The Real-World Safety and Effectiveness of Prochlorperazine in Indian Patients with Dizziness.

Background: Considering the prevailing concerns about extrapyramidal symptoms (EPS) associated with oral prochlorperazine, this study was conducted to assess the safety of oral prochlorperazine (in recommended dose/duration) in the management of acute dizziness. Effectiveness was also assessed in the Indian real-world setting. Methods: A prospective, multicentric, single-arm observational study was conducted across 20 centers in India. Data from 500 patients were analyzed. Patients presenting with a complaint of dizziness, receiving prochlorperazine (Stemetil(R) MD-5 mg, t.i.d.) as per the routine clinical practice were enrolled. Safety and effectiveness at Week-1, compared to baseline, were assessed. Results: The mean (SD) age of the population was 43.3 (11.93) years with a marginally higher proportion of women (women: 52.2% Vs men 47.8%). The mean (SD) dose of prochlorperazine was 14.9 (0.24) mg/day. Only three patients (0.006%) reported adverse drug reactions (headache, asthenia, somnolence) during the conduct of the study, which were mild in severity and were completely resolved. Further, a significant reduction in the number of episodes of dizziness was noted at the end of Week-1(p<.0001). Moreover, improvement in the number of episodes from baseline to Week-1 was significant for nausea, vomiting, lightheadedness, and headache. Conclusion: Prochlorperazine was well-tolerated in the management of acute dizziness when administered at a mean dose of 14.9 mg/day, and mean duration of 7.2 days. Additionally, prochlorperazine was effective in providing significant symptomatic relief from dizziness and associated vomiting and nausea.