Bromocriptine

Bromocriptine is prescribed for a number of different medical conditions. Your doctor will tell you why it has been prescribed for you.

• Bromocriptine prevents the production of a chemical called prolactin. Prolactin is involved in a number of processes within the body, including milk production after childbirth. It also affects the levels of the hormones involved with controlling the menstrual cycle and fertility. Bromocriptine is therefore helpful in preventing or reducing milk production when this is needed for medical reasons. Likewise, it is helpful in some types of infertility, breast problems and menstrual problems caused by higher than usual levels of prolactin.
• High levels of prolactin occur in people with prolactinomas. A prolactinoma is a non-cancerous swelling in the pituitary gland. This can cause various symptoms including reduced fertility, breast changes, and headaches. Prolactinomas can be treated successfully with medicines which reduce the production of prolactin, such as bromocriptine. In these cases, treatment is usually long-term.
• Bromocriptine can be prescribed to treat Parkinson's disease, although other treatments are usually preferred. In Parkinson's disease, a number of cells in a small part of the brain become damaged and die. These brain cells normally pass messages down nerves in the spinal cord by producing a chemical called dopamine, and it is these messages which control the muscles of the body. As the cells are damaged, the amount of dopamine that is produced is reduced. A combination of the reduction of cells and a low level of dopamine in the cells in this part of the brain, causes nerve messages to the muscles to become slowed and abnormal. This produces the main symptoms of Parkinson's disease, which are stiffness, shaking (tremor), and slowness of movement. Bromocriptine encourages the release of dopamine which helps to ease these symptoms.
• Bromocriptine also affects the production of growth hormone and has sometimes been used for the treatment of conditions such as acromegaly, although other treatments are often preferred. Acromegaly is a disorder which causes enlargement of the hands and feet, and makes facial features more prominent.

Pregnancy

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
• Prolactin-secreting adenomas may expand and compression of optic/other cranial nerves may occur, emergency pituitary surgery becoming necessary; in most cases, the compression resolves following delivery
• Reinitiation of Parlodel treatment has been reported to produce improvement in the visual fields of patients in whom nerve compression has occurred during pregnancy
• In patients being treated for hyperprolactinemia, Parlodel should be withdrawn when pregnancy is diagnosed
• Acromegaly, prolactinoma, or Parkinson disease
  • Patients who subsequently become pregnant, determine whether continuing therapy is medically necessary or can discontinues
  • If it is continued, discontinue therapy in those who may experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless withdrawal of Parlodel is considered to be medically contraindicated

Cycloset

• Because human studies cannot rule out the possibility of harm, Cycloset should be used during pregnancy only if clearly necessary

Lactation

Parlodel: Avoid use during lactation in postpartum women

Cycloset

• Cycloset is contraindicated in women who are nursing
• Cycloset contains bromocriptine which inhibits lactation; use of bromocriptine for inhibition of postpartum lactation was withdrawn based on postmarketing reports of stroke in this setting

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Bromocriptine is part of the drug class:

• Dopamine agonists

Common side effects include:

• nausea
• headache
• dizziness
• vomiting
• diarrhea
• constipation
• stomach cramps
• heartburn
• loss of appetite
• weakness
• tiredness
• drowsiness
• difficulty sleeping
• depression

This is not a complete list of bromocriptine side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take bromocriptine exactly as prescribed.

Bromocriptine comes in tablet and capsule form. It is taken up to 3 times depending on what is beinh treated. Take bromocriptine daily with food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of bromocriptine at the same time.

You should not use this medication if you are allergic to bromocriptine or to an ergot medicine (Ergomar, Cafergot, Migergot, D.H.E. 45, Migranal, Methergine).

You should not use Parlodel if you have:

• uncontrolled high blood pressure (hypertension);

• hypertension caused by pregnancy (including eclampsia and preeclampsia);

• if you are also using an ergot medicine to treat migraine headaches; or

• if you have recently had a baby and you have a history of coronary artery disease or severe heart disease.

