Efficacy and safety of nifedipine GITS in Chinese patients with hypertension – A post‐marketing surveillance study

2007 ◽  
Vol 16 (sup1) ◽  
pp. 18-23 ◽  
Author(s):  
Yong Huo ◽  
Jian Zhang ◽  
Qing He ◽  
Hong Chen ◽  
Jishun Ma ◽  
...  
Keyword(s):  
Surveillance Study ◽  
Chinese Patients ◽  
Efficacy And Safety ◽  
Post Marketing Surveillance ◽  
Post Marketing

Nifedipine OROS in Chinese patients with hypertension – results of a post‐marketing surveillance study in Taiwan

2005 ◽  
Vol 14 (sup1) ◽  
pp. 32-38 ◽  
Author(s):  
Kwo‐Chang Ueng ◽  
Zhih‐Cheng Chen ◽  
Poh‐Shiow Yeh ◽  
Kuo‐Chun Hung ◽  
Shao‐An Hu ◽  
...  
Keyword(s):  
Surveillance Study ◽  
Chinese Patients ◽  
Post Marketing Surveillance ◽  
Post Marketing

scholarly journals 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

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.

scholarly journals 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

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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