If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Parlodel (bromocriptine (parlodel)), like certain drugs that are used for mental or mood problems, migraines, or stomach or bowel problems. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Parlodel.Safety and efficacy of Parlodel (bromocriptine mesylate) have not been established in patients with renal or hepatic disease. Since parkinsonian patients may manifest mild degrees of dementia, caution should be used when treating such patients.Parlodel administered alone or concomitantly with levodopa may cause hallucinations (visual or auditory). 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 Parlodel 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.The risk of using Parlodel in combination with other drugs has not been systematically evaluated, but alcohol may potentiate the side effects of Parlodel. Since pregnancy may occur prior to reinitiation of menses, a pregnancy test is recommended at least every 4 weeks during the amenorrheic period, and, once menses are reinitiated, every time a patient misses a menstrual period. No data are available for bromocriptine use in pediatric patients under the age of 8 years. 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. In those instances in which Parlodel treatment was terminated, the changes slowly reverted towards normal.In a few patients on Parlodel, particularly on long-term and high-dose treatment, retroperitoneal fibrosis has been reported. )* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name100. Parlodel may interact with dopamine antagonists, butyrophenones, and certain other agents. 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:2… Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in Parlodel-treated patients than in levodopa/carbidopa-treated patients. 104.
94N-0304.] A few cases of cerebrospinal fluid rhinorrhea have been reported in patients receiving Parlodel for treatment of large prolactinomas. The high dose was approximately 63 times the maximum human dose administered in controlled clinical trials (100 mg/day), based on body surface area. In contrast to the findings in rats, the uteri from mice killed after 74 weeks of treatment did not exhibit evidence of drug-related changes.Bromocriptine mesylate was evaluated for mutagenic potential in the battery of tests that included Ames bacterial mutation assay, mutagenic activity No mutagenic effects were obtained in any of these tests.Fertility and reproductive performance in female rats were not influenced adversely by treatment with bromocriptine beyond the predicted decrease in the weight of pups due to suppression of lactation.
Patients who have experienced somnolence and/or an episode of sudden sleep onset must not drive or operate machines. 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 in a few patients. Caution should therefore be used when co-administering drugs which are strong inhibitors of this enzyme (such as azole antimycotics, HIV protease inhibitors). The occurrence of adverse reactions may be lessened by temporarily reducing dosage to ½ SnapTabs tablet 2 or 3 times daily.
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