Aspirin - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Aspirin. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE AND ASPIRIN TABLETS Addiction, Abuse, and Misuse Because the use of oxycodone and aspirin tablets 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 (see WARNINGS ). Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of oxycodone and aspirin tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of oxycodone and aspirin tablets are essential (see WARNINGS ). Accidental Ingestion Accidental ingestion of even one dose of oxycodone and aspirin tablets, especially by children, can result in a fatal overdose of oxycodone (see WARNINGS ). Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of oxycodone and aspirin tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [ see WARNINGS ]. Neonatal Opioid Withdrawal Syndrome (NOWS) If opioid use is require
WARNINGS Addiction, Abuse, and Misuse Oxycodone and aspirin tablets contain Oxycodone, a Schedule II controlled substance.
As an opioid, oxycodone and aspirin tablets exposes users to the risks of addiction, abuse, and misuse (see DRUG ABUSE AND DEPENDENCE ).
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed oxycodone and aspirin tablets.
Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing oxycodone and aspirin tablets, and reassess all patients receiving oxycodone and aspirin tablets for the development of these behaviors and conditions.
Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).
The potential for these risks should not, however, prevent the proper management of pain in any given patient.
Patients at increased risk may be prescribed opioids such as oxycodone and aspirin tablets but use in such patients necessitates intensive counseling about the risks and proper use of oxycodone and aspirin tablets along with frequent reevaluation for signs of addiction, abuse, and misuse.
Consider prescribing naloxone for the emergency treatment of opioid overdose [see WARNINGS , DOSAGE AND ADMINISTRATION ].
Opioids are sought by nonmedical use and are subject to diversion from legitimate prescribed use.
Consider these risks when prescribing or dispensing oxycodone and aspirin tablets.
Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on careful storage of the drug during the course of treatment and proper disposal of unused drug (see PRECAUTIONS; Information for Patients /Caregivers).
Contact local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended.
Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.
Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status (see OVERDOSAGE ).
Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.
While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of oxycodone and aspirin tablets, the risk is greatest during the initiation of therapy or following a dosage increase.
To reduce the risk of respiratory depression, proper dosing and titration of oxycodone and aspirin tablets are essential (see DOSAGE AND ADMINISTRATION ).
Overestimating the oxycodone and aspirin tablets when converting patients from another opioid product can result in a fatal overdose with the first dose.
Accidental ingestion of even one dose of oxycodone and aspirin tablets, especially by children can result in respiratory depression and death due to an overdose of oxycodone.
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 PRECAUTIONS ; Information for Patients/Caregivers ].
Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia.
Opioid use increases the risk of CSA in a dose-dependent fashion.
In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper (see DOSAGE AND ADMINISTRATION ).
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