Rupatadine 10mg tablets

BackgroundOral H1-antihistamines (OAHs) are among the most frequently used medications for the treatment of allergic rhinitis (AR).ObjectiveTo perform a systematic review and network meta-analysis comparing the efficacy and safety of individual OAHs in patients with AR.MethodsWe searched 4 electronic bibliographic databases and 3 clinical trial databases for randomized controlled trials assessing adults with perennial or seasonal AR, and comparing (1) OAH versus placebo or (2) different individual OAHs. We performed a network meta-analysis on the Total Nasal Symptom Score, Total Ocular Symptom Score, Rhinoconjunctivitis Quality-of-Life Questionnaire, development of adverse events, and withdrawals due to adverse events. Certainty of evidence for comparisons involving the most clinically relevant second-generation OAHs was assessed using Grading of Recommendations, Assessment and Evaluation approach to network meta-analysis.ResultsWe included 74 randomized controlled trials (21 on perennial AR and 53 on seasonal AR). Cetirizine, ebastine, bilastine, and rupatadine were among the individual medications associated with the highest efficacy for improving nasal symptoms. For other efficacy outcomes, the most efficacious interventions varied. A similar frequency of adverse events was observed among different individual second-generation OAHs, with serious adverse events being rare. For most comparisons, the certainty of evidence was rated as "low" or "very low," indicating substantial uncertainty regarding the treatment effects.ConclusionsAlthough some OAHs seem to be more efficacious than others, most of the differences between individual second-generation medications are trivial or small. In addition, we did not find any relevant differences in the safety profiles of second-generation OAHs.

Abstract licence: CC BY

This systematic review and meta-analysis aimed to compare the efficacy and safety of olopatadine and rupatadine in the treatment of allergic rhinitis (AR). By synthesizing data from randomized controlled trials (RCTs), this study aimed to evaluate symptom reduction, specifically in terms of the Total Nasal Symptom Score (TNSS), and assess the incidence of adverse effects between these two second-generation antihistamines. A comprehensive literature search was conducted in PubMed, Google Scholar, Web of Science, Embase, and Cochrane databases from November 2024 to February 2025. Studies were selected based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Clinical trials comparing olopatadine and rupatadine in AR patients were included, with a focus on TNSS reduction and adverse event incidence. The Jadad scale was used for quality assessment. Data were analyzed using the DerSimonian and Laird random effects model, with mean differences and risk ratios (RR) calculated. Heterogeneity was assessed using the chi-square test and I² statistic. A total of four RCTs involving 304 patients (153 in the olopatadine group, 151 in the rupatadine group) met the inclusion criteria. Olopatadine demonstrated superior TNSS reduction (mean difference: 2.51; 95% CI: 1.58 to 3.44; p<0.0001), with low heterogeneity (I²=0%). Adverse events were comparable between groups (RR=0.66; 95% CI: 0.29-1.50; P=0.33), with dry mouth, headache, and mild sedation being the most frequently reported. Olopatadine showed greater efficacy in reducing symptoms of allergic rhinitis compared to rupatadine, while both drugs had similar safety profiles. These findings suggest that olopatadine may be preferred for more symptom relief, though larger trials are needed for further validation.

Abstract licence: CC BY

Introduction Rupatadine is a marketed second generation antihistamine, with anti-PAF activity, indicated for symptomatic treatment of allergic rhinitis and urticaria. This study was conducted to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of rupatadine in healthy Japanese subjects after single and multiple oral doses. Methods In this randomised, double-blind, placebo-controlled study, 27 male and female healthy Japanese subjects were administered single and multiple escalating rupatadine dose of 10, 20 and 40 mg or placebo. Blood samples were collected at different time points for PK measurements and subjects were assessed for safety and tolerability. The effect of rupatadine on cognitive functioning was evaluated by means of computerized cognitive tests: rapid visual information processing (RVP), reaction time (RT), spatial working memory (SWM) and visual analogue scales (VAS). Results Exposure to rupatadine as measured by Cmax and AUC was found to increase in a dose dependent manner over the dose range of 10–40 mg for both single and multiple dose administration. The safety assessments showed that all treatment related side effects were of mild intensity and there were no serious adverse events (SAEs) or withdrawals due to treatment–emergent adverse events (TEAEs) in this study. The therapeutic dose of rupatadine did not show any CNS impairment in any of the cognitive tests. Conclusions This study demonstrated that rupatadine is safe and well tolerated by Japanese healthy subjects. The PK-PD profile confirmed previous experience with rupatadine.

Abstract licence: CC BY 4.0