(hye" droe mor' fone)
Hydromorphone may be habit-forming. Do not take more of it or take it more often than directed by your doctor. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse hydromorphone if you have or have ever had any of these conditions.
Do not allow anyone else to take your medication. Hydromorphone may harm or cause death to other people who take your medication, especially children. Keep hydromorphone in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep hydromorphone out of the reach of children. Keep track of how many tablets or how much liquid is left so you will know if any medication is missing.
Hydromorphone may cause slowed or stopped breathing, especially when you begin your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Your doctor will adjust your dose carefully, to control your pain and decrease the risk that you will experience serious breathing problems. Tell your doctor if you have slowed breathing or have or have ever had asthma. Your doctor will probably tell you not to take hydromorphone. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (a group of diseases that affect the lungs and airways)or kyphoscoliosis (curving of the spine that may cause breathing problems). The risk that you will develop breathing problems may be higher if you are an older adult or are weakened or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.
Drinking alcohol, taking prescription or non-prescription medications that contain alcohol, or using street drugs during your treatment with hydromorphone increases the risk that you will experience serious, life-threatening side effects. Talk to your doctor about the risks of drinking alcohol or using street drugs during your treatment.
Taking certain other medications during your treatment with hydromorphone may increase the risk that you will experience serious, life-threatening side effects. Tell your doctor if you are taking or plan to take any of the following medications: other narcotic pain medications; medications for anxiety, seizures, mental illness, or nausea; muscle relaxants; sedatives; sleeping pills; or tranquilizers.
Your doctor should only prescribe hydromorphone extended-release (long-acting) tablets for you if you are opioid tolerant (have been treated with certain doses of narcotic medications for at least one week, allowing your body to adjust to this type of medication). Hydromorphone extended-release tablets may cause serious breathing problems or death if they are taken by a person who is not opioid tolerant.
Swallow the extended-release tablets whole. Do not split, chew, dissolve, or crush them. If you swallow broken, chewed, crushed, or dissolved tablets you may receive too much hydromorphone at once instead of receiving the medication slowly over time. This may cause serious breathing problems or death.
If you are taking hydromorphone extended release tablets, your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin your treatment and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking hydromorphone.
WHY is this medicine prescribed?
Hydromorphone is used to relieve pain. Hydromorphone extended-release tablets are used only in people who are opioid tolerant and who are expected to need medication to relieve moderate to severe pain around-the-clock for longer than a few days. Hydromorphone extended-release tablets should not be used to treat pain that occurs after surgery. 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 liquid, a tablet, and an extended-release (long-acting) tablet to take by mouth. The liquid is usually taken every 3-6 hours and the tablets are usually taken every 4-6 hours. The extended-release tablets are taken once daily with or without food. Take hydromorphone at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take hydromorphone exactly as directed.
Tell your doctor if you feel that your pain is not controlled during your treatment with hydromorphone. Do not change the dose of your medication without talking to your doctor.
Do not stop taking hydromorphone without talking to your doctor. If you suddenly stop taking hydromorphone, you may experience withdrawal symptoms including restlessness, teary eyes, runny nose, yawning, sweating, chills, hair standing on end, muscle or 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. If you do not take hydromorphone extended-release tablets for longer than 3 days for any reason, talk to your doctor before you start taking the medication again.
Are there 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 taking hydromorphone,
- tell your doctor and pharmacist if you are allergic to hydromorphone, any other medications, sulfites, or any of the ingredients in hydromorphone tablets, solution, or extended-release tablets. Ask your pharmacist or check the Medication Guide 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 the medications listed in the IMPORTANT WARNING section and any of the following: buprenorphine (Buprenex, Butrans, in Suboxone); butorphanol (Stadol); ipratropium (Atrovent); medications for glaucoma, irritable bowel disease, Parkinson's disease, ulcers, and urinary problems;and pentazocine (Talwin). Also tell your doctor or pharmacist if you are taking any of the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have any of the conditions listed in the IMPORTANT WARNING section, paralytic ileus (condition in which food does not move through the intestines), or a blockage in the stomach or intestines. Your doctor may tell you not to take hydromorphone.
- if you will be taking the extended-release tablets, also tell your doctor if you have ever had surgery that caused a change in the way food moves through your stomach or intestines or if you have any condition that cause narrowing of the esophagus (tube that carries food from the mouth to the stomach), stomach or intestines such as cystic fibrosis (a condition that causes the body to produce thick, sticky mucus that may clog the pancreas, lungs, and other parts of the body), peritonitis (inflammation of the lining of the abdomen (stomach area), Meckel's diverticulum (a bulge in the lining of the small intestine that is present at birth), chronic intestinal pseudo-obstruction (condition in which the muscles in the intestine do not move food smoothly through the intestine), or inflammatory bowel disease (IBD; a group of conditions that cause inflammation of the lining of the intestine. Your doctor may tell you not to take hydromorphone extended release tablets.
- 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; low blood pressure; 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); seizures; 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 gallbladder, pancreas, liver, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking hydromorphone, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking hydromorphone.
- 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 hydromorphone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. 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 to take a dose?
If you are taking the tablets or solution, take 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 take a double dose to make up for a missed one.
If you are taking the extended-release tablets, skip the missed dose and continue your regular dosing schedule. Do not take more than one dose of the extended-release tablets in 24 hours.
What SIDE EFFECTS can this medicine cause?
Hydromorphone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- dry mouth
- mood changes
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
- swelling of the eyes, face, lips, tongue, mouth, throat, arms, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
Hydromorphone may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
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). Flush any medication that is outdated or no longer needed down the toilet. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of 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:
- 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 circles in the middle of the eyes)
- 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, call your doctor.
If you are taking the extended release tablets, you may see the tablet shell in your stool. This is normal and does not mean that you did not receive the full dose of 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.
- Also available generically