Bromocriptine

What it is used for

Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate tablets are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine mesylate tablets 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 mesylate tablets therapy may be used to reduce the tumor mass prior to surgery. Acromegaly Bromocriptine mesylate tablets therapy is indicated in the treatment of acromegaly.

Bromocriptine mesylate tablets therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately ½ 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 mesylate tablets offers potential benefit before the effects of irradiation are manifested.

Parkinson's Disease Bromocriptine mesylate tablets 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 mesylate tablets 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 mesylate tablets 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 mesylate tablets 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 mesylate tablets. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in bromocriptine mesylate-treated patients than in levodopa/carbidopa-treated patients.

Patients unresponsive to levodopa are poor candidates for bromocriptine mesylate tablets therapy.

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Cardiac Valvulopathy and Pericardial Fibrosis
• Pleural, Pulmonary, and Retroperitoneal Fibrosis
• Hypotension/Orthostatic Hypotension
• Risks with Use of bromocriptine mesylate for Postpartum Lactation Inhibition or Suppression
• Impulse Control Disorders and Compulsive Behaviors
• Falling Asleep During Activities of Daily Living
• Visual Impairment in Patients with Prolactin-secreting Adenomas
• Exacerbation of Psychosis in Patients with Severe Psychotic Disorders
• Risks in Patients with Hereditary Problems of Galactose Intolerance, Severe Lactase Deficiency, or Glucose-Galactose Malabsorption
• Additional Clinically Significant Adverse Reactions and Risks in Patients with Acromegaly
• Additional Clinically Significant Adverse Reactions and Risks in Patients with Idiopathic Parkinson's Disease or Postencephalitic Parkinsonism

Who should not take it

Bromocriptine mesylate capsules are contraindicated in patients with:

• History of cardiac valvular disorders or a history of pericardial fibrosis.
• History of pleural, pulmonary, or retroperitoneal fibrotic disorders.
• Uncontrolled hypertension.
• Hypersensitivity to bromocriptine or to any of the excipients of bromocriptine mesylate capsules or sensitivity to other ergot alkaloids.

Other medicines and interactions

Alcohol

Alcohol may potentiate bromocriptine mesylate -associated adverse reactions.

Dopamine Antagonists

The concomitant use of bromocriptine mesylate with dopamine antagonists resulted in a decreased efficacy of bromocriptine mesylate.

Strong and Moderate CYP3A4 Inhibitors

Avoid concomitant use of bromocriptine mesylate with strong CYP3A4 inhibitors. Follow the recommended bromocriptine mesylate dosage modifications during concomitant use with moderate CYP3A4 inhibitors.

Bromocriptine is a substrate of CYP3A4. Concomitant use with strong and moderate CYP3A4 inhibitors increases bromocriptine exposure, which may increase the risk of bromocriptine mesylate-associated adverse reactions.

Ergot Alkaloids

Concomitant use of bromocriptine mesylate with other ergot alkaloids is not recommended. If use is unavoidable, dosage reduction may be necessary in those cases where high dosages of bromocriptine mesylate are being used (such as patients with Parkinson's disease).