The aim of the study was to find out drug related problems with a special focus on ADRs during Tolvaptan administration and also to assess the change in serum (Na+) levels, improvement in physical and mental functioning of patients before and after Tolvaptan administration. A total of 74 patients prescribed with Tolvaptan were selected during the study period and their data relevant to the study was collected which includes urine sodium, serum sodium, serum osmolarity, urine osmolarity, liver function test, renal function test, was collected. 12 –item short-form (SF-12) General Health Survey Questions and Glasgow coma scale were used for mental and physical functioning assessment after drug entry. Adverse event that occurred includes Thirst (21 patients), Dry mouth (7 patients), and Hyperkalemia (7 patients) and all events was confirmed using Naranjo probability ADR scale in which causality for majority of adverse event was probable (5-9). Out of 74, 15 patients who were admitted directly to the intensive care unit (ICU), 14 patients (93.3%) were shifted within 3days of treatment with Tolvaptan to the ward and remaining one was shifted on day 5. The primary efficacy outcome in the study was change in average serum sodium concentration baseline to day 3, 5, and 7. The patient on Tolvaptan exhibited a highly significant improvement in serum sodium from base line to 7th day. The effect of Tolvaptan on SF12 General Health Survey was examined and a remarkable increase in Physical Component Score (PCS) and Mental Component Score (MCS) was found after treatment. The vasopressin receptor antagonist, Tolvaptan was superior in raising and maintaining serum sodium (Na+) in patients with hyponatremia with minimal side effects and can be safely administered without any major concerns at a dose of 15mg OD for 7 days
Remya Reghu, PC, S., Das, A. R., M, N. C., Joseph, T., K, A. Kumar, Venugopal, A., P, S. T., and P., Gkumar K., “A study on safety and efficacy of tolvaptan in hyponatremic patients with urinary sodium loss.”, International Journal of Pharmaceutical Sciences Review and Research , vol. 38, no. 1, pp. 115-119, 2016.