Generic name: OXYCODONE HYDROCHLORIDE 2.5mg, ACETAMINOPHEN 325mg
Dosage form: tablet
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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 ENDOCET and adjust the dosage accordingly [see WARNINGS].
Initiating Treatment with ENDOCET
Initiate treatment with ENDOCET tablets 2.5 mg/325 mg adult dosage, with one or 2 tablets every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.
The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.
|Strength||Usual Adult Dosage||
Maximal Daily Dose
|ENDOCET 2.5 mg/325 mg||
1 or 2 tablets every 6 hours as needed for pain
|ENDOCET 5 mg/325 mg||1 tablet every 6 hours as needed for pain||12 Tablets|
|ENDOCET 7.5 mg/325 mg||1 tablet every 6 hours as needed for pain||8 Tablets|
|ENDOCET 10 mg/325 mg||1 tablet every 6 hours as needed for pain||6 Tablets|
Conversion from Oxycodone Hydrochloride and Acetaminophen to Extended-Release Oxycodone
The relative bioavailability of Oxycodone Hydrochloride and Acetaminophen Tablets or Oral Solution 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 ENDOCET to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving ENDOCET 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 ENDOCET 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 Hydrochloride and Acetaminophen Tablets and Oral Solution
When a patient who has been taking Oxycodone Hydrochloride and Acetaminophen Tablets or Oral Solution regularly and may be physically dependent no longer requires therapy with Oxycodone Hydrochloride and Acetaminophen Tablets or Oral Solution, use a gradual downward titration of the dosage to prevent signs and symptoms of withdrawal. Do not stop Oxycodone Hydrochloride and Acetaminophen Tablets or Oral Solution abruptly [see WARNINGS, DRUG ABUSE AND DEPENDENCE].
More about Endocet (acetaminophen / oxycodone)
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- Drug class: narcotic analgesic combinations