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 PRIMLEV™ and adjust the dosage accordingly [see WARNINGS].
Initial Dosage
Initiating Treatment with Primlev™
The usual adult dosage is as follows. The total daily dose of acetaminophen should not exceed 4 grams.
|
Strength
|
Usual Adult Dosage
|
Maximal Daily Dose
|
|
5 mg/300 mg
|
1 tablet every 6 hours as needed for pain
|
12 Tablets
|
|
7.5 mg/300 mg
|
1 tablet every 6 hours as needed for pain
|
8 Tablets
|
|
10 mg/300 mg
|
1 tablet every 6 hours as needed for pain
|
6 Tablets
|
Conversion from PRIMLEV™ to Extended-Release Oxycodone
The relative bioavailability of PRIMLEV™ 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 PRIMLEV™ to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving PRIMLEV™ 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 PRIMLEV™ 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 PRIMLEV™
When a patient who has been taking PRIMLEV™ regularly and may be physically dependent no longer requires therapy with PRIMLEV™, use a gradual downward titration of the dosage to prevent signs and symptoms of withdrawal. Do not stop PRIMLEV™ abruptly [see WARNINGS, DRUG ABUSE AND DEPENDENCE].
