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 61-11)1-5, 7-11.
Table 6: Adult Maximum Oral/Intranasal/Transdermal Fentanyl Dosages
| Fentanyl Dosage Form | Dosage Strengths | Maximum Dose |
|---|---|---|
| buccal tablet (Fentora®, generic) | 100 mcg, 200 mcg, 400 mcg, 600 mcg, or 800 mcg per tablet | 800 mcg/dose; no more than 4 tablets at one time per breakthrough episode, and no more than 2 doses per breakthrough pain episode; if more than 4 breakthrough episodes per 24 hours occur once maintenance dose determined, long-acting opioid dose should be re-evaluated |
| intranasal spray (Lazanda®) | 100 mcg, 300 mcg, or 400 mcg per actuation | 800 mcg/dose; if more than 4 breakthrough episodes per 24 hours occur once maintenance dose determined, long-acting opioid dose should be re-evaluated |
| sublingual tablet (Abstral®) | 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, or 800 mcg per tablet | 800 mcg/dose; no more than 4 tablets at one time per breakthrough episode, and no more than 2 doses per breakthrough pain episode; if more than 4 breakthrough episodes per 24 hours occur once maintenance dose determined, long-acting opioid dose should be re-evaluated |
| sublingual spray (Subsys®) | 100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, or 1600 mcg per spray | 1600 mcg/dose; no more than 2 doses per breakthrough pain episode; if more than 4 breakthrough episodes per 24 hours occur once maintenance dose determined, long-acting opioid dose should be re-evaluated |
| transmucosal lozenge (Actiq®, generic) | 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, or 1600 mcg per lozenge | no more than 2 units/lozenges per breakthrough pain episode; no more than 4 lozenge units/day; if more than 4 breakthrough episodes per 24 hours occur once maintenance dose determined, long-acting opioid dose should be re-evaluated |
| transdermal patch (Duragesic®, generic) | 12 mcg/hr, 25 mcg/hr, 37.5 mcg/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr | maximum dose not identified; dosages titrated every 3 days after initial dose, then every 6 days thereafter; most patients controlled with every 72 hour administration; a small percentage require every 48 hour administration |