AUDIENCE: Family Practice, Psychiatry, Pain Management, Nursing, Endocrinology
ISSUE: FDA is warning about several safety issues with the entire class of opioid pain medicines. See the http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm for a complete listing. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks.
BACKGROUND: Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines are not able to provide enough pain relief (see List of Opioid Medicines in the http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm). However, opioids also carry serious risks, including of misuse and abuse, addiction, overdose, and death.
Prescription opioids are divided into two main categories – immediate-release (IR) products, usually intended for use every 4 to 6 hours; and extended release/long acting (ER/LA) products, intended to be taken once or twice a day, depending on the individual product and patient.
See the http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm for additional information, including a listing of opioids, serotonergic medicines, and a data summary.
Health care professionals should discontinue opioid treatment and/or use of the other medicine if serotonin syndrome is suspected.
Health care professionals should perform diagnostic testing if adrenal insufficiency is suspected. If diagnosed, treat with corticosteroids and wean the patient off of the opioid, if appropriate. If the opioid can be discontinued, follow-up assessment of adrenal function should be performed to determine if treatment with corticosteroids can be discontinued.
Decreased sex hormone levels:
Health care professionals should conduct laboratory evaluation in patients presenting with such signs or symptoms.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
Rectal morphine is used to relieve moderate to severe pain. Morphine is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the body senses pain.
How should this medicine be used?
Rectal morphine comes as a suppository to insert in the rectum. It is usually inserted every 4 hours. Use rectal morphine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use morphine exactly as directed.
Your doctor may adjust your dose of morphine during your treatment to control your pain as well as possible. If you feel that your pain is not controlled, call your doctor. Do not change the dose of your medication without talking to your doctor.
Morphine may be habit-forming. Do not use a larger dose, use it more often, or use it for a longer period of time than prescribed by your doctor.
Do not stop using morphine without talking to your doctor. Your doctor may decrease your dose gradually. If you suddenly stop using morphine, you may experience withdrawal symptoms such as anxiety; sweating; difficulty falling asleep or staying asleep; chills; shaking of a part of your body that you cannot control; nausea; diarrhea; runny nose, sneezing or coughing; hair on your skin standing on end; or hallucinating (seeing things or hearing voices that do not exist).
To use the suppositories, follow these steps:
- Remove the wrapper.
- Dip the tip of the suppository in water.
- Lie down on your left side and raise your right knee to your chest (A left-handed person should lie on the right side and raise the left knee.)
- Using your finger, insert the suppository about 1 inch (2.5 centimeters) into the rectum.
- Hold it in place with your finger for a few moments
- Stand up after about 15 minutes. Wash your hands thoroughly and resume normal activities.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using rectal morphine,
- tell your doctor and pharmacist if you are allergic to morphine, any other medications, or any of the ingredients in morphine suppositories. Ask your pharmacist for a list of the ingredients.
- do not use rectal morphine if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), procarbazine (Matulane), selegiline (Eldepryl), and tranylcypromine (Parnate) or if you have stopped taking any of these medications within the past 2 weeks.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines (found in cold and allergy medications); barbiturates such as phenobarbital and primidone (Mysoline); butorphanol (Stadol); medications for anxiety, mental illness, pain, seizures, or nausea; muscle relaxants; nalbuphine (Nubain); pentazocine (Talwin, in Talacen); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have ever had major surgery. Also tell your doctor if you have or have ever had a head injury; a brain tumor; seizures; mental illness; lung disease such as asthma, chronic obstructive pulmonary disease (COPD; a group of diseases that cause gradual loss of lung function), or other breathing problems; prostatic hypertrophy (enlargement of a male reproductive gland); urinary problems; low blood pressure; irregular heartbeat; Addison's disease (condition in which the body does not make enough of certain natural substances); or liver, kidney, pancreatic, intestinal, or gallbladder disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using morphine, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using morphine.
- you should know that morphine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- ask your doctor about the safe use of alcoholic beverages while you are using morphine.
What special dietary instructions should I follow?
Drink plenty of fluids while you are using this medication.
What should I do if I forget a dose?
Insert the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not insert a double dose to make up for a missed one.
What side effects can this medication cause?
Morphine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- difficulty falling asleep or staying asleep
- stomach pain
- loss of appetite
- dry mouth
- mood changes
- vision problems
- decreased urination
- decreased sexual desire or ability
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- slowed, shallow, or irregular breathing
- blue or purple color to the skin
- fast, slow, or pounding heartbeat
- swelling of the arms, hands, feet, ankles, or lower legs
Morphine may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
Store rectal morphine in a safe place so that no one else can use it accidentally or on purpose. Keep track of how many suppositories are left so you will know if any are missing.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- slow, shallow, or irregular breathing
- blue or purple color to the skin
- loss of consciousness
- limp muscles
- cold, clammy skin
- slow heartbeat
- blurred vision
What other information should I know?
Keep all appointments with your doctor.
This prescription is not refillable. If you are taking morphine to control your pain on a long-term basis, be sure to schedule appointments with your doctor so that you do not run out of medication. If you are using morphine on a short term basis, call your doctor if you continue to experience pain after you finish the medication.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
- RMS® Suppository