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Bromocriptine: Pediatric drug information

Bromocriptine: Pediatric drug information
(For additional information see "Bromocriptine: Drug information" and see "Bromocriptine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Cycloset;
  • Parlodel
Therapeutic Category
  • Anti-Parkinson's Agent, Dopamine Agonist;
  • Antidiabetic Agent, Dopamine Agonist;
  • Antidiabetic Agent, Oral;
  • Ergot Derivative
Dosing: Pediatric

Note: Bromocriptine is available as a regular-release tablet or capsule (eg, Parlodel) and a quick-release tablet (Cycloset); they are not interchangeable due to differences in the formulations and resulting pharmacokinetics. All pediatric dosing based on the regular-release tablet or capsule (eg, Parlodel); the quick-release tablet (Cycloset) is only approved for use in adults for treatment of type 2 diabetes mellitus.

Hyperprolactinemia secondary to pituitary adenoma

Hyperprolactinemia secondary to pituitary adenoma:

Children and Adolescents: Limited data available in ages 7 to 11 years; very limited data in ages <7 years: Regular-release tablet/capsule (eg, Parlodel): Oral: Initial: 1.25 to 2.5 mg once daily, usually administered at bedtime; dosage may be increased in 1.25 mg increments every 3 to 7 days as tolerated to achieve a therapeutic response; in older adolescents (≥16 years), doses may be titrated sooner at every 2 days. Usual reported effective range: 5 to 7.5 mg/day in 1 to 3 divided doses; usual maximum daily dose: 15 mg/day, although some (~30%) patients may require doses up to 20 to 30 mg/day. Usual duration of therapy is 2 years; may consider tapering dose with possible discontinuation if prolactin levels are normal and MRI shows no evidence of tumor (Ref).

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

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, adjustment may be necessary due to extensive metabolism; use with caution.

Dosing: Adult

(For additional information see "Bromocriptine: Drug information")

Diabetes mellitus, type 2, treatment

Diabetes mellitus, type 2, treatment (alternative agent) (Cycloset only):

Note: Agents other than bromocriptine are recommended for treatment of patients with type 2 diabetes mellitus (Ref).

Oral: Initial: 0.8 mg once daily in the morning. If additional glycemic control is needed, may increase dose in 0.8 mg increments at weekly intervals as tolerated; usual dose: 1.6 to 4.8 mg once daily (maximum: 4.8 mg/day).

Hyperprolactinemic disorders

Hyperprolactinemic disorders (alternative to cabergoline) (excluding Cycloset):

Oral: Initial: 1.25 to 2.5 mg once daily; may increase dose by 2.5 mg/day every 2 to 7 days as tolerated, if needed based on serum prolactin levels (range: 2.5 to 15 mg/day administered in 1 or 2 divided doses) (Ref). Note: In patients with persistently elevated serum prolactin levels despite maximally tolerated dosage, consider switching to cabergoline (Ref).

Duration of therapy: Treatment for ≥2 years has been recommended to reduce the risk of recurrence. Ensure that prolactin levels are normal and there is no visible tumor on MRI (in patients with prolactinoma) prior to tapering and discontinuing (Ref).

Neuroleptic malignant syndrome, moderate to severe

Neuroleptic malignant syndrome, moderate to severe (excluding Cycloset) (off-label use):

Note: Consider for use in combination with supportive care, benzodiazepines, and/or dantrolene in patients with moderate to severe symptoms at presentation (eg, hyperthermia, evidence of rhabdomyolysis) and for those not responding to initial withdrawal of medication and supportive care (Ref).

Oral or via NG tube: Initial: 2.5 mg every 6 to 12 hours; if needed, may increase to a maximum of 45 mg/day. After the patient is stabilized and symptoms have resolved, consider taper over days to weeks rather than abrupt discontinuation (Ref).

Parkinson disease

Parkinson disease (alternative agent) (excluding Cycloset):

Note: Agents other than bromocriptine are recommended for treatment of patients with Parkinson disease (Ref).

