Opioid pain relievers can be helpful for managing pain. However, these medications often carry risks, not just to individuals but also to their friends, families, and surrounding communities. They can be misused, stolen, or abused, and they may put people who take too much at a risk of fatal overdose. 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. It's important to understand the steps you can take to promote more responsible pain management, protect yourself and your prescription, and reduce the risks to those around you.
One potential risk is misusing your medication. Misuse happens when someone takes a medicine incorrectly. Some people may misuse their medication in ways that seem harmless, like skipping a dose to avoid certain side effects or chewing a tablet so it's easier to swallow. However, those small changes can have big effects on the way a medication works. Misuse of opioid medications, whether intentional or accidental, can cause potentially fatal adverse events.
Examples of misuse include:
There is also the risk of your pain medication being taken by someone else. When a medication is stolen or otherwise ends up in the hands of someone who was not prescribed the medication, it's known as diversion. It is important to be aware of this risk because there is no way to know how a drug will affect the body and health of someone who uses another person's prescription medication.
Examples of diversion include:
It is important to be aware of the risk of an overdose. Pain medications, such as long-acting opioid medications, can put you at risk for overdose if they are not taken correctly. An overdose can occur if a person takes more of a medication than was prescribed by a doctor, which can result in serious, negative consequences.
Because the use of 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 and reassess all patients regularly for the development of these behaviors and conditions.
Serious, life-threatening, or fatal respiratory depression may occur with use of XTAMPZA ER, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of XTAMPZA ER are essential.
Accidental ingestion of even one dose of XTAMPZA ER, especially by children, can result in a fatal overdose of oxycodone.
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.
If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery.
Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription.
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. Regularly evaluate patients receiving XTAMPZA ER and any CYP3A4 inhibitor or inducer.
These are not all the possible side effects of XTAMPZA ER. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1‑800‑FDA‑1088. For more information, go to dailymed.nlm.nih.gov.
See full Prescribing Information, including Boxed Warning on Addiction, Abuse and Misuse and other serious risks, accompanying this piece or at XTAMPZAER.com/PI. Speak to your healthcare provider if you have questions about XTAMPZA ER.