Bromocriptine may contain lactose. Before taking Parlodel, tell your doctor if you have a hereditary form of galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption.

To make sure you can safely take bromocriptine, tell your doctor if you have any of these other conditions:

• high or low blood pressure, heart disease, or a history of heart attack;

• liver or kidney disease;

• a tumor of the pituitary gland;

• a stomach ulcer or history of stomach or intestinal bleeding; or

• a history of mental illness or psychosis.

FDA pregnancy category B. Bromocriptine is not expected to harm an unborn baby. However, a pituitary tumor in the mother can expand during pregnancy. High blood pressure can also occur during pregnancy and bromocriptine could be dangerous if taken by a pregnant woman with high blood pressure. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Some women take Parlodel in order to normalize menstrual periods and increase their chances of becoming pregnant. Tell your doctor as soon as you become pregnant. You may need to stop taking Parlodel. Follow your doctor's instructions.

If you are not taking Parlodel to help you get pregnant, use a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy during treatment. Your doctor may also want you to have a pregnancy test every 4 weeks during treatment.

Bromocriptine lowers the hormone needed to produce breast milk. Do not breast-feed a baby while taking this medication.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Parlodel is usually taken twice daily with meals.

While using bromocriptine, you may need blood tests at your doctor's office. Visit your doctor regularly.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking Parlodel.

Some people taking Parkinson's disease medications have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk of melanoma. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

Store at room temperature away from moisture, heat, and light.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some serious side effects have occurred during the use of bromocriptine to stop milk flow after pregnancy or abortion. These side effects have included strokes, seizures (convulsions), and heart attacks. Some deaths have also occurred. You should discuss with your doctor the good that bromocriptine will do as well as the risks of using it.

Check with your doctor immediately if any of the following side effects occur:

• Dizziness or lightheadedness, especially when getting up from a lying or sitting position
• nausea

• Confusion
• hallucinations (seeing, hearing, or feeling things that are not there)
• uncontrolled movements of the body, such as the face, tongue, arms, hands, head, and upper body

• Abdominal or stomach pain (continuing or severe)
• increased frequency of urination
• loss of appetite (continuing)
• lower back pain
• runny nose (continuing)
• weakness

• Black, tarry stools
• bloody vomit
• chest pain (severe)
• convulsions (seizures)
• fainting
• fast heartbeat
• headache (unusual)
• increased sweating
• nausea and vomiting (continuing or severe)
• nervousness
• shortness of breath (unexplained)
• vision changes (such as blurred vision or temporary blindness)
• weakness (sudden)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation
• diarrhea
• drowsiness or tiredness
• dry mouth
• leg cramps at night
• loss of appetite
• mental depression
• stomach pain
• stuffy nose
• tingling or pain in the fingers and toes when exposed to cold
• vomiting

Some side effects may be more likely to occur in patients who are taking bromocriptine for Parkinson's disease, acromegaly, or pituitary tumors since they may be taking larger doses.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Hypersensitivity to Bromocriptine or to any of the excipients of Bromocriptine mesylate, uncontrolled hypertension and sensitivity to any ergot alkaloids. In patients being treated for hyperprolactinemia, Bromocriptine should be withdrawn when pregnancy is diagnosed (see PRECAUTIONS, Hyperprolactinemic States). In the event that Bromocriptine is reinstituted to control a rapidly expanding macroadenoma (see PRECAUTIONS, Hyperprolactinemic States) and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing Bromocriptine must be weighed against the possible risk of its use during a hypertensive disorder of pregnancy. When Bromocriptine is being used to treat acromegaly, prolactinoma, or Parkinson's disease in patients who subsequently become pregnant, a decision should be made as to whether the therapy continues to be medically necessary or can be withdrawn. If it is continued, the drug should be withdrawn in those who may experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless withdrawal of Bromocriptine is considered to be medically contraindicated.

