Xtampza 9mg Extended-Release Capsule is an extended-release form of oxycodone and it’s an opioid medication. It’s used in adults to treat long-term pain that isn’t relieved by non-opioid pain medications. Xtampza ER (oxycodone) is a capsule that’s taken by mouth every 12 hours. Xtampza ER (oxycodone) is available as a brand-name medication only; there’s no lower-cost generic yet. Common side effects include nausea, headache, and constipation. Xtampza ER (oxycodone) is a controlled substance because it has a warning for misuse and dependence. LEARN MORE HERE
Xtampza ER (oxycodone) is a controlled substance, which means that it’s more likely to be misused or cause dependence. There are federal and state laws that limit the amount of medication that can be prescribed or dispensed within a certain period of time.
What is Xtampza 9mg Extended-Release Capsule?
What is Xtampza ER (oxycodone) used for?
- Long-term pain that isn’t relieved by non-opioid pain medications alone
How Xtampza ER (oxycodone) works
Xtampza ER (oxycodone) is an opioid. It attaches to certain mu-opioid receptors in your brain to lower how much pain you feel.
What are the risks and warnings for Xtampza 9mg Extended-Release Capsule?
Xtampza 9mg Extended-Release Capsule can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Potential for addiction and misuse
- Risk factors: Personal or family history of alcohol or substance use disorder | Personal or family history of mental health problems
Xtampza ER (oxycodone) is a controlled substance that has a risk for misuse and addiction. Take the medication exactly as prescribed. Don’t change how much or how often you take it without talking to your prescriber first.
Misusing Xtampza ER (oxycodone) can raise the risk for serious and possibly life-threatening side effects, such as dangerously slow breathing, not able to stay awake, addiction, and opioid overdose. You’ll be prescribed the lowest amount of Xtampza ER (oxycodone) that’s necessary to manage your pain for the shortest period of time possible.
Because of the risk for misuse and addiction, Xtampza ER (oxycodone) is only available through a Risk Evaluation and Mitigation Strategy (REMS) program called the Opioid Analgesic REMS program. Your prescriber and pharmacy must register with the program, receive training on proper medication use, and discuss with you about how to safely take Xtampza ER (oxycodone).
Dangerously slow breathing (respiratory depression)
- Risk factors: Taking medications that can cause slow breathing | Drinking alcohol | Older age | Being frail | Medical conditions that cause breathing problems (e.g., COPD, asthma, head injury) | Taking too much Xtampza ER (oxycodone)
Xtampza 9mg Extended-Release Capsule can cause dangerously slow breathing, which can be life-threatening. This can happen to anyone and at recommended doses. But the risk is greatest when you first start treatment or when your prescriber raises your dose.
Don’t drink alcohol while you’re taking Xtampza ER (oxycodone). Also don’t take Xtampza ER (oxycodone) with medications that slow your body down (e.g., benzodiazepines, other opioids, muscle relaxants). This can put you at risk for having dangerously slow breathing.
Your prescriber will recommend that you have naloxone (Narcan) to carry with you at all times. Naloxone is a medication that can reverse slowed breathing from opioids. Use naloxone, call 911, and get medical help right away if you or your loved one notices that you have trouble breathing or have bluish-colored lips, fingers, or toes.
Risk for opioid overdose
- Risk factors: History of opioid use disorder | Previous opioid overdose | Taking high doses of Xtampza ER (oxycodone) | Taking more opioids than prescribed | Alcohol use
Take Xtampza ER (oxycodone) exactly as prescribed. Taking too much medication or taking it more often than prescribed can lead to an overdose. It can be very dangerous if someone accidentally swallows the medication. Be sure to keep Xtampza ER (oxycodone) out of reach from children, pets, and visitors to prevent accidental exposure or overdose.
Symptoms of an opioid overdose include not responding to sound or touch, extremely slow breathing, slow heartbeat, extreme sleepiness, and cold or clammy skin. Be sure you and your loved ones know how to recognize an overdose. Your prescriber will recommend getting naloxone (Narcan) — either by prescription or over the counter. Naloxone can help treat an opioid overdose. Carry naloxone with you at all times; use it and call 911 right away if an overdose happens.
Difficulty concentrating and extreme sleepiness
- Risk factors: Taking high doses of Xtampza ER (oxycodone) | Age 65 years or older | Drinking alcohol | Taking other medications that can cause sleepiness
Xtampza 9mg Extended-Release Capsule can cause extreme sleepiness and lower your ability to think, react, and focus. Don’t drink alcohol with Xtampza ER (oxycodone). Also don’t take Xtampza ER (oxycodone) with other medications that can cause sleepiness or “brain fog” (e.g., benzodiazepines, muscle relaxants, sleep medications). Otherwise, these side effects might worsen.