Oral: 1.25 mg twice daily, increased by 2.5 mg daily in 2- to 4-week intervals as needed (maximum: 100 mg/day). Note: The European Medicines Agency has suggested a maximum dose of 30 mg/day to reduce the risk of cardiac fibrosis (Ref).

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

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, adjustment may be necessary due to extensive hepatic metabolism; use with caution.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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)

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 patients who become pregnant during treatment - hypertension during treatment should generally result in efforts to withdraw); postpartum patients with a history of coronary artery disease or other severe cardiovascular conditions (unless withdrawal of medication is medically contraindicated).

Canadian labeling: Additional contraindications (not in US labeling): Uncontrolled hypertension of pregnancy; history of toxemia of pregnancy.

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). 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).

• Hallucinations: Visual or auditory hallucinations may occur when administered alone or concomitantly with levodopa; 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.

• 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.

• 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.

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. Apathy, anxiety, depression, fatigue, insomnia, pain, and sweating have occurred during taper or after discontinuation of therapy, which may not respond well to levodopa. Educate patient on potential of withdrawal symptoms; consider readministration of a dopamine agonist at the lowest effective dose in patients experiencing symptoms.

• Visual monitoring: Rapidly progressing visual field loss requires neurosurgical consultation.

Dosage Forms: US

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

Generic Equivalent Available: US

Yes

Pricing: US

Capsules (Bromocriptine Mesylate Oral)

5 mg (per each): $9.31

Capsules (Parlodel Oral)

5 mg (per each): $11.76

Tablets (Bromocriptine Mesylate Oral)

2.5 mg (per each): $4.14 - $6.27

Tablets (Cycloset Oral)

0.8 mg (per each): $6.78

Tablets (Parlodel Oral)

2.5 mg (per each): $7.32

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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

Capsule, Oral:

Generic: 5 mg

Tablet, Oral:

Generic: 2.5 mg

Administration: Pediatric

Oral: Regular-release tablets/capsules: Administer with food to decrease GI distress.

Administration: Adult

Oral: 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.

In neuroleptic malignant syndrome, administration via nasogastric tube has been described (Ref).

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F).

Use

Parlodel: Treatment of prolactin-secreting adenomas (FDA approved in ages ≥11 years and adults); treatment of dysfunctions associated with hyperprolactinemia, including amenorrhea with or without galactorrhea, infertility, or hypogonadism (FDA approved in adults); treatment of acromegaly (FDA approved in adults); treatment of Parkinson disease (FDA approved in adults).

Cycloset: Treatment of type 2 diabetes mellitus as an adjunct to diet and exercise (FDA approved in adults). Note: Although FDA approved, bromocriptine is not generally used in patients with type 2 diabetes but may be tried in specific situations (ADA 2021).

Medication Safety Issues
Sound-alike/look-alike issues:

Bromocriptine may be confused with benztropine, brimonidine

Cycloset may be confused with Glyset

Parlodel may be confused with pindolol, Provera

Metabolism/Transport Effects

Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

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

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

Alpha-/Beta-Agonists: Bromocriptine may enhance the hypertensive effect of Alpha-/Beta-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider therapy modification

Alpha1-Agonists: Bromocriptine may enhance the hypertensive effect of Alpha1-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider therapy modification

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

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider therapy modification

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

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

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). Risk D: 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). Risk D: Consider therapy modification

Arginine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

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

Beta-Blockers (Beta1 Selective): May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May enhance the hypoglycemic effect of Antidiabetic Agents. Beta-Blockers (Nonselective) may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

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

Bortezomib: May enhance the therapeutic effect of Antidiabetic Agents. Bortezomib may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

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

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

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

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

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

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

CYP3A4 Inducers (Strong): May decrease the serum concentration of Bromocriptine. Risk C: 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. Risk D: 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. Risk D: Consider therapy modification

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

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

Dihydroergotamine: Ergot Derivatives may enhance the vasoconstricting effect of Dihydroergotamine. Risk X: Avoid combination

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

Domperidone: May diminish the therapeutic effect of Bromocriptine. Risk C: Monitor therapy

