Generic Name: hydromorphone extended-release (HYE-droe-MOR-fone)
Brand Name: Exalgo
Hydromorphone extended-release 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.
Hydromorphone extended-release 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 hydromorphone extended-release whole. Do NOT break, crush, cut, chew, or dissolve hydromorphone extended-release before swallowing it. Do NOT inject hydromorphone extended-release. Doing any of these things could result in very serious side effects, including severe trouble breathing and death from overdose.
Accidental swallowing of hydromorphone extended-release may be fatal, especially in children. Keep hydromorphone extended-release out of the reach of children. Seek emergency medical care right away if another person swallows hydromorphone extended-release.
Long-term use of hydromorphone extended-release 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.
Hydromorphone extended-release is used for:
Managing moderate to severe pain in certain patients when continuous (around-the-clock) treatment is needed for an extended period of time. Hydromorphone extended-release 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. Hydromorphone extended-release is not for use right after surgery if you have not already been using narcotic pain medicines, if only occasional or as-needed pain relief is needed, or if the pain is mild or is not expected to last for an extended period of time.
Hydromorphone extended-release is a narcotic (opioid) pain medicine. It works in the brain and nervous system to reduce pain.
Do NOT use hydromorphone extended-release if:
- you are allergic to any ingredient in hydromorphone extended-release 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 mixed agonist/antagonist pain medicines (eg, buprenorphine, 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.
Before using hydromorphone extended-release:
Some medical conditions may interact with hydromorphone extended-release. 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 hydromorphone extended-release. 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 hydromorphone extended-release's side effects
- Mixed agonist/antagonist pain medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine) or naltrexone because they may decrease hydromorphone extended-release'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 hydromorphone extended-release 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 hydromorphone extended-release:
Use hydromorphone extended-release as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Hydromorphone extended-release comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get hydromorphone extended-release refilled.
- Take hydromorphone extended-release by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Hydromorphone extended-release must only be taken by mouth. Do not inject hydromorphone extended-release.
- Swallow hydromorphone extended-release whole. Do NOT break, cut, crush, chew, or dissolve the tablet before swallowing it. If you cannot swallow hydromorphone extended-release whole, tell your doctor.
- Do not suddenly stop taking hydromorphone extended-release. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop hydromorphone extended-release, your doctor will gradually lower your dose.
- Hydromorphone extended-release works best if it is taken at the same time each day. Do not miss any doses.
- If you miss a dose of hydromorphone extended-release, 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 hydromorphone extended-release.
Important safety information:
- Hydromorphone extended-release 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 hydromorphone extended-release 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 hydromorphone extended-release. 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 hydromorphone extended-release; 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.
- Hydromorphone extended-release 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.
- Hydromorphone extended-release 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.
- Hydromorphone extended-release 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 hydromorphone extended-release, 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 hydromorphone extended-release before you receive any medical or dental care, emergency care, or surgery.
- Seek emergency medical care right away if another person swallows hydromorphone extended-release. Accidental swallowing of hydromorphone extended-release may be fatal, especially in children.
- Use hydromorphone extended-release with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness and breathing problems.
- Hydromorphone extended-release 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 hydromorphone extended-release while you are pregnant. Long-term use of hydromorphone extended-release during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Hydromorphone extended-release is found in breast milk. Do not breast-feed while taking hydromorphone extended-release.
When used for long periods of time or at high doses, hydromorphone extended-release 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 hydromorphone extended-release stops working well. Do not take more than prescribed.
Some people who use hydromorphone extended-release 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 hydromorphone extended-release, 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 hydromorphone extended-release:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; decreased appetite; diarrhea; dizziness, drowsiness; dry mouth; headache; joint pain; mild itching; nausea; tiredness; vomiting.
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 hydromorphone extended-release:
Store hydromorphone extended-release 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 hydromorphone extended-release in the bathroom. Keep hydromorphone extended-release out of the reach of children and away from pets.
- If you have any questions about hydromorphone extended-release, please talk with your doctor, pharmacist, or other health care provider.
- Hydromorphone extended-release 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 hydromorphone extended-release 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 hydromorphone extended-release. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to hydromorphone extended-release. 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 hydromorphone extended-release.
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.
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