Exalgo

Pronunciation: HYE-droe-MOR-fone
Generic Name: Hydromorphone Extended-Release
Brand Name: Exalgo

Exalgo contains hydromorphone, a narcotic pain medicine. Tell your doctor if you have a history of alcohol or other substance abuse or dependence before you use Exalgo.

Exalgo is used to treat constant (around-the-clock), moderate to severe pain that is expected to last for an extended amount of time. Exalgo is not for patients who only need occasional or "as-needed" pain relief. It should not be used to treat pain after surgery.

Exalgo should only be used by patients who have already been taking narcotic pain medicine and are tolerant to its effect. Use of Exalgo by people who are not used to taking narcotic pain medicine may cause severe and sometimes fatal breathing problems. Fatal overdose can occur if Exalgo is accidentally swallowed, especially in children.

Swallow Exalgo whole. Do NOT break, crush, chew, dissolve, or inject Exalgo. Doing so may cause the release of too much medicine into the bloodstream, which could be fatal.

Exalgo is used for:

Treating moderate to severe pain in patients who are already tolerant to narcotic pain medicine.

Exalgo is an opioid (narcotic) analgesic. It works by binding to certain receptors in the brain and nervous system to reduce pain.

Do NOT use Exalgo if:

• you are allergic to any ingredient in Exalgo, including sulfites or to any other codeine- or morphine-related medicine (eg, morphine, codeine, oxycodone)


• you are not already taking narcotic pain medicine


• you have difficult or slowed breathing, or you are having a severe asthma attack


• you have certain stomach or bowel problems (blockage, paralytic ileus, "blind loops," narrow bowel, "short gut" syndrome, inflammation, Meckels diverticulum), cystic fibrosis, or you have had bowel surgery that resulted in narrowing of the bowels


• you have increased pressure in the brain


• you are taking sodium oxybate (GHB) or 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.

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 a history of lung or breathing problems (eg, asthma, emphysema, bronchitis, chronic obstructive pulmonary disease [COPD], sleep apnea), seizures (eg, epilepsy), adrenal gland problems (eg, Addison disease), an enlarged prostate, heart problems (eg, cor pulmonale), low blood pressure, an underactive thyroid, or urinary blockage


• if you have severe drowsiness, a recent head injury, spinal problems, growths in the brain, or increased pressure in the brain


• if you have liver or kidney problems, gallbladder problems, pancreas problems, or stomach or bowel problems (eg, inflammation, constipation), severe diarrhea caused by an antibiotic, or if you have had stomach or bowel surgery


• if you drink alcohol regularly, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts


• if you have a personal or family history of mental or mood problems, alcohol abuse, or other substance abuse or dependence


• if you are very overweight, in very poor health, or will be having surgery


• if you are dehydrated or have low blood volume, low blood oxygen levels, high blood carbon dioxide levels, or shock caused by serious heart problems

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


• Anticholinergics (eg, scopolamine, benztropine) because the risk of severe constipation or trouble urinating may be increased


• Barbiturate anesthetics (eg, thiopental), cimetidine, MAOIs (eg, phenelzine), or sodium oxybate (GHB) because the risk of severe drowsiness, coma, or slowed or difficult breathing may be increased


• Agonist/antagonist analgesics (eg, pentazocine) or naltrexone because they may decrease Exalgo's effectiveness and withdrawal may occur


• Rifamycins (eg, rifampin) because they may decrease Exalgo's effectiveness

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.


• Swallow Exalgo whole. Do NOT break, crush, chew, dissolve, or inject Exalgo.


• Take Exalgo at the same time each day. Do not take it more often than 1 time per day.


• Do not change your dose or suddenly stop taking Exalgo without checking with your doctor.


• If Exalgo is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Exalgo properly.


• If you miss a dose of Exalgo, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses within 24 hours of each other. If you miss Exalgo for 3 or more days, check with your doctor before you take another dose.

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

Important safety information:

• Exalgo may cause drowsiness, dizziness, blurred vision, or lightheadedness. 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 while you are taking Exalgo.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you take Exalgo; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Exalgo may cause dizziness, lightheadedness, 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.


• Exalgo may be habit-forming. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Misuse or abuse of Exalgo may cause severe side effects, including severe breathing problems, seizures, coma, and possibly death.


• 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.


• Constipation is a common side effect of Exalgo. Talk to your doctor about using laxatives or stool softeners to prevent or treat constipation while you use Exalgo.


• Severe or persistent diarrhea may decrease the amount of Exalgo that is absorbed into your body. This may make the medicine less effective, or cause withdrawal symptoms. Tell your doctor if you have severe or persistent diarrhea.


• 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.


• 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: Exalgo may cause harm to the fetus. 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. 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. Dependence is unlikely to be an issue in terminally ill patients where comfort is more important.

If you are taking Exalgo regularly, do not suddenly stop taking it without checking with your doctor. WITHDRAWAL symptoms have occurred when Exalgo is suddenly stopped and may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping Exalgo.

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; dizziness, drowsiness; headache; lightheadedness; 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, or tongue); chest pain; confusion; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; seizure; severe or persistent constipation, stomach pain, or vomiting; severe or persistent dizziness, drowsiness, or headache; shallow, slowed, or difficult breathing; stomach swelling; tremor; trouble urinating; vision changes.

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.

See also: Exalgo side effects (in more detail)

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; chest pain; cold and clammy skin; coma; confusion; difficult or slow breathing; limp muscles; numbness of an arm or leg; pinpoint pupils; seizures; severe drowsiness or dizziness; 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 is a summary only. It does not contain all information about Exalgo. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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