Make sure you know how Xtampza ER (oxycodone) affects you before driving a car or doing activities that require your concentration. Talk to your prescriber right away if you feel too sleepy from the medication.
Drug interactions
Xtampza ER (oxycodone) interacts with several medications. Let your care team know what medications you’re taking to make sure they’re safe for you to take together. Also speak with your care team first before making any changes to your medications because sudden dose adjustments can be harmful.
Some medications can raise the level of Xtampza ER (oxycodone) in your body, which can raise your risk for serious side effects like potentially life-threatening slowed breathing. Medications that can lead to this type of interaction include erythromycin and ritonavir (Norvir), among others.
Other interactions, such as with rifampin (Rifadin) or carbamazepine (Tegretol), can lower the levels of Xtampza ER (oxycodone) in your body. This can cause the opioid medication to work less well to manage your pain. These interactions might also lead to withdrawal symptoms.
Harm to newborn babies
Long-term use of Xtampza ER (oxycodone) during pregnancy can cause your unborn baby to become dependent on the medication. This is because Xtampza ER (oxycodone) can pass through the placenta to your unborn baby.
Once your baby is born, they can experience withdrawal symptoms, such as high-pitched crying, poor feeding behavior, trembling, abnormal sleep patterns, and even seizures. This condition is called neonatal opioid withdrawal syndrome and can be life-threatening if not recognized and treated in time. Let your healthcare professional (HCP) know if you’ve taken Xtampza ER (oxycodone) during pregnancy or if you notice these symptoms in your baby.
Physical dependence and withdrawal
- Risk factors: Long-term use of Xtampza ER (oxycodone)
If taken regularly for a long time, Xtampza ER (oxycodone) can cause physical dependence. This means that your body relies on the medication to function. And you might experience withdrawal if you lower your dose too quickly or suddenly stop taking the medication. Withdrawal symptoms include anxiety, restlessness, irritability, runny nose, yawning, sweating, and chills.
Don’t suddenly lower your dose or stop taking Xtampza ER (oxycodone) suddenly without talking to your prescriber first. If needed, your prescriber will slowly lower your dose over time to prevent withdrawal symptoms. Talk to an HCP if you have concerns about taking Xtampza ER (oxycodone) because of the risk for withdrawal.
Low blood pressure
Xtampza 9mg Extended-Release Capsule can cause extremely low blood pressure. For example, your blood pressure might suddenly drop when you stand from a sitting or lying down position. This can lead to dizziness and fainting. To avoid falling, get up slowly if you’ve been sitting or lying down. Talk to an HCP if dizziness or lightheadedness doesn’t go away.
Low adrenal hormone levels
- Risk factors: Taking Xtampza ER (oxycodone) for longer than 1 month
Some people taking opioids like Xtampza ER (oxycodone) have had low adrenal hormone levels. This can be more likely to happen after taking opioids for longer than 1 month. Tell your HCP if you have symptoms of low adrenal hormone levels, such as tiredness, dizziness, weakness, not feeling hungry, nausea, and vomiting. If your adrenal hormone levels are too low, you might need to stop Xtampza ER (oxycodone) and get treated with corticosteroids.
Seizures
- Risk factors: History of seizure conditions
If you’ve had a seizure in the past, Xtampza ER (oxycodone) can raise the risk of having seizures more often. Opioids can also raise your risk of seizures in certain situations. Get medical help immediately if you have a seizure while you’re taking Xtampza ER (oxycodone).
What are the side effects of Xtampza ER (oxycodone)?
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Nausea (17%)
- Headache (14%)
- Constipation (13%)
- Sleepiness (9%)
- Itching (7%)
- Vomiting (6%)
- Dizziness (6%)
Other Side Effects
- Blurry vision
- Stomach pain
- Low appetite
- Rash
Serious Side Effects
Contact your healthcare provider immediately if you experience any of the following.
- Dangerously slow breathing: trouble breathing; bluish-colored lips, fingers, or toes
- Accidentally taking too much (overdose): not responding to sound or touch, slowed breathing, slow heartbeat, extreme sleepiness, cold or clammy skin
- Opioid withdrawal: anxiety, suicidal thoughts, restlessness, irritability, runny nose, yawning, sweating, chills, wide pupils
- Serious allergic reaction: itchy, red rash (hives); shortness of breath; chest tightness; swelling of lips, tongue, throat, face, or eyes
When do Xtampza ER (oxycodone) possible side effects begin and end?