Xtampza ER
Xtampza ER (ex tamp’ zah ee ar) is a brand-name medication prescribed for severe pain. Xtampza ER belongs to a group of drugs called opioid analgesics.
Xtampza ER (ex tamp’ zah ee ar) is a brand-name medication prescribed for severe pain. Xtampza ER belongs to a group of drugs called opioid analgesics.
- Brand
- • Capsule ER 12 Hour Abuse-Deterrent
- • 9mg
- • 60 Capsules
Dosage settings
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Intro
Introduction
Written by Patricia Weiser, PharmD
Medically reviewed by Rosanna Sutherby, PharmD
Updated on October 30, 2023
Xtampza ER (ex tamp’ zah ee ar) is a brand-name medication prescribed for severe pain. Xtampza ER belongs to a group of drugs called opioid analgesics.
Boxed warnings
Xtampza ER has boxed warnings, which are the most serious warnings from the Food and Drug Administration (FDA). These include:
- risk of misuse and addiction
- risk of serious respiratory depression
- risk of accidental ingestion
- risk of neonatal opioid withdrawal syndrome (NOWS)
- risk of serious harm if taken with certain other drugs
For details, see the “Interactions and warnings for Xtampza ER” section.
Uses
Uses of Xtampza ER
The Food and Drug Administration (FDA) approves prescription drugs such as Xtampza ER for certain conditions. The approved use for Xtampza ER is described below.
Use for pain
Doctors may prescribe Xtampza ER* oral capsules for treating severe pain. It’s used for this purpose in adults. It’s usually prescribed as a long-term treatment.
Xtampza ER is a pain reliever (opioid analgesic). These drugs are prescribed for severe, long-term (chronic) pain that can’t be managed with other treatment options.
Doctors may not prescribe Xtampza ER in certain situations, such as for pain that can be managed with non-opioid pain medications or immediate-release* opioid analgesics. In addition, doctors may not prescribe Xtampza ER “as needed” for pain.
* ER stands for “extended release,” which means the drug is slowly released into your body over a period of time. This differs from an immediate-release medication, which releases the drug into your body right away.
Side effects
Side effects of Xtampza ER
Xtampza ER may cause mild or serious side effects. More common mild side effects of Xtampza ER and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.
To learn more about Xtampza ER’s side effects, see this article or ask your doctor or pharmacist. You can also refer to the prescribing information for Xtampza ER listed in the “Resources” section.
Mild side effects
More common mild side effects of Xtampza ER are listed below.
This article doesn’t include all possible mild side effects of the drug. To learn more about Xtampza ER’s side effects, refer to the prescribing information for Xtampza ER listed in the “Resources” section.
With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.
Xtampza ER’s mild side effects include:
- nausea
- headache
- constipation
- drowsiness
- itching
- vomiting
- dizziness
- mild allergic reaction*
* For details about this side effect, see the “Interactions and warnings for Xtampza ER” section.
Serious side effects
Serious side effects of Xtampza ER are listed below.
This article doesn’t include all possible serious side effects of the drug. To learn more about Xtampza ER’s side effects, refer to the prescribing information for Xtampza ER listed in the “Resources” section.
With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.
In general, Xtampza ER’s serious side effects include:
- low blood pressure
- syncope (fainting)
- impairment of mental or physical abilities, which may make it unsafe to drive or operate machinery
- boxed warnings: risk of misuse and addiction, serious respiratory depression, accidental ingestion, neonatal opioid withdrawal syndrome (NOWS), and serious harm if taken with certain other drugs*
- severe allergic reaction*
* For details about this side effect, see the “Interactions and warnings for Xtampza ER” section.
Interactions and warnings
Interactions and warnings for Xtampza ER
Below, you’ll find information about Xtampza ER’s possible interactions and warnings.
Interactions of Xtampza ER
Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.
Before you take Xtampza ER, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:
- prescription or over-the-counter drugs
- vitamins, herbs, or supplements
To learn about drug-condition interactions, see the “Warnings for Xtampza ER” section below.
Warnings for Xtampza ER
Some people should not take Xtampza ER, and others should take it cautiously.
Boxed warnings
Xtampza ER has boxed warnings about the following risks. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).
