Skip to Content

Bromocriptine

Medically reviewed by Drugs.com. Last updated on Jul 17, 2020.

Pronunciation

(broe moe KRIP teen)

Index Terms

  • Bromocriptine Mesylate
  • Cycloset

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Parlodel: 5 mg

Generic: 5 mg

Tablet, Oral:

Cycloset: 0.8 mg

Parlodel: 2.5 mg [scored]

Generic: 2.5 mg

Brand Names: U.S.

  • Cycloset
  • Parlodel

Pharmacologic Category

  • Anti-Parkinson Agent, Dopamine Agonist
  • Antidiabetic Agent, Dopamine Agonist
  • Ergot Derivative

Pharmacology

Semisynthetic ergot alkaloid derivative and a sympatholytic dopamine D2 receptor agonist which activates postsynaptic dopamine receptors in the tuberoinfundibular (inhibiting pituitary prolactin secretion) and nigrostriatal pathways (enhancing coordinated motor control).

In the treatment of type 2 diabetes mellitus, the mechanism of action is unknown; however, bromocriptine is believed to affect circadian rhythms which are mediated, in part, by dopaminergic activity, and are believed to play a role in obesity and insulin resistance. It is postulated that bromocriptine (when administered during the morning and released into the systemic circulation in a rapid, 'pulse-like' dose) may reset hypothalamic circadian activities which have been altered by obesity, thereby resulting in the reversal of insulin resistance and decreases in glucose production, without increasing serum insulin concentrations (Gaziano 2010; Pijl 2000).

Distribution

Vd: ~61L

Metabolism

Primarily hepatic via CYP3A; extensive first-pass biotransformation (Cycloset: ~93%)

Excretion

Feces (~82%); urine (2% to 6%)

Time to Peak

Serum: Cycloset: 53 minutes; Parlodel: 2.5 ± 2 hours

Duration of Action

8 to12 hours

Half-Life Elimination

Cycloset: ~6 hours; Parlodel: 4.85 hours

Protein Binding

90% to 96% (primarily albumin)

Special Populations: Hepatic Function Impairment

Plasma levels may increase with hepatic impairment.

Use: Labeled Indications

Diabetes mellitus, type 2 (Cycloset only): To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise

Hyperprolactinemia (excluding Cycloset): Treatment of prolactin-secreting pituitary adenoma or disorders associated with hyperprolactinemia including amenorrhea with or without galactorrhea, hypogonadism, or infertility

Parkinson disease (excluding Cycloset): Treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson disease; as adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor)

Off Label Uses

Neuroleptic malignant syndrome

Data from a limited number of patients studied (case reports) suggest that bromocriptine may be beneficial for the treatment of neuroleptic malignant syndrome [Rosenberg 1989], [Strawn 2007]. Additional data may be necessary to further define the role of bromocriptine in this condition.

Contraindications

Hypersensitivity to bromocriptine, ergot alkaloids, or any component of the formulation.

Additional product-specific contraindications:

Cycloset: Syncopal migraine; postpartum patients; lactating patients.

Parlodel: Uncontrolled hypertension; pregnancy (risk to benefit evaluation must be performed in women who become pregnant during treatment for acromegaly, prolactinoma, or Parkinson disease - hypertension during treatment should generally result in efforts to withdraw); postpartum women with a history of coronary artery disease or other severe cardiovascular conditions (unless withdrawal of medication is medically contraindicated).

Dosing: Adult

Diabetes mellitus, type 2 (Cycloset only): Oral: Note: Agents other than bromocriptine are recommended for treatment of patients with type 2 diabetes mellitus (ADA 2020).

Initial: 0.8 mg once daily in the morning; may increase at weekly intervals in 0.8 mg increments as tolerated; usual dose: 1.6 to 4.8 mg once daily (maximum: 4.8 mg/day).

Hyperprolactinemia: Oral: Initial: 1.25 to 2.5 mg daily; may be increased by 2.5 mg daily as tolerated every 2 to 7 days until optimal response (range: 2.5 to 15 mg/day).

Parkinsonism: Oral: 1.25 mg twice daily, increased by 2.5 mg daily in 2- to 4-week intervals as needed (maximum: 100 mg/day).