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

Ergot Derivatives: May enhance the adverse/toxic effect of Bromocriptine. Risk X: Avoid combination

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

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

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

Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

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

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

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

Kava Kava: May enhance the adverse/toxic effect of Anti-Parkinson Agents (Dopamine Agonist). Kava Kava may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Risk C: Monitor therapy

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Foslevodopa. Risk C: Monitor therapy

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

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

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

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

Methysergide: Ergot Derivatives may enhance the vasoconstricting effect of Methysergide. Risk X: Avoid combination

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

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

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

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

Nefazodone: Bromocriptine may enhance the serotonergic effect of Nefazodone. This could result in serotonin syndrome. Nefazodone may increase the serum concentration of Bromocriptine. Management: Consider alternatives to this combination. If combined, monitor for increased bromocriptine toxicities and consider bromocriptine dose reductions. Additionally, monitor for signs and symptoms of serotonin syndrome/serotonin toxicity. Risk D: Consider therapy modification

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

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: 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. Risk D: Consider therapy modification

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

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

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

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

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

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

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

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

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

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

Serotonin 5-HT1D Receptor Agonists (Triptans): Bromocriptine may enhance the adverse/toxic effect of Serotonin 5-HT1D Receptor Agonists (Triptans). Management: Consider alternatives to this combination when possible. If combined, monitor for increased bromocriptine and triptan toxicities. Risk D: Consider therapy modification

Silodosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

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

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

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

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

Dietary Considerations

Administer with food to decrease GI distress.

Reproductive Considerations

Bromocriptine is approved for the treatment of hyperprolactinemic disorders. Increased prolactin concentrations due to a prolactinoma may cause galactorrhea, amenorrhea, oligomenorrhea, or luteal phase insufficiency. Treatment with bromocriptine may restore ovulatory cycles; fertility may return prior to regular menses (ES [Melmed 2011]; ESE [Luger 2021]). According to the manufacturer, 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. Patients not seeking to become pregnant should be advised to use a mechanical contraceptive during therapy until normal ovulatory menses is established. Contraception can then be discontinued if pregnancy is desired.

Treatment with a dopamine agonist such as bromocriptine is recommended for patients with a prolactinoma who are trying to conceive (ES [Melmed 2011]; ESE [Luger 2021]). Bromocriptine has a shorter half-life in comparison to other recommended agents (Glezer 2020).

Normalizing prolactin concentrations during dopamine agonist treatment for a micro- or macroadenoma also improves fertility by restoring nocturnal penile tumescence, sperm count, and sperm motility (ES [Melmed 2011]).

Pregnancy Considerations

Bromocriptine crosses the placenta (ES [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. Although available evidence suggests bromocriptine use early in pregnancy does not cause harm to the fetus, it is recommended that dopamine agonist therapy be discontinued once pregnancy is discovered (ES [Melmed 2011]; ESE [Luger 2021]).

If treatment of a prolactinoma during pregnancy is required, a dopamine agonist such as bromocriptine may be used. Serum prolactin concentrations are increased during pregnancy; monitoring prolactin levels may not be reliable for tumor progression (ES [Melmed 2011]; ESE [Luger 2021]).

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. Although use may be considered for some patients, additional studies are needed. If used, anticoagulation with heparin is required (ACOG 212 2019; ESC [Bauersachs 2016]; ESC [Regitz-Zagrosek 2018]; Sliwa 2017; Sliwa 2021).

Agents other than bromocriptine are recommended for treatment of pregnant patients with type 2 diabetes mellitus (ADA 2023).

Regardless of indication, if bromocriptine is needed, monitor closely for hypertensive disorders (including eclampsia, preeclampsia, and gestational hypertension) during pregnancy and immediately postpartum.

Monitoring Parameters

Prolactin serum levels (recommendations vary: baseline followed by weekly to monthly assessments for first 3 months and then longer intervals for duration [Cozzi 2022]; others suggest at baseline followed by assessment 2 to 4 weeks after therapy started, and then a minimum of 3 to 6 months thereafter [Eren 2011]); BP and heart rate (orthostatic vital signs; baseline and periodically thereafter); hepatic, renal, hematopoietic, and cardiovascular function (periodically); visual field (prolactinoma; periodic); pregnancy test during amenorrheic period; observe for rhinorrhea or signs/symptoms of GI bleed (patients with history of peptic ulcer); melanoma skin examinations (regular assessment).