To learn more about these warnings, read below. You can also talk with your doctor or pharmacist.
Risk of misuse and addiction. Taking Xtampza ER may lead to misuse and addiction. Misuse means a drug is taken in a way other than how it’s prescribed. With addiction, you feel unable to stop using a drug, even though it may be causing harm.
Xtampza ER is a controlled substance. A controlled substance is a drug the government regulates due to the risk of dependence or misuse.
It isn’t clear if misuse or addiction occurred in studies of Xtampza ER, but these are well-known risks of taking opioids. Opioid misuse and addiction can increase the risk of overdose, which may be fatal.
If you have concerns about misusing or becoming addicted to Xtampza ER, tell your doctor. If you’re at risk for misuse or addiction, they’ll likely recommend a different treatment option for your pain. Or they may prescribe the lowest dosage of Xtampza for the shortest duration possible to help minimize your risk.
Risk of serious respiratory depression. Taking Xtampza ER may cause severe respiratory depression (slow, shallow breathing).
It isn’t clear if serious respiratory depression occurred in studies of Xtampza ER. But it is a well-known risk of taking opioids, especially if you take more than prescribed or overdose. Opioid overdose can be fatal.
If you have concerns about overdose and respiratory depression, tell your doctor. They’ll likely recommend keeping naloxone (Narcan) nasal spray nearby as a precaution. This drug is used in an emergency to reverse the effects of opioids and restore natural breathing. For more information about Narcan, talk with your doctor or pharmacist.
Risk of accidental ingestion. Accidentally taking Xtampza ER (even a single capsule) can cause an overdose in people who’ve never taken an opioid before. This is especially dangerous in children if they accidentally ingest the drug.
Symptoms of an overdose may include extreme drowsiness, loss of consciousness, or respiratory depression (slowed, shallow breathing).
If you have concerns about this risk, tell your doctor. They’ll likely recommend storing your medication in a secure location, away from children or others who might accidentally take it.
Risk of neonatal opioid withdrawal syndrome. For more information about this risk see the “Pregnancy or breastfeeding and Xtampza ER” section below.
Risk of serious harm if taken with certain other drugs. Like all opioids, Xtampza ER is considered a central nervous system (CNS) depressant. CNS depressants can slow various aspects of brain function. Taking Xtampza ER with other CNS depressants, such as benzodiazepines or alcohol, can further increase the risk of CNS depression.
Additionally, taking Xtampza ER with drugs that affect an enzyme called CYP3A4 may change the level of Xtampza ER in your body. Depending on how the other drug affects this enzyme, Xtampza’s effects can either increase or decrease. An increase further raises the risk of CNS depression. A decrease can make the drug less effective and lead to withdrawal symptoms.
Symptoms of CNS depression may include severe drowsiness, breathing problems, and coma, and can be life threatening.
Before taking other medications during Xtampza ER treatment, talk with your doctor or pharmacist. They can check for potential drug interactions and recommend other options, if necessary, to help prevent harmful effects.
Other warnings
Xtampza ER could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether Xtampza ER is a safe option for you.
Ask your doctor about specific warnings for Xtampza ER, and be sure to tell your doctor about your:
- current health, including any allergies to medications
- past health conditions or surgeries
Allergic reaction
Xtampza ER can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.
If you’ve had an allergic reaction to Xtampza ER or any of its ingredients, your doctor will likely not prescribe Xtampza ER. They can tell you about medications that are safer options for you.
A mild allergic reaction may cause the following symptoms:
A severe allergic reaction may cause the following symptoms:
- swelling under your skin, usually in your hands, feet, eyelids, or lips
- swelling of your mouth, throat, or tongue, which can cause breathing problems
If you have an allergic reaction to Xtampza ER, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.
Overdose of Xtampza ER
You should not take more Xtampza ER than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.
If you think you’ve taken too much Xtampza ER, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.
Pregnancy or breastfeeding and Xtampza ER
Information about Xtampza ER and pregnancy and breastfeeding is described below.
Xtampza ER and pregnancy
There are risks to taking Xtampza ER during pregnancy. But there are also risks with having unmanaged severe pain while pregnant. (Keep in mind that Xtampza ER is prescribed for pain. Note that Xtampza ER is not recommended for pain related to labor or childbirth.)
