Generic name: ACETAMINOPHEN 320.5mg, CAFFEINE 30mg, DIHYDROCODEINE BITARTRATE 16mg
Dosage form: capsule
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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 24-72 hours of initiating therapy and following dosage increases with TREZIX™ and adjust the dosage accordingly [see WARNINGS].
Initiating treatment with TREZIX™
The usual adult dosage is two (2) TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsules orally every four (4) hours, as needed. No more than five (5) doses, or ten (10) capsules should be taken in a 24-hour period.
Conversion from Other Opioids to TREZIX™
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of TREZIX™. It is safer to underestimate a patient’s 24-hour TREZIX™ dosage than to overestimate the 24-hour TREZIX™ dosage and manage an adverse reaction due to overdose.
Titration and Maintenance of Therapy
Individually titrate TREZIX™ to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving TREZIX™ 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 TREZIX™ 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 TREZIX™
When a patient who has been taking TREZIX™ regularly and may be physically dependent no longer requires therapy with TREZIX™, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue TREZIX™ in a physically-dependent patient [see WARNINGS, DRUG ABUSE AND DEPENDENCE].
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