Exalgo is an opioid pain medication. An opioid is sometimes called a narcotic.

Exalgo extended-release tablets are used to treat moderate to severe pain.

Exalgo extended-release tablets are for around-the-clock treatment of moderate to severe pain. It is not for use on an as-needed basis for pain.

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

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

Exalgo can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use hydromorphone in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

Hydromorphone may be habit-forming, even at regular doses. Take Exalgo exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Tell your doctor if you are pregnant. Exalgo may cause life-threatening withdrawal symptoms in a newborn if the mother has taken this medicine during pregnancy.

Do not drink alcohol. Dangerous side effects or death could occur when alcohol is combined with hydromorphone.

Before using Exalgo

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

• breathing problems, sleep apnea;

• a blockage in your stomach or intestines; or

• a bowel obstruction called paralytic ileus.

Do not use Exalgo if you have used a 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 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.

You may not be able to take Exalgo if you are NOT already being treated with a similar opioid (narcotic) pain medicine and are tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Hydromorphone may be habit-forming. Never share Exalgo with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away Exalgo to any other person is against the law.

To make sure Exalgo is safe for you, tell your doctor if you have:

• any type of breathing problem or lung disease;

• a history of head injury, brain tumor, or seizures;

• a history of drug abuse, alcohol addiction, or mental illness;

• urination problems;

• liver or kidney disease;

• sulfite allergy;

• Addison's disease or other adrenal gland disorders;

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

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

It is not known whether this medicine will harm an unborn baby. 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.

Hydromorphone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Exalgo.

Take Exalgo exactly as prescribed. Follow all directions on your prescription label. Hydromorphone can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use Exalgo in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Hydromorphone may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.

Do not crush, break, or open an Exalgo extended-release tablet. Swallow it whole to avoid exposure to a potentially fatal dose.

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

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

Never crush or break an Exalgo tablet to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

Store at room temperature away from moisture, heat, and light.

Keep track of the amount of medicine used from each new bottle. Hydromorphone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover Exalgo tablets. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused tablets down the toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.

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

• breathing problems, sleep apnea;

• a blockage in your stomach or intestines; or

• a bowel obstruction called paralytic ileus.

Do not use Exalgo if you have used a 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 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.

You may not be able to take Exalgo if you are NOT already being treated with a similar opioid (narcotic) pain medicine and are tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Hydromorphone may be habit-forming. Never share Exalgo with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away Exalgo to any other person is against the law.

To make sure Exalgo is safe for you, tell your doctor if you have:

• any type of breathing problem or lung disease;

• a history of head injury, brain tumor, or seizures;

• a history of drug abuse, alcohol addiction, or mental illness;

• urination problems;

• liver or kidney disease;

• sulfite allergy;

• Addison's disease or other adrenal gland disorders;

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

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

It is not known whether this medicine will harm an unborn baby. 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.

Hydromorphone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Exalgo.

Since Exalgo 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 or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with hydromorphone.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Exalgo will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Get emergency medical help if you have any signs of an allergic reaction to Exalgo: 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.

Call your doctor at once if you have:

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

• confusion, feelings of extreme happiness or sadness;

• severe weakness or drowsiness;

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

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex; or

• 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.

Hydromorphone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Common Exalgo 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.

Hydromorphone 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.