Safety and Effectiveness of Penles® Tape 18 mg (Lidocaine) for Pain Relief in Skin Laser Treatment (Drug Use-results Survey)

Abstract

We conducted a drug use-results survey of Penles® Tape 18 mg, a patch formulation containing lidocaine 18 mg, for pain relief in skin laser treatment and collected case report forms of 304 cases. Five adverse drug reactions occurred in four patients (1.43%) of 280 patients in the safety population, all of which were non-serious. The effectiveness measured by the pain level at the time of laser irradiation to the skin evaluated by physicians was 80.6% (241/299 cases). The above results confirmed the safety and effectiveness of Penles® Tape 18 mg for pain relief in skin laser treatment.