HYDROMORPHONE EXTENDED RELEASE - ORAL

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HYDROMORPHONE EXTENDED RELEASE - ORAL

PHONETIC PRONUNCIATION: (hye-droe-MOR-fone)

COMMON BRAND NAME(S): Exalgo

GENERIC NAME(S): hydromorphone HCl

Uses

USES: See also Warning section. This medication contains hydromorphone in a long-acting form. It is used to help relieve severe ongoing pain (such as due to cancer). Hydromorphone belongs to a class of drugs known as opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain. Do not use the extended-release form of hydromorphone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.


How to use HYDROMORPHONE EXTENDED RELEASE - ORAL

HOW TO USE: See also Warning section. Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking this product and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily at the same time each day, not as needed for sudden (breakthrough) pain. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible). Swallow the tablet whole. Do not crush, break, chew, or dissolve the tablet. Doing so can release all of the drug at once, increasing the risk of side effects. Hydromorphone comes in a rapid-acting form and a slow-release form. Check with your pharmacist to make sure you are taking the correct form. The dosage is based on your medical condition and response to treatment. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed. If you do not take this medication for 3 days in a row, call your doctor before restarting the medication. Your restarting dose may need to be lower. Before you start using this medication, ask your doctor or pharmacist if you should stop or change how you use your other opioid medication(s). Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using hydromorphone safely with other drugs. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watery eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well. Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details. Tell your doctor if your pain persists or worsens.

Side Effects

SIDE EFFECTS: See also Warning section. Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener). To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. You may notice an empty tablet shell in your stool. This is harmless because your body has already absorbed the medicine. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as agitation, hallucinations, confusion), severe stomach/abdominal pain, difficulty urinating, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss). Get medical help right away if you have any very serious side effects, including: fainting, slow/shallow breathing, severe drowsiness/difficulty waking up, seizures. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking hydromorphone, tell your doctor or pharmacist if you are allergic to hydromorphone; or to other opioid pain medications (such as hydrocodone, morphine); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stomach/intestinal problems (such as blockage, stomach or bypass surgery, constipation, diarrhea due to infection, paralytic ileus), difficulty swallowing, difficulty urinating (such as due to enlarged prostate), disease of the pancreas (pancreatitis), gallbladder disease. This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.) This drug passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: See also Warning section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), naltrexone. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, slow heartbeat, coma.

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Faq for HYDROMORPHONE EXTENDED RELEASE - ORAL

Hydromorphone extended release is used to treat moderate to severe pain when around-the-clock pain relief is required.

Hydromorphone extended release works by changing how the brain and nervous system respond to pain. It belongs to a class of drugs known as opioid analgesics.

Common side effects of hydromorphone extended release may include nausea, vomiting, constipation, dizziness, drowsiness, headache, dry mouth, and sweating.

Hydromorphone extended release should be taken exactly as prescribed by your doctor. It is usually taken every 12 or 24 hours, depending on the specific formulation. It should not be crushed or chewed but swallowed whole with water.

You should avoid driving or operating machinery as hydromorphone extended release may impair your thinking and reactions. Also, avoid alcohol consumption as it can increase drowsiness and dizziness.

Hydromorphone extended release has a potential for abuse and addiction, especially if used for a long time or in higher doses than prescribed. It is important to take it only as directed by your doctor.

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.

Hydromorphone extended release can interact with certain medications, such as other opioids, sedatives, tranquilizers, muscle relaxants, or antidepressants. It is important to inform your doctor about all the medications you are taking to avoid potentially harmful interactions.

Hydromorphone extended release should be stored at room temperature away from light, moisture, and heat. Keep it out of the reach of children and dispose of any unused medication properly.

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Warning

WARNING: Hydromorphone has a risk for abuse and addiction, which can lead to overdose and death. Hydromorphone may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of hydromorphone that works, and take it for the shortest possible time. See also How to Use section for more information about addiction. The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Be sure you know how to take hydromorphone and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up. Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away. Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight. Hydromorphone extended-release should be used only if you have been regularly taking moderate to large amounts of opioid pain medication. This medication may cause overdose (even death) if taken by a person who has not been regularly taking opioids. This product is designed to slowly release hydromorphone. Do not break, crush, dissolve, or chew this medication. Taking broken, crushed, dissolved, or chewed forms of extended-release hydromorphone could cause a fatal overdose.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.