• For Healthcare Professionals
Opioid pain relievers come with risks. Opioid pain relievers come with risks.

Opioid pain relievers come with risks. It’s important that we all learn how to take and store our pain medications more responsibly to help protect ourselves and our communities.

Managing pain responsibly

Opioid pain relievers can be helpful for managing pain. However, these medications often carry risks, not just to individuals but also to their friends, families, and surrounding communities. They can be misused, stolen, or abused, and they may put people who take too much at a risk of fatal overdose. It’s important to understand the steps you can take to promote more responsible pain management, protect yourself and your prescription, and reduce the risks to those around you.

What are some potential risks I should be aware of when taking a pain medication?

Risk of misuse

One potential risk is misusing your medication. Misuse happens when someone takes a medicine incorrectly. Some people may misuse their medication in ways that seem harmless, like skipping a dose to avoid certain side effects or chewing a tablet so it’s easier to swallow. However, those small changes can have big effects on the way a medication works. Misuse of opioid medications, whether intentional or accidental, can cause potentially fatal adverse events.

Examples of misuse include:

Breaking a tablet into multiple pieces so it's easier to swallow

Breaking a tablet into multiple pieces so it’s easier to swallow

Taking a double dose to make up for a missed dose

Taking a double dose
to make up for a
missed dose

Cutting up a tablet or pill to strengthen or weaken a dose

Cutting up a tablet or pill to strengthen or weaken a dose

Risk of diversion

There is also the risk of your pain medication being taken by someone else. When a medication is stolen or otherwise ends up in the hands of someone who was not prescribed the medication, it’s known as diversion. It is important to be aware of this risk because there is no way to know how a drug will affect the body and health of someone who uses another person’s prescription medication.

Some examples of diversion include:

risk of someone else use medication
  • When someone finds a prescription medication belonging to someone else in a medicine cabinet or sitting on the kitchen counter and uses it
risks of selling or give to a family member
  • When someone steals a prescription with the intention of giving it or selling it to others
  • When someone gives a prescription medication to a family member or a friend

Risk of overdose

It is important to be aware of the risk of an overdose. Pain medications, such as long-acting opioid medications, can put you at risk for overdose if they are not taken correctly. An overdose can occur if a person takes more of a medication than was prescribed by a doctor, which can result in serious, negative consequences.

Signs and symptoms of a drug overdose include:

  • Small, constricted “pinpoint” pupils
  • Falling asleep or loss of consciousness
  • Slow, shallow breathing
  • Pale, blue, or cold skin
  • Slowed breathing rate or difficulty breathing
  • Constipation (severe)
  • Poor coordination
  • Seizures
  • Choking or gurgling sounds
  • Limp body

Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an overdose.

Setting yourself up for responsible pain management

  • Always follow your doctor’s instructions and take your medicine only as prescribed. Take each dose exactly as prescribed—no more and no less
  • If you have difficulty swallowing your pain medication, do not crush, grind, cut, or dissolve, as these methods may not be safe. Talk to your doctor about safe alternative ways to take your medicine
  • Do not stop taking your medication or change how or how often you take it without speaking to your doctor first
  • Don’t take your opioid medication while taking other medications or over-the-counter medicines, vitamins, or herbal supplements without speaking to your doctor to make sure it is safe to use them together. Some medications and supplements can interact with each other in harmful ways
  • Tell your doctor if your pain improves or changes because this information can help your doctor manage your pain more effectively and safely
  • If you’re struggling to manage side effects or feel that you aren’t getting enough pain relief, don’t alter your medication. Instead, consult your doctor. They can help you find the best way to take it and may adjust your dose to better manage both your pain and any side effects
  • Store your prescription opioid medication in a safe, secure location away from others, especially children, so that it cannot be taken or used without your knowledge
  • Never share or give away your medicine
  • If you need to dispose of your medication, make sure you dispose of it properly
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INDICATIONS AND USAGE

XTAMPZA® ER (oxycodone) is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid 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 by your healthcare provider, you are at risk for opioid addiction, abuse, and misuse that can lead to death.
  • Not to be taken on an "as needed" basis

IMPORTANT SAFETY INFORMATION ABOUT XTAMPZA ER

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER

Addiction, Abuse, and Misuse

Because the use of XTAMPZA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing reassess all patients regularly for the development of these behaviors or conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of XTAMPZA ER, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of XTAMPZA ER are essential.

Accidental Ingestion

Accidental ingestion of even one dose of XTAMPZA ER, especially by children, can result in a fatal overdose of oxycodone.

Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of XTAMPZA ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

Neonatal Opioid Withdrawal Syndrome (NOWS)

If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription.

Cytochrome P450 3A4 Interaction

The concomitant use of XTAMPZA ER with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Regularly evaluate patients receiving XTAMPZA ER and any CYP3A4 inhibitor or inducer.

Important information about XTAMPZA ER:

  • Get emergency help or call 911 right away if you take too much XTAMPZA ER (overdose). When you first start taking XTAMPZA ER, when your dose is changed, or if you take too much (overdose), serious 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 overdose.
  • Taking XTAMPZA ER 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.
  • Taking XTAMPZA ER 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 XTAMPZA ER. They could die from taking it. Selling or giving away XTAMPZA ER is against the law.
  • Store XTAMPZA ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take XTAMPZA ER if you have:

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

Before taking XTAMPZA ER, tell your healthcare provider if you have a history of:

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

Tell your healthcare provider if you are:

  • noticing your pain getting worse. If your pain gets worse after you take XTAMPZA ER, do not take more of XTAMPZA ER without first talking to your healthcare provider. Talk to your healthcare provider if the pain you have increases, if you feel more sensitive to pain, or if you have new pain after taking XTAMPZA ER.

IMPORTANT SAFETY INFORMATION ABOUT XTAMPZA ER

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER

Addiction, Abuse, and Misuse

Because the use of XTAMPZA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing reassess all patients regularly for the development of these behaviors or conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of XTAMPZA ER, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of XTAMPZA ER are essential.

Accidental Ingestion

Accidental ingestion of even one dose of XTAMPZA ER, especially by children, can result in a fatal overdose of oxycodone.

Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of XTAMPZA ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

Neonatal Opioid Withdrawal Syndrome (NOWS)

If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription.

Cytochrome P450 3A4 Interaction

The concomitant use of XTAMPZA ER with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Regularly evaluate patients receiving XTAMPZA ER and any CYP3A4 inhibitor or inducer.

  • pregnant or planning to become pregnant. Prolonged use of XTAMPZA ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life‑threatening if not recognized and treated.
  • breastfeeding. Not recommended during treatment with XTAMPZA ER. 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 XTAMPZA ER with certain other medicines can cause serious side effects that could lead to death.

When taking XTAMPZA ER:

  • Do not change your dose. Take XTAMPZA ER 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. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • If you cannot swallow XTAMPZA ER capsules, see the detailed Instructions for Use in the Medication Guide.
  • Always take XTAMPZA ER capsules with approximately the same amount of food to ensure enough medicine is absorbed.
  • Swallow XTAMPZA ER whole. Do not snort, or inject XTAMPZA ER because this may cause you to overdose and die.
  • The contents of the XTAMPZA ER capsules may be sprinkled on soft food, sprinkled into a cup and then put directly into the mouth, or given through a nasogastric or gastrostomy tube.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • Do not stop taking XTAMPZA ER without talking to your healthcare provider.
  • Dispose of expired, unwanted or unused XTAMPZA ER 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.

While taking XTAMPZA ER, DO NOT:

  • Drive or operate heavy machinery, until you know how XTAMPZA ER affects you. XTAMPZA ER can make you sleepy, dizzy, or light‑headed.
  • Drink alcohol or use prescription or over‑the‑counter medicines that contain alcohol. Using products containing alcohol during treatment with XTAMPZA ER may cause you to overdose and die.

The possible side effects of XTAMPZA ER are:

  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and 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, or throat, 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 XTAMPZA ER. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1‑800‑FDA‑1088. For more information, go to dailymed.nlm.nih.gov.

See full Prescribing Information, including Boxed Warning on Addiction, Abuse and Misuse and other serious risks, and the Medication Guide accompanying this piece or at XTAMPZAER.com/PI. Speak to your healthcare provider if you have questions about XTAMPZA ER.

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