rsion from Other Oral Opioids to OPANA ER
While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variability in the relative potency of different opioid drugs and formulations. As such, it is safer to underestimate a patient’s 24-hour oral oxymorphone dose and provide rescue medication (e.g. immediate-release oxymorphone) than to overestimate the 24-hour oral oxymorphone dose and manage an adverse reaction. Consider the following general points:
In a Phase 3 clinical trial with an open-label titration period, patients were converted from their prior opioid to OPANA ER using the following table as a guide for the initial OPANA ER dose.
The table is not a table of equianalgesic doses.
The conversion ratios in this table are only to be used for the conversion from oral therapy with one of the listed opioid analgesics to OPANA ER.
Do not use this table to convert from OPANA ER to another opioid. Doing so will result in an over-estimation of the dose of the new opioid and may result in fatal overdose.
For example, a patient receiving oxycodone at a total daily dose of 40 mg would then be converted to a total daily dose of 20 mg of oxymorphone (40 mg x 0.5), dosed as OPANA ER 10 mg twice daily.
CONVERSION RATIOS TO OPANA ER
Opioids Total Daily Oral Dose Oral Conversion Ratio
Oxymorphone 10 mg 1
Hydrocodone 20 mg 0.5
Oxycodone 20 mg 0.5
Methadone 20 mg 0.5
Morphine 30 mg 0.333
2.2 Titration and Maintenance of Therapy
Individually titrate OPANA ER to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reeva luate patients receiving OPANA ER to assess the maintenance of pain control and the relative incidence of adverse reactions. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.
If the level of pain increases, attempt to identify the source of increased pain, while adjusting the OPANA ER dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 3 days, OPANA ER dosage adjustments, preferably at increments of 5-10 mg every 12 hours, may be done every 3 to 7 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication with a small dose of an immediate-release medication (e.g. immediate-release oxymorphone).
During chronic, around-the-clock opioid therapy, especially for non-cancer pain syndromes, reassess the continued need for around-the-clock opioid therapy periodically (e.g., every 6 to 12 months) as appropriate.
If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
2.3 Discontinuation of OPANA ER
When a patient no longer requires therapy with OPANA ER, use a gradual downward titration of the dose every two to four days, to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue OPANA ER.
2.4 Administration of OPANA ER
Instruct patients to swallow OPANA ER tablets intact. The tablets are not to be crushed, dissolved, or chew |
