Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis.

Limited efficacy data in combination with thiazolidinediones.

Efficacy has not been confirmed in combination with insulin.

CYCLOSET may cause somnolence.

CYCLOSET is contraindicated in:

• Patients with syncopal migraine. Bromocriptine increases the likelihood of a hypotensive episode among patients with syncopal migraine. Loss of consciousness during a migraine may reflect dopamine receptor hypersensitivity. CYCLOSET is a dopamine receptor agonist and may, therefore, potentiate the risk for syncope in these patients
• Women who are nursing their children. CYCLOSET may inhibit lactation. There are postmarketing reports of stroke in this patient population although causality has not been proven

Hypotension, including orthostatic hypotension, can occur, particularly upon initiation of CYCLOSET therapy and with dose escalation.

Reports of hypoglycemia.

In patients with severe psychotic disorders, treatment with a dopamine receptor agonist such as CYCLOSET may exacerbate the disorder or may diminish the effectiveness of drugs used to treat the disorder. Therefore, the use of CYCLOSET in patients with severe psychotic disorders in not recommended.

CYCLOSET is contraindicated in postpartum patients. Serious and life-threatening adverse reactions including hypertension, myocardial infarction, seizures, stroke and psychosis have been reported postmarketing in postpartum women who were administered bromocriptine for inhibition of lactation. These risks may be higher in postpartum patients with cardiovascular disease. The indication for use of bromocriptine for inhibition of postpartum lactation was withdrawn from bromocriptine-containing products and is not approved for CYCLOSET.

Dopamine receptor antagonists, including neuroleptic agents that have dopamine D2 receptor antagonist properties (e.g., clozapine, olanzapine, ziprasidone), may reduce the effectiveness of CYCLOSET, and CYCLOSET may reduce the effectiveness of these agents. CYCLOSET has not been studied in patients taking neuroleptic drugs. The concomitant use of CYCLOSET and dopamine receptor antagonists, including neuroleptic drugs, is not recommended.

Concomitant use of dopamine receptor antagonists, such as neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes), or metoclopramide may diminish the effectiveness of CYCLOSET, and CYCLOSET may diminish the effectiveness of these other therapies. The concurrent use of CYCLOSET with these agents has not been studied in clinical trials and is not recommended.

CYCLOSET in combination with ergot-related drugs may cause an increase in the occurrence of ergot-related side effects, such as nausea, vomiting, and fatigue, and may also reduce the effectiveness of these ergot therapies when used to treat migraine. The concurrent use of these ergot agents within 6 hours of CYCLOSET dosing is not recommended.

CYCLOSET dose should not exceed 1.6 mg once daily during concomitant use of a moderate CYP3A4 inhibitor (e.g., erythromycin).

CYCLOSET is extensively metabolized by the liver via CYP3A4. Therefore, potent inhibitors or inducers of CYP3A4 may increase or reduce the circulating levels of CYCLOSET. 

Avoid concomitant use of CYCLOSET and strong CYP3A4 inhibitors (e.g., azole antimycotics, HIV protease inhibitors) and ensure adequate washout of the strong CYP3A4 inhibitor drug before initiating CYCLOSET treatment.

CYCLOSET may increase the unbound fraction of other concomitantly used highly protein-bound therapies (e.g., salicylates, sulfonamides, chloramphenicol and probenecid), which may alter their effectiveness and risk for side effects.

Concomitant use of CYCLOSET with sympathomimetic drugs for more than 10 days duration is not recommended.

Concomitant use of CYCLOSET with selective 5-hydroxytryptamine1B (5-HT1B) agonists (e.g., sumatriptan) should be avoided.

Studies in pregnant women have not shown that bromocriptine increases the risk of abnormalities when administered during pregnancy.

CYCLOSET is contraindicated in women who are nursing their children.

GoToSource

• Use in patients under the age of 18. GoToSource

• Pituitary adenomas, peripartum cardiomyopathy and anhedonia in depressed patients. GoToSource

• Parkinson’s disease, hyperprolactinemia and acromegaly. GoToSource

• Restless legs syndrome. GoToSource

Psychosis, fibrosis (thickening and scarring of connective tissue) and cardiovascular events (myocardial infarction, stroke). GoToSource

Compulsive behaviors (gambling, hypersexuality, excessive eating and shopping). GoToSource

Hypoglycemia (low blood sugar), orthostatic hypotension (fall in blood pressure when upright position is assumed) and syncope (temporary loss of consciousness). GoToSource

No major injury lawsuits reported.