Neuroleptic malignant syndrome (off-label use): Oral: 2.5 mg (orally or via gastric tube) every 8 to 12 hours, increased to a maximum of 45 mg daily, if needed; continue therapy until NMS is controlled, then taper slowly (Gortney 2009; Strawn 2007).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Hyperprolactinemia secondary to pituitary adenoma:

Children and Adolescents <16 years: Limited data available in age <11 years: Oral: Initial: 1.25 to 2.5 mg daily; dosage may be increased as tolerated to achieve a therapeutic response; usual effective range: 5 to 7.5 mg/day in divided doses; maximum daily dose: 10 mg/day (Fideleff 2009; Gillam 2004)

Adolescents ≥16 years: Oral: Initial: 1.25 to 2.5 mg daily; may be increased by 2.5 mg daily as tolerated every 2 to 7 days until optimal response; usual effective range: 5 to 7.5 mg/day in divided doses; maximum daily dose: 15 mg/day (Fideleff 2009; Gillam 2004)

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Administration

Administer with food to decrease GI distress.

Cycloset: Administer within 2 hours of waking in the morning. If the morning dose is missed, wait until the next morning and resume with the usual dose.

Dietary Considerations

Administer with food to decrease GI distress.

Storage

Store at 20°C to 25°C (68°F to 77°F).

Drug Interactions

Abametapir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Alcohol (Ethyl): Bromocriptine may enhance the adverse/toxic effect of Alcohol (Ethyl). Alcohol (Ethyl) may enhance the adverse/toxic effect of Bromocriptine. Monitor therapy

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Alizapride: May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Avoid combination

Alpha-/Beta-Agonists: Ergot Derivatives may enhance the hypertensive effect of Alpha-/Beta-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Avoid combination

Alpha1-Agonists: Ergot Derivatives may enhance the hypertensive effect of Alpha1-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha1-Agonists. Avoid combination

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Amisulpride (Injection): May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Avoid combination

Amisulpride (Oral): Anti-Parkinson Agents (Dopamine Agonist) may diminish the therapeutic effect of Amisulpride (Oral). Amisulpride (Oral) may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Avoid combination

Androgens: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Exceptions: Danazol. Monitor therapy

Antihepaciviral Combination Products: May increase the serum concentration of Ergot Derivatives. Avoid combination

Antipsychotic Agents (First Generation [Typical]): Anti-Parkinson Agents (Dopamine Agonist) may diminish the therapeutic effect of Antipsychotic Agents (First Generation [Typical]). Antipsychotic Agents (First Generation [Typical]) may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Management: Avoid concomitant therapy if possible. If antipsychotic use is necessary, consider using atypical antipsychotics such as clozapine, quetiapine, or ziprasidone at lower initial doses, or a non-dopamine antagonist (eg, pimavanserin). Exceptions: Methotrimeprazine. Consider therapy modification

Antipsychotic Agents (Second Generation [Atypical]): May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Management: Consider avoiding atypical antipsychotic use in patients with Parkinson disease. If an atypical antipsychotic is necessary, consider using clozapine, quetiapine, or ziprasidone at lower initial doses, or a non-dopamine antagonist (eg, pimavanserin). Consider therapy modification

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Beta-Blockers: May enhance the vasoconstricting effect of Ergot Derivatives. Management: Avoid coadministration of beta-blockers and ergot derivatives whenever possible. If concomitant use cannot be avoided, monitor patients closely for evidence of excessive peripheral vasoconstriction. Consider therapy modification

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Brivudine [INT]: May enhance the adverse/toxic effect of Anti-Parkinson Agents (Dopamine Agonist). Specifically, the risk of chorea may be increased. Monitor therapy

Bromopride: May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Monitor therapy

Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Avoid combination

BuPROPion: Anti-Parkinson Agents (Dopamine Agonist) may enhance the adverse/toxic effect of BuPROPion. Monitor therapy

Chloroprocaine: May enhance the hypertensive effect of Ergot Derivatives. Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

CYP3A4 Inducers (Strong): May decrease the serum concentration of Bromocriptine. Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Bromocriptine. Management: The bromocriptine dose should not exceed 1.6 mg daily with use of a moderate CYP3A4 inhibitor. The Cycloset brand specifically recommends this dose limitation, but other bromocriptine products do not make such specific recommendations. Consider therapy modification

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Bromocriptine. Management: Consider alternatives to the use of bromocriptine with strong CYP3A4 inhibitors. If combined, monitor closely for increased bromocriptine toxicities and consider bromocriptine dose reductions. Exceptions: Nefazodone. Consider therapy modification

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Diethylstilbestrol: May enhance the adverse/toxic effect of Bromocriptine. Specifically, the risk for amenorrhea may be increased with the combination. Monitor therapy

Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Monitor therapy

Lisuride: May enhance the adverse/toxic effect of Ergot Derivatives. Avoid combination