Mechanism of Action

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).

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: ~61L

Protein binding: 90% to 96% (primarily albumin)

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

Bioavailability: Cycloset: 65% to 95%

Half-life elimination: Cycloset: ~6 hours; Parlodel: 4.85 hours

Time to peak, serum: Cycloset: 53 minutes; Parlodel: 2.5 ± 2 hours

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

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic function impairment: Plasma levels may increase with hepatic impairment.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Apo bromocriptine | Bromocriptine | Parlodel | Serocryptin;
  • (AR) Argentina: Parlodel | Serocryptin;
  • (AT) Austria: Parlodel | Umprel;
  • (AU) Australia: Bromocriptine-bc | Bromohexal | Bromolactin | Kripton | Parlodel | Sbpa bromocriptine;
  • (BD) Bangladesh: Bromergon | Bromocriptin | Bromodel | Bromolac | Bromotine | Bromtine | Criptine | Medocriptin | Parlodel;
  • (BE) Belgium: Parlodel;
  • (BG) Bulgaria: Bromcriptin | Bromocriptin | Medocriptine | Parlodel | Serocryptin;
  • (BR) Brazil: Bagren | Mesilato de bromocriptina | Parlodel;
  • (CH) Switzerland: Parlodel | Parlodel SRO;
  • (CI) Côte d'Ivoire: Apo bromocriptine | Criptine | Parlodel;
  • (CL) Chile: Criten | Grifocriptina | Kriptonal | Parlodel | Umprel;
  • (CN) China: Bai mo ting | Bromocriptin richter | Bromocriptine | Ergolactin | Medocriptine | Parlodel | Serocryptin;
  • (CO) Colombia: Bromocriptina | Lactidel | Lactostat | Omocrit | Parlodel;
  • (CZ) Czech Republic: Medocriptine | Parlodel | Serocryptin;
  • (DE) Germany: Bromocrel | Bromocriptin | Bromocriptin abz | Bromocriptin CT | Bromocriptin hexal | Kirim | Kirim Gyn | Parlodel | Pravidel;
  • (DO) Dominican Republic: Parlodel;
  • (EC) Ecuador: Brameston | Bromocriptina | Grifocriptina | Parlodel;
  • (EE) Estonia: Bromergon | Bromocriptin abz | Bromocriptin richter | Parlodel;
  • (EG) Egypt: Bromocriptin | Bromocriptine | Dopagon | Lactodel | Parlodel;
  • (ES) Spain: Lactismine | Parlodel;
  • (FI) Finland: Bromokin | Parlodel;
  • (FR) France: Bromo-kin | Parlodel;
  • (GB) United Kingdom: Bromocriptine | Bromocriptine berk | Bromocriptine cox | Bromocriptine kent | Parlodel;
  • (GR) Greece: Parlodel;
  • (HK) Hong Kong: Apo bromocriptine | Bromergon | Bromocriptin richter | Medocriptine | Parlodel | Serocryptin | Syntocriptine;
  • (HR) Croatia: Bromergon;
  • (HU) Hungary: Bromocriptin richter | Cycloset | Parlodel | Serocryptin;
  • (ID) Indonesia: Cripsa | Elkrip | Parlodel | Serocryptine;
  • (IE) Ireland: Parlodel;
  • (IL) Israel: Parilac | Parlodel;
  • (IN) India: B-crip | Brainstar | Briptin | Brom | Bromitine | Bromogen | Bromorex | Bromotin | Criptal | Criptin | D bro | Diacriptin | Encript | Glucomind | Parlodel | Pravidel | Proctinal | Semi brom | Serocryptin | Sicriptin;
  • (IQ) Iraq: Criptikin;
