Medication Guide

Oxymorphone Hydrochloride Extended-Release Tablets are:

• A strong prescription pain medicine that contains and opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine, when other pain medicines do not treat your pain well enough or you cannot tolerate them.
• A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
• Not to be taken on an “as needed” basis.

• Get emergency help or call 911 right away if you take too much Oxymorphone Hydrochloride Extended-Release Tablets (overdose). When you first start taking Oxymorphone Hydrochloride Extended-Release Tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
• Taking Oxymorphone Hydrochloride Extended-Release Tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your Oxymorphone Hydrochloride Extended-Release Tablets. They could die from taking it. Selling or giving away Oxymorphone Hydrochloride Extended-Release Tablets is against the law.
• Store Oxymorphone Hydrochloride Extended-Release Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have a narrowing of the stomach or intestines.

• head injury, seizures
• problems urinating
• abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems
•  liver, kidney, thyroid problems
• pancreas or gallbladder problems

Tell your healthcare provider if you are:

• noticing your pain getting worse. If your pain gets worse after you take Oxymorphone Hydrochloride Extended-Release Tablets, do not take more of Oxymorphone Hydrochloride Extended-Release Tablets without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking Oxymorphone Hydrochloride Extended-Release Tablets.
• pregnant or planning to become pregnant. Use of Oxymorphone Hydrochloride Extended-Release Tablets for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breast-feeding. Not recommended during treatment with Oxymorphone Hydrochloride Extended-Release Tablets. It may harm your baby.
• living in a household where there are small children or someone who has abused street or prescription drugs.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Oxymorphone Hydrochloride Extended-Release Tablets with certain other medicines can cause serious side effects that could lead to death.

• Do not change your dose. Take Oxymorphone Hydrochloride Extended-Release Tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 12 hours at the same time every day on an empty stomach, at least 1 hour before or 2 hours after meals as needed for pain. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time.
• Swallow Oxymorphone Hydrochloride Extended-Release Tablets whole. Do not cut, break, chew, crush, dissolve, snort, or inject Oxymorphone Hydrochloride Extended-Release Tablets because this may cause you to overdose and die.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking Oxymorphone Hydrochloride Extended-Release Tablets without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused Oxymorphone Hydrochloride Extended-Release Tablets by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

• Drive or operate heavy machinery, until you know how Oxymorphone Hydrochloride Extended-Release Tablets affect you. Oxymorphone Hydrochloride Extended-Release Tablets can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Oxymorphone Hydrochloride Extended-Release Tablets may cause you to overdose and die.

• constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain.
  Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away if you have:

• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, throat, or hands, hives, itching, rash, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of Oxymorphone Hydrochloride Extended-Release Tablets. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

For more information go to dailymed.nlm.nih.gov.

For more information about Oxymorphone Hydrochloride Extended-Release Tablets, call Impax Laboratories, Inc. at 1-800-934-6729.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
Impax Generics
Hayward, CA 94544

Rev. 01/2024