Objectives:Allergic rhinitis (AR) is a global health problem. Almost 10%–25% of population worldwide is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor antagonists, and intranasal corticosteroids are the pillars in the management of AR. The combination therapy of montelukast with antihistaminic provides enhancing and complimentary effects, thereby reducing the symptoms effectively, but there are scanty data regarding the comparisons of combinations. Therefore, we aimed to compare the efficacy, safety, and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine combination in patients of AR.Materials and Methods:Seventy patients with AR participated in a prospective, randomized, double-blind, parallel, active-controlled, comparative 4-week trial. The patients between the age group of 18–65 years of either gender having moderate-severe intermittent or mild persistent AR were included in the study. The study inclusion criteria required the patients with total nasal symptom score (TNSS) of 5 or higher. The patients were randomly divided into two treatment groups with montelukast-levocetirizine (10 mg and 5 mg) in one group and montelukast-fexofenadine (10 mg and 120 mg) in another group. TNSS parameter was the main effectiveness parameter.Results:Evaluation of TNSS revealed significant difference (P < 0.05) when compared from baseline to 4th week in both groups. The mean change of TNSS, i.e., 9.46 was significant (P < 0.05) in montelukast-fexofenadine group. The cost-effectiveness ratio was less in montelukast-levocetirizine group than in montelukast-fexofenadine group.Conclusion:The decrease in TNSS was more in montelukast-fexofenadine group, but the cost-effectiveness is more with montelukast-levocetirizine combination.

Background: Package inserts are the authentic source of information for the new molecules in the market. Incomplete and incorrect product information may promote irrational prescribing and may have serious consequences. Hence, our aim was to analyse and compare the information supplied in the package insert according to the section 6.2 and section 6.3 of schedule D of Drugs and Cosmetic Act, 1940 in public (government) and private (non-government) sector. Methods: Package inserts of allopathic drugs which were supplied by government from drug store of tertiary care centre and hospital and from pharmacies on request were collected. A total of 270 package inserts in English were collected that is 38 from government hospital and 232 from the pharmacies nearby the hospital. The package inserts were analysed for the presentation of completeness of the information as per section 6.2 and 6.3. Results: The presentation of information on analysing 233 package inserts (28 government and 205 non government) was not uniform and it was difficult to locate and retrieve information easily due to lack of common layout and heading. Moreover, the package inserts were of variable shape and size with different font size which made it inconvenient for analysing as well as for reference. Posology and method of administration was incomplete in 3% package insert in non- government cases whereas in government supply it was 7%. Use of drug in pregnancy and lactation was deficient in 11% and 14% packages inserts of non-government sources and government sources respectively. Instructions for use were lacking in 25% and 29% package inserts of government and non-government sources respectively. Conclusions: The need of the hour is to further refine contents of the circulated package inserts to make them complete, reliable and up to date. This can be a step forward for ethical and effective dissemination of healthcare services in our growing society. [Int J Basic Clin Pharmacol 2013; 2(2.000): 165-169

Objective:To compare efficacy, safety and cost-effectiveness of rupatadine and olopatadine in patients of chronic spontaneous urticaria.Materials and Methods:A 6-week, single-centered, randomized, double blind, parallel group comparative clinical study was conducted on patients with chronic spontaneous urticaria. Following inclusion and exclusion criteria, 60 patients were recruited and were randomized to two treatment groups and received the respective drugs for 6 weeks. At follow-up, parameters assessed were mean total symptom score (MTSS) calculated by adding the mean number of wheals (MNW) and the mean pruritus score (MPS), number of wheals, size of wheal, scale for interference of wheals with sleep (SIWS).Results:Both the drugs significantly reduced the MTSS, number of wheals, size of wheal, scale for interference of wheals with sleep, but olopatadine was found to be superior. In olopatadine group, there was significantly higher reduction in MTSS (p = 0.01), Number of wheals (P < 0.05), Size of wheals (p < 0.05), Scale for intensity of erythema (p < 0.05) and change in eosinopils count (p = 0.015) than that of rupatadine. Incidence of adverse effects was found to be less in olopatadine group when compared with rupatadine group. Cost effectiveness ratio was less in olopatadine group as compared to rupatadine group throughout the treatment.Conclusions:Olopatadine is a better choice in chronic spontaneous urticaria in comparison to rupatadine due to its better efficacy, safety and cost effectiveness profile.

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