The extent of use of concomitant medication was similar in the two treatment groups.Ĭases of methemoglobinemia have been reported in association with local anesthetic use. About half of the patients also took oral medication commonly used in the treatment of post-herpetic neuralgia. 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. Mean lidocaine blood concentrations after three consecutive daily applications of three LIDODERM patches simultaneously for 12 hours per day in healthy volunteers (n = 15). The mean plasma pharmacokinetic profile for the 15 healthy volunteers is shown in Figure 1. 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)
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