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Healthcare Professional Patient/Caregiver

How is Xtampza ER different from other long-acting pain medications?

Xtampza ER can be taken in multiple ways that do not involve swallowing pills or capsules

  • According to an FDA publication, up to 40% of Americans may experience difficulties swallowing tablets and capsules
  • Many patients with chronic pain also experience issues with swallowing

Harris Interactive Inc. Pill-Swallowing Problems in America: A National Survey of Adults. New York, NY: Harris Interactive Inc. for Schwarz Pharma; 2003. pp. 1–39.

If you have difficulty swallowing Xtampza ER capsules, talk to your doctor. Xtampza ER can be taken 4 ways, including several not previously available in other ER opioid medications:

  • Oral capsule

  • Sprinkled on soft foods

  • Sprinkled in a cup and then directly into mouth

  • Taken through feeding tubes

Xtampza ER MUST be taken with food.

It's important that you take your medication exactly as prescribed

Unlike other ER opioid medications, Xtampza ER is designed with DETERx® technology

DETERx technology can help prevent problems such as misuse or abuse

  • Misuse is when a medicine is used incorrectly (this can be on purpose or not)
  • Abuse is when a medicine is used for a nonmedical purpose, such as “getting high”

Store Xtampza ER away from children and in a safe place to prevent stealing or abuse.

Although Xtampza ER is formulated to make manipulation more difficult, it cannot entirely prevent abuse; abuse of Xtampza ER by injection and via the oral and nasal routes is still possible


Xtampza® ER (oxycodone) is:

  • 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 by your healthcare provider, 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.
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Addiction, Abuse, and Misuse

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 Xtampza ER and monitor all patients regularly for the development of these behaviors or conditions.

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to

  • complete a REMS-compliant education program,
  • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
  • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
  • consider other tools to improve patient, household, and community safety.

Life-threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Xtampza ER. Monitor for respiratory depression, especially during initiation of Xtampza ER or following a dose increase.

Accidental Ingestion

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

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Xtampza ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

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. Monitor patients receiving Xtampza ER and any CYP3A4 inhibitor or inducer.

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.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

Important Safety Information about Xtampza ER

Do not take Xtampza ER if you have:

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

Tell your healthcare provider if you are:

When taking Xtampza ER:

While taking Xtampza ER, DO NOT:

The possible side effects of Xtampza ER are:

Get emergency medical help if you have:

These are not all the possible side effects of XTAMPZA ER. Call your doctor for medical advice about side effects.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.