Comparative Pharmacology
Head-to-head clinical analysis: IONSYS versus ULTRAM ER.
Peer-Reviewed Evidence
Head-to-head clinical analysis: IONSYS versus ULTRAM ER.
IONSYS vs ULTRAM ER
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
IONSYS is an iontophoretic delivery system for fentanyl, a mu-opioid receptor agonist. Fentanyl binds to mu-opioid receptors in the CNS, inhibiting ascending pain pathways and altering pain perception and emotional response.
Tramadol is a centrally acting synthetic opioid analgesic that binds to μ-opioid receptors and inhibits serotonin and norepinephrine reuptake.
Apply one 40 mcg fentanyl iontophoretic transdermal system to skin on upper arm or chest; delivers 40 mcg per dose on-demand for up to 24 hours or 80 doses, whichever is shorter. Maximum 2 doses per hour, 6 doses per application. Patient must be opioid-tolerant.
100 mg orally once daily initially, titrate up to 100 mg twice daily as needed; maximum 200 mg/day.
None Documented
None Documented
Terminal elimination half-life: 16.3 ± 9.1 hours for fentanyl released from IONSYS; accounts for prolonged release from depot and is longer than intravenous fentanyl (3-12 hours).
The terminal elimination half-life of tramadol is approximately 6.3 hours (range 5-9 hours), while its active metabolite M1 has a half-life of about 7.4 hours. Clinically, this supports dosing every 24 hours for the extended-release formulation.
Renal: approximately 90% as fentanyl metabolites (mainly norfentanyl) and less than 10% as unchanged drug; fecal: less than 10%.
Renal excretion of tramadol and its metabolites accounts for approximately 90% of total elimination. About 10% is excreted unchanged, 30% as O-desmethyltramadol (M1), and the remainder as other minor metabolites. Biliary/fecal excretion is minimal (<10%).
Category C
Category C
Opioid Analgesic
Opioid Analgesic