Safety & Efficacy of a Fixed Dose Combination of Paracetamol (125 mg), Phenylephrine (2.5 mg) and Chlorpheniramine Maleate (1mg) [Flucold Drops] in the Treatment of Common Cold and Flu Syndrome in Children : Postmarketing Surveillance Study

Background :The common cold and flu syndrome primarily affects the upper respiratory tract, along with a low fever and some systemic symptoms such as sore throat, cough, nasal decongestion, headache, and so on. Several clinical studies have shown that combining analgesics, antihistaminics, and decongestants provides better symptom relief in the common cold. The current post-marketing surveillance study was designed to look into the safety and efficacy of commercially available Flucold Drops in the Indian population. Methodology :A current prospective, single arm, multicenter, post-marketing clinical study included 224 subjects, 220 of whom completed the study. All patients were given Flucold Drops for three days and then monitored for the next six days. During the study, the incidence of adverse events (AE) and serious adverse events (SAE) was assessed. The efficacy of the Flucold Drops was evaluated using VAS score changes from the beginning to the end of the treatment. The product’s safety was also evaluated using blood biomarkers such as haemoglobin, platelet count, SGOT, SGPT, and creatinine level. Results : Results show the reduction in symptomatic score of common cold and flu syndrome observed after 2rd follow-up visit (0.202+0.325 to 0.139+0.231). During the study, no intervention-related adverse events were observed. Furthermore, no Serious Adverse Events (SAE) were observed in the study or follow-up period. The study found no changes in the levels of blood biomarkers (haemoglobin, platelets, SGOT, SGPT, and creatinine). Conclusions : Flucold Drops are safe and effective in the treatment of common cold and flu syndrome in Children and infants.

Study of Safety and Efficacy for the Combination of Chlorpheniramine maleate and Phenylephrine in Infants suffering from Allergic Rhinitis and Associated Symptoms

Introduction: The epidemiological data suggest that thereis alarming rise in the prevalence of allergic rhinitis. It oftengoes intractable in small children. A combination of nasaldecongestant and antihistaminic drug is preferred over thevarious aetiologies associated with allergic rhinitis. Studyobjective was to evaluate the efficacy and safety for thecombination of Chlorpheniramine maleate and Phenylephrinein patients of allergic rhinitis and associated symptoms.Material and Methods: Total 215 patients were enrolledout of which 177 patients completed the study and efficacyassessment was made by reduction in TSS and four pointLikert-Type scales. Safety assessment was made by analysingthe adverse events during clinical trial.Results: There was significant reduction in TSS from 5.677(baseline) to 2.711 (day 3) and 0.542 (day 5). At day 3 andday 5 there was reduction of 52.23% and 90.44% as comparedto baseline. Nearly all the patients had > 50% reduction insymptom score at all visits and majority of patients hadcomplete relief from the symptom.Conclusion: A combination of Phenylephrine andChlorpheniramine maleate was found to be efficacious as wellas safe in the treatment of allergic rhinitis.

Efficacy and Safety of a Fixed Dose Combination of Paracetamol, Chlorpheniramine Maleate, Phenylephrine and Caffeine in Treatment of Common Cold: A Phase IV, Open-Labelled, Multi-Centric Study

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. It also leads to reduction in subjective alertness and impaired psychomotor functioning. A combination of Paracetamol as an analgesic, anti-inflammatory and antipyeretic, Chlorpheniramine maleate, an anti-histaminic, and Phenylephrine as a nasal decongestant is popular in the treatment of common cold. Addition of caffeine enhances alertness and psychomotor functioning. 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 262 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 7.67 (day 1) to 3.78 (day 3) and 0.66 (day 5). Most of the patients had >50% reduction in total symptom score at visit 3 and 59.16 % patients had complete relief from the symptoms at the end of study. Out of 262 patients, 46 i.e. 17.56% experienced adverse event. Sedation and drowsiness (12.21%) was the most common adverse event seen in patients. Conclusion: A fixed dose combination of Chlorpheniramine maleate, Paracetamol, Phenylephrine and Caffeine is safe and effective in the treatment of common cold.

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

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.

Rapid determination of 17 anti-inflammatory and analgesic chemicals illegally added into Chinese patent medicine and health foods by UPLC-MS/MS / 中草药

