Hydromorphone is an opioid medication used to treat moderate to severe pain.

The extended-release form of hydromorphone is for around-the-clock treatment of moderate to severe pain, not for use on an as-needed basis for pain.

Hydromorphone may also be used for purposes not listed in this medication guide.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

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 to 6 hours and the tablets are usually taken every 4 to 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.

Do not allow the hydromorphone liquid to touch your skin or clothing. If such contact occurs, remove any clothes exposed to the oral liquid and wash your skin thoroughly with cool water.

Your doctor may start you on a low dose of hydromorphone and gradually increase your dose, not more often than once every 3 to 4 days. Your doctor may decrease your dose if you experience side effects. Tell your doctor if you feel that your pain is not controlled or if you experience side effects 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. Your doctor will probably decrease your dose gradually. 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.

Follow the directions on your prescription label and read all medication guides. Never use hydromorphone in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Stop taking all other around-the-clock narcotic pain medications when you start taking hydromorphone.

Swallow the capsule or tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, open, or dissolve.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Do not stop using hydromorphone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using hydromorphone.

Never crush or break a hydromorphone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This can cause in death.

Store at room temperature away from moisture, heat, and light. Throw away any unused liquid after 90 days.

Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

You should not take hydromorphone if you have ever had an allergic reaction to hydromorphone or other narcotic medicines, or if you have:

• severe asthma or breathing problems;

• a blockage in your stomach or intestines; or

• a bowel obstruction called paralytic ileus.

Do not use hydromorphone if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you have ever had:

• a head injury, brain tumor, or seizures;

• breathing problems, sleep apnea;

• alcoholism, drug addiction, or mental illness;

• urination problems;

• liver or kidney disease;

• a sulfite allergy; or

• problems with your gallbladder, pancreas, or thyroid.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Do not breast-feed. Hydromorphone can pass into breast milk and may cause drowsiness or breathing problems in a nursing baby.

Since hydromorphone is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A hydromorphone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, very slow breathing, or coma.

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). You must immediately dispose of any medication that is outdated or no longer needed through a medicine take-back program. If you do not have a take-back program nearby or one that you can access promptly, flush any hydromorphone liquid or tablets that are outdated or no longer needed down the toilet. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how hydromorphone will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Hydromorphone may cause serious side effects. Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;

• a slow heart rate or weak pulse;

• confusion, feelings of extreme happiness or sadness;

• severe weakness or drowsiness;

• a light-headed feeling, like you might pass out;

• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects of hydromorphone may include:

• drowsiness, tiredness;

• dizziness;

• headache; or

• constipation, nausea, vomiting, stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications--opioid pain medicine or prescription cough medicine;

• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect hydromorphone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Keep all appointments with your doctor and laboratory. Your doctor may order certain lab tests to check your body's response to hydromorphone.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking hydromorphone.

If you are taking the extended-release tablet and you have any x-ray tests, tell the technician that you are taking this medication.

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.