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Morphine Sulf Rect 20mg Suppository

Manufacturer PERRIGO Active Ingredient Morphine Suppositories(MOR feen) Pronunciation MOR-feen SUL-fayt REK-tal SUP-uh-ZIH-tor-ee
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)
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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 rectal suppositories are a strong pain medicine used to relieve severe pain. They work by changing how your brain and nervous system respond to pain. Because they are inserted into the rectum, they can be helpful if you cannot take medicine by mouth.
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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. 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's too 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 bathrooms and areas where children or pets may access it
Store it in a secure location, such as a locked box or area, to prevent unauthorized use
 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 proper disposal methods, including 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 the missed dose as soon as you remember
If it's 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 as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Avoid alcohol and other sedating medications (e.g., tranquilizers, sleeping pills) as they can increase drowsiness and breathing problems.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and consider using a stool softener or laxative as recommended by your doctor.
  • Store the suppositories in the refrigerator as directed, as they may melt at room temperature.
  • Do not share this medication with anyone else, as it can be dangerous and is against the law.
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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:

severePain: May require higher initial doses or more frequent administration, titrated to effect.
opioidNaive: Start with lower doses (e.g., 10 mg) and titrate carefully.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, highly individualized by specialist)
Infant: Not established (use with extreme caution, highly individualized by specialist)
Child: Not established (use with extreme caution, highly individualized by specialist)
Adolescent: Not established (use with extreme caution, highly individualized by specialist)
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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 if possible; if necessary, use very low doses with extended intervals and close monitoring. Accumulation of active metabolites (M6G) is significant.
Dialysis: Morphine and its metabolites are partially dialyzable. Supplemental dosing may be required post-dialysis, but caution is paramount due to accumulation.

Hepatic Impairment:

Mild: Reduce dose by 25-50%.
Moderate: Reduce dose by 50-75%.
Severe: Avoid if possible; if necessary, use very low doses with extended intervals and close monitoring.

Pharmacology

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Mechanism of Action

Morphine is a potent opioid agonist that primarily exerts its analgesic effects by binding to and activating mu-opioid receptors in the central nervous system (CNS), including the brain, spinal cord, and peripheral tissues. This binding inhibits the release of neurotransmitters involved in pain transmission (e.g., substance P, acetylcholine, norepinephrine, dopamine) and modulates the perception of pain.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (20-70% rectally, due to first-pass metabolism in rectal mucosa and liver)
Tmax: 30-60 minutes (rectal)
FoodEffect: Not applicable for rectal administration.

Distribution:

Vd: 3-4 L/kg
ProteinBinding: Approximately 30-35%
CnssPenetration: Yes (readily crosses blood-brain barrier)

Elimination:

HalfLife: 2-4 hours (parent drug); M6G and M3G have longer half-lives, especially in renal impairment.
Clearance: Approximately 15-30 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide conjugates)
Unchanged: <10% (excreted unchanged in urine)
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Pharmacodynamics

OnsetOfAction: 15-60 minutes (rectal)
PeakEffect: 60-120 minutes (rectal)
DurationOfAction: 4-5 hours

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 regularly for the development of these behaviors and conditions.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.
ACCIDENTAL INGESTION: Accidental ingestion of even one dose of morphine, especially by children, can result in a fatal overdose.
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.
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

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 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 Potentially Life-Threatening Condition

If you take this medication with certain other drugs, you may be at risk for a severe and potentially deadly condition called serotonin syndrome. Seek medical help immediately if you experience:

 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. Contact your doctor right away if you:

Feel very tired or weak
 Pass out
Experience severe dizziness
 Have a very upset stomach, throwing up, or decreased appetite

Hormonal Changes: A Potential Long-Term Effect

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

Lowered interest in sex
 Fertility problems
No menstrual period
 Ejaculation problems

Other Side Effects: Less Severe but Still Important

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

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 or seek medical help. Remember to report any side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice about side effects.
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Seek Immediate Medical Attention If You Experience:

  • Slow, shallow, or difficult breathing
  • Extreme drowsiness or difficulty waking up
  • Blue-tinged lips or fingernails
  • Severe dizziness or lightheadedness
  • Pinpoint pupils
  • Severe constipation or inability to have a bowel movement
  • Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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Before Using This Medicine

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

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 severely 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. It is crucial 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 adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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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, 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 can lead to tolerance, where the medication may not work as well, and you may need 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 first, as sudden changes 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.

