Patients prescribed fentanyl sublingual tablets for breakthrough pain should begin therapy with an initial 100 mcg dose, with the exception of those previously treated with fentanyl oral transmucosal lozenges. Dose conversions between fentanyl oral transmucosal lozenges and sublingual tablets are summarized in Table 2.
To administer fentanyl sublingual tablets, the unwrapped tablet should be placed on the floor of the mouth, under the tongue and allowed to dissolve completely. Fentanyl sublingual tablets should not be chewed or swallowed. Patients should be advised to not eat or drink until the tablet is dissolved. In patients with xerostomia, the mouth should be moistened before the tablet is administered. If patients do not achieve adequate analgesia within 30 minutes, a second fentanyl sublingual tablet dose may be administered as directed. No more than two doses should be administered for any breakthrough pain episode. If pain relief for the breakthrough episode is not relieved with the 100 mcg dose, titrate using multiples of 100 mcg or 200 mcg tablets until adequate analgesia is achieved. Doses may be titrated upward to 200 mcg, 300 mcg, 400 mcg, 600 mcg, or 800 mcg per dose. Doses higher than 800 mcg have not been evaluated in clinical trials. If adequate pain relief is not achieved within 30 minutes of the first dose, a second dose of the same strength may be administered. Patients should not use more than 4 tablets at one time. Patients must wait at least 2 hours before administering fentanyl sublingual tablets for another episode of breakthrough pain. Once an effective fentanyl sublingual tablet dose has been determined, patients should be maintained on this dose. If pain is not effectively managed with this dose of fentanyl sublingual tablet, a patient may use a second dose as directed by their health care provider, with no more than two doses being used to treat any breakthrough pain episode. Again, patients must wait at least two hours before treating subsequent breakthrough pain episodes. Fentanyl sublingual tablets should be used for no more than four breakthrough pain episodes per day. If more than four breakthrough pain episodes happen per day, the long-term opiate maintenance dose should be re-evaluated. To discontinue fentanyl sublingual tablet use, a downward titration is recommended to minimize potential withdrawal adverse effects3, 7-11.