infants for signs of sedation, respiratory depression, poor feeding, and poor weight gain. Use with caution, preferably for short durations and at the lowest effective dose. Consider alternative analgesics if possible.

Infant Risk: Moderate to High (L3-L4) depending on dose, duration, and infant age/health. Neonates and premature infants are at higher risk.
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Pediatric Use

Use with extreme caution and only under specialist supervision due to high variability in pharmacokinetics and increased risk of respiratory depression. Dosing must be individualized and carefully titrated. Rectal administration is less common and often reserved for specific situations (e.g., NPO status).

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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

  • Rectal administration of morphine can be useful for patients who are NPO (nothing by mouth), have difficulty swallowing, or are experiencing severe nausea/vomiting.
  • Bioavailability via the rectal route is highly variable, making dose titration crucial. Patients may require higher rectal doses compared to oral doses to achieve equivalent analgesia.
  • Opioid-induced constipation is a universal side effect; prophylactic bowel regimen (stool softener + stimulant laxative) should be initiated concurrently with morphine therapy.
  • Monitor for signs of opioid-induced neurotoxicity (e.g., myoclonus, hyperalgesia, delirium), especially in patients with renal impairment due to M6G and M3G accumulation.
  • Always have naloxone readily available when prescribing opioids, and consider co-prescribing it for patients at high risk of overdose.
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Alternative Therapies

  • Other opioid analgesics (e.g., oxycodone, hydromorphone, fentanyl, codeine)
  • 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: Price varies widely by pharmacy and quantity (e.g., $10-$50 for 30 suppositories) per 30 suppositories
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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, do not share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital 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 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.