Classes
DEA Class; Rx
Common Brand Names; Cycloset, Parlodel
- Antiparkinson Agents, Dopamine Agonists;
- Hyperprolactinemia;
- Metabolic & Endocrine, Other
Description
Used in adult and pediatric patients 11 years and older with selected conditions such as acromegaly, a variety of hyperprolactinemia syndromes, and prolactin-secreting pituitary adenomas; micronized product used in adults with type 2 diabetes mellitus; use for Parkinson’s disease largely replaced by other agents
Do not use during breast-feeding or during the postpartum period
Indications
Indicated for treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism; also indicated in patients with prolactin-secreting adenomas
Indicated as adjunctive treatment to levodopa for the signs and symptoms of idiopathic/postencephalitic Parkinson disease
Indicated for acromegaly
Contraindications
Parlodel
Hypersensitivity to bromocriptine, ergot-related drugs, or to any of the excipients in Parlodel
Uncontrolled hypertension
Pregnancy in patients treated for hyperprolactinemia (see Pregnancy)
Postpartum period in women with a history of coronary artery disease and other severe cardiovascular conditions
Cycloset
Hypersensitivity to bromocriptine, ergot-related drugs, or any of the excipients in Cycloset
Syncopal migraine
Women who are nursing (see Lactation)
Postpartum patients
Adverse Effects
Cycloset
Monotherapy
- Nausea (32.5 %)
- Rhinitis (13.8%)
- Headache (12.5%)
- Asthenia (12.5%)
- Dizziness (12.5%)
- Constipation (11.3%)
Adjunct to sulfonylurea
- Nausea (25.4%)
- Asthenia (18.9%)
- Headache (16.8%)
- Dizziness (11.9%)
- Rhinitis (10.7%)
Adjunct to diet or ≤2 antidiabetic medications (eg, metformin, insulin secretagogues, and/or insulin)
- Nausea (32.2%)
- Dizziness (14.8%)
- Fatigue (13.9%)
- Headache (11.4%)
Parlodel
Hyperprolactinemic indications
- Nausea (49%)
- Headache (19%)
- Dizziness (17%)
Acromegaly
- Nausea (18%)
- Constipation (14%)
Warnings
Dosage forms for Cycloset and Parlodel and not interchangeable
Discontinuation of treatment should be undertaken gradually whenever possible, even if patient is to remain on levodopa; a symptom complex resembling the neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, reported in association with rapid dose reduction, withdrawal of, or changes in antiparkinsonian therapy
Use with caution in patients with cardiovascular disease, dementia, hepatic impairment, and peptic ulcer disease
Symptoms including apathy, anxiety, depression, fatigue, insomnia, sweating, and pain reported during taper or after discontinuation of dopamine agonists; these symptoms generally do not respond to levodopa; prior to discontinuation of therapy, patients should be informed about potential withdrawal symptoms, and closely monitored during and after discontinuation of treatment; in case of severe withdrawal symptoms, re-administration of a dopamine agonist at lowest effective dose may be considered
Pregnancy and Lactation
Parlodel
- Safety of Parlodel treatment during pregnancy to the mother and fetus has not been established
- If pregnancy occurs during Parlodel administration, careful observation of these patients is mandatory
Cycloset
- There are no available data on use in pregnant women with type 2 diabetes; prolonged experience with bromocriptine use in pregnant women for other indications over several decades
Lactation
Parlodel: Avoid use during lactation in postpartum women
Cycloset is contraindicated in women who are nursing
Maximum Dosage
4.8 mg/day PO for type 2 diabetes mellitus; usual maximum 30 mg/day PO for Parkinson’s disease, hyperprolactinemic conditions, or prolactin-secreting adenomas. While maximum is 100 mg/day for acromegaly, patients rarely exceed 60 mg/day PO.
4.8 mg/day PO for type 2 diabetes mellitus; usual maximum 30 mg/day PO for Parkinson’s disease, hyperprolactinemic conditions, or prolactin-secreting adenomas. While maximum is 100 mg/day for acromegaly, patients rarely exceed 60 mg/day PO.
16 years and older: 15 mg/day for hyperprolactinemic indications, some off-label data suggest 20 mg/day PO for selected conditions; safety and efficacy not established for diabetes.
13 to 15 years: 10 mg/day for prolactin-secreting pituitary adenoma, some off-label data suggest 20 mg/day PO; safety and efficacy not established for diabetes or other indications.
11 to 12 years: 10 mg/day PO for selected indications.
7 to 10 years: Safety and efficacy have not been established; some off-label data suggest 5 mg/day PO for selected indications.
Safety and efficacy have not been established.
How supplied
Bromocriptine mesylate
tablet (Parlodel)
2.5mg
capsule (Parlodel)
5mg
tablet (Cycloset)
0.8mg