Bromocriptine

What is Bromocriptine?

• Bromocriptine (Parlodel) is an ergot derivative with potent dopamine receptor agonist activity used to treat symptoms of hyperprolactinemia (high levels of a natural substance called prolactin in the body) , acromegaly (condition in which there is too much growth hormone in the body) and Parkinson's disease.

• Bromocriptine under the brand name Cycloset is used with a diet and exercise program and sometimes with other medications to control blood sugar levels in people with type 2 diabetes.

Bromocriptine

Bromocriptine

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What are the uses of this medicine?

Bromocriptine (Parlodel) is used:

• is used to treat symptoms of hyperprolactinemia (high levels of a natural substance called prolactin in the body) including lack of menstrual periods, discharge from the nipples, infertility (difficulty becoming pregnant) and hypogonadism (low levels of certain natural substances needed for normal development and sexual function). Bromocriptine (Parlodel) may be used to treat hyperprolactinemia caused by certain types of tumors that produce prolactin, and may shrink these tumors.
• in the treatment of acromegaly.
• in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson's disease.

How does this medicine work?

• Bromocriptine (broe" moe krip' teen) is a semisynthetic ergot alkaloid derivative which acts as a dopamine receptor agonist.
• Bromocriptine has strong agonist activity on the D2 class of dopamine receptors and partial antagonist of the D1 receptors in central nervous system.
• Bromocriptine was approved for use in the United States in 1978, the first in this class of agents, and has been in wide use since.
• Current indications are the therapy of symptomatic Parkinson disease as well as spastic disorders and extrapyramidal disorders caused by medications.
• Bromocriptine also has inhibitory activity on prolactin and growth hormone release, and its indications also include treatment of amenorrhea and galactorrhea related to hyperprolactinemia, female infertility, acromegaly, Cushing syndrome and premenstrual syndrome.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to bromocriptine or to any of the excipients of bromocriptine mesylate.
• uncontrolled hypertension and sensitivity to any ergot alkaloids
• pregnancy
• postpartum period in women with a history of coronary artery disease and other severe cardiovascular conditions

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• amitriptyline (Elavil)
• antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• antihistamines
• chloramphenicol
• dexamethasone (Decadron, Dexpak)
• other dopamine agonists such as cabergoline (Dostinex), levodopa (Dopar, Larodopa), pergolide (Permax), and ropinirole (Requip)
• ergot-type medications such as dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylates (Germinal, Hydergine), ergonovine (Ergotrate), ergotamine (Bellergal-S, Cafergot, Ergomar, Wigraine), methylergonovine (Methergine), and methysergide (Sansert)
• haloperidol (Haldol)
• imipramine (Tofranil)
• insulin
• macrolide antibiotics such as clarithromycin (Biaxin, in PrevPac) and erythromycin (E.E.S., E-Mycin, Erythrocin)
• certain medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra)
• oral medications for diabetes
• medications for asthma, colds, high blood pressure, migraines, and nausea
• medications for mental illness such as clozapine (Clozaril, FazaClo), olanzapine (Zyprexa, in Symbyax), thiothixene (Navane), and ziprasidone (Geodon)
• methyldopa (in Aldoril)
• metoclopramide (Reglan)
• nefazodone
• octreotide (Sandostatin)
• pimozide (Orap)
• probenecid (in Col-Probenecid, Probalan)
• reserpine
• rifampin (Rifadin, in Rifamate, in Rifater, Rimactane)
• sumatripta (Imitrex)

Is this medicine FDA approved?

• It was patented in 1968 and approved for medical use in 1975.

How should this medicine be used?

Recommended dosage: Hyperprolactinemic Indications: In Adults:

• The initial dosage of bromocriptine mesylate tablets in adults is one ½ to one 2.5 mg scored tablet daily.
• An additional 2.5 mg tablet may be added to the treatment regimen as tolerated every 2 to 7 days until an optimal therapeutic response is achieved. The therapeutic dosage ranged from 2.5‑15 mg daily in adults studied clinically.

In pediatric patients:

• The therapeutic dosage ranged from 2.5‑10 mg daily in children with prolactin‑secreting pituitary adenomas.

Acromegaly:

• The initial recommended dosage is one ½ to one 2.5 mg bromocriptine mesylate tablet on retiring (with food) for 3 days.
• An additional one ½ to 1 tablet should be added to the treatment regimen as tolerated every 3 to 7 days until the patient obtains optimal therapeutic benefit.
• The usual optimal therapeutic dosage range of bromocriptine varies from 20‑30 mg/day in most patients.
• The maximal dosage should not exceed 100 mg/day.

Parkinson’s Disease:

• The initial dose of bromocriptine is one ½ of a 2.5 mg tablet twice daily with meals.
• Assessments are advised at 2‑week intervals during dosage titration to ensure that the lowest dosage producing an optimal therapeutic response is not exceeded.
• If necessary, the dosage may be increased every 14 to 28 days by 2.5 mg/day with meals.
• The safety of bromocriptine has not been demonstrated in dosages exceeding 100 mg/day.

