Pinimenthol ointment in patients suffering from upper respiratory tract infections – A post-marketing observational study

In order to gain further experience regarding the tolerability of Pinimenthol^® ointment¹ in adolescents (⩾12 years) and adults suffering from upper respiratory tract infections, a post-marketing observational study was performed. In this study, data of 3060 patients were collected (64.9% prospectively over an individual observation period of 5–14 days, 35.1% retrospectively). The prospective documentation also comprised data concerning treatment effects.Sample size of the post-marketing observational study was calculated in the way that adverse drug reactions with an event probability of at least 1:1000 would occur within the study at least once with a probability of 95%.Most patients suffered from cold, acute or chronic bronchitis, bronchial catarrh or hoarseness. Pinimenthol^® ointment was prescribed to inunction (29.6%), inhalation (17.3%) or inunction and inhalation (53.1%), respectively. The mean duration of study participation was 8.0±3.4 days.The tolerability was rated as excellent or good by 96.7% of physicians and 95.7% of patients. A total of 22 patients (0.7%) reported adverse drug reactions which mostly affected the skin or mucus membrane and therefore correspond to the expected adverse effects profile of Pinimenthol^® ointment. The treatment effect was mostly judged as excellent or good (physicians: 88.3%; patients: 88.1%).In conclusion, the study confirms Pinimenthol^® ointment as a well tolerated therapy option for upper respiratory tract infections in both adolescents and adults.