Objective: To estabilsh a rapid and accurate method for the determination of 17 anti-inflammatory and analgesic chemicals (paracetamol, aspirin, phenacetin, chlorpheniramine maleate, rofecoxib, piroxicam, lornoxicam, meloxicam, prednisone acetate, sulindac, naproxen, dexamethasone acetate, phenylbutazone, oxaprozin, celecoxib, diclofenac sodium, and indomethacin) which were illegally added into the Chinese patent medicines (CPM) and the health foods. Methods: The UPLC-MS/MS method was adopted. The samples were extracted with methanol by ultrasonic processing and separated on a Waters Acquity BEH C18 column (100 mm × 2.1 mm, 1.7 μm) with 0.1% formic acid methanol (A) and 0.1% formic acid water (B) as the mobile phase by gradient elution (0-4 min, 40% A; 4-5 min, 40%-50% A; 5-6 min, 50%-60% A; 6-12 min, 60%-80% A; 12-13 min, 80% A; 13-14 min, 80%-40% A) at a flow rate of 0.2 mL/min, and the column temperature was 40℃. A positive-ion (ESI+) source and a MRM mode were used to separately and quantitatively determinate the 17 anti-inflammation and analgesia chemicals. The obtained molecular ions, fragment ions, and retention time for MRM channels were used to identify the 17 chemicals by comparison with those of reference substances. The obtained peak areas were used to determinate the accurate content of chemicals in commonly used drugs in clinic. Results: A good resolution of the 17 chemicals, including paracetamol, aspirin, phenacetin, chlorpheniramine maleate, rofecoxib, piroxicam, lornoxicam, meloxicam, prednisone acetate, sulindac, naproxen, dexamethasone acetate, phenylbutazone, oxaprozin, celecoxib, diclofenac sodium, and indomethacin was obtained under this UPLC and MS/MS condition. The limits of qualitation and quantitation were in the range of 0.3-5.0 and 0.9-15.0 ng/g. The standard addition recoveries were in the range of 90.5%-113.8%. The six components in samples (paracetamol, prednisone acetate, diclofenac sodium, indometacin, chlorpheniramine maleate, and naproxen) were detected. Conclusion: The method is simple, accurate, and has high sensitivity, which can be used for the qualitative and quantitative determination of illegally added chemicals in CPM and health foods.

The Effect of H1-Receptor Antagonist on Hemodynamic Change during Anesthesia / 대한마취과학회지

baseline for safe use of a drug. RESULTS: SVR and PVR failed to show statistically significant changes. Heart rates were increased only at 2 minute after administration of chlorpheniramine maleate. Blood pressures were increased but returned to basal level within 4 minutes. Cardiac output showed statistically significant increase until 8 minutes. However, the changes of hemodynamic values were maintained within 20% of basal levels. CONCLUSIONS: Chlorpheniramine maleate is observed to cause statistically significant hemodynamic change after intravenous administration during anesthesia. But the changes were within 20% of basal levels, and we can safely use chlorpheniramine maleate 8 mg IV in the view of hemodynamic changes.

Effect of azelastine hydrochloride on experimental asthma and its mechanism in guinea pigs / 中国临床药理学与治疗学

AIM: To probe the effect of azelastine hydrochloride on experimental asthma and its mechanism. METHODS: Experimental asthma models of guinea pigs induced by histamine and acetylcholine in vivo as well as guinea pig tracheal spirals in vitro were used in this experiment. RESULTS: Azelastine hydrochloride inhibited asthma induced by histamine and acetylcholine in guinea pigs in a dose dependent manner, prolonged the incubation period of histamine and acetylcholine induced asthma (P

Elaboration of the protocol for dosage of chlorpheniramine maleate in some pharmaceutical products by method of anhydrous excipient

A titration in nonaqueous medium was proposed to determine simultaneously the mixtures of Chlorpheniramine maleat and the other halogen salts (Dextromethorphan HBr and phenylpropanilamin HCl). The first one was assayed for having the equivalent point EP1. For the second halogen salts we added (CH3COO)2 for liberating halogen radicaux and trans forming to base form. This form was recorded the equivalent point EP2.

Determination of three components in Cang'ebiyan Tablets / 中成药

AIM: To establish method of determing baicalin,chlorogenic acid and chlorpheniramine maleate in Cang'ebiyan Tablets(Fructus Xanthii,Herba Cemtipedae,Radix Astragali,Flos Chrysanthemi indici,etc). METHODS: The VP-ODS C_(18) column(4.6 mm?250 mm,5 ?m) was used with a mobile phase of acetonitrile-0.4%H_3PO_4 0-9 min(14∶86),9-20 min(28∶72) gradient elution,the wavelength of detector was set at 0-9 min 327 nm for determining chlorogenic acid content,9-20 min 280 nm for determining baicalin.The VP-ODS C_(18) column(4.6 mm?250 mm,5 ?m) was used with a mobile phase of acetonitrile-0.5% sodium dodecylsulfate-H_3PO_4,the wavelength of detector was set at 262 nm for determining chlorpheniramine maleate. RESULTS: The calibration curves were linear in the range of 0.21-3.14 ?g/mL(r=0.999 9) for baicalin,in the range of(0.05-0.81 ?g/mL)(r=0.999 9) for chlorogenic acid,in the range of 0.10-1.57 ?g/mL(r=0.999 9) for chlorpheniramine maleate,respectively.The average recoveries were 102.44%,RSD=0.57%(n=6);(98.68%,)RSD=0.30%(n=6);99.46%,RSD=0.70%(n=6),respectively. CONCLUSION: The method is simple,realizable and reproducible and can be used effectively for the quality control of Cang'ebiyan Tablets.