Abstract

POST-MARKETING SURVEILLANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY FOR THE COMBINATION OF PARACETAMOL, PHENYLEPHRINE AND CHLORPHENIRAMINE MALEATE IN PAEDIATRIC PATIENTS OF COMMON COLD

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

Abstract

Introduction: Common cold is one of the most frequently occurring disease in clinical practices. Common cold is self-recovering in nature so symptomatic treatment is often accepted. A combination of an antipyretic (Paracetamol), nasal decongestant (Phenylephrine) and antihistaminic (Chlorpheniramine Maleate) with Sodium Citrate as expectorant and Menthol for cooling effects can be used for the symptomatic treatment of common cold. This post marketing surveillance (PMS) study was conducted to evaluate the efficacy and safety for the combination of Paracetamol, Phenylephrine, Chlorpheniramine maleate, Sodium Citrate and Menthol for the treatment of common cold. Methodology: Of 200 enrolled, 182 patients completed the study. Efficacy assessment was made by reduction in total symptom score (TSS) and then was further extrapolated to four-point Likert-type symptom severity scale. Safety assessment was done by analysing the adverse events during the study. Results: At baseline visit, the mean TSS was 5.703 which was reduced to 3.335 at day 3 and was further reduced to 0.802 at day 5. At day 3 and 5, reduction in the mean TSS as compared to the baseline was 41.522% and 85.934% respectively. During the study only 6 adverse drug reactions were reported and all of them were of non-serious nature. Conclusion: The fixed dose combination of Paracetamol 250mg, Phenylephrine 2mg, Chlorpheniramine Maleate 2mg, Sodium Citrate 60mg and Menthol 1mg per 5ml was found to be efficacious and safe for the symptomatic treatment of common cold In the Indian patients of age 2 to 12 years.

Keywords: Paracetamol, Phenylephrine, Chlorpheniramine Maleate, Common cold.