WARNING

Taking Xtampza ER (oxycodone extended-release) carries certain risks, and it’s important for individuals to be aware of them. Some of the key risks associated with Xtampza ER include:

• Opioid-Related Risks: Xtampza ER is an opioid analgesic, and like all opioids, it comes with the risk of misuse, abuse, addiction, and overdose. The potential for dependence and tolerance can increase with prolonged use.
• Respiratory Depression: Opioids can suppress respiratory function, and taking Xtampza ER in higher doses or inappropriately may lead to respiratory depression, which is a serious and potentially life-threatening side effect.
• Central Nervous System Effects: Xtampza ER can cause drowsiness, dizziness, and impair cognitive function. This may affect an individual’s ability to drive or operate machinery safely.
• Gastrointestinal Effects: Common side effects include nausea, vomiting, and constipation. Constipation can be severe and may require intervention.
• Potential for Drug Interactions: Xtampza ER may interact with other medications, including other opioids, benzodiazepines, muscle relaxants, and certain antidepressants. These interactions can potentiate adverse effects.
• Hypotension (Low Blood Pressure): Xtampza ER can cause low blood pressure, leading to symptoms such as lightheadedness or fainting.
• Risk of Overdose: Taking too much Xtampza ER, either accidentally or intentionally, can lead to an overdose. Overdose symptoms may include extreme drowsiness, difficulty waking up, confusion, slow or shallow breathing, or unresponsiveness.
• Potential for Withdrawal: Prolonged use of Xtampza ER can lead to physical dependence, and abrupt discontinuation may result in withdrawal symptoms.
• Special Population Considerations: Xtampza ER should be used with caution in certain populations, including pregnant women, breastfeeding mothers, and individuals with certain medical conditions.

It’s crucial for individuals taking Xtampza ER to use the medication exactly as prescribed by their healthcare provider, to communicate openly about any side effects or concerns, and to attend regular follow-up appointments. Healthcare providers will carefully balance the potential benefits of pain relief with the risks associated with opioid use, and they may explore alternative pain management strategies when appropriate. Patients should always seek medical advice and not make changes to their medication regimen without consulting their healthcare provider.

Why is this medication prescribed?

Xtampza ER (oxycodone extended-release) is a prescription medication used to manage severe pain that requires around-the-clock, long-term treatment and for which alternative treatment options are inadequate. It is an opioid analgesic, and it works by binding to opioid receptors in the brain and spinal cord, reducing the perception of pain.

How should this medicine be used?

Here are some general guidelines for using Xtampza ER, but it’s crucial to follow your healthcare provider’s instructions:

• Dosage: The dosage of Xtampza ER is individualized based on the patient’s pain severity, response to opioids, and previous opioid therapy. It’s important to start with the lowest effective dose to minimize the risk of adverse effects.
• Administration: Xtampza ER is an extended-release formulation, which means it releases the medication slowly over an extended period. It is usually taken every 12 hours. The capsules should be swallowed whole with enough water to ensure complete swallowing.
• Food Interaction: Xtampza ER can be taken with or without food. However, consistent administration with food or consistently without food is recommended to maintain blood levels of the medication.
• Avoid Crushing or Chewing: It’s important not to crush, chew, or dissolve the capsules, as this could lead to the rapid release of a potentially fatal dose of oxycodone.
• Individualized Treatment: The dosage and duration of treatment with Xtampza ER should be individualized according to the patient’s needs. Regular reassessment of the patient’s pain and clinical condition is essential to determine the ongoing need for opioid analgesics.
• Tolerance and Dependence: Prolonged use of opioid analgesics may lead to the development of tolerance (the need for increasing doses to maintain pain control) and physical dependence (withdrawal symptoms upon abrupt discontinuation). Your healthcare provider will manage these aspects as part of the treatment plan.

It’s crucial to take Xtampza ER exactly as prescribed by your healthcare provider. Do not self-adjust the dose, and do not share the medication with others. Misuse of opioid medication can lead to serious health risks, including overdose and death.

As with any medication, there are potential side effects and risks associated with Xtampza ER, and your healthcare provider will weigh these against the potential benefits to determine if it is an appropriate treatment for your specific situation. Always consult with your healthcare provider for personalized advice and guidance.

Other uses for this medicine

Xtampza ER (oxycodone extended-release) is primarily prescribed for the management of severe pain, especially in cases where around-the-clock, long-term opioid treatment is necessary. Its use is typically limited to pain management, and it’s not commonly prescribed for other medical conditions.

What special precautions should I follow?

Special precautions should be taken when using Xtampza ER, and it’s important to follow your healthcare provider’s guidance closely. Here are some general precautions associated with the use of Xtampza ER:

• Opioid Risks: Xtampza ER belongs to the opioid class of medications, and like all opioids, it carries risks of misuse, abuse, addiction, and overdose. It should be used only under the supervision of a healthcare professional and at the prescribed dosage.
• Medical History: Inform your healthcare provider about your complete medical history, especially if you have a history of respiratory problems, kidney or liver disease, head injuries, mental health disorders, or a history of substance abuse.
• Drug Interactions: Xtampza ER may interact with other medications, including other opioids, benzodiazepines, muscle relaxants, and certain antidepressants. Inform your healthcare provider about all the medications you are taking to avoid potential interactions.
• Pregnancy and Breastfeeding: Xtampza ER should be used with caution in pregnant women, as it may pass into breast milk and harm a nursing infant. Inform your healthcare provider if you are pregnant or breastfeeding.
• Respiratory Depression: Opioids like Xtampza ER can cause respiratory depression, which is a potentially life-threatening condition. This risk is higher in individuals with respiratory conditions. Your healthcare provider will monitor you closely for respiratory function.
• Tolerance and Dependence: Prolonged use of opioids can lead to the development of tolerance and physical dependence. Abrupt discontinuation of the medication can result in withdrawal symptoms. Your healthcare provider will manage these aspects of the treatment plan.
• Dosing and Administration: Xtampza ER should be taken exactly as prescribed by your healthcare provider. Do not crush or chew the capsules, as this can lead to a potentially fatal dose of oxycodone.
• Alcohol and Other Central Nervous System Depressants: Xtampza ER should not be used in combination with alcohol or other central nervous system depressants, as this can increase the risk of respiratory depression and other serious side effects.

