Generic Name: hydromorphone extended-release (HYE-droe-MOR-fone)
Brand Name: Exalgo

Exalgo is a narcotic pain medicine that may become habit-forming. Misuse or abuse can lead to overdose and death. Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.

Exalgo may cause severe and sometimes fatal breathing problems. The risk may be greater when you first start this drug or with any increase in dose. Contact your doctor right away if you experience slow, shallow, or difficult breathing.

Be sure to swallow Exalgo whole. Do NOT break, crush, cut, chew, or dissolve Exalgo before swallowing it. Do NOT inject or snort Exalgo. Doing any of these things could result in very serious side effects, including severe trouble breathing and death from overdose.

Accidental swallowing of even one dose of Exalgo may be fatal, especially in children. Keep Exalgo out of the reach of children. Seek emergency medical care right away if another person swallows Exalgo.

Long-term use of Exalgo during pregnancy may cause dependence in the unborn baby. This can lead to withdrawal in the newborn, which can be life-threatening. Discuss any questions or concerns with your doctor.


Exalgo is used for:

Managing severe pain in certain patients. Exalgo is only for use when continuous (around-the-clock) treatment is needed for a long time. It is only for use when other pain treatments do not treat your pain well enough or you cannot take them. Exalgo should only be used by patients who have already been taking other narcotic pain medicine on a regular schedule and are tolerant to its effects. It is NOT for use right after surgery if you have not already been using narcotic pain medicines, if you need only occasional or as-needed pain relief, or if the pain is mild or is not expected to last for a long time.

Exalgo is a narcotic (opioid) pain medicine. It works in the brain and nervous system to reduce pain.

Do NOT use Exalgo if:

  • you are allergic to any ingredient in Exalgo or to sulfites
  • you have not already been taking other narcotic pain medicine on a regular schedule
  • you have difficult, shallow, or slowed breathing
  • you have severe lung problems (eg, severe asthma) or you are having an asthma attack
  • you have known or suspected stomach or bowel blockage (eg, paralytic ileus), certain other stomach or bowel problems (eg, narrowing, "blind loops," "short gut" syndrome, small bowel inflammation, Meckel diverticulum), certain esophagus problems, or cystic fibrosis, or if you have had bowel surgery that resulted in narrowing of the bowels
  • you are taking buprenorphine, a mixed agonist/antagonist pain medicine (eg, butorphanol, nalbuphine, pentazocine), or sodium oxybate (GHB)
  • you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or if you have taken an MAOI within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Fact or Fiction? The Top 15 Osteoarthritis Myths

Before using Exalgo:

Some medical conditions may interact with Exalgo. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had an allergic reaction to any other codeine- or morphine-related medicine (eg, oxycodone)
  • if you have a history of chronic obstructive pulmonary disease (COPD) or other lung or breathing problems (eg, asthma, emphysema, bronchitis), sleep apnea, curvature of the spine (scoliosis), a certain heart problem (cor pulmonale), high levels of carbon dioxide in the blood (hypercapnia or hypercarbia), or low levels of oxygen in the blood (hypoxia)
  • if you have severe drowsiness, a recent head injury, growths in the brain (eg, lesions, tumors), increased pressure in the brain, or a history of seizures (eg, epilepsy)
  • if you have a history of liver or kidney problems, gallbladder problems, pancreas problems (eg, pancreatitis), thyroid problems, a urinary blockage or trouble urinating, or stomach or bowel problems (eg, blockage, inflammation)
  • if you have low blood pressure, dehydration, low blood volume, constipation, stomach pain, poor health, or trouble swallowing
  • if you drink alcohol, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
  • if you or a member of your family have a history of mental or mood problems (eg, depression), or alcohol or other substance abuse or dependence
  • if you are very overweight, or have recently had or will be having surgery (eg, stomach or bowel surgery)
  • if you are taking carisoprodol