Lorcaserin (Withdrawn From US Market): May enhance the adverse/toxic effect of Ergot Derivatives. Specifically, use of these drugs together may increase the risk of developing valvular heart disease. Lorcaserin (Withdrawn From US Market) may enhance the serotonergic effect of Ergot Derivatives. This could result in serotonin syndrome. Avoid combination

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Macrolide Antibiotics: May increase the serum concentration of Ergot Derivatives. Cabergoline and Clarithromycin may interact, see specific monograph for full details. Exceptions: Azithromycin (Systemic); Fidaxomicin; Spiramycin. Avoid combination

Maitake: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Methotrimeprazine: Anti-Parkinson Agents (Dopamine Agonist) may diminish the therapeutic effect of Methotrimeprazine. Methotrimeprazine may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Avoid combination

Methylphenidate: May enhance the adverse/toxic effect of Anti-Parkinson Agents (Dopamine Agonist). Monitor therapy

Metoclopramide: May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Avoid combination

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nefazodone: Ergot Derivatives may enhance the serotonergic effect of Nefazodone. This could result in serotonin syndrome. Nefazodone may increase the serum concentration of Ergot Derivatives. Avoid combination

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nitroglycerin: Ergot Derivatives may diminish the vasodilatory effect of Nitroglycerin. This is of particular concern in patients being treated for angina. Nitroglycerin may increase the serum concentration of Ergot Derivatives. Avoid combination

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Protease Inhibitors: May increase the serum concentration of Ergot Derivatives. Avoid combination

Prothionamide: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Quinolones: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Reboxetine: May enhance the hypertensive effect of Ergot Derivatives. Monitor therapy

Ritodrine: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Roxithromycin: May increase the serum concentration of Ergot Derivatives. Avoid combination

Salicylates: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Serotonergic Agents (High Risk): Ergot Derivatives may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) when these agents are combined. Exceptions: Nefazodone. Monitor therapy

Serotonin 5-HT1D Receptor Agonists (Triptans): May enhance the vasoconstricting effect of Ergot Derivatives. Ergot Derivatives may enhance the vasoconstricting effect of Serotonin 5-HT1D Receptor Agonists (Triptans). Avoid combination

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Solriamfetol: May enhance the adverse/toxic effect of Anti-Parkinson Agents (Dopamine Agonist). Monitor therapy

Somatostatin Analogs: May increase the serum concentration of Bromocriptine. Somatostatin Analogs may also delay bromocriptine absorption and time to maximum plasma concentrations. Monitor therapy

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Sulpiride: May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Avoid combination

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Adverse Reactions

Note: Frequency of adverse effects may vary by dose and/or indication.

>10%:

Gastrointestinal: Constipation (11% to 14%), nausea (18% to 33%)

Nervous system: Dizziness (≤13%), headache (≤13%)

Neuromuscular & skeletal: Asthenia (13%)

Respiratory: Rhinitis (14%)

1% to 10%:

Cardiovascular: Orthostatic hypotension (6%), Raynaud's disease (<2%), syncope (<2%), vasospasm (digital: 3%)

Endocrine & metabolic: Hypoglycemia (4%)

Gastrointestinal: Abdominal cramps, abdominal distress, anorexia (4% to 5%), diarrhea (9%), dyspepsia (4% to 8%), gastrointestinal hemorrhage (<2%), vomiting (2% to 6%), xerostomia (≤4%)

Infection: Infection (6%)

Nervous system: Drowsiness (3%)

Ophthalmic: Amblyopia (8%)

Respiratory: Nasal congestion (≤4%), sinusitis (10%)

<1%:

Cardiovascular: Bradycardia, cardiac arrhythmia, vasodepressor syncope, ventricular tachycardia

Dermatologic: Alopecia, pallor

Nervous system: Cold intolerance, delusion, heavy headedness, insomnia, lassitude, lethargy, paranoid ideation, paresthesia, sleep disorder, tingling of the ears, visual hallucination

Neuromuscular & skeletal: Muscle cramps

Respiratory: Dyspnea

Frequency not defined:

Cardiovascular: Erythromelalgia, hypotension

Dermatologic: Skin mottling, skin rash

Genitourinary: Urinary frequency, urinary incontinence, urinary retention

Nervous system: Ataxia, auditory hallucination, confusion, depression, epileptiform seizure, fatigue, involuntary body movements, nervousness, nightmares, numbness, on-off phenomenon, sudden onset of sleep, vertigo

Ophthalmic: Blepharospasm, visual disturbance

Postmarketing:

