Bromocriptine mesylate (Parlodel) in the management of amenorrhea/galactorrhea associated with hyperprolactinemia.

The efficacy and safety of bromocriptine mesylate (5 to 7.5 mg per day for up to 24 weeks) were studied in 22 clinical trials involving 226 patients who had amenorrhea/galactorrhea associated with hyperprolactinemia and no demonstrable pituitary tumor. Of the 187 patients evaluated for efficacy, 80% experienced reinitiation of menses (or pregnancy without first having menses); the average treatment time (excluding those who conceived) was 5.7 weeks. Galactorrhea was significantly (at least 75%) reduced in 76% of the 187 patients after an average treatment tome of 6.4 weeks, and was completely suppressed in 58% after 12.7 weeks. Maximum reduction in serum prolactin levels occurred within the first 4 weeks of therapy and the reduced levels were maintained during treatment; moreover, there was a strong correlation between prolactin reduction and clinical improvement. Adverse reactions were reported by 68% of the 226 patients evaluated for safety; in general, these reactions were mild and transient. Several patients experienced hypotension, but only 1 discontinued therapy because of it. Based on these findings, bromocriptine mesylate was judged safe and efficacious for this purpose.