The drug should not be used during the postpartum period in women with a history of coronary artery disease and other severe cardiovascular conditions unless withdrawal is considered medically contraindicated. If the drug is used in the postpartum period, the patient should be observed with caution.

Bromocriptine mesylate Tablets

2.5 mg

Bromocriptine mesylate tablets are available in bottles containing 30 and 100 tablets of 2.5 mg - each bottle contains a desiccant.

Round, off-white, bevelled-edge scored tablets, each containing 2.5 mg Bromocriptine (as the mesylate). Engraved “PARLODEL 2½’’ on one side and 017 twice on the scored side. Complies with USP dissolution test 1.

Packages of 30.....................................................................................NDC 63304-962-30

Packages of 100...................................................................................NDC 63304-962-01

Bromocriptine mesylate Capsules

5 mg

Caramel and white capsules, each containing 5 mg Bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg’’ on one half and 102 on other half.

Packages of 30..............................................................NDC 63304-158-30

Packages of 100............................................................NDC 63304-158-01

Store and Dispense

Below 25ºC (77ºF); tight, light-resistant container.

Distributed by:

Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA

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

Administer with food to decrease GI distress.

Cycloset: Administer within 2 hours of waking in the morning.

Applies to bromocriptine: compounding powder, oral capsule, oral tablet

Gastrointestinal

Gastrointestinal side effects have included nausea (18% to 49%), constipation (3% to 14%), vomiting (2% to 5%), abdominal cramps (5%), indigestion/dyspepsia (4%), anorexia (4%), diarrhea (3%), gastrointestinal bleeding (less than 2%), abdominal discomfort, anorexia, dry mouth, and peptic ulcers have been reported.[Ref]

Nervous system

Nervous system side effects have included headache (19%), dizziness (17%), fatigue (7%), lightheadedness (5%), and drowsiness/tiredness (3%). Other side effects occurring less frequently (less than 2%) have included faintness, vertigo, paresthesia, insomnia, decreased sleep requirement, heavy headedness, sluggishness, reduced tolerance to cold, asthenia, tingling of ears, and numbness. A syndrome resembling neuroleptic malignant syndrome has been reported on abrupt withdrawal of bromocriptine.[Ref]

Cardiovascular

Syncope and symptomatic hypotension (decreases in supine systolic and diastolic pressures of greater than 20 mm and 10 mm Hg, respectively) have been reported in approximately 30% of postpartum patients.

Seizures and/or strokes have been reported with bromocriptine administration. Many of the patients experiencing seizures and/or strokes reported developing a continuous headache, often progressively severe, hours to days prior to the acute event. In addition, visual disturbances (blurred vision and transient cortical blindness) have been reported to also precede stroke and/or seizure events. If a patient experiences severe, progressive, or unremitting headache (with or without visual disturbance), or evidence of CNS toxicity develops, bromocriptine therapy should be discontinued and the patient should be evaluated promptly.[Ref]

Cardiovascular side effects have included postural/orthostatic hypotension (6%), digital vasospasm (3%), syncope (less than 2%), seizures, stroke, and myocardial infarction. Rare cardiovascular side effects including arrhythmia, pleural and pericardial effusions, constrictive pericarditis, ventricular tachycardia, bradycardia, and vasovagal attack have been reported.

