Acta Scientific Paediatrics (ASPE)

Research Article Volume 7 Issue 6

Post-Marketing Surveillance to Establish the Safety and Efficacy of Maxtra®P Syrup in the Symptomatic Treatment of Common Cold in the Indian Pediatric Population

Bhupesh Dewan*, Sanjaykumar Navale, Siddheshwar Shinde and Janaki Chaudhary

Zuventus Healthcare Limited, Mumbai, Maharashtra, India

*Corresponding Author: Bhupesh Dewan, Zuventus Healthcare Limited, Mumbai, Maharashtra, India.

Received: May 08, 2024; Published: May 26, 2024

Abstract

The common cold ranks as the most frequently encountered respiratory illness in pediatric medical practice. Although not considered serious, the common cold is widespread and can be debilitating, leading to school absenteeism, disturbed sleep, reduced food intake, and interference with daily routines. It impacts not only a child’s general well-being but also family life as it may require parents to stay home to care for sick children. The main goals of common cold management are the reduction of symptom duration and severity. Effective treatments for common cold include over-the-counter analgesics, nasal saline irrigation, decongestants, and with or without antihistamines. Aims. To evaluate the safety and symptomatic efficacy of a fixed dose combination of Paracetamol 125mg, Phenylephrine 5mg, and Chlorpheniramine maleate 1mg per 5 ml (Maxtra®P) syrup in Indian children with common cold. Method. This active post-marketing surveillance study was carried out from February 2021 to November 2022. A total number of 200 children with common cold were prescribed Maxtra®P syrup for patients of age 6 to 18 years for 5 days. Safety assessment was done by analysing adverse events during the trial and assessment of treatment response. Efficacy assessment was based on a reduction in the severity of symptoms and the number of patients achieving complete remission at the end of the study. Results. Out of 200 children, 93% achieved complete relief from common cold symptoms on day 5. At the end of the study, symptoms such as sneezing, headache, hoarseness, wheezing, difficulty in breathing, and malaise completely disappeared in all children. A statistically significant reduction (p < 0.0001) in symptom score was observed for all the symptoms from baseline to day 5. Maxtra®P syrup was well-tolerated and the results suggest no new safety concerns. Mild adverse events such as drowsiness and dizziness were reported in two children. Patients and investigators rated Maxtra®P syrup treatment as ‘good’ and ‘excellent’ in providing symptomatic relief in 94% and 96.5% of children respectively, suggesting a positive global response to treatment. Conclusion. Maxtra®P syrup was found to be well tolerated and efficacious in the symptomatic relief of the common cold in the Indian pediatric population

Keywords: Chlorpheniramine Maleate; Common Cold; Maxtra®P syrup; Paracetamol; Phenylephrine