Cardiovascular: Acquired valvular heart disease, cold extremity, constrictive pericarditis, pericardial effusion, pericarditis, peripheral edema, tachycardia

Dermatologic: Allergic skin reaction, pale extremities (fingers and toes)

Endocrine & metabolic: Increased libido

Gastrointestinal: Abdominal pain, dysphagia, gastrointestinal ulcer

Genitourinary: Retroperitoneal fibrosis

Nervous system: Anxiety, atypical sexual behavior, dyskinesia, impulsivity, neuroleptic malignant syndrome (syndrome-like symptoms), pathological gambling, psychomotor agitation, psychosis

Neuromuscular & skeletal: Dyskinesia, lower limb cramp

Ophthalmic: Blurred vision

Otic: Tinnitus

Respiratory: Pleural effusion, pleurisy, pleuropulmonary fibrosis, pulmonary fibrosis, rhinorrhea (cerebrospinal fluid, hyperprolactinemic indications)

Warnings/Precautions

Concerns related to adverse effects:

• Cardiac valvular fibrosis: Ergot alkaloids and derivatives have been associated with fibrotic valve thickening (eg, aortic, mitral, tricuspid); usually associated with long-term, chronic use.

• Cardiovascular effects: Hypotension, including orthostatic hypotension and syncope, may occur, particularly upon initiation of therapy and dose escalation. In addition, hypertension, seizures, MI, and stroke have been reported. Severe headache or visual changes may precede events. The onset of reactions may be immediate or delayed (often may occur in the second week of therapy). Discontinue therapy and evaluate promptly if hypertension, severe, progressive, or unremitting headache (with or without visual disturbance), or evidence of CNS toxicity develops. In a scientific statement from the American Heart Association, bromocriptine has been determined to be an agent that may cause direct myocardial toxicity (magnitude: major) (AHA [Page 2016]).

• CNS depression: May cause CNS depression, which may impair physical or mental abilities, and episodes of sudden sleep onset particularly in patients with Parkinson disease; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving). Consider dosage reduction or discontinuation of therapy if symptoms occur.

• Hallucinations: Visual or auditory hallucinations may occur when administered alone or concomitantly with levodopa; dose reductions or discontinuation may be necessary. Symptoms may persist for several weeks following discontinuation.

• Impulse control disorders: Dopamine agonists used for Parkinson disease or restless legs syndrome have been associated with compulsive behaviors and/or loss of impulse control, which has manifested as new or increased gambling urges, sexual urges, uncontrolled spending, or other intense urges. Dose reduction or discontinuation of therapy reverses these behaviors in some, but not all cases.

• Melanoma: Risk for melanoma development is increased in Parkinson disease patients; drug causation or factors contributing to risk have not been established. Monitor all patients closely for melanoma and perform periodic skin examinations.

• Pleural/retroperitoneal fibrosis: Cases of pleural and pericardial effusions, as well as pleural, pulmonary, and/or retroperitoneal fibrosis and constrictive pericarditis have been reported with prolonged and high-dose daily use. Discontinue therapy if fibrotic changes are suspected.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (myocardial infarction; residual atrial, nodal, or ventricular arrhythmia).

• Dementia: Use with caution in patients with dementia; high doses may be associated with confusion and mental disturbances.

• Galactose intolerance/malabsorption (Parlodel): Avoid use in patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.

• Hepatic impairment: Use with caution in patients with hepatic impairment; dosage adjustment may be necessary due to extensive hepatic metabolism.

• Macroadenomas: Discontinuation of therapy in patients with macroadenomas has been associated with rapid regrowth of tumor and increased prolactin serum levels.

• Peptic ulcer disease: Use with caution in patients with peptic ulcer disease; severe gastrointestinal bleeding has been reported (some fatal).

• Prolactin-secreting adenomas: Cerebrospinal fluid rhinorrhea has been observed in some of these patients.

• Psychosis: Use with caution in patients with psychosis; dopamine agonists may exacerbate the disorder or diminish the effectiveness of drugs used to treat the disorder. Use in patients with severe psychotic disorder is not recommended.

Special populations:

Postpartum patients: Adverse events, such as hypertension, myocardial infarction, psychosis, seizures, and stroke have been reported in postpartum patients; these reactions can be severe and life threatening. Risk may be increased in patients with cardiovascular disease. Use is contraindicated in the postpartum period in patients with a history of coronary artery disease or other severe cardiovascular conditions (unless withdrawal of medication is medically contraindicated).

Dosage form specific issues:

• Interchangeability (Cycloset): Due to a difference in the formulation and resulting pharmacokinetics of Cycloset ("quick-release" tablet) compared to other formulations of bromocriptine, interchangeability with any other bromocriptine product is not recommended in the setting of type 2 diabetes mellitus management.

