Medication Guide

Oxymorphone Hydrochloride (ox” i mor’ fone hye” droe klor’ ide) Extended-Release Tablets, USP, CII

Oxymorphone hydrochloride extended-release tablets are:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid 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 for use to treat pain that is not around-the-clock.

Important information about oxymorphone hydrochloride extended-release tablets:

• Get emergency help 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.
• 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 your oxymorphone hydrochloride extended-release tablets. They could die from taking it. Store oxymorphone hydrochloride extended-release tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away oxymorphone hydrochloride extended-release tablets is against the law.

Do not take oxymorphone hydrochloride extended-release tablets if you have:

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

Before taking oxymorphone hydrochloride extended-release tablets, tell your healthcare provider if you have a history of:

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

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of oxymorphone hydrochloride extended-release tablets 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.
• 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.

When taking oxymorphone hydrochloride extended-release tablets:

• 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. 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.
• After you stop taking oxymorphone hydrochloride extended-release tablets, flush any unused tablets down the toilet.

While taking oxymorphone hydrochloride extended-release tablets DO NOT:

• 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.

The possible side effects of oxymorphone hydrochloride extended-release tablets:

• 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 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 doctor 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  Amneal Pharmaceuticals at 1-877-835-5472.

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

Manufactured by:
Amneal Pharmaceuticals of NY, LLC
Brookhaven, NY 11719

Distributed by:
Amneal Specialty, a division of Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 04-2019-00