A case of severe dilated cardiomyopathy has been reported in a 31-year-old African American female one month after initiating treatment of a microprolactinoma with bromocriptine 5 mg orally daily. An echocardiogram showed a markedly dilated left ventricle with severe reduction in the left-ventricular ejection fraction. The patient returned to NYHA Class I four weeks after bromocriptine was stopped.[Ref]

Respiratory

Respiratory side effects have included nasal congestion (3%) and shortness of breath. Pulmonary infiltrates, pleural effusion, and thickening of the pleura have been reported with long-term administration (6 months to 36 months) of bromocriptine doses ranging from 20 mg to 100 mg daily. Upon termination of bromocriptine therapy, these changes slowly reverted towards normal.[Ref]

Rare cases of cerebrospinal fluid rhinorrhea have been reported in patients who have received previous transphenoidal surgery and/or pituitary radiation, and who were receiving bromocriptine for tumor recurrence.[Ref]

Musculoskeletal

Musculoskeletal side effects have included muscle cramps, facial pallor, abnormal involuntary movements, ataxia, edema of the feet and ankles, and erythromelalgia.[Ref]

Rare musculoskeletal side effects including tingling of fingers, cold feet, numbness, muscle cramps in feet and legs, and exacerbation of Raynaud's Syndrome have been reported during bromocriptine therapy.[Ref]

Psychiatric

Parkinsonian patients may manifest mild degrees of dementia, therefore, caution should be used when treating such patients.

Bromocriptine, alone or in combination with levodopa, may cause hallucinations (visual or auditory). Hallucinations usually resolve with dosage reduction; occasionally, discontinuation of the drug is required. Rarely, after high doses, hallucinations have persisted for several weeks after discontinuation of the drug.[Ref]

Psychiatric side effects have included delusional psychosis, paranoia, depression, anxiety, confusion, "on-off" phenomenon, and nightmares. High doses of bromocriptine may be associated with confusion and mental disturbances (hallucinations). Postmarketing reports suggest that patients treated with antiparkinson medications can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and other intense urges. Patients may be unable to control these urges while taking the medications used for the treatment of Parkinson's disease and that increase central dopaminergic tone.[Ref]

Ocular

Ocular side effects have included visual disturbance and blepharospasm. Secondary deterioration of visual field may develop in patients receiving treatment for hyperprolactinemia due to chiasmal herniation. The visual field defect may improve on reduction of bromocriptine dosage.[Ref]

Genitourinary

Genitourinary side effects have included urinary frequency, urinary incontinence, and urinary retention.[Ref]

Dermatologic

Dermatologic side effects have included mottling of skin and skin rash.[Ref]

Other

Other side effects have included hair loss, alcohol potentiation, reduced tolerance to cold, tingling of the ears, sign and symptoms of ergotism such as tingling of the fingers, cold feet, numbness, muscle cramps of feet and legs or exacerbation of Raynaud's syndrome.[Ref]

Local

Local side effects have included retroperitoneal fibrosis in a few patients receiving long-term therapy (2 to 10 years) with bromocriptine in doses ranging from 30 to 140 mg daily.[Ref]

Oncologic

Studies have shown that Parkinson's patients have an approximately 2 to 6 fold higher risk of developing melanoma than the general population. It is not clear whether this increased risk was due to Parkinson's disease or other factors, such as drugs used to treat Parkinson's disease.

Some side effects of bromocriptine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Initial: 1.25 mg twice daily with meals.
Titration: Add 2.5 mg/day, with meals, to dosage regimen every 14 to 28 days.
Maximum dosage: 100 mg/day.

For the Cycloset (R) trade name of bromocriptine only:

Initial: 0.8 mg orally daily taken within two hours after waking in the morning with food
Titration: Increase by 0.8 mg weekly as tolerated
Maintenance: 1.6 to 4.8 mg orally daily taken within two hours after waking in the morning with food

The maximum dosage should not exceed 4.8 mg daily.