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:

  • Severe respiratory depression (slowed or stopped breathing)
  • Extreme somnolence progressing to stupor or coma
  • Skeletal muscle flaccidity
  • Cold, clammy skin
  • Pinpoint pupils
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Circulatory collapse
  • Cardiac arrest
  • Death

What to Do:

Immediately call 911 or emergency medical services. Administer naloxone if available and trained to do so. Call 1-800-222-1222 (Poison Control Center) for further guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of serotonin syndrome or severe respiratory depression)
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Major Interactions

  • CNS Depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, tricyclic antidepressants, phenothiazines): Increased risk of respiratory depression, profound sedation, coma, and death.
  • Mixed Agonist/Antagonist Opioid Analgesics (e.g., butorphanol, nalbuphine, pentazocine): May reduce analgesic effect and/or precipitate withdrawal symptoms.
  • Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans): Risk of serotonin syndrome.
  • Anticholinergics (e.g., atropine, scopolamine): Increased risk of urinary retention and/or severe constipation.
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Moderate Interactions

  • Muscle Relaxants: Enhanced neuromuscular blockade and increased risk of respiratory depression.
  • Diuretics: Opioids may reduce the efficacy of diuretics by causing ADH release.
  • Antihypertensives: May cause additive hypotensive effects.
  • P-glycoprotein (P-gp) Inhibitors/Inducers: May alter morphine exposure (e.g., quinidine, rifampin).
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Minor Interactions

  • Cimetidine: May inhibit morphine metabolism, leading to increased morphine levels.
  • Ritonavir: May increase morphine levels.

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 mental status and identify risk for excessive sedation.

Timing: Prior to initiation of therapy

Bowel function

Rationale: To assess baseline bowel habits and plan for constipation prophylaxis.

Timing: Prior to initiation of therapy

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Routine Monitoring

Pain assessment

Frequency: Regularly (e.g., every 2-4 hours initially, then as needed)

Target: Acceptable pain level as defined by patient goals

Action Threshold: Uncontrolled pain or adverse effects requiring dose adjustment

Respiratory rate and depth

Frequency: Regularly (e.g., every 1-4 hours, or more frequently with dose changes)

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

Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation (e.g., cyanosis, somnolence)

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

Frequency: Regularly (e.g., every 1-4 hours, or more frequently with dose changes)

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 discomfort

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Symptom Monitoring

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

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 can lead to neonatal opioid withdrawal syndrome.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations cannot be ruled out.
Second Trimester: Risk of neonatal opioid withdrawal syndrome with prolonged use.
Third Trimester: High risk of neonatal opioid withdrawal syndrome with prolonged use. Risk of respiratory depression in the neonate if used near delivery.
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Lactation

Morphine is excreted into breast milk. Use with caution. Monitor infants for signs of sedation, respiratory depression, and poor feeding. Consider alternative analgesics or temporary cessation of breastfeeding.

Infant Risk: Moderate risk (L3). Potential for sedation, respiratory depression, constipation, and poor weight gain in the infant.
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Pediatric Use

Not routinely recommended for rectal administration in children due to variable absorption and difficulty in precise dosing. If used, it must be done with extreme caution, under specialist supervision, and with careful titration and monitoring.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Rectal absorption of morphine can be highly variable, leading to unpredictable plasma concentrations. This route is generally reserved for situations where oral or parenteral routes are not feasible.
  • Always initiate bowel regimen (stool softener plus stimulant laxative) concurrently with opioid therapy to prevent opioid-induced constipation.
  • Tolerance to the analgesic effects of morphine can develop over time, requiring dose escalation. However, tolerance to constipation and miosis (pupil constriction) is less likely to occur.
  • Physical dependence and withdrawal symptoms can occur upon abrupt discontinuation or rapid dose reduction after prolonged use. Tapering is essential.
  • Educate patients and caregivers on the safe storage of opioids to prevent accidental ingestion, especially by children.
  • Naloxone should be readily available for patients at high risk of opioid overdose (e.g., those on high doses, concomitant CNS depressants, history of substance use disorder).
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Alternative Therapies

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

Average Cost: Varies widely (e.g., $50 - $200+) per 30 suppositories (20mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (depends on insurance plan formulary)
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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 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.