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® 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.