World Journal of
Pharmaceutical and Life Sciences

SAFETY AND EFFICACY FOR THE COMBINATION OF PARACETAMOL, PHENYLEPHRINE AND LEVOCETIRIZINE IN PATIENTS OF COMMON COLD AND ALLERGIC RHINITIS: POST MARKETING SURVEILLANCE STUDY

Dr. Mayuresh Kiran, Lalit Pawaskar*, Pramita Waghambare and Shaheen Sheikh

ABSTRACT

Introduction: Common cold and allergic rhinitis are the most commonly encountered diseases in clinical practices. Though it is self-limiting in nature, it causes major loss of school and work days. Single drug therapy is considered to be ineffective to provide complete symptomatic relief so the multiple drug combinations are commonly considered for the treatment. A combination of Paracetamol (anti-inflammatory/ antipyeretic), Phenylephrine (nasal decongestant) and Levocetirizine (anti-histaminic) can be used for the treatment of common cold and allergic rhinitis. This post marketing surveillance study was conducted to evaluate the efficacy and safety for the combination of Paracetamol, Phenylephrine and Levocetirizine in treatment of common cold and allergic rhinitis. Methodology: Out of total 200 enrolled, 188 trial subjects completed the study. Efficacy assessment was done by reduction in total symptom score (TSS) which was extrapolated to four-point Likert type symptom severity scale. Safety assessment was made by analysing the reported adverse events during the study. Results: At baseline the mean TSS was 6.531 which was reduced to 3.345 by 48.778 % as compared to the baseline at day 3 and was further reduced to 0.935 by 85.672 % as compared to the baseline at day 5. In the population of recruited trial subjects, 22 adverse drug reactions (ADR) were reported by 17 trial subjects. All reported ADRs were of expected and non-serious nature. Conclusion: Combination of Paracetamol, Levocetirizine and Phenylephrine was found to be efficient and safe for the symptomatic treatment of common cold and allergic rhinitis.

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