![]() Statistically significant differences favoring LIDODERM were observed in terms of time to exit from the trial (14 versus 3.8 days at p-value <0.001), daily average pain relief, and patient's preference of treatment. The constant type of pain was evaluated but not the pain induced by sensory stimuli (dysesthesia). Multiple-dose, two-week treatment with LIDODERM was compared to vehicle patch (without lidocaine) in a double-blind, crossover clinical trial of withdrawal-type design conducted in 32 patients, who were considered as responders to the open-label use of LIDODERM prior to the study. LIDODERM performed statistically better than vehicle patch in terms of pain intensity from 4 to 12 hours. Pain intensity and pain relief scores were evaluated periodically for 12 hours. Single-dose treatment with LIDODERM was compared to treatment with vehicle patch (without lidocaine), and to no treatment (observation only) in a double-blind, crossover clinical trial with 35 post-herpetic neuralgia patients. The mean plasma pharmacokinetic profile for the 15 healthy volunteers is shown in Figure 1.įigure 1 Mean lidocaine blood concentrations after three consecutive daily applications of three LIDODERM patches simultaneously for 12 hours per day in healthy volunteers (n = 15). Repeated application of three patches simultaneously for 12 hours (recommended maximum daily dose), once per day for three days, indicated that the lidocaine concentration does not increase with daily use. Mean peak blood concentration of lidocaine is about 0.13 mcg/mL (about 1/10 of the therapeutic concentration required to treat cardiac arrhythmias). At least 95% (665 mg) of lidocaine will remain in a used patch. When LIDODERM is used according to the recommended dosing instructions, only 3 ± 2% of the dose applied is expected to be absorbed. Normal volunteers (n = 15, 12-hour wearing time) Blood samples were withdrawn for determination of lidocaine concentration during the application and for 12 hours after removal of patches. In a pharmacokinetic study, three LIDODERM patches were applied over an area of 420 cmĢ of intact skin on the back of normal volunteers for 12 hours. The amount of lidocaine systemically absorbed from LIDODERM is directly related to both the duration of application and the surface area over which it is applied.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |