"Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
In addition to requiring new labeling on these prescript"...
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.
HYDROMORPHONE EXTENDED RELEASE - ORAL
COMMON BRAND NAME(S): Exalgo
WARNING: 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.
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 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.
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 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.
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