Data not available

LactMed Record Number

432

Last Revision Date

20170411

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

Dosage Forms & Strengths

tablet (Parlodel)

• 2.5mg

capsule (Parlodel)

• 5mg

tablet (Cycloset)

• 0.8mg

Hyperprolactinemia-Associated Dysfunctions (Parlodel)

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

1.25-2.5 mg PO qDay initially; may increase by 2.5 mg/day q2-7Days until optimal therapeutic response achieved

Usual therapeutic dosage ranges from 2.5-15 mg/day

Up to 30 mg/day has been used in some patients with amenorrhea and/or galactorrhea

Parkinson Disease (Parlodel)

Indicated as adjunctive treatment to levodopa for the signs and symptoms of idiopathic/postencephalitic Parkinson disease

1.25 mg PO q12hr initially; may increase dose by 2.5 mg/day q2-4Weeks until optimal therapeutic response achieved

Safety >100 mg/day not established

Acromegaly (Parlodel)

Indicated for acromegaly

1.25-2.5 mg PO qHS for 3 days initially; may increase by 1.25-2.5 mg/day q3-7Days until optimal therapeutic response achieved

Not to exceed 100 mg/day

Type 2 Diabetes Mellitus (Cycloset)

Quick release formulation (Cycloset) is the only bromocriptine product indicated for diabetes mellitus type 2 as adjunct to diet and exercise to improve glycemic control

0.8 mg PO qDay initially; may increase by 0.8-mg increments qWeek as tolerated

Usual dosage ranges between 1.5-4.8 mg PO qDay; not to exceed 4.8 mg (6 tablets)/day

Note: Cycloset is not indicated for hyperprolactinemia, Parkinson disease, or acromegaly

see Dosage Modifications (Cycloset) and Administratio (Cycloset)

Neuroleptic Malignant Syndrome (Off-label, Parlodel)

2.5-5 mg PO 2-3 times/day; not to exceed 45 mg/day

[Strawn JR, Keck PE Jr, and Caroff SN, "Neuroleptic Malignant Syndrome," Am J Psychiatry, 2007, 164(6):870-6]

Dosage Modifications

Hepatic impairment: Safety and efficacy has not been established; dosage adjustment may be necessary due to extensive hepatic metabolism; use with caution

Renal impairment: Safety and efficacy has not been established

Cycloset

• Concomitant use with CYP3A4 inhibitor
  • Strong CYP3A4 inhibitor (eg, azole antimycotics, HIV protease inhibitors): Avoid use; ensure adequate washout of the strong CYP3A4 inhibitor drug before initiating Cycloset treatment
  • Moderate CYP3A4 inhibitor (eg, erythromycin): Dose should not exceed 1.6 mg PO qDay

Dosing Considerations

Dosage forms for Cycloset and Parlodel and not interchangeable

Cycloset

• Limitations of use
  • Not for treatment of type 1 diabetes or diabetic ketoacidosis
  • Limited efficacy data in combination with thiazolidinediones
  • Efficacy has not been confirmed in combination with insulin

Parlodel

• Patients treated with pituitary irradiation should be withdrawn from Parlodel therapy on a yearly basis to assess both the clinical effects of radiation on the disease process and effects of Parlodel therapy; usual withdrawal period range, 4-8 weeks; recurrence of the signs/symptoms or increases in growth hormone indicate the disease is still active and further courses of Parlodel should be considered

Dosage Forms & Strengths

tablet (Parlodel)

• 2.5mg

capsule (Parlodel)

• 5mg

Hyperprolactinemia (Parlodel)

≤10 years: Safety and efficacy not established

11-15 years: 1.25-2.5 mg PO qDay initially; therapeutic dosage ranges from 2.5-10 mg/day; may need to increase dose for optimal therapeutic response

≥16 years: Safety and efficacy not established

see Administration (Parlodel)

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)

Cautions

Dosage forms for Cycloset and Parlodel and not interchangeable

Avoid abrupt withdrawal (associated with neuroleptic malignant syndrome-like symptoms); discontinue gradually

Use with caution in patients with cardiovascular disease, dementia, hepatic impairment, and peptic ulcer disease

Somnolence

• Somnolence, and episodes of sudden sleep onset has been reported, particularly in patients with Parkinson’s disease
• Inform and advise not to drive or operate machines during treatment; dose reduction or termination of therapy may be considered
• During the first days of treatment, hypotensive reactions may occasionally occur and result in reduced alertness, particular care should be exercised when driving a vehicle or operating machinery