If you’re planning a pregnancy or can become pregnant, talk with your doctor about treatment options for pain during pregnancy. Together, you can discuss the risks and benefits of your treatment options and decide whether or not you should take Xtampza ER during pregnancy.
Boxed warning: Risk of neonatal opioid withdrawal syndrome. Taking opioids, such as Xtampza ER, during pregnancy may lead to neonatal opioid withdrawal syndrome (NOWS). With NOWS, a baby is born with opioid dependence. This means that their body needs the drug in order to function. This is caused by being exposed to the drug during fetal development. If this condition is not promptly recognized and treated, the baby may experience life threatening withdrawal symptoms. (Withdrawal symptoms occur when you stop taking a drug your body is dependent on.)
NOWS was not reported in studies of Xtampza ER, but it is a well-known risk of taking opioids during pregnancy.
Symptoms of NOWS in a newborn may include high-pitched crying, tremors, increased body temperature, and trouble sleeping.
If you become pregnant during Xtampza ER treatment, tell your doctor. They’ll discuss the risks and benefits of stopping or continuing treatment. If you continue treatment, they’ll recommend a plan for monitoring and treating your baby for NOWS after delivery.
Xtampza ER and breastfeeding
There are risks to taking Xtampza ER while breastfeeding. But there are also risks with having unmanaged severe pain during this time. (Keep in mind that Xtampza ER is prescribed for severe pain.)
For instance, Xtampza ER may cause severe drowsiness or respiratory depression (slowed, shallow breathing) in a breastfed child.
If you’re planning to breastfeed, talk with your doctor about treatment options for severe pain. Together, you can discuss the risks and benefits of your treatment options and decide whether or not you should take Xtampza ER during this time. Your doctor may recommend other healthy ways to feed your child.
FAQ
Common questions about Xtampza ER
Below you’ll find answers to a few commonly asked questions about Xtampza ER.
Is Xtampza ER safe for older adults?
Generally, yes, as long as the dosage isn’t started too high or increased too quickly.
In studies, no unusual side effects were reported in older adults (ages 65 years and older) compared with younger adults.
However, it takes slightly longer for oxycodone (the active drug in Xtampza ER), to clear from the body when you’re older. This may increase the risk of side effects, such as respiratory depression (slow, shallow breathing). Also, older adults are more likely to have medical conditions or take other medications that can interact with Xtampza ER.
Because of these factors, doctors will likely start with a low dose when they prescribe Xtampza ER to an older person. If it’s needed, they’ll increase the dosage slowly while closely watching for side effects. And they’ll prescribe it for the shortest time. The goal is to switch to a non-opioid pain reliever when possible.
Talk with your doctor if you have questions about taking this medication at your age.
How does Xtampza ER work? And how long does it take to start working?
Xtampza ER is an opioid analgesic (pain reliever). It works to manage severe pain by attaching to opioid receptors (binding sites) in your body. This interrupts the pain signals between your body and brain and reduces feelings of pain.
Xtampza ER starts working a few hours after you take a dose. The capsule is meant to keep working for 12 hours. Be sure to take Xtampza ER with food. Taking it on an empty stomach may reduce its effect, and it may not work as well to relieve your pain.
If you’d like to know more about Xtampza ER’s mechanism of action (how it works), talk with your doctor or pharmacist.
Ask your doctor
What to ask your doctor
Let your doctor know if you have questions about Xtampza ER or would like more details about it.
Here’s a list of some possible questions you may want to ask your doctor:
- Do you recommend keeping Narcan (naloxone) nasal spray with me in case of an accidental overdose of Xtampza ER?
- What should I do if my pain isn’t managed well enough with Xtampza ER?
- Am I at higher risk for Xtampza’s side effects than others?
- What should I do to help prevent constipation from this medication?
Resources
Resources
- Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
- Weller AE, et al. (2021). Neonatal opioid withdrawal syndrome (NOWS): A transgenerational echo of the opioid crisis. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7919394/
- Xtampza ER (oxycodone) extended-release capsules for oral use, CII. (2021). https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208090s015lbl.pdf
Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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