Administration:

• Bromocriptine (Parlodel) comes as a capsule and a tablet to take by mouth.
• It is recommended that bromocriptine mesylate tablets and capsules be taken with food.
• When bromocriptine (Parlodel) is used to treat hyperprolactinemia, it is usually taken once a day with food. When bromocriptine (Parlodel) is used to treat acromegaly, it is usually taken once a day at bedtime with food. When bromocriptine (Parlodel) is used to treat Parkinson's disease, it is usually taken twice a day with food.
• Take bromocriptine at around the same time(s) every day.
• Your doctor will probably start you on a low dose of bromocriptine and gradually increase your dose, not more than once every 2 to 28 days.
• Do not stop taking bromocriptine without talking to your doctor.
• If you suddenly stop taking bromocriptine, you may experience a lack of interest or concern for usual activities or things you usually care about, anxiety, depression, tiredness, difficulty falling asleep or staying asleep, sweating, or pain.
• Your doctor will probably decrease your dose gradually.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a capsule and a tablet

This medicine is available in fallowing brand namesː

• Parlodel

What side effects can this medication cause?

The most common side effects of this medicine include: In Hyperprolactinemic Indications:

• nausea , headache , dizziness , fatigue, lightheadedness, vomiting, abdominal cramps, nasal congestion, constipation, diarrhea and drowsiness

In Acromegaly:

• nausea , constipation, postural/orthostatic hypotension, anorexia, dry mouth/nasal stuffiness, indigestion/dyspepsia, digital vasospasm, drowsiness/tiredness and vomiting.

In Parkinson’s Disease:

• nausea, abnormal involuntary movements, hallucinations, confusion, “on‑off” phenomenon, dizziness, drowsiness, faintness/fainting, vomiting, asthenia, abdominal discomfort, visual disturbance, ataxia, insomnia, depression, hypotension, shortness of breath, constipation, and vertigo.

Bromocriptine may cause serious side effects, including:

• fainting
• watery discharge from the nose
• numbness, tingling, or pain in your fingers especially in cold weather
• black and tarry stools
• severe headache
• blurred or impaired vision
• slow or difficult speech
• weakness or numbness of an arm or leg
• bloody vomit
• vomiting material that looks like coffee grounds
• swelling of the feet, ankles, or lower legs
• seizures
• chest pain
• pain in the arms, back, neck or jaw
• shortness of breath
• confusion
• hallucinations

What special precautions should I follow?

• During clinical trials, dizziness, drowsiness, faintness, fainting, and syncope have been reported early in the course of bromocriptine therapy.
• Bromocriptine has been associated with somnolence, and episodes of sudden sleep onset, particularly in patients with Parkinson’s disease. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely.
• All patients receiving bromocriptine should be cautioned with regard to engaging in activities requiring rapid and precise responses, such as driving an automobile or operating machinery.
• Patients receiving bromocriptine for hyperprolactinemic states associated with macroadenoma or those who have had previous transsphenoidal surgery, should be told to report any persistent watery nasal discharge to their physician.
• Patients receiving bromocriptine for treatment of a macroadenoma should be told that discontinuation of drug may be associated with rapid regrowth of the tumor and recurrence of their original symptoms.
• Patients and their caregivers should be alerted to the possibility that patients may experience intense urges to spend money uncontrollably, intense urges to gamble, increased sexual urges and other intense urges and the inability to control these urges while taking bromocriptine. Advise patients and their caregivers to inform their healthcare provider if they develop new or increased uncontrolled spending, gambling urges, sexual urges, or other urges while being treated with bromocriptine
• Especially 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.
• Bromocriptine should not be used during lactation in postpartum women.
• Since hyperprolactinemia with amenorrhea/galactorrhea and infertility has been found in patients with pituitary tumors, a complete evaluation of the pituitary is indicated before treatment with bromocriptine mesylate.
• Symptomatic hypotension can occur in patients treated with bromocriptine for any indication. Since, especially 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.
• Bromocriptine therapy is associated with low rate of transient serum enzyme elevations during treatment and has been implicated in rare cases of acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• nausea, vomiting, constipation, diaphoresis, dizziness, pallor, severe hypotension, malaise, confusion, lethargy, drowsiness, delusions, hallucinations, and repetitive yawning

Management of overdosage:

• Treatment of overdose consists of removal of the drug by emesis (if conscious), gastric lavage, activated charcoal, or saline catharsis.
• Careful supervision and recording of fluid intake and output is essential.
• Hypotension should be treated by placing the patient in the Trendelenburg position and administering I.V. fluids.
• If satisfactory relief of hypotension cannot be achieved by using the above measures to their fullest extent, vasopressors should be considered.

Can this medicine be used in pregnancy?

• The safety of bromocriptine treatment during pregnancy to the mother and fetus has not been established.

Can this medicine be used in children?

• The safety and effectiveness of bromocriptine for the treatment of prolactin‑secreting pituitary adenomas have been established in patients age 16 to adult.
• Safety and effectiveness of bromocriptine in pediatric patients have not been established for any other indication listed.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• BROMOCRIPTINE MESYLATE

Inactive ingredients:

• POVIDONE, UNSPECIFIED
• STARCH, CORN
• LACTOSE, UNSPECIFIED FORM
• MAGNESIUM STEARATE
• MALEIC ACID
• ISOPROPYL ALCOHOL
• SILICON DIOXIDE

Who manufactures and distributes this medicine?

Distributed by:

• Sun Pharmaceutical Industries, Inc.
• Cranbury, NJ

Manufactured for:

• Validus Pharmaceuticals LLC
• Parsippany, NJ
• Product of Italy

What should I know about storage and disposal of this medication?

• Store at 68° to 77°F (20° to 25°C); excursions permitted to 59° to 86°F (15° to 30°C).
• Dispense in a tight, light-resistant container.

• Dailymed label info on Bromocriptine
• FDA Bromocriptine

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