Generic Name: hydromorphone (oral) (HYE droe MOR fone)
Brand Names: Dilaudid, Exalgo, Hydrostat IR
What is Exalgo?
Exalgo (hydromorphone) 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.
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 addiction and withdrawal symptoms in a newborn.
Do not drink alcohol. Dangerous side effects or death can 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:
severe asthma or breathing problems;
a blockage in your stomach or intestines; or
a bowel obstruction called paralytic ileus.
Do not use Exalgo 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.
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;
liver or kidney disease;
Addison's disease or other adrenal gland disorders; or
problems with your gallbladder, pancreas, or thyroid.
Hydromorphone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.
FDA pregnancy category C. It is not known whether Exalgo will harm an unborn baby. Hydromorphone may cause breathing problems, behavior changes, or life-threatening addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy. Tell your doctor if you are pregnant.
See also: Pregnancy and breastfeeding warnings (in more detail)
Hydromorphone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Exalgo.
How should I use 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.
After you have stopped using Exalgo extended-release tablets, 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.
What happens if I miss a dose?
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.
What happens if I overdose?
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.
What should I avoid?
Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with hydromorphone. Check your food and medicine labels to be sure these products do not contain alcohol.
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.
Exalgo side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Exalgo: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
weak or shallow breathing;
confusion, feelings of extreme happiness or sadness;
severe weakness or drowsiness; or
a light-headed feeling, like you might pass out.
Common Exalgo side effects may include:
constipation, nausea, vomiting, stomach pain;
headache, tired feeling;
dry mouth; or
sweating, mild itching.
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.
See also: Side effects (in more detail)
What other drugs will affect Exalgo?
Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Exalgo with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
Other drugs may interact with hydromorphone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Compare with other treatments for:
Where can I get more information?
- Your pharmacist can provide more information about Exalgo.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Exalgo only for the indication prescribed.
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