ablets whole. Crushing, dissolving, or chewing OPANA ER can cause rapid release and absorption of a potentially fatal dose of oxymorphone.
Accidental Exposure
Accidental ingestion of OPANA ER, especially in children, can result in a fatal overdose of oxymorphone [see Warnings and Precautions (5.3)].
Interaction with Alcohol
The co-ingestion of alcohol with OPANA ER may result in an increase of plasma levels and potentially fatal overdose of oxymorphone [see Warnings and Precautions (5.4)]. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while on OPANA ER.
1 INDICATIONS AND USAGE
OPANA ER is an opioid agonist indicated for the relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time. (1)
Limitations of Use
OPANA ER is not for use:
•As an as-needed (prn) analgesic
•For pain that is mild or not expected to persist for an extended period of time
•For acute pain
•For postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.
2 DOSAGE AND ADMINISTRATION
2.1 Initial Dosing
Initiate the dosing regimen for each patient individually, taking into account the patient"s prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with OPANA ER [see Warnings and Precautions (5.2)].
Consider the following factors when selecting an initial dose of OPANA ER:
Total daily dose, potency, and any prior opioid the patient has been taking previously;
Reliability of the relative potency estimate used to calculate the equivalent dose of oxymorphone needed (Note: potency estimates may vary with the route of administration);
Patient"s degree of opioid experience and opioid tolerance;
General condition and medical status of the patient;
Concurrent medication;
Type and severity of the patient"s pain.
OPANA ER tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information (17)].
OPANA ER is administered at a frequency of twice daily (every 12 hours). Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.
Use of OPANA ER as the First Opioid Analgesic
Initiate Opana ER therapy with the 5 mg tablet twice daily (at 12-hour intervals). Adjust the dose of OPANA ER in increments of 5-10 mg every 12 hours every 3 to 7 days.
Conversion from OPANA to OPANA ER
Patients receiving OPANA may be converted to OPANA ER by administering half the patient's total daily oral OPANA dose as OPANA ER, every 12 hours.
Conversion from Parenteral Oxymorphone to OPANA ER
The absolute oral bioavailability of OPANA ER is approximately 10%. Convert patients receiving parenteral oxymorphone to OPANA ER by administering 10 times the patient"s total daily parenteral oxymorphone dose as OPANA ER in two equally divided doses (e.g., [IV dose x 10] divided by 2). Due to patient variability with regards to opioid analgesic response, upon conversion monitor patients closely to eva luate for adequate analgesia and side effects.
Conve |
