No

Anti-Parkinson's Agent (Dopamine Agonist); Ergot Derivative

Amenorrhea with or without galactorrhea; infertility or hypogonadism; prolactin-secreting adenomas; acromegaly; Parkinson's disease

The indication for prevention of postpartum lactation was withdrawn voluntarily by Sandoz Pharmaceuticals Corporation

Unlabeled uses: Neuroleptic malignant syndrome

B

Hypersensitivity to bromocriptine, ergot alkaloids, or any component; uncontrolled hypertension; severe ischemic heart disease or peripheral vascular disorders; pregnancy (risk to benefit evaluation must be performed in women who become pregnant during treatment for acromegaly, prolactinoma, or Parkinson's disease - hypertension during treatment should generally result in efforts to withdraw)

Use with caution in patients with impaired renal or hepatic function, a history of psychosis, or cardiovascular disease (myocardial infarction, arrhythmia). Patients who receive bromocriptine during and immediately following pregnancy as a continuation of previous therapy (ie, acromegaly) should be closely monitored for cardiovascular effects. Discontinuation of bromocriptine in patients with macroadenomas has been associated with rapid regrowth of tumor and increased prolactin serum levels. Use with caution in patients with a history of peptic ulcer disease, dementia, or concurrent antihypertensive therapy. Safety and effectiveness in patients <15 years of age have not been established.

>10%:

Central nervous system: Headache, dizziness

Gastrointestinal: Nausea

1% to 10%:

Cardiovascular: Orthostatic hypotension

Central nervous system: Fatigue, lightheadedness, drowsiness

Gastrointestinal: Anorexia, vomiting, abdominal cramps, constipation

Respiratory: Nasal congestion

<1%: Hair loss, arrhythmias, visual hallucinations, paranoia, insomnia

Symptoms of overdose include nausea, vomiting, hypotension

Hypotension, when unresponsive to I.V. fluids or Trendelenburg positioning, often responds to norepinephrine infusions started at 0.1-0.2 mcg/kg/minute followed by a titrated infusion

CYP3A3/4 enzyme substrate

Increased toxicity: Isometheptene ad phenylpropanolamine (and other sympathomimetics) should be avoided in patients receiving bromocriptine; may increase risk of hypertension and seizure

Erythromycin, fluvoxamine, and nefazodone may increase bromocriptine concentrations

Semisynthetic ergot alkaloid derivative and a dopamine receptor agonist which activates postsynaptic dopamine receptors in the tuberoinfundibular and nigrostriatal pathways

Protein binding: 90% to 96%

Metabolism: Majority of drug metabolized in the liver

Half-life (biphasic): Initial: 6-8 hours; Terminal: 50 hours

Time to peak serum concentration: Oral: Within 1-2 hours

Elimination: In bile; only 2% to 6% excreted unchanged in urine

Adults: Oral:

Neuroleptic malignant syndrome: 2.5-5 mg 3 times/day

Hyperprolactinemia: 2.5 mg 2-3 times/day

Acromegaly: Initial: 1.25-2.5 mg increasing as necessary every 3-7 days; usual dose: 20-30 mg/day Children (11-15 years old): Oral

Proloactin-secreting adenomas: Initial: 1.25-2.5 mg/day; daily range 2.5-10 mg.

Dosing adjustment in hepatic impairment: No guidelines are available, however, may be necessary

May be administered with food to decrease GI distress

Monitor blood pressure closely as well as hepatic, hematopoietic, and cardiovascular function

Drowsiness is common; may cause hallucinations

Used to treat neuroleptic malignant syndrome and cocaine abuse; fluvoxamine and nefazodone may increase bromocriptine concentrations; monitor for hypotension, headache, nausea

No information available to require special precautions

No effects or complications reported

Take exactly as directed (may be prescribed in conjunction with levodopa/carbidopa); do not change dosage or discontinue without consulting prescriber. Therapeutic effects may take several weeks or months to achieve and you may need frequent monitoring during first weeks of therapy. Take with meals if GI upset occurs, before meals if dry mouth occurs, after eating if drooling or if nausea occurs. Take at the same time each day. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake); void before taking medication. Do not use alcohol and prescription or OTC sedatives or CNS depressants without consulting prescriber. Urine or perspiration may appear darker. You may experience drowsiness, dizziness, confusion, or vision changes (use caution when driving, climbing stairs, or engaging in tasks requiring alertness until response to drug is known); orthostatic hypotension (use caution when changing position - rising to standing from sitting or lying); constipation (increased exercise, fluids, or dietary fruit and fiber may help); nasal congestion (consult prescriber for appropriate relief); nausea, vomiting, loss of appetite, or stomach discomfort (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help). Report unresolved constipation or vomiting; chest pain or irregular heartbeat; acute headache or dizziness; CNS changes (hallucination, loss of memory, seizures, acute headache, nervousness, etc); painful or difficult urination; increased muscle spasticity, rigidity, or involuntary movements; skin rash; or significant worsening of condition. Breast-feeding precautions: Do not breast-feed.

Raise bed rails and institute safety measures; aid patient with ambulation; may cause postural hypotension and drowsiness

Capsule, as mesylate: 5 mg

Tablet, as mesylate: 2.5 mg

Dackis CA and Gold MS, "Bromocriptine as Treatment of Cocaine Abuse," Lancet, 1985, 1(8438):1151-2.

de Groot AN, van Dongen PW, Vree TB, et al, "Ergot Alkaloids. Current Status and Review of Clinical Pharmacology and Therapeutic Use Compared With Other Oxytocics in Obstetrics and Gynaecology," Drugs, 1998, 56(4):523-35.

Koller WC, Silver DE, and Lieberman A, "An Algorithm for the Management of Parkinson's Disease," Neurology, 1994, 44(12 Suppl 10):S1-52.

LeJoyeux M, et al, "Serotonin Syndrome: Incidence, Symptoms, and Treatment," CNS Drugs, 1994, 2:132-43.

Melmed S and Braunstein GD, "Bromocriptine and Pleuropulmonary Disease," Arch Intern Med, 1989, 149(2):258-9.

Morgans D, "Re: Parlodel," Aust N Z J Obstet Gynaecol, 1995, 35(2):228-9.

Mueller PS, Vester JW, and Fermaglich J, "Neuroleptic Malignant Syndrome. Successful Treatment With Bromocriptine," JAMA, 1983, 249(3):386-8.

Parkes D, "Drug Therapy: Bromocriptine," N Engl J Med, 1979, 301(16):873-8.

Stern MB, "Contemporary Approaches to the Pharmacotherapeutic Management of Parkinson's Disease: An Overview," Neurology, 1997, 49(1 Suppl 1):S2-9.

Watts RL, "The Role of Dopamine Agonists in Early Parkinson's Disease," Neurology, 1997, 49(1 Suppl 1):S34-48.