Hydromorphone Sustained-Release - Oral

Pronunciation: hye-droe-MOR-fone

Common Brand Name(s): Palladone XL

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.

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 How to Use and Drug Interactions sections. 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.

Uses

This medication is used to treat severe ongoing pain (usually lasting longer than a few days). It acts on certain centers in the brain to give you pain relief. This medication is a long-acting opioid (narcotic) pain reliever.

You should use the stronger forms of this medication (18 milligrams or more per capsule) only if you have already been regularly taking moderate to large amounts of a powerful opioid medication (such as morphine, oxycodone). A person who has not been taking powerful opioids regularly can develop serious (possibly fatal) breathing problems (such as very slow/shallow breathing) if they take these strong capsules.

Do not use the sustained-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

Read the Patient Information Leaflet if available from your pharmacist before you start taking hydromorphone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food, usually every 12 hours or as directed by your doctor. Take this medication on a regular schedule as directed by your doctor, not as needed for sudden (breakthrough) pain. 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 capsules whole. Do not crush, chew, or dissolve the capsules or their contents. Doing so can destroy the long action of the drug and may lead to the release of a very large (possibly fatal) amount of drug into your body.

If you are an adult and have trouble swallowing the capsule, you may open the capsule and carefully sprinkle its contents on a spoonful of soft, cool food (for example, applesauce) just before you take it. Swallow all of the drug/food mixture right away without chewing. Then rinse your mouth and swallow the rinse liquid to make sure that you have swallowed all of the medicine. Do not chew the mixture or prepare a supply in advance.

Children should not be given this medication by opening the capsules and sprinkling it on applesauce. There is a risk that a child may chew the drug/food mixture, which can result in a fatal overdose of hydromorphone. Talk to your doctor or pharmacist for more details.

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.

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.

Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.

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 does not get better or if it gets worse.

Side Effects

See also Warning section.

Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, increased sweating, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

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:

  • interrupted breathing during sleep (sleep apnea)
  • mental/mood changes (such as agitation, hallucinations, confusion)
  • difficulty urinating
  • vision changes
  • slow/fast heartbeat
  • severe stomach/abdominal pain
  • 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:

  • slow/shallow breathing
  • severe drowsiness/difficulty waking up
  • fainting
  • 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

Before taking hydromorphone, tell your doctor or pharmacist if you are allergic to it; or to other opioid pain medications (such as hydrocodone, morphine); or if you have any other allergies. This product may contain inactive ingredients, 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:

  • kidney disease
  • liver disease
  • lung disease (such as asthma, chronic obstructive pulmonary disease-COPD)
  • a certain spinal problem (kyphoscoliosis)
  • breathing problems (such as slow/shallow breathing, sleep apnea)
  • certain heart problems (irregular heartbeat)
  • personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
  • brain disorders (such as seizures, head injury, tumor, increased intracranial pressure)
  • underactive thyroid (hypothyroidism)
  • difficulty urinating (for example, due to enlarged prostate or narrowed urethra)
  • disease of the pancreas (such as pancreatitis)
  • mental/mood disorders (such as toxic psychosis)
  • gallbladder disease
  • adrenal gland problem (such as Addison's disease)
  • intestinal disorders (such as colitis, blockage, paralytic ileus, infectious diarrhea)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) 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 (cannabis).

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Before having surgery, tell your doctor or dentist that you are using this medication.

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.

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 (cannabis), 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 and lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

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, severe drowsiness, slow heartbeat, severe dizziness, pinpoint pupils, coma.

Notes

Do not share this medication with others. Sharing 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.

Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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