References

  1. Pappas Diane E. “The Common Cold”. Principles and Practice of Pediatric Infectious Diseases (2018): 199-202.e1.
  2. Geppe Natalia A., et al. "The Common Cold and Influenza in Children: To Treat or Not to Treat?” Microorganisms4 (2023): 858.
  3. DeGeorge Katharine C., et al. "Treatment of the Common Cold”. American Family Physician5 (2019): 281-289.
  4. Eccles Ron Ingo Fietze and Uwe-Bernd Rose. "Rationale for treatment of common cold and flu with multi-ingredient combination products for multi-symptom relief in adults”. Open Journal of Respiratory Diseases03 (2014): 73-82.
  5. Allan G Michael and Bruce Arroll. “Prevention and treatment of the common cold: making sense of the evidence”. CMAJ: Canadian Medical Association Journal = Journal de l'Association Medicale Canadienne3 (2014): 190-199.
  6. Schot MJC., et al. "Burden of disease in children with respiratory tract infections in primary care: diary-based cohort study”. Family Practice6 (2019): 723-729.
  7. Sutter AIM., et al. "Antihistamines for the common cold”. The Cochrane Database of Systematic Reviews 3 (2003): CD001267.
  8. Picon Paulo Dornelles., et al. "Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial”. BMC Infectious Diseases 13 (2013): 556.
  9. De Sutter AN I M., et al. "Oral antihistamine-decongestant-analgesic combinations for the common cold”. The Cochrane Database of Systematic Reviews 2 (2012): CD004976.
  10. Hellgren J., et al. "Allergic rhinitis and the common cold--high cost to society”. Allergy6 (2010): 776-783.
  11. Nichol K L., et al. "Burden of upper respiratory illnesses among college and university students: 2002-2003 and 2003-2004 cohorts”. Vaccine 24 (2006): 44-46.
  12. De Sutter An Im., et al. "Oral antihistamine-decongestant-analgesic combinations for the common cold”. The Cochrane Database of Systematic Reviews1 (2022): CD004976.
  13. Alomar Muaed., et al. "Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future”. Therapeutic Advances in Drug Safety 11 (2020): 2042098620938595.
  14. Kiran M., et al. "An open-labeled, multicentric, post-marketing surveillance (PMS) to substantiate the safety and efficacy of sinarest syrup in patients of common cold”. World Journal of Pharmaceutical Research7 (2017): 1559-1569.
  15. Kiran Mayuresh., et al. "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”. World Journal of Pharmaceutical Research8 (2021): 1504-1513.
  16. Kiran Mayuresh., et al. "Post-Marketing Surveillance Study to Substantiate the Efficacy and Safety for the Combination of Paracetamol, Phenylephrine, Chlorpheniramine Maleate, Sodium Citrate and Menthol in Indian Patients of Common Cold”. International Journal of Innovative Research in Medical Science (IJIRMS)07 (2021): 430-434.
  17. Kiran M Pawaskar L., et al. "An open-labeled, multicentric, post-marketing surveillance (pms) to substantiate the safety and efficacy of sinarest levo syrup in patients of common cold and allergic rhinitis”. European Journal of Pharmaceutical and Medical Research8 (2017): 535-538.
  18. Kiran Mayuresh., et al. "Efficacy and safety for the combination of paracetamol, phenylephrine and chlorpheniramine maleate in Indian pediatric patients of common cold and allergic rhinitis-post-marketing surveillance study”. International Journal of Medical Science and Diagnosis Research (IJMSDR)7 (2021) :01-07.
  19. Krishnaprasad K., et al. "Health outcome and safety assessment of a fixed dose combination of Amantadine, Paracetamol, Chlorpheniramine maleate, and Phenylephrine introduction in India: A prescription event monitoring study”. Perspectives in Clinical Research2 (2012): 62-65. doi:10.4103/2229-3485.96447.
  20. Kumar Pankaj., et al. "A Prospective, Interventional, Multicentre, Post-marketing Clinical Study of a fixed-dose combination of Paracetamol (125 mg), Phenylephrine HCL (5 mg), Chlorpheniramine Maleate (1 mg) and Sodium Citrate (60 mg/5 mL) for the Treatment of Common Cold and Flu Syndrome in Children”. Journal of Indian Medical Association 10 (2022): 71-75.

Citation

Citation: Bhupesh Dewan., et al. “Post-Marketing Surveillance to Establish the Safety and Efficacy of Maxtra®P Syrup in the Symptomatic Treatment of Common Cold in the Indian Pediatric Population".Acta Scientific Paediatrics 7.6 (2024): 13-20.

Copyright

Copyright: © 2024 Bhupesh Dewan., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.




Metrics

Acceptance rate32%
Acceptance to publication20-30 days

Indexed In




News and Events


  • Certification for Review
    Acta Scientific certifies the Editors/reviewers for their review done towards the assigned articles of the respective journals.
  • Submission Timeline for Upcoming Issue
    The last date for submission of articles for regular Issues is July 30, 2024.
  • Publication Certificate
    Authors will be issued a "Publication Certificate" as a mark of appreciation for publishing their work.
  • Best Article of the Issue
    The Editors will elect one Best Article after each issue release. The authors of this article will be provided with a certificate of "Best Article of the Issue"
  • Welcoming Article Submission
    Acta Scientific delightfully welcomes active researchers for submission of articles towards the upcoming issue of respective journals.

Contact US