Important Dosage and Administration Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS].

Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS].

Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with oxycodone and acetaminophen tablets and adjust the dosage accordingly [see WARNINGS].

Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose
Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with oxycodone and acetaminophen tablets [see WARNINGS; Life-Threatening Respiratory Depression, PRECAUTIONS; Information for Patients/Caregivers].
Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing regulations (e.g., by prescription, directly from a pharmacist, or as part of a community-based program).
Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. The presence of risk factors for overdose should not prevent the proper management of pain in any given patient [see WARNINGS; Addiction, Abuse, and Misuse, Life-Threatening Respiratory Depression, Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants].
Consider prescribing naloxone when the patient has household members (including children) or other close contacts at risk for accidental ingestion or overdose.

Initial Dosage

Initiating Treatment with Oxycodone and Acetaminophen Tablets

The usual adult dosage is 1 or 2 tablets every 6 hours and the maximal daily dose is 12 tablets. The total daily dose of acetaminophen should not exceed 4 grams.

Conversion from Oxycodone and Acetaminophen Tablets to Extended-Release Oxycodone

The relative bioavailability of oxycodone and acetaminophen tablets compared to extended-release oxycodone is unknown, so conversion to extended-release oxycodone must be accompanied by close observation for signs of excessive sedation and respiratory depression.

Titration and Maintenance of Therapy

Individually titrate oxycodone and acetaminophen tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving oxycodone and acetaminophen tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the oxycodone and acetaminophen tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation of Oxycodone and Acetaminophen Tablets

When a patient who has been taking oxycodone and acetaminophen tablets regularly and may be physically dependent no longer requires therapy with oxycodone and acetaminophen tablets, use a gradual downward titration of the dosage to prevent signs and symptoms of withdrawal. Do not stop oxycodone and acetaminophen tablets abruptly [see WARNINGS, DRUG ABUSE AND DEPENDENCE].