BROMOCRIPTINE MESYLATE TABLETS, USP 2.5 mg
Bromocriptine mesylate, USP is an ergot derivative with potent dopamine receptor agonist activity. Each bromocriptine mesylate tablet for oral administration contains 2.5 mg (as the mesylate) and each bromocriptine mesylate capsule for oral administration contains 5 mg bromocriptine (as the mesylate).
Bromocriptine is indicated for the following:
Bromocriptine mesylate tablets and capsules are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocriptine therapy may be used to reduce the tumor mass prior to surgery.
Bromocriptine mesylate tablet and capsule therapy is indicated in the treatment of acromegaly. Bromocriptine therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately half of patients treated, although not usually to normal levels.
Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with bromocriptine offers potential benefit before the effects of irradiation are manifested.
Bromocriptine mesylate tablets or capsules are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson's disease. As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), bromocriptine therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing "end of dose failure" on levodopa therapy. Bromocriptine therapy may permit a reduction of the maintenance dose of levodopa and, thus may ameliorate the occurrence and/or severity of adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements (e.g., dyskinesias) and the marked swings in motor function ("on-off" phenomenon). Continued efficacy of bromocriptine therapy during treatment of more than 2 years has not been established.
Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson's disease with bromocriptine. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in bromocriptine treated patients than in levodopa/carbidopa treated patients. Patients unresponsive to levodopa are poor candidates for bromocriptine therapy.
Published Studies Related to Bromocriptine
Randomized clinical trial of quick-release bromocriptine among patients with type 2 diabetes on overall safety and cardiovascular outcomes. [2010.07]
CONCLUSIONS: The frequency of SAEs was comparable between the treatment arms. Compared with patients in the placebo arm, fewer patients taking bromocriptine-QR experienced a cardiovascular end point.
Cabergoline versus bromocriptine for symptomatic treatment of premenstrual mastalgia: a randomised, open-label study. [2010.06]
OBJECTIVE: To compare the effectiveness and side effects of cabergoline with bromocriptine for the symptomatic treatment of cyclic mastalgia as a part of the premenstrual syndrome... CONCLUSIONS: Cabergoline is as effective as bromocriptine for the treatment of cyclic mastalgia but has minimal side effects compared to bromocriptine. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.
A comparison of bromocriptine & cabergoline on fertility outcome of hyperprolactinemic infertile women undergoing intrauterine insemination. [2010.05]
BACKGROUND & OBJECTIVES: The aim of this study was to compare the effects of bromocriptine versus cabergoline on pregnancy in hyperprolactinaemic infertile women... CONCLUSION: Our results suggest that cabergoline treatment in infertile women with prolactinemia is more effective. It lowers prolactin with better tolerability and much more effective in the achievement of pregnancy.
Evaluation of bromocriptine in the treatment of acute severe peripartum cardiomyopathy: a proof-of-concept pilot study. [2010.04.06]
CONCLUSIONS: In this trial, the addition of bromocriptine to standard heart failure therapy appeared to improve left ventricular ejection fraction and a composite clinical outcome in women with acute severe PPCM, although the number of patients studied was small and the results cannot be considered definitive. Larger-scale multicenter and blinded studies are in progress to test this strategy more robustly.
Effect of bromocriptine on antipsychotic drug-induced hyperprolactinemia: eight-week randomized, single-blind, placebo-controlled, multicenter study. [2010.02]
AIM: The objective of the present study was to assess the efficacy and safety of bromocriptine treatment for patients with antipsychotic-drug-induced hyperprolactinemia in clinical practice... CONCLUSION: Administration of bromocriptine is a safe method for treating antipsychotic-drug-induced hyperprolactinemia without exacerbating either psychotic symptoms or EPS.
Clinical Trials Related to Bromocriptine
Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy [Recruiting]
This is a randomized, controlled clinical trial to evaluate the efficacy and safety of
bromocriptine for improvement of left ventricular function of women with Peripartum
cardiomyopathy (PPCM). A Multi center trial in Germany.
Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease [Recruiting]
The purpose of this study is to determine whether pramipexole and bromocriptine are
effective in the treatment of non-motor symptoms in Parkinson's Disease.
Comparing Prism Adaptation Therapy and Bromocriptine Medication for Spatial Neglect: Theoretical and Practical Outcomes [Recruiting]
The purpose of this research study is to examine the effects of prism adaptation or
bromocriptine treatment on two visual-spatial recovery components. After a stroke, an
"internal GPS", locating where objects or people lie in a particular area of space, may be
impaired. Alternately, a stroke may impair precise visual-spatial hand and body aiming
movements. The research team wishes to discover whether using prism goggles, or taking a
medication (bromocriptine) affects visual-spatial where or aiming errors selectively after
This research represents one of the first attempts to apply what we know about the brain
from neuroscience research, to modern clinical rehabilitation practices.
QR-Bromocriptine as an Adjunct to Insulin and Metformin in the Treatment of Type 2 Diabetes [Recruiting]
QR-Bromocriptine as an add-on treatment to insulin and metformin in the management of type 2
diabetes will result in improved glycemic control, reduced exogenous insulin requirement,
increased lean fat mass and improved pancreatic beta-cell function.
Risperidone-Induced Hyperprolactinemia Treated With Bromocriptine [Not yet recruiting]
Antipsychotic drugs can cause a clinically relevant hyperprolactinemia due to blocking the
dopamine receptors in the pituitary. Schizophrenic patients suffering from a
neuroleptic-induced hyperprolactinemia will be examined endocrinologically. Adverse drug
effects and diagnoses will be confirmed by measuring hormones.
Page last updated: 2010-10-05