  • (IT) Italy: Bromocriptina drm | Parlodel;
  • (JO) Jordan: Parlodel | Ronalin | Serocryptin;
  • (JP) Japan: Corpadel | Deparo | Erenant | Melen | Melen merck hoei | Melen nichiiko | Melen tatumi | Morolack | Padoparine | Padoparine nikken | Palolactin | Parlodel | Parlomin | Parukizone | Prospeline | Serocryptin | Upnol B;
  • (KE) Kenya: Bromodel | Cripton | Lactodel | Parlodel;
  • (KR) Korea, Republic of: Antilactin | Bromidine | Celltrion bromocriptine mesylate | Monaritin | Paluderin | Parlodel | Practin | Pravidel | Serocryptin;
  • (KW) Kuwait: Parlodel | Serocryptin;
  • (LB) Lebanon: Parlodel | Serocryptin;
  • (LT) Lithuania: Bromergon | Bromocriptin medochemie | Bromocriptinum | Parlodel | Pravidel;
  • (LU) Luxembourg: Pravidel;
  • (LV) Latvia: Bromergon | Bromocriptin | Bromocriptinum | Parlodel;
  • (MA) Morocco: Parlodel;
  • (MX) Mexico: Bromocriptina | Bromocriptina iqfa | Bromocriptina serral | Crilem | Criptan | Kriptiser | Lactess | Parlodel | Serocryptin;
  • (MY) Malaysia: Bromocriptine | Bromtine | Butin | Criptamine | Medocriptine | Parlodel | Zolac;
  • (NG) Nigeria: Bromolact;
  • (NL) Netherlands: Bromocriptine | Parlodel;
  • (NO) Norway: Bromocriptine mesylate | Parlodel;
  • (NZ) New Zealand: Alpha-bromocriptine | Apo bromocriptine | Parlodel;
  • (PE) Peru: Aprolac | Bromocriptina | Grifocriptina | Parlodel;
  • (PH) Philippines: Parlodel | Provasyn;
  • (PK) Pakistan: Brolib | Brotin | Parlodel;
  • (PL) Poland: Bromergon | Bromocorn | Ergolaktyna | Parlodel;
  • (PR) Puerto Rico: Bromocriptine mesylate | Cycloset | Parlodel;
  • (PT) Portugal: Bromocriptina | Parlodel;
  • (PY) Paraguay: Parlodel | Serocryptin;
  • (QA) Qatar: Parlodel;
  • (RU) Russian Federation: Abergin | Apo bromocriptin | Bromergon | Bromocriptin | Bromocriptine | Bromocriptine mesylate | Parlodel;
  • (SA) Saudi Arabia: Apo bromocriptine | Parlodel | Ronalin | Serocryptin;
  • (SD) Sudan: Parlodine;
  • (SE) Sweden: Parlodel | Pravidel;
  • (SG) Singapore: Apo bromocriptine | Bromocriptine richter | Bromtine | Butin | Parlodel | Serocryptin;
  • (SI) Slovenia: Bromergon;
  • (SK) Slovakia: Medocriptin | Parlodel;
  • (TH) Thailand: Brameston | Brocaden | Bromergon | Bromocriptine | Parilac | Parlodel | Suplac;
  • (TN) Tunisia: Bromocriptine | Parlodel | Ronalin;
  • (TR) Turkey: Galaktomin | Gynodel | Parlodel;
  • (TW) Taiwan: Barlolin | Broma del | Bromotine | Butin | Crip | Criptine | Demil | Deprolac | Elerus | Lehduo | Parilac | Parlodel | Parloten | Pirodal | Syntocriptine | Unew | Updopa | Volbro;
  • (UA) Ukraine: Bromcriptin | Bromcriptin K | Bromergon | Parlodel | Ronalin;
  • (UG) Uganda: Dopagon;
  • (UY) Uruguay: Lutandrone | Parlodel;
  • (VE) Venezuela, Bolivarian Republic of: Parlodel | Serocryptin;
  • (ZA) South Africa: Apo bromocriptine | Parlodel;
  • (ZM) Zambia: Parlodel | Sicriptin;
  • (ZW) Zimbabwe: Apo bromocriptine
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