XTAMPZA ER OXYCODONE 13.5 mg Capsule, Extended Release, 20-count

1 INDICATIONS AND USAGE XTAMPZA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. XTAMPZA ER is an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death,which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including XTAMPZA ER, for use in patients for whom alternative treatment optionsare ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

( 1 , 5.1 ) XTAMPZA ER is not indicated as an as-needed (prn) analgesic. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ], reserve opioid analgesics, including XTAMPZA ER, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. XTAMPZA ER is not indicated as an as-needed (prn) analgesic.

2 DOSAGE AND ADMINISTRATION XTAMPZA ER should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. ( 2.1 ) XTAMPZA ER at a total daily dose greater than 72 mg (equivalent to 80 mg oxycodone hydrochloride [HCl]) or a single dose greater than 36 mg (equivalent to 40 mg oxycodone HCl) is only for use in patients in whom tolerance to an opioid of comparable potency has been established. ( 2.1 ) Patients considered opioid-tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone HCl per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.

( 2.1 ) Use the lowest effective dose for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of XTAMPZA ER for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2 , 5 ) Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse.

( 2.1 , 5.1 ). Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with XTAMPZA ER. Consider this risk when selecting an initial dose and when making dose adjustments.

( 2.1 , 5.2 ) Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with XTAMPZA ER, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose. ( 2.2 , 5.1 , 5.2 , 5.3 ) XTAMPZA ER is administered, twice daily, every 12 hours, and must be taken with food . Instruct patients to take XTAMPZA ER capsules with approximately the same amount of food for every dose to ensure consistent plasma levels are achieved.

( 2.1 , 2.3 ) For patients who are not opioid tolerant, initiate with 9 mg (equivalent to 10 mg oxycodone HCl per day). ( 2.3 ) The daily dose of XTAMPZA ER must be limited to a maximum of 288 mg per day (equivalent to 320 mg oxycodone HCl per day). ( 2.1 ) Hepatic impairment : Initiate therapy at 1/3 to 1/2 the usual dosage and titrate carefully.

Regularly evaluate. Use alternate analgesia for patients requiring less than 9 mg. ( 2.4 , 8.6 ) Periodically reassess patients receiving XTAMPZA ER to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse.

( 2.5 ) Do not rapidly reduce or abruptly discontinue XTAMPZA ER in a physically-dependent patient because rapid reduction or abrupt discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. ( 2.6 , 5.14 ) Instruct patients to take XTAMPZA ER capsules with food in order to ensure consistent plasma levels are achieved. For patients who have difficulty swallowing, XTAMPZA ER can also be taken by sprinkling the capsule contents on soft foods or into a cup and then administering directly into the mouth, or through a gastrostomy or nasogastric feeding tube.

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2.1Important Dosage and Administration Instructions XTAMPZA ER should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. XTAMPZA ER single doses greater than 36 mg (equivalent to 40 mg oxycodone hydrochloride [HCl]) or a total daily dose greater than 72 mg (equivalent to 80 mg oxycodone HCl) are to be administered only to patients in whom tolerance to an opio…

3 DOSAGE FORMS AND STRENGTHS XTAMPZA ER capsules contain yellow to light brown microspheres, and each available strength has an outer opaque capsule with colors as identified below. Strength Capsule Description 9 mg (equivalent to 10 mg oxycodone HCl) Size 3, ivory cap printed with "XTAMPZA ER" and white body printed with "9 mg" 13.5 mg (equivalent to 15 mg oxycodone HCl) Size 2, Swedish orange cap printed with "XTAMPZA ER" and white body printed with "13.5 mg" 18 mg (equivalent to 20 mg oxycodone HCl) Size 1, rich yellow cap printed with "XTAMPZA ER" and white body printed with "18 mg" 27 mg (equivalent to 30 mg oxycodone HCl) Size 0, light gray cap printed with "XTAMPZA ER" and white body printed with "27 mg" 36 mg (equivalent to 40 mg oxycodone HCl) Size 00, flesh color cap printed with "XTAMPZA ER" and white body printed with "36 mg" Extended-release capsules: 9 mg (equivalent to 10 mg oxycodone HCl) 13.5 mg (equivalent to 15 mg oxycodone HCl) 18 mg (equivalent to 20 mg oxycodone HCl) 27 mg (equivalent to 30 mg oxycodone HCl) 36 mg (equivalent to 40 mg oxycodone HCl).

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17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store XTAMPZA ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving XTAMPZA ER unsecured can pose a deadly risk to others in the home [see Warnings and Precautions (5.1 , 5.2) , Drug Abuse and Dependence (9.2) ].

Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused XTAMPZA ER should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.

Addiction, Abuse, and Misuse Inform patients that the use of XTAMPZA ER, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1) ] . Instruct patients not to share XTAMPZA ER with others and to take steps to protect XTAMPZA ER from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression including information that the risk is greatest when starting XTAMPZA ER or when the dosage is increased, and that it can occur even at recommended dosages.

Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions (5.2) ] . Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.2) ]. Interactions with Benzodiazepines and other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if XTAMPZA ER is used with benzodiazepines or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids), and not to use these concomitantly unless supervised by a healthcare provider [ see Warnings and Precautions (5.3) , Drug Interactions (7) ] .

Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.

Discuss with the patient the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program) [see Dosage and Administration (2.2) , Warnings and Precautions (5.3) ] . Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to patients and caregivers that effects of opioid overdose reversal agents like naloxone and nalmefene are temporary, and that they must call 911 or get emergency medical help right away in cases of known or suspected opioid overdose, even if an opioid overdose reversal agent is administered [ see Overdosage (10) ].

Advise patients and caregivers: how to treat with the overdose reversal agent in the event of an opioid overdose. to tell family and friends about the opioid over…

Medication Guide XTAMPZA ® ER (ex tamp' zah ee ar) (oxycodone) extended-release capsules, CII This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: December 2025 XTAMPZA ER 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 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. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose. Taking XTAMPZA ER with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), 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 problems urinating liver, kidney, thyroid problems 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 that you have increases, if you feel more sensitive to pain, or if you have new pain after taking XTAMPZA ER. pregnant or planning to become pregnant.

Use of XTAMPZA ER for an extended period of time 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 . 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 n…