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

Hydromorphone rectal 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.

Using 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.

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 hydromorphone.

Do not take a hydromorphone rectal suppository by mouth. It is for use only in your rectum.

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.

Wash your hands before and after inserting the rectal suppository.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

If you need surgery, tell the surgeon ahead of time that you are using rectal hydromorphone.

Do not stop using this medicine suddenly after long-term use, or you could have serious withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store in the refrigerator, do not freeze. Protect from light. 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 use rectal hydromorphone if you have ever had an allergic reaction to a narcotic medicine, or if you have:

• severe asthma or breathing problems;

• a brain tumor; or

• abnormal curvature of the spine that affects breathing.

You should not use rectal 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:

• breathing problems, sleep apnea;

• a head injury or seizure;

• liver or kidney disease;

• a stomach or intestinal disorder;

• an enlarged prostate or urination problems;

• a thyroid disorder; or

• Addison's disease or other adrenal gland disorders.

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.

You should not breastfeed while using rectal hydromorphone.

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 scheduled dose. Do not use extra medicine to make up the missed dose.

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 who accidentally sucks on or swallows a hydromorphone suppository, or in any other person using the medicine without a prescription. Overdose symptoms may include slow heart rate, severe drowsiness, muscle weakness, cold and clammy skin, very slow breathing, or coma.

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.

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;

• severe drowsiness;

• little or no urination;

• confusion, mood changes, severe anxiety, feeling of fear;

• 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:

• constipation;

• dizziness, drowsiness;

• sweating;

• weakness, muscle stiffness; or

• joint or muscle 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.