RESUMO
Aim of Study: To evaluate adverse drug reaction (ADR) profile of antimicrobials over 3‑year period. Material and Methods: A retrospective cross‑sectional study was undertaken using suspected adverse drug data collection form available under Pharmacovigilance Programme of India (PvPI). Results: A total of 2,586 ADR events were recorded in 3 years, out of which 392 (15.15%) were because of antimicrobials. Male: female was 1.02:1. Medicine department contributed maximally (98.97%). The intravenous (IV) route of drug administration accounted maximum ADRs (53.32%), followed by oral route (45.41%). Monotherapy was responsible for 80.87%, whereas combination therapy for 19.13%. Combinations therapy was irrational in 79.67%. The most common antibiotic resulting in ADRs was injection ceftriaxone (35.71%), followed by tab. azithromycin (7.39%), tab. ofloxacin + ornidazol (5.35%), ofloxacin (3.57%), ciprofloxacin (2.29%), amoxicillin (2.55%), tab. cefixime (2.29%), inj. linezolid (2.04%). Rash remained the most common ADR, followed by diarrhoea and gastritis. Most common organ system involved was dermatological (47.44%), followed by gastrointestinal (GI) (39.28%), central nervous system (CNS) (5.35%), cardiovascular system (CVS) (3.57%) and renal and genitourinary (1.78%). While 47.96% ADR’s were latent, 26.785% were acute and 25.26% were sub‑acute. Moreover, 89.79% of ADRs were moderate in nature, whereas 26.88% were severe and 3.33% mild in nature. Furthermore, 92.86% were non‑serious and 7.14% serious in nature. Also, 65.06% of antimicrobial caused ADRs were type A and 34.64% were type B reactions. As per World Health Organization‑The Uppsala Monitoring Centre (WHO‑UMC) scale, 73.98% of ADRs were probable/likely and 26.02% as possible. However, 99.47% of ADRs required intervention. Conclusion: The current study suggest that ADRs due to antimicrobials is a significant health problem.
RESUMO
The present study was conducted to assess and compare the cognitive and psychomotor effects of fexofenadine, a newer second generation antihistamine with cetirizine, diphenhydramine and placebo in 10 healthy adult volunteers in a double blind, randomized cross over study. Following single dose of each drug, the volunteers were subjected to perform a series of tests of cognitive and psychomotor performance at 1, 3 and 6 hours post dose. The test battery consisted of both subjective and objective tests which were further grouped into instrumental and non-instrumental. Instrumental tests included – Simple reaction time (SRT), Multiple Choice ReactionTime Task (MCRT) and Critical Flicker Fusion frequency threshold (CFFT). The tests used in the non instrumental group were- Stanford Sleepiness Scale (SSS), Digit Cancellation Task (DCT), Digit Symbol Substitution Task (DSST) and mental arithmetic tests. Fexofenadine at doses of 120 mg was not significantly different from placebo in any of the tests used. However, as expected for a verum, all the measures were significantly disrupted by diphenhydramine 25 mg upto 6 hours post dose. Cetirizine 10 mg has produced significant subjective somnolence at 3 & 6 hours post dose but without any impairment of objective tests. These results allow the conclusion that fexofenadine at its recommended therapeutic dose of 120 mg is free from impairment effects on aspects of psychomotor function and hence can be used safely. Cetirizine is mildly sedating though it did not impair any of the objective psychometric tests.