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The safety of DOSTINEX Tablets has been evaluated in more than 900 patients with hyperprolactinemic disordersMost adverse events were mild or moderate in severity.
Following single oral doses of 0.5 mg to 1.5 mg given to 12 healthy adult volunteersmean peak plasma levels of 30 to 70 picogramspgmL of cabergoline were observed within 2 to 3 hoursOver the 0.5-to-7 mg dose rangecabergoline plasma levels appeared to be dose-proportional in 12 healthy adult volunteers and nine adult parkinsonian patientsA repeat-dose study in 12 healthy volunteers suggests that steady-state levels following a once-weekly dosing schedule are expected to be twofold to threefold higher than after a single doseThe absolute bioavailability of cabergoline is unknownA significant fraction of the administered dose undergoes a first-pass effectThe elimination half-life of cabergoline estimated from urinary data of 12 healthy subjects ranged between 63 to 69 hoursThe prolonged prolactin-lowering effect of cabergoline may be related to its slow elimination and long half-life.
Consumers and health professionals are advised that Pfizer Australiain consultation with the TGAhas initiated a recall for product correction of cabergoline 0.5 mg tabletsmarketed as Dostinexand cabergoline 1 mg and 2 mg tabletsmarketed as Cabaser
In the 8-weekdouble-blind period of the comparative trial with bromocriptinecabergoline n=223bromocriptine n=236 in the intent-to-treat analysisprolactin was normalized in 77of the patients treated with Dostinex at 0.5 mg twice weekly compared with 59of those treated with bromocriptine at 2.5 mg twice dailyRestoration of menses occurred in 77of the women treated with Dostinexcompared with 70of those treated with bromocriptineAmong patients with galactorrheathis symptom disappeared in 73of those treated with Dostinex compared with 56of those treated with bromocriptine.
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