1.1.8. Dosage Limits

The lowest effective fentanyl transmucosal, buccal, intranasal, or sublingual dose should be administered to patients with renal or hepatic dysfunction, as well as those patients receiving concurrent CYP3A4 inhibitor drugs.

Patient profiles containing prescriptions for greater than 6 units of fentanyl oral transmucosal lozenges during a transition phase will be reviewed. Patient profiles containing prescriptions for more than one strength of buccal, nasal, sublingual, or transmucosal fentanyl concurrently for greater than two months will be reviewed.  Patient profiles containing prescriptions for greater than four doses per day of fentanyl intranasal spray or fentanyl sublingual tablets will be reviewed. Patient profiles documenting treatment of more than 4 breakthrough episodes daily with fentanyl buccal, transmucosal, or sublingual dosage forms will be reviewed (see Table 6^1-11)^{1-5, 7-11}.