BROMOCRIPTINE SUMMARY
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:
Hyperprolactinemia-Associated Dysfunctions
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.
Acromegaly
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.
Parkinson's Disease
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.
|
NEWS HIGHLIGHTS
Published Studies Related to Bromocriptine
Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects. [2009.03]
AIMS: To assess the sleepiness induced by pramipexole, a D2/D3-dopamine receptor agonist commonly used in Parkinson's disease and restless legs syndrome, without the problem of the confounding factors related to the disease... CONCLUSIONS: These results show that a single oral dose of pramipexole induces sleepiness as assessed by MSLT in healthy young subjects, independent of disease-related sleep dysfunction.
Clinical efficacy of novel unidirectional buccoadhesive vs. vaginoadhesive bromocriptine mesylate discs for treating pathologic hyperprolactinemia. [2008.11]
OBJECTIVE: To test the clinical effectiveness of new bioadhesive unidirectional buccal and vaginal bromocriptine methylate discs in hyperprolactinemic patients... Buccoadhesive discs have the advantages of being gender nonspecific (i.e., could be used by men), avoiding manipulating the vagina, which could be inconvenient to some patients, such as virgins; not being dependent on cyclic estrogen (E) levels; and could be easily used during menstruation.
The effects of bromocriptine on attention deficits after traumatic brain injury: a placebo-controlled pilot study. [2008.02]
OBJECTIVE: To evaluate the effects of bromocriptine on a variety of aspects of attention, ranging from laboratory-based impairment measures to caregiver ratings and work productivity, in individuals after traumatic brain injury... CONCLUSIONS: Bromocriptine in a dose of 5 mg, given twice a day to individuals with attentional complaints after TBI, does not seem to enhance attentional skills, and it may be associated with an excess of adverse events. It is not clear whether intermittent dosing or lower doses might confer benefit.
Role of bromocriptine and pyridoxine in premenstrual tension syndrome. [2007.10]
Premenstrual syndrome (PMS) is a universal problem of women of reproductive age group... It is concluded that both the drugs are effective for treatment of premenstrual syndrome but, pyridoxine showed significantly higher response rate and lesser incidence of side effects than bromocriptine.
Low intensity laser therapy is comparable to bromocriptine-evening primrose oil for the treatment of cyclical mastalgia in Egyptian females. [2007.09]
One of the successful treatments for cyclical mastalgia is bromocriptine evening primrose combination. A double blind study was applied on 80 patients with cyclical mastalgia... In conclusion, LILT is recommended as a new treatment modality for cyclical mastalgia.
Clinical Trials Related to Bromocriptine
Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy [Not yet recruiting]
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.
Randomized Single-Blind Placebo Controlled Comparative Trial of Pramipexole and Bromocriptine in Parkinson's Disease. [Completed]
The objective of the trial was to investigate the efficacy and safety of Pramipexole tablets
in patients with Parkinson's disease (who can be treated with L-DOPA concomitantly) in a
double-blind, comparative method using Bromocriptine tablets as comparators (phase III
comparative trial).
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
stroke.
This research represents one of the first attempts to apply what we know about the brain
from neuroscience research, to modern clinical rehabilitation practices.
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.
The Therapeutic Effect of Bromocriptin in Patients With Primary Aldosteronism [Recruiting]
we propose that bromocriptine may be an alternative treatment of primary aldosteronism, both
APA and BAH.
|
|
|
|
Page last updated: 2009-10-20
|
