Dilaudid-5

Hydromorphone is an opioid pain medication, sometimes called a narcotic.

Hydromorphone is used to treat moderate to severe pain.

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

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

You should not take hydromorphone if you have severe breathing problems, or a blockage in your stomach or intestines.

Hydromorphone can slow or stop your breathing, and may be habit-forming. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

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

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

You should not take this medicine 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.

Some medicines can interact with hydromorphone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure hydromorphone is safe for you, tell your doctor if you have ever had:

• any type of breathing problem or lung disease;

• a injury, brain tumor, or seizures;

• drug or alcohol addiction, or mental illness;

• urination problems;

• liver or kidney disease;

• sulfite allergy;

• problems with your gallbladder, pancreas, or thyroid; or

• Addison's disease or other adrenal gland disorder.

If you use hydromorphone 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 habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

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

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

Avoid driving or operating machinery until you know how hydromorphone will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

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

Like other narcotic medicines, hydromorphone can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, pinpoint pupils, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing;

• 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 may include:

• constipation, nausea, vomiting, stomach pain;

• dizziness, drowsiness;

• headache, tired feeling;

• feelings of extreme happiness or sadness;

• sweating, mild itching;

• dry mouth; or

• flushing (warmth, redness, or tingly feeling).

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.