Efficacy and safety of paracetamol, phenylephrine, chlorpheniramine maleate and sodium citrate in Indian paediatric patients with common cold: an active post-marketing surveillance study

Authors

  • Mayuresh D. Kiran Medical Services and Pharmacovigilance, Centaur Pharmaceuticals Pvt Ltd., Mumbai, Maharashtra, India
  • Lalit J. Pawaskar Pharmacovigilance and Biomedical Research, Centaur Pharmaceuticals Pvt Ltd., Mumbai, Maharashtra, India
  • Pramita D. Waghambare Pharmacovigilance and Biomedical Research, Centaur Pharmaceuticals Pvt Ltd., Mumbai, Maharashtra, India
  • Aakansha V. Singh Medical Services, Centaur Pharmaceuticals Pvt Ltd., Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20241594

Keywords:

Paracetamol, Phenylephrine, Chlorpheniramine maleate, Sodium citrate, Common cold

Abstract

Background: The common cold, mainly caused by viruses, brings discomfort to children with symptoms like sneezing, congestion, runny nose, and sore throat. As no specific antiviral treatments are available to relieve common cold symptoms, it is typically managed using decongestants, antihistamines, and antipyretics. This study aims to assess the safety and efficacy of a fixed-dose combination (FDC) of paracetamol, phenylephrine, chlorpheniramine maleate and sodium citrate in children aged 2 to 12 years with common cold.

Methods: This non-randomized, open-label, non-comparative, active post-marketing surveillance (PMS) study was conducted across multiple centres in India, involving 417 patients. The study assessed efficacy using the total symptom score (TSS) scale over 5 days with visits on days 1, 3, and 5. Safety was evaluated based on adverse events reported by patients on days 3 and 5 of the trial.

Results: Initially, 417 patients were enrolled in the active PMS, of which 309 completed the study. The mean TSS showed a notable decrease from 8.95 at visit 1 to 0.19 at visit 3, depicting a significant reduction i.e., 97.90% as compared to baseline. At visit 1, most patients (95.79%) exhibited severe symptoms, whereas by visit 3, 83.82% were symptom-free, with only 16.18% experiencing mild symptoms.

Conclusions: This active PMS study examined the safety and efficacy of an FDC of paracetamol, phenylephrine, chlorpheniramine maleate and sodium citrate in treating common cold in children in India. The findings indicate a significant reduction in symptoms, with many patients becoming symptom-free by the third visit, demonstrating its efficacy and safety.

Metrics

Metrics Loading ...

References

Allan GM, Arroll B. Prevention and treatment of the common cold: making sense of the evidence. CMAJ. 2014;186(3):190-9.

Geppe NA, Zaplatnikov AL, Kondyurina EG, Chepurnaya MM, Kolosova NG. The Common Cold and Influenza in Children: To Treat or Not to Treat? Microorganisms. 2023;11(4):858.

Abdallah NA, Fathy ME, Tolba MM, El-Brashy AM, Ibrahim FA. A quality-by-design eco-friendly UV-HPLC method for the determination of four drugs used to treat symptoms of common cold and COVID-19. Scientific Reports. 2023;13(1):1616.

Mammari N, Albert Q, Devocelle M, Kenda M, Kočevar Glavač N, Sollner Dolenc M, et al. Natural products for the prevention and treatment of common cold and viral respiratory infections. Pharmaceuticals. 2023;16(5):662.

Gelotte CK, Albrecht HH, Hynson J, Gallagher V. A multicenter, randomized, placebo‐controlled study of pseudoephedrine for the temporary relief of nasal congestion in children with the common cold. J Clin Pharmacol. 2019;59(12):1573-83.

Troullos E, Baird L, Jayawardena S. Common cold symptoms in children: results of an Internet-based surveillance program. J Med Internet Res. 2014;16(6):e2868.

Hasan MM, Saha KK, Yunus RM, Alam K. Prevalence of acute respiratory infections among children in India: Regional inequalities and risk factors. Maternal Child Health J. 2022;26(7):1594-602.

Wardani RS, Schellack N, Govender T, Dhulap AN, Utami P, Malve V, Wong YC. Treatment of the common cold with herbs used in Ayurveda and Jamu: monograph review and the science of ginger, liquorice, turmeric and peppermint. Drugs in Context. 2023;2:12.

Woo T. Pharmacology of cough and cold medicines. J Pediatr Heal Care. 2008;22(2):73-9.

DeGeorge KC, Ring DJ, Dalrymple SN. Treatment of the common cold. Ame Family Physician. 2019;100(5):281-9.

Picon PD, Costa MB, da Veiga Picon R, Fendt LC, Suksteris ML, Saccilotto IC, Dornelles AD, Schmidt LF. Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial. BMC Infect Dis. 2013;13(1):1-8.

Eccles R, Fietze I, Rose UB. Rationale for treatment of common cold and flu with multi-ingredient combination products for multi-symptom relief in adults. Open J Respiratory Dis. 2014;4(03):73.

Document entitled “fixed dose combinations approved by DCG (I) since 1961 to 31st December 2019” available on the regulatory agency. Available at: https://cdsco.gov.in/opencms/opencms/en/Approval_new/FDC-New-Drugs-Marketing/. Accessed on 25 April, 2024.

Salisbury-Afshar E. Oral antihistamine/decongestant/ analgesic combinations for the common cold. Am Family Physician. 2012;86(9):812-3.

Kiran M, Pawaskar L, George S. efficacy and safety for a combination of paracetamol, chlorpheniramine maleate, phenylephrine, sodium citrate and menthol in the symptomatic treatment of common cold and allergic rhinitis: phase iv clinical study. Int J Curr Med Pharm Res. 2017;3(5):1804-8.

Kiran M, Pawaskar L, Waghambare P, Sheikh S. 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. Int J Innovative Res Med Sci. 2021;6(07):430-34.

Downloads

Published

2024-06-03

How to Cite

Kiran, M. D., Pawaskar, L. J., Waghambare, P. D., & Singh, A. V. (2024). Efficacy and safety of paracetamol, phenylephrine, chlorpheniramine maleate and sodium citrate in Indian paediatric patients with common cold: an active post-marketing surveillance study. International Journal of Basic & Clinical Pharmacology, 13(4), 469–474. https://doi.org/10.18203/2319-2003.ijbcp20241594

Issue

Section

Original Research Articles