EFFICACY AND SAFETY FOR THE COMBINATION OF PARACETAMOL, PHENYLEPHRINE AND CHLORPHENIRAMINE MALEATE IN INDIAN PAEDIATRIC PATIENTS OF COMMON COLD AND ALLERGIC RHINITIS- POST-MARKETING SURVEILLANCE STUDY
Introduction: Common cold is Self-recovering respiratory diseases which can be caused by viral infection. As till date there is no treatment for the common cold and it is self-limiting in nature, symptomatic treatment is the only option. Symptomatic treatment of common cold with a single drug is not efficacious as compared to the multiple drug combination. Combination of antipyretic (Paracetamol), nasal decongestant (Phenylephrine) and anti-histaminic agent (Chlorpheniramine Maleate) can be used for the symptomatic treatment of common cold. This post marketing surveillance study was conducted to test the efficacy and safety for the fixed dose combination of Paracetamol 125mg, Phenylephrine Hydrochloride 2.5mg and Chlorpheniramine Maleate 1mg per ml in Indian patients of age 1 to 12 months.
Methodology: Out of 200 enrolled, 164 patients completed the study. Efficacy was evaluated by total symptom score (TSS) ranging from 0 to 10 where 0 was no symptom to 10 was the maximum tolerated symptoms. TSS was further extrapolated to four-point-Likert-type-symptom-severity-scale. Safety assessment was done by evaluation of adverse events reported by the patient.
Results: TSS was reduced from 5.91 on day 1 to 3.57 on day 3 and 1.47 on day 5. At day 3 and day 5 the percentage reduction in the TSS as compared to the baseline was 39.48 and 75.05 respectively. During the study only 8 episodes of ADRs were reported including sedation and drowsiness.
Conclusion: Combination of Paracetamol, Phenylephrine and Chlorpheniramine Maleate was found to be efficacious and safe for the treatment of common cold and allergic rhinitis.
Keywords: Paracetamol, Phenylephrine, Chlorpheniramine Maleate, Common Cold, Allergic Rhinitis.
Copyright (c) 2021 International Journal of Medical Science And Diagnosis Research
This work is licensed under a Creative Commons Attribution 4.0 International License.