A prospective, post-marketing surveillance (PMS) study to monitor the safety of fixed dose combination of Triprolidine Hydrochloride IP 2.5 mg and Phenylephrine Hydrochloride IP 5 mg [Recofast Tablets] for the symptomatic relief in patients with upper respiratory tract infections

Abstract

Upper Respiratory Tract Infection (URTI) is the most frequent illness in humans. The vast majority of acute upper respiratory tract infections are caused by viruses. These cause a variety of patient diseases including acute bronchitis, common cold, influenza, and respiratory distress syndromes.The study was conducted in patients with upper respiratory tract infections to see if the medication provides symptomatic relief in these conditions. Other conditions like allergic rhinitis and influenza were also included in the study for symptomatic relief.This is an open label, multicentric, active Post Marketing Surveillance (PMS) study with an objective to assess safety of fixed dose combination regarding Recofast tablets (Triprolidine Hydrochloride IP 2.5 mg and Phenylephrine Hydrochloride IP 5 mg) which was evaluated in 150 participants from different geographical regions. And then results were documented. A total of 19 (13%) patients recorded minor adverse event from these regions. Out of 150 patients 95 were male & 55 were female. All the patients were in the range of 18-80 years.No significant adverse events were observed during the course of the study, only 13% patients recorded minor adverse events from all regions. Thus this formulation is completely safe and effective in the management of Upper Respiratory Tract Infections and allergies.