Other warnings/precautions:

Appropriate use (Cycloset): Not indicated for use in type 1 diabetes mellitus or diabetic ketoacidosis.

• Discontinuation of therapy: Dopaminergic agents have been associated with a syndrome resembling neuroleptic malignant syndrome on abrupt withdrawal or significant dosage reduction after long-term use; gradual dosage reduction is recommended when discontinuing therapy.

• Visual monitoring: Monitoring and careful evaluation of visual changes during the treatment of hyperprolactinemia is recommended to differentiate between tumor shrinkage and traction on the optic chiasm; rapidly progressing visual field loss requires neurosurgical consultation.

Monitoring Parameters

Blood pressure and heart rate (orthostatic vital signs; baseline and periodically thereafter); hepatic, renal, hematopoietic, and cardiovascular function (periodically); visual fields (prolactinoma; periodic); pregnancy test during amenorrheic period; prolactin levels; GI bleeding (patients with history of peptic ulcer); melanoma skin examinations (regular assessment)

Diabetes mellitus, type 2: Serum glucose and HbA1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2020])

Reproductive Considerations

Females with hyperprolactinemia may be infertile, have amenorrhea and galactorrhea. During treatment with bromocriptine, fertility may occur prior to restoration of menses in infertile women, therefore, a pregnancy test is recommended every 4 weeks during the amenorrheic period. Once menses resume, pregnancy tests should be done any time a menstrual period is missed. Women not seeking pregnancy should be advised to use appropriate contraception. A mechanical contraceptive should be used during therapy until normal ovulatory menses is established. Contraception can then be discontinued if pregnancy is desired.

Bromocriptine is approved for the treatment of prolactin-secreting pituitary adenomas (prolactinomas) and may be the preferred dopamine agonist for females planning a pregnancy due to its shorter half-life in comparison to other recommended agents. Early fetal exposure may occur prior to pregnancy detection (Glezer 2020).

Pregnancy Risk Factor

B

Pregnancy Considerations

Bromocriptine crosses the placenta (Endocrine Society [Melmed 2011]).

Data collected from women taking bromocriptine during pregnancy suggest the incidence of birth defects is not increased with use. However, the majority of women discontinued use within 8 weeks of pregnancy.

Bromocriptine is approved for the treatment of prolactin-secreting pituitary adenomas (prolactinomas). Bromocriptine should be discontinued once pregnancy is confirmed unless needed for treatment of a rapidly expanding macroadenoma; treatment can be continued in patients with symptomatic growth. Monitoring of prolactin levels should be suspended during pregnancy (Endocrine Society [Melmed 2011]; Glezer 2020). If treatment is withdrawn, monitor for signs and symptoms of an enlarging prolactin secreting tumor.

The incidence of Parkinson disease in pregnancy is relatively rare. Information related to the use of bromocriptine in pregnant patients is limited for this indication and other agents may be preferred (Olivola 2020; Young 2020).

Bromocriptine has been evaluated for the adjunctive treatment of peripartum cardiomyopathy (ESC [Bauersachs 2016]), although use for this purpose remains controversial and additional studies may be needed (Sliwa 2017).

Regardless of indication, if bromocriptine is needed, monitor closely for hypertensive disorders during pregnancy and immediately postpartum.

Patient Education

What is this drug used for?

• It is used to treat acromegaly.

• It is used to treat high prolactin levels.

• It is used to treat Parkinson's disease.

• It is used to treat some prolactin-secreting tumors.

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

• It may be given for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach

• Throwing up

• Constipation

• Feeling sleepy, tired, or weak

• Trouble sleeping

• Stuffy nose

• Runny nose

• Diarrhea

• Not hungry

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight

• Low blood sugar like dizziness, headache, feeling tired, feeling weak, shaking, fast heartbeat, confusion, increased hunger, or sweating

• Severe dizziness

• Passing out

• Vision changes

• Mood changes

• Behavioral changes

• Chest pain

• Trouble controlling body movements that is new or worse

• Severe headache

• Shortness of breath

• Excessive weight gain

• Swelling of arms or legs

• Strong urges that are hard to control like eating, gambling, sex, or spending money

• Falling asleep during activities such as eating or talking

• Back pain

• Black, tarry, or bloody stools

• Seizures

• Throwing up blood

• Severe stomach pain

• Sensing things that seem real but are not

• Unable to pass urine

• Change in amount of urine passed

• Confusion

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.