Parlodel

• Avoid use in patients with galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption
• Used with caution in patients with a history of psychosis or cardiovascular disease
• In patients undergoing treatment for macroadenoma-related hyperprolactinemia or who have undergone transsphenoidal surgery, a persistent watery nasal discharge may be sign of CSF rhinorrhea
• Visual field impairment is a known complication of macroprolactinoma; Parlodel therapy may lead to a reduction in hyperprolactinemia and often to a resolution of the visual impairment; monitor visual fields in patients with macroprolactinoma
• Cold-sensitive digital vasospasm has been observed in some acromegalic patients; response is reversible by dose reduction of Parlodel and may be prevented by keeping the fingers warm
• Cases of severe gastrointestinal bleeding from peptic ulcers have been reported; patients with a history of peptic ulcer or gastrointestinal bleeding should be observed carefully during treatment with Parlodel
• Possible tumor expansion while receiving Parlodel therapy has been reported; all patients should be carefully monitored and, if evidence of tumor expansion develops, discontinuation of treatment and alternative procedures considered
• High doses of Parlodel may be associated with confusion and mental disturbances; parkinsonian patients may manifest mild degrees of dementia, caution should be used when treating such patients
• Auditory or visual hallucinations may occur when administered alone or concomitantly with levodopa; hallucinations usually resolve with dosage reduction; occasionally, discontinue therapy
• Postmarketing reports suggest that patients treated with anti-Parkinson medications can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and other intense urges
• History of MI and a residual atrial, nodal or ventricular arrhythmia, especially with Parkinson disease
• Retroperitoneal fibrosis has been reported in a few patients receiving long-term therapy
• Hypertension
  • Hypertension have been reported, sometimes at the initiation of therapy, but often developing in the second week of therapy; periodic blood pressure monitoring, during the first weeks of therapy is prudent
  • Seizures have also been reported both with and without the prior development of hypertension; stroke have been reported mostly in postpartum patients whose prenatal and obstetric courses had been uncomplicated
  • Use of the drug in patients with uncontrolled hypertension is not recommended (see Contraindications [Parlodel])
  • Exercise caution when administering Parlodel therapy concomitantly with other medications known to lower blood pressure
  • If hypertension, severe, progressive, or unremitting headache (with or without visual disturbance), or evidence of CNS toxicity develops, evaluate patient and therapy should be discontinued

Cycloset

• Somnolence may occur; inform patients should be made aware of this potential side effect, particularly when initiating therapy; patients experiencing somnolence should refrain from driving or operating heavy machinery
• Fibrotic valve thickening (eg, aortic, mitral, tricuspid), possibly due to excess serotonin activity, usually associated with long-term, chronic use of ergot alkaloids and derivatives reported
• Dopamine receptor antagonists
  • Dopamine receptor antagonists, including neuroleptic agents that have dopamine D2 receptor antagonist properties (eg, clozapine, olanzapine, ziprasidone), may reduce the effectiveness of Cycloset and Cycloset may reduce the effectiveness of these agents; concomitant use with dopamine receptor antagonists, including neuroleptic drugs, is not recommended
  • Other dopamine receptor agonists are indicated for the treatment of Parkinson’s disease, hyperprolactinemia, restless leg syndrome, acromegaly, and other disorders; effectiveness and safety of Cycloset in patients currently treated with other dopamine receptor agonists is unknown; concomitant use is not recommended
• Hypotension
  • Hypotension, including orthostatic hypotension, can occur, particularly upon Cycloset initiation and with dose escalation
  • Assess orthostatic vital signs prior to initiation of Cycloset and periodically thereafter; during early treatment, patients should be advised to make slow postural changes and to avoid situations that could lead to serious injury if syncope was to occur
  • Use caution in patients taking anti-hypertensive medication