Oxycodone and Acetaminophen Tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Oxycodone and Acetaminophen Tablets and know how they will react to the medication [see PRECAUTIONS; Information for Patients/Caregivers].
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store Oxycodone and Acetaminophen Tablets 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 Oxycodone and Acetaminophen Tablets unsecured can pose a deadly risk to others in the home [see WARNINGS, DRUG ABUSE AND DEPENDENCE].
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused Oxycodone and Acetaminophen Tablets 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 Oxycodone and Acetaminophen Tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS].
Instruct patients not to share oxycodone and acetaminophen tablets with others and to take steps to protect oxycodone and acetaminophen tablets 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 Oxycodone and Acetaminophen Tablets 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, Life Threatening Respiratory Depression].
Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS].
Interactions with Benzodiazepines and Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if Oxycodone and Acetaminophen Tablets are used with benzodiazepines and other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider [see WARNINGS, PRECAUTIONS; Drug Interactions].
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 WARNINGS, DOSAGE AND ADMINISTRATION].
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 all cases of known or suspected opioid overdose, even if an opioid overdose reversal agent is administered [see OVERDOSAGE].
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 overdose reversal agent, and to keep it in a place where family and friends can access it in an emergency
* to read the Patient Information (or other educational material) that will come with their opioid overdose reversal agent. Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do.
Inform patients and caregivers not to increase opioid dosage without first consulting a clinician. Advise patients to seek medical attention if they experience symptoms of hyperalgesia, including worsening pain, increased sensitivity to pain, or new pain [see WARNINGS, ADVERSE REACTIONS].
Serotonin Syndrome
Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see PRECAUTIONS; Drug Interactions].
Monoamine Oxidase Inhibitor (MAOI) Interaction
Inform patients to avoid taking Oxycodone and Acetaminophen Tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Oxycodone and Acetaminophen Tablets [see PRECAUTIONS; Drug Interactions].
Important Administration Instructions
Instruct patients how to properly take Oxycodone and Acetaminophen Tablets [see DOSAGE AND ADMINISTRATION, WARNINGS].
Advise patients not to adjust the medication dose themselves and to consult with their healthcare provider prior to any dosage adjustment.
Advise patients who are treated with Oxycodone and Acetaminophen Tablets for more than a few weeks not to abruptly discontinue the medication. Advise patients to consult with their physician for a gradual discontinuation dose schedule to taper off the medication.
Important Discontinuation Instructions
In order to avoid developing withdrawal symptoms, instruct patients not to discontinue Oxycodone and Acetaminophen Tablets without first discussing a tapering plan with the prescriber [see DOSAGE AND ADMINISTRATION].
Maximum Daily Dose of Acetaminophen
Inform patients to not take more than 4000 milligrams of acetaminophen per day. Advise patients to call their prescriber if they take more than the recommended dose.
Driving or Operating Heavy Machinery
Inform patients that Oxycodone and Acetaminophen Tablets may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication [see PRECAUTIONS].
Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see ADVERSE REACTIONS, CLINICAL PHARMACOLOGY].
Adrenal Insufficiency
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see WARNINGS].
Inform patients that Oxycodone and Acetaminophen Tablets may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see WARNINGS].
Anaphylaxis
Inform patients that anaphylaxis have been reported with ingredients contained in Oxycodone and Acetaminophen Tablets. Advise patients how to recognize such a reaction and when to seek medical attention [see CONTRAINDICATIONS, ADVERSE REACTIONS].
Inform female patients of reproductive potential that use of Oxycodone and Acetaminophen Tablets for an extended period of time during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see WARNINGS, PRECAUTIONS; Pregnancy].
Embryo-Fetal Toxicity
Inform female patients of reproductive potential that Oxycodone and Acetaminophen Tablets can cause fetal harm and to inform the healthcare provider of a known or suspected pregnancy [see PRECAUTIONS; Pregnancy].
Lactation
Advise breastfeeding women using Oxycodone and Acetaminophen Tablets to carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct breastfeeding women to seek immediate medical care if they notice these signs [see PRECAUTIONS; Nursing Mothers].
Infertility
Inform patients that use of opioids for an extended period of time may cause reduced fertility. It is not known whether these effects on fertility are reversible [see ADVERSE REACTIONS].