Hydromorphone has a high risk for abuse and severe, possibly fatal, breathing problems. The risk for harm is higher if you take the wrong dose/strength, or if you take it along with other drugs that might also affect breathing. Be sure you know how to take hydromorphone and what other drugs you should avoid taking with it. The risk for breathing problems might also be higher when you start this medication and after a dose increase. Get immediate medical help if you notice unusual slow/shallow breathing.
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 slow/shallow breathing, irritability, shaking, persistent crying, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. If a child accidentally swallows this drug, get emergency medical help right away.
Hydromorphone extended-release should be used only if you have been regularly taking moderate to large amounts of narcotic pain medication. This medication may cause overdose (even death) if taken by a person who has not been regularly taking narcotic medication.
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.Who should not take Exalgo ER?
See also Warning section.
This medication contains hydromorphone in a long-acting form. It is used to help relieve moderate to severe ongoing pain (such as due to cancer). Hydromorphone belongs to a class of drugs known as narcotic (opiate) 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.
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 taking this medication, ask your doctor or pharmacist if you should stop or change the dose of your other narcotic medication(s). For added pain relief, your doctor may direct you to also take quick-acting narcotic or non-narcotic pain medications (such as acetaminophen, ibuprofen). Ask your doctor or pharmacist if you have any questions 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 immediately.
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.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your pain persists or worsens.
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 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.
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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking hydromorphone, tell your doctor or pharmacist if you are allergic to hydromorphone; or to other narcotic 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 regular use/abuse of 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. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Alcohol may worsen this effect. Avoid alcoholic beverages.
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 immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.
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 medications for pain (narcotic agonists/antagonists such as butorphanol, nalbuphine, pentazocine), narcotic antagonists (such as 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 affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and other narcotic pain relievers (such as codeine, hydrocodone).
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.
If overdose is suspected, contact a poison control center or emergency room immediately. 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 breathing, slow heartbeat, loss of consciousness.
Do not share this medication with others. It is against the law.
This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.
If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not take 2 doses in 24 hours. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
See also Warning section. Properly discard this product when it is expired or no longer needed. Read the Medication Guide for details. To discard this medication, the FDA recommends flushing down the toilet or pouring into a drain. However, consult your pharmacist or local waste disposal company.
Information last revised May 2014. Copyright(c) 2014 First Databank, Inc.
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