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?
Hydromorphone suppositories are used to relieve moderate to severe pain. Hydromorphone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
How should this medicine be used?
Hydromorphone comes as a suppository to insert in the rectum. It is usually inserted once every 6 to 8 hours. Insert hydromorphone 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 hydromorphone suppositories exactly as directed.
Hydromorphone suppositories may be habit forming. Do not use a larger dose, use them more often, or use them for a longer period of time than prescribed by your doctor.
Do not stop using hydromorphone suppositories without talking to your doctor. If you suddenly stop using hydromorphone suppositories, you may experience withdrawal symptoms including restlessness, teary eyes, runny nose, yawning, sweating, chills, hair standing on end, muscle and joint pain, widening of the pupils (black circles in the middle of the eyes), irritability, anxiety, backache, weakness, stomach cramps, difficulty falling asleep or staying asleep, nausea, loss of appetite, vomiting, diarrhea, fast breathing, or fast heartbeat. Your doctor will probably decrease your dose gradually.
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 hydromorphone suppositories,
- tell your doctor and pharmacist if you are allergic to hydromorphone, any other medications, or any of the ingredients in hydromorphone suppositories. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what 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: antidepressants ('mood elevators') such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); other narcotic medications for pain; medications for anxiety, seizures, mental illness or nausea; 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 have or have ever had a head injury or any condition that caused damage to your brain, any condition that increases the pressure in your brain; slowed breathing; or any condition that affects your breathing such as asthma, chronic obstructive pulmonary disease (COPD; a group of diseases including chronic bronchitis and emphysema that affect the lungs and airways), or kyphoscoliosis (curving of the spine that may cause breathing problems). Your doctor may tell you not to use hydromorphone suppositories.
- tell your doctor if you are an older adult or if you are weakened or malnourished by disease. Also tell your doctor if you have or have ever had hypothyroidism (condition in which the thyroid gland produces less hormone than normal); Addison's disease (condition in which the adrenal gland produces less hormone than normal); any condition that causes difficulty urinating such as an enlarged prostate (a male reproductive gland) or urethral stricture (blockage of the tube that allows urine to leave the body); or liver or kidney disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using hydromorphone suppositories, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using hydromorphone suppositories.
- you should know that hydromorphone may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- you should know that drinking alcohol during your treatment with hydromorphone suppositories increases the risk that you will experience serious or life-threatening side effects. Talk to your doctor about the risks of drinking alcohol during your treatment with hydromorphone suppositories.
- you should know that hydromorphone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using hydromorphone suppositories. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Use 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 use a double dose to make up for a missed one.
What side effects can this medication cause?
Hydromorphone suppositories may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- mood changes
- difficulty urinating
- narrowing of the pupils (dark circles in the center of the eyes)
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
- slowed or stopped breathing
- breathing that is irregular or that stops and starts
Hydromorphone suppositories may cause other side effects. Call your doctor if you have any unusual problems while you are 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 in the refrigerator. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
Store hydromorphone suppositories in a refrigerator in a safe place so that no one else can take the medication 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 or if someone swallows hydromorphone suppositories, 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:
- slowed or stopped breathing
- coma (loss of consciousness for a period of time)
- muscle weakness
- cold, clammy skin
- narrowing or widening of the pupils (dark circle in the middle of the eye)
- slowed or stopped heartbeat
What other information should I know?
Keep all appointments with your doctor.
This prescription is not refillable. If you continue to have pain after you finish the hydromorphone suppositories, call your doctor.
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.
- available generically