Always follow your healthcare provider’s instructions and communicate any concerns or side effects promptly. If you have questions or experience adverse effects, contact your healthcare provider for guidance. It’s important to use Xtampza ER responsibly and under the supervision of a healthcare professional.

What special dietary instructions should I follow?

There are generally no specific dietary restrictions associated with Xtampza ER. However, it’s essential to maintain a balanced and healthy diet as part of your overall well-being. If you have any concerns or questions about dietary interactions with Xtampza ER, it’s best to discuss them with your healthcare provider or pharmacist.

What should I do if I forget a dose?

If you forget to take a dose of Xtampza ER, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses to make up for a missed one.

What side effects can this medication cause?

Xtampza ER (oxycodone extended-release) can cause various side effects, some of which are common, while others are less common but more severe. It’s important to note that not everyone will experience these side effects, and the severity can vary from person to person. If you are prescribed Xtampza ER, it’s crucial to be aware of potential side effects and promptly report any concerns to your healthcare provider. Common side effects may include:

• Nausea and Vomiting: Opioid medications, including Xtampza ER, can cause nausea and vomiting, especially when starting the treatment.
• Constipation: Opioids are known to cause constipation. Maintaining a healthy diet with adequate fiber, hydration, and, if necessary, the use of stool softeners or laxatives can help manage this side effect.
• Dizziness and Drowsiness: Xtampza ER may cause dizziness and drowsiness, which can impair your ability to operate machinery or drive. Avoid alcohol and other substances that may enhance these effects.
• Headache: Some individuals may experience headaches as a side effect of Xtampza ER.
• Itching: Opioids can sometimes cause itching or rash.
• Fatigue: Feeling tired or fatigued can be a common side effect.
• Dry Mouth: Some individuals may experience dry mouth as a result of taking Xtampza ER.
• Sweating: Excessive sweating can occur in some individuals.

More severe side effects that require immediate medical attention include:

• Difficulty Breathing: Opioids can suppress respiratory function, and difficulty breathing is a serious side effect that requires immediate medical attention.
• Severe Constipation or Bowel Obstruction: If you experience severe constipation or signs of a bowel obstruction (such as persistent abdominal pain or bloating), seek medical help.
• Allergic Reactions: Allergic reactions to medications can occur. Seek medical attention if you experience symptoms such as rash, itching, swelling, severe dizziness, or difficulty breathing.
• Seizures: While rare, opioids may lower the seizure threshold, and seizures can occur in susceptible individuals.
• Low Blood Pressure: Xtampza ER can cause low blood pressure, leading to symptoms such as lightheadedness or fainting.

It’s essential to use Xtampza ER under the supervision of a healthcare provider, and any side effects or concerns should be promptly communicated to them. Additionally, if you experience signs of an overdose, such as extreme drowsiness, difficulty waking up, or shallow breathing, seek emergency medical attention immediately.

What should I know about storage and disposal of this medication?

Storage and Disposal of Xtampza ER:

• Storage: Store Xtampza ER at room temperature, away from light and moisture. Keep it in a secure location to prevent accidental ingestion by children or pets.
• Disposal: Dispose of unused or expired Xtampza ER properly. Follow your local guidelines for medication disposal. Do not flush medications down the toilet unless instructed to do so. Many communities have drug take-back programs or provide specific instructions for safe disposal. Check with your pharmacist or local waste management for guidance.

In case of emergency/overdose

In case of a suspected overdose or emergency, seek immediate medical attention. Overdose symptoms may include extreme drowsiness, difficulty waking up, confusion, slow or shallow breathing, or unresponsiveness. If you can, inform healthcare professionals about the specific opioid you have taken (in this case, Xtampza ER).

What other information should I know?

• Follow Prescribing Instructions: Take Xtampza ER exactly as prescribed by your healthcare provider. Do not change the dosage or frequency without consulting your healthcare professional.
• Avoid Alcohol and CNS Depressants: Do not consume alcohol or other central nervous system depressants while taking Xtampza ER, as it can increase the risk of respiratory depression and other serious side effects.
• Avoid Grapefruit Juice: Grapefruit juice may interact with Xtampza ER. It’s advisable to avoid consuming grapefruit or grapefruit juice while taking this medication.
• Regular Follow-up: Attend regular follow-up appointments with your healthcare provider to assess the effectiveness of the medication and to monitor for any side effects or changes in your health condition.
• Tolerance and Dependence: Long-term use of opioids can lead to tolerance and physical dependence. Do not abruptly stop taking Xtampza ER without consulting your healthcare provider, as this can lead to withdrawal symptoms.
• Inform Healthcare Providers: Inform all healthcare providers involved in your care that you are taking Xtampza ER, including dentists or emergency room staff. This is important for proper management of your healthcare needs.
• Pregnancy and Breastfeeding: Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding, as Xtampza ER may have implications for pregnancy and nursing.
• Driving and Operating Machinery: Xtampza ER may cause drowsiness and dizziness. Avoid driving or operating machinery until you know how the medication affects you.

Always consult with your healthcare provider or pharmacist if you have questions or concerns about your medication. They can provide personalized advice based on your specific health condition and medical history.