Some MEDICINES MAY INTERACT with Exalgo. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
  • Sodium oxybate (GHB) because the risk of severe drowsiness, coma, confusion, or slowed or difficult breathing may be increased
  • Anticholinergics (eg, scopolamine, benztropine) because the risk of constipation and trouble urinating may be increased
  • MAOIs (eg, phenelzine) because the risk of a severe reaction, including fever, seizures, and coma may be increased
  • Other narcotic pain medicines (eg, morphine, oxycodone) because they may increase the risk of Exalgo's side effects
  • Buprenorphine, mixed agonist/antagonist pain medicines (eg, butorphanol, nalbuphine, pentazocine), or naltrexone because they may decrease Exalgo's effectiveness and withdrawal may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Exalgo may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Exalgo:

Use Exalgo as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Exalgo comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Exalgo refilled.
  • Take Exalgo by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Exalgo must only be taken by mouth. Do not inject or snort Exalgo.
  • Swallow Exalgo whole. Do NOT break, cut, crush, chew, or dissolve the tablet before swallowing it. If you cannot swallow Exalgo whole, tell your doctor.
  • Do not suddenly stop taking Exalgo. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop Exalgo, your doctor will gradually lower your dose.
  • Exalgo works best if it is taken at the same time each day. Do not miss any doses.
  • If you miss a dose of Exalgo, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than your prescribed dose in 24 hours.

Ask your health care provider any questions you may have about how to use Exalgo.

Important safety information:

  • Exalgo may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol, other opiate pain medicines, or certain other medicines. Use Exalgo with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or take medicines (prescription or nonprescription) that contain alcohol while you are taking Exalgo. Check with your pharmacist if you have questions about whether any of your medicines contain alcohol.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you take Exalgo; the risk of severe drowsiness or breathing problems may be increased. Ask your pharmacist if you have questions about which medicines may increase the risk of these effects.
  • Exalgo may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.
  • You may notice the tablet shell in your stool. This is normal and not a cause for concern.
  • Exalgo contains sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if this product has sulfites in it.
  • Exalgo may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking Exalgo, talk with your doctor or pharmacist.
  • If your pain continues or becomes worse or if you have side effects that concern you, contact your doctor.
  • Tell your doctor or dentist that you take Exalgo before you receive any medical or dental care, emergency care, or surgery.
  • Seek emergency medical care right away if another person swallows Exalgo. Accidental swallowing of Exalgo may be fatal, especially in children.
  • Use Exalgo with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness and breathing problems.
  • Exalgo should be used with extreme caution in CHILDREN younger than 17 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Exalgo while you are pregnant. Long-term use of Exalgo during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Exalgo is found in breast milk. Do not breast-feed while taking Exalgo.

When used for long periods of time or at high doses, Exalgo may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Exalgo stops working well. Do not take more than prescribed.

Some people who use Exalgo for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Exalgo, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rapid heartbeat; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Exalgo:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; decreased appetite; diarrhea; dizziness, drowsiness; dry mouth; headache; joint pain; mild itching; mild stomach pain; nausea; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); abnormal sighing; burning, numbness, or tingling; chest pain; confusion; decreased coordination; fainting; fast, slow, or irregular heartbeat; hallucinations; memory problems; mental or mood changes (eg, agitation, depression); seizure; severe or persistent constipation, stomach pain, or vomiting; severe or persistent dizziness, drowsiness, headache, or light-headedness; shallow, slowed, or difficult breathing; shortness of breath; stomach swelling; suicidal thoughts or actions; swelling of the hands, ankles, or feet; tremor; trouble urinating; vision changes (eg, blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin or nails; cold and clammy skin; coma; difficult, shallow, or slow breathing; fainting; limp muscles; pinpoint or enlarged pupils; severe drowsiness, dizziness, or light-headedness; shortness of breath; slow or irregular heartbeat.

Proper storage of Exalgo:

Store Exalgo at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store Exalgo in the bathroom. Keep Exalgo out of the reach of children and away from pets.

General information:

  • If you have any questions about Exalgo, please talk with your doctor, pharmacist, or other health care provider.
  • Exalgo is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Exalgo or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Exalgo. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Exalgo. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Exalgo.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Hide
(web2)
Close