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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.
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.
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.
DOSAGE AND ADMINISTRATION
It is recommended that Parlodel® (bromocriptine mesylate) be taken with food. Patients should be evaluated frequently during dose escalation to determine the lowest dosage that produces a therapeutic response.
The initial dosage of Parlodel SnapTabs® in adults is ½ to one 2½ mg scored tablet daily. An additional 2½ mg tablet may be added to the treatment regimen as tolerated every 2-7 days until an optimal therapeutic response is achieved. The therapeutic dosage ranged from 2.5-15 mg daily in adults studied clinically.
Based on limited data in children of age 11 to 15, (see Pediatric Use) the initial dose is ½ to one 2½ mg scored tablet daily. Dosing may need to be increased as tolerated until a therapeutic response is achieved. The therapeutic dosage ranged from 2.5-10 mg daily in children with prolactin-secreting pituitary adenomas.
In order to reduce the likelihood of prolonged exposure to Parlodel should an unsuspected pregnancy occur, a mechanical contraceptive should be used in conjunction with Parlodel therapy until normal ovulatory menstrual cycles have been restored. Contraception may then be discontinued in patients desiring pregnancy.
Thereafter, if menstruation does not occur within 3 days of the expected date, Parlodel therapy should be discontinued and a pregnancy test performed.
Virtually all acromegalic patients receiving therapeutic benefit from Parlodel also have reductions in circulating levels of growth hormone. Therefore, periodic assessment of circulating levels of growth hormone will, in most cases, serve as a guide in determining the therapeutic potential of Parlodel. If, after a brief trial with Parlodel therapy, no significant reduction in growth hormone levels has taken place, careful assessment of the clinical features of the disease should be made, and if no change has occurred, dosage adjustment or discontinuation of therapy should be considered.
The initial recommended dosage is ½ to one 2½ mg Parlodel SnapTabs tablet on retiring (with food) for 3 days. An additional ½ to 1 SnapTabs tablet should be added to the treatment regimen as tolerated every 3-7 days until the patient obtains optimal therapeutic benefit. Patients should be reevaluated monthly and the dosage adjusted based on reductions of growth hormone or clinical response. The usual optimal therapeutic dosage range of Parlodel varies from 20-30 mg/day in most patients. The maximal dosage should not exceed 100 mg/day.
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 as well as the effects of Parlodel therapy. Usually a 4-8 week withdrawal period is adequate for this purpose. Recurrence of the signs/symptoms or increases in growth hormone indicate the disease process is still active and further courses of Parlodel should be considered.
The basic principle of Parlodel therapy is to initiate treatment at a low dosage and, on an individual basis, increase the daily dosage slowly until a maximum therapeutic response is achieved. The dosage of levodopa during this introductory period should be maintained, if possible. The initial dose of Parlodel is ½ of a 2½ mg SnapTabs 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 14-28 days by 2½ mg/day with meals. Should it be advisable to reduce the dosage of levodopa because of adverse reactions, the daily dosage of Parlodel, if increased, should be accomplished gradually in small (2½ mg) increments.
The safety of Parlodel has not been demonstrated in dosages exceeding 100 mg/day.
Parlodel® (bromocriptine mesylate) SnapTabs®
Round, off-white, beveled-edge SnapTabs®, each containing 2½mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½” on one side and scored on reverse side. Complies with USP dissolution test 1.
Packages of 30…………………………..NDC 0078-0017-15
Packages of 100…………………………NDC 0078-0017-05
Parlodel® (bromocriptine mesylate) Capsules
Caramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg” on one half and “ ” on other half.
Packages of 30…………………………..NDC 0078-0102-15
Packages of 100…………………………NDC 0078-0102-05
Store and Dispense
Below 25°C (77°F); tight, light-resistant container. January 2012
Manufactured by: Novartis Pharmaceuticals Corporation Suffern, New York 10901. Distributed by: Novartis Pharmaceuticals Corporation East Hanover , New Jersey 07936
Last reviewed on RxList: 1/17/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Parlodel Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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