Bromocriptine Mesylate

Parlodel® (bromocriptine mesylate) is an ergot derivative with potent dopamine receptor agonist activity. Each Parlodel® (bromocriptine mesylate) SnapTabs® tablet for oral administration contains 2½ mg and each capsule contains 5 mg bromocriptine (as the mesylate). Bromocriptine mesylate is chemically designated as Ergotaman-3',6',18-trione, 2-bromo-12'-hydroxy-2'-(1-methylethyl)-5'-(2-methylpropyl)-, (5'α)-monomethanesulfonate (salt).

The structural formula is:

2½ mg SnapTabs®

Active Ingredient: bromocriptine mesylate, USP

Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, povidone, starch, and another ingredient

5 mg Capsules

Active Ingredient: bromocriptine mesylate, USP

Inactive Ingredients: colloidal silicon dioxide, gelatin, lactose, magnesium stearate, red iron oxide, silicon dioxide, sodium lauryl sulfate, starch, titanium dioxide, yellow iron oxide, and another ingredient

Hyperprolactinemia-Associated Dysfunctions

Parlodel® (bromocriptine mesylate) is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Parlodel treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of Parlodel therapy may be used to reduce the tumor mass prior to surgery.

Acromegaly

Parlodel therapy is indicated in the treatment of acromegaly. Parlodel therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately ½ of patients treated, although not usually to normal levels.

Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with Parlodel offers potential benefit before the effects of irradiation are manifested.

Parkinson's Disease

Parlodel SnapTabs® or capsules are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson's disease. As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), Parlodel therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing “end of dose failure'' on levodopa therapy. Parlodel therapy may permit a reduction of the maintenance dose of levodopa and, thus may ameliorate the occurrence and/or severity of adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements (e.g., dyskinesias) and the marked swings in motor function (“on-off'' phenomenon). Continued efficacy of Parlodel therapy during treatment of more than 2 years has not been established.

Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson's disease with Parlodel. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in Parlodel-treated patients than in levodopa/carbidopa-treated patients. Patients unresponsive to levodopa are poor candidates for Parlodel therapy.

Ergot-derivative dopamine receptor agonist and prolactin inhibitor.a b

Hyperprolactinemic Disorders

Treatment of male and female dysfunctions associated with hyperprolactinemia, including amenorrhea and/or galactorrhea, hypogonadism, and infertility.a b

Used in patients with prolactin-secreting adenomas (e.g., prolactinoma), including macroadenomas, to decrease tumor size; may be used prior to surgery in patients undergoing excision of the tumor (adenectomy).a b

Treatment of female infertility associated with hyperprolactinemia; used to induce ovulation in appropriately selected anovulatory women.b

Treatment of hypogonadism and galactorrhea that persist following radiation therapy or surgery in hyperprolactinemic males with prolactin-secreting adenomas and adequate testosterone concentrations.a b Some clinicians consider bromocriptine the treatment of choice for reduction of large tumors (macroadenomas).b

Parkinsonian Syndrome

Symptomatic management of idiopathic or postencephalitic parkinsonian syndrome.a b

Used as an adjunct to levodopa for the symptomatic management of parkinsonian syndrome in patients with advanced disease.111 112 a

Has been used as monotherapy for initial symptomatic management of parkinsonian syndrome†.111 Most clinicians would use levodopa for initial therapy in individuals >70 years of age (less likely than younger individuals to develop levodopa-related motor complications and because of concerns about cognitive dysfunction), in patients with cognitive impairment, and in those with severe disease.111 A dopamine receptor agonist may be preferred for initial therapy in patients ≤70 years of age.111

Acromegaly

Treatment of acromegaly, alone or as adjunctive therapy with pituitary irradiation or surgery.a b

Male Infertility

Has been used to increase sperm counts and restore fertility† in oligospermic men without hyperprolactinemia who are unresponsive to traditional drug therapy.b

Neuroleptic Malignant Syndrome

Has been used to relieve extrapyramidal reactions, hyperthermia, and hypertension of neuroleptic malignant syndrome† (NMS) associated with neuroleptic drug therapy (e.g., haloperidol, fluphenazine).b

Hepatic Encephalopathy

Has been used in the management of chronic hepatic encephalopathy†.b

Postpartum Breast Engorgement

Used in the past for prevention of postpartum breast engorgement†;106 b FDA has withdrawn approval of bromocriptine for this indication because the risk of serious, potentially fatal adverse effects100 102 104 107 108 outweigh the limited benefits associated with this use.101 103 (See Cardiovascular Effects under Cautions.)

Storage

Oral

Tight, light-resistant containers at <25°C.a

This medication guide provides information about the Parlodel brand of bromocriptine. Cycloset is another brand of bromocriptine that is not covered in this medication guide.

The Parlodel brand of bromocriptine is used to treat certain conditions caused by a hormone imbalance in which there is too much prolactin in the blood (hyperprolactinemia). Symptoms include lack of sexual development in adolescents. Women may have missed menstrual periods, loss of interest in sex, hot flashes, infertility, or unexpected breast milk production and leakage from the nipples. Men may have enlarged breasts, decreased libido, decreased facial or body hair, and loss of muscle. Parlodel is also used to treat these disorders when they are caused by brain tumors that can produce prolactin.

Parlodel is sometimes used together with surgery or radiation in treating acromegaly, a condition caused by a pituitary gland tumor that produces too much growth hormone. Parlodel is also used to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control.

Bromocriptine may also be used for purposes not listed in this medication guide.

This medication guide provides information about the Parlodel brand of bromocriptine. Cycloset is another brand of bromocriptine that is not covered in this medication guide.

You should not use Parlodel if you have uncontrolled high blood pressure, if you have high blood pressure caused by pregnancy (eclampsia or preeclampsia), or if you have recently had a baby and you have a history of coronary artery disease or severe heart disease. You may need to stop taking Parlodel if you become pregnant during treatment. Follow your doctor's instructions.

You should not breast-feed a baby while taking bromocriptine.

Tell your doctor right away if you become pregnant while taking bromocriptine.

• Breastfeeding (and Formula Feeding)
• Parkinson's Disease
• Sleep Disorder Drugs