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

Introduction: Common cold is frequently occurring medical condition in developing countries like India. Common cold is self-limiting in nature so symptomatic treatment is always suggested. This study was conducted to test the efficacy and safety for the fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 2 mg per tablet for the treatment of common cold. Methodology: Total 180 patients were enrolled out of which 159 completed the study. Efficacy assessment was done by decrease in total symptom score (TSS) of common cold at day 3 and 5 as compared to the baseline (day 1). Safety assessment was made by analyzing the reported adverse events through the study. Results: Mean TSS at baseline was 6.62 which was decreased to 3.55 at day 3 and was further decreased to 0.68 at day 5. Majority of patients had complete relief from the symptoms of common cold and nearly all the patients had >50 % reduction in TSS. Also no unexpected or serious adverse event was found to be reported in the study duration of 5 days. Conclusion: Fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 2 mg per tablet was found to be efficacious and safe for the symptomatic treatment of common cold in Indian patients. Keywords: Common cold, Paracetamol, Chlorpheniramine Maleate and Phenylephrine

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MAINTENANCE OF HOMEOSTASIS – AN OBSERVATIONAL STUDY COMPARING BIPOLAR AND MONOPOLAR TURP

International Journal of Medical Science and Diagnosis Research ◽

10.32553/ijmsdr.v5i7.829 ◽

2021 ◽

Vol 5 (7) ◽

Author(s):

Maurya Rajesh K. ◽

Kumar Vinay ◽

Kumar Vinay

Keyword(s):

Common Cold ◽

Medical Condition ◽

Symptomatic Treatment ◽

Fixed Dose Combination ◽

Fixed Dose ◽

Complete Relief ◽

Chlorpheniramine Maleate ◽

Phenylephrine Hydrochloride ◽

Efficacy Assessment ◽

Dose Combination

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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

International Journal of Medical Science and Diagnosis Research ◽

10.32553/ijmsdr.v5i7.819 ◽

2021 ◽

Vol 5 (7) ◽

Author(s):

Mayuresh Kiran ◽

Lalit Pawaskar ◽

Shaheen Sheikh ◽

Pramita Waghambare

Keyword(s):

Allergic Rhinitis ◽

Common Cold ◽

Symptomatic Treatment ◽

Surveillance Study ◽

Fixed Dose ◽

Multiple Drug ◽

Efficacy And Safety ◽

Chlorpheniramine Maleate ◽

Post Marketing Surveillance ◽

Post Marketing

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.

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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 ◽

10.23958/ijirms/vol06-i07/1159 ◽

2021 ◽

Vol 6 (07) ◽

pp. 430-434

Author(s):

Dr. Mayuresh Kiran ◽

Mr. Lalit Pawaskar ◽

Ms. Shaheen Sheikh ◽

Ms. Pramita Waghambare

Keyword(s):

Common Cold ◽

Sodium Citrate ◽

Symptomatic Treatment ◽

Surveillance Study ◽

Fixed Dose ◽

Daily Routine ◽

Efficacy And Safety ◽

Chlorpheniramine Maleate ◽

Post Marketing Surveillance ◽

Post Marketing

Introduction: Common cold is frequently encountered by people and it also largely affects productivity of the daily routine life. Combination of Paracetamol, Phenylephrine and Chlorpheniramine maleate which acts as an antipyretic, nasal decongestant and anti-histaminic respectively, can be used for the symptomatic treatment of common cold. To the above-mentioned combination, Sodium Citrate was added as an expectorant and Menthol for cooling effect and this post marketing surveillance study was conducted to test the efficacy and safety for the symptomatic treatment of common cold. Methodology: Out of 200 enrolled, 174 patients completed the study. Safety assessment was made by analysing the adverse events reported by the patient or their guardian. Efficacy was evaluated by total symptom score [TSS] (eleven-point scale ranging from 0 to 10 where 0 is no symptom to 10 is the maximum symptoms) which was extrapolated to four-point Likert-type symptom severity scales. Results: TSS was reduced from 5.57 at baseline visit to 3.40 at day 3 to 1.69 at day 5. At day 3 and day 5 there was TSS reduction of 38.865 % and 69.690 % respectively as compared to baseline. 18 episodes of adverse drug reactions were reported and all of them were of expected and non-serious nature. Conclusion: Fixed-dose combination of Paracetamol 125mg, Phenylephrine 5mg, Chlorpheniramine Maleate 1mg, Sodium Citrate 60mg and mentholated flavoured syrupy base q.s. per 5ml was found to be safe and efficacious for the treatment of common cold in children of age between 2 to 12 years.

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Efficacy and safety of a fixed dose combination of paracetamol, chlorpheniramine maleate and phenylephrine in treatment of common cold: a phase IV, open-labelled, multi-centric study

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20185123 ◽

2018 ◽

Vol 8 (1) ◽

pp. 34 ◽

Cited By ~ 1

Author(s):

Mayuresh D. Kiran ◽

Monali P. Vakharia ◽

Lalit J. Pawaskar ◽

Shaheen N. Sheikh

Keyword(s):

Adverse Events ◽

Common Cold ◽

Fixed Dose Combination ◽

Fixed Dose ◽

Low Grade ◽

Efficacy And Safety ◽

Chlorpheniramine Maleate ◽

Multicentric Study ◽

Dose Combination ◽

Phase Iv

Background: Acute coryza or common cold affects the upper airways, sometimes in association with low-grade fever and systemic symptoms, and usually presents with at least two of the following symptoms: cough, dysphonia, throat discomfort, sore throat, nasal congestion, rhinorrhoea, sneezing, headaches, myalgia and fever. A triple combination of analgesics, decongestants and antihistamines provides better relief for multiple symptoms in common cold and allergic rhinitis according to various studies. A combination of Paracetamol as an analgesic, anti-inflammatory and antipyretic, Chlorpheniramine maleate, an anti-histaminic and Phenylephrine as a nasal decongestant is popular in the treatment of common cold. Hence the present study was planned to evaluate efficacy and safety of this combination in treatment of common cold.Methods: This was a phase IV, open-labelled, multicentric study in 159 patients. Efficacy assessment was done by analyzing the reduction in mean TSS at each follow-up visit and safety assessment was done by analyzing the adverse events during the study.Results: There was reduction in mean TSS from 6.62 (day 1) to 3.56 (day 3) and 0.69 (day 5). Most of the patients had >50% reduction in total symptom score at visit 3 and 58.49% patients had complete relief from the symptoms at the end of study. Out of 159 patients, 26 i.e. 16.36% experienced adverse events. Sedation and drowsiness (6.29%) were the most common adverse event seen in patients.Conclusions: A fixed dose combination of Chlorpheniramine maleate, Paracetamol, and Phenylephrine is safe and effective in the treatment of common cold.

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