parlodel

Important safety information

Cardiac Valvulopathy and Pericardial Fibrosis: During bromocriptine mesylate treatment, monitor for the development of valvulopathy with a cardiac echocardiogram at intervals of 6 to 12 months or as clinically indicated and monitor for chest pain and signs and symptoms of heart failure (if heart failure occurs, exclude valvular fibrosis and pericarditis). Consider additional clinical and diagnostic monitoring at baseline and as necessary during bromocriptine mesylate treatment. Use bromocriptine mesylate in patients treated with other drugs associated with valvulopathy is not recommended. Discontinue bromocriptine mesylate if the patient has a new diagnosis of valvular regurgitation, valvular restriction, valve leaflet thickening, or pericarditis. (5.1) Pleural, Pulmonary and Retroperitoneal Fibrosis: During bromocriptine mesylate treatment monitor for signs and symptoms of progressive fibrosis, (e.g., pleuro-pulmonary disease, renal impairment, ureteral/abdominal vascular obstruction). Consider clinical and diagnostic monitoring for pleural, pulmonary, and retroperitoneal fibrosis at baseline and as necessary during bromocriptine mesylate treatment. If pleural, pericardial, retroperitoneal, or pulmonary fibrosis occur, discontinue bromocriptine mesylate (5.2) Hypotension/Orthostatic Hypotension: Check blood pressure at baseline and during treatment with bromocriptine mesylate and monitor for hypotension. Patients with Parkinson’s disease being treated with bromocriptine mesylate should be monitored for signs and symptoms of orthostatic hypotension (5.3) Risks with Use of Bromocriptine Mesylate for Postpartum Lactation Inhibition or Suppression: Avoid use of bromocriptine mesylate for the inhibition or suppression of physiologic lactation. Use of bromocriptine, another dopamine agonist for this unapproved use has been associated with cases of hypertension, stroke, myocardial infarction, seizures, and death. (5.4) Impulse Control Disorders and Compulsive Behaviors: Specifically ask patients about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating or other urges while being treated with bromocriptine mesylate. Consider dosage reduction or stopping bromocriptine mesylate if a patient develops such urges while taking bromocriptine mesylate. (5.5) Falling Asleep During Activities of Daily Living: If symptoms of daytime sleepiness or episodes of falling asleep occur while taking bromocriptine mesylate, advise patients not to drive or perform dangerous activities. Consider reducing the dosage or stopping bromocriptine mesylate if patients experience somulence or sudden sleep onset (5.6). Visual Impariment in Patients with Prolactin-Secreting Adenomas: Recommend monitoring of visual fields in bromocriptine mesylate-treated patients with macroprolactinoma for an early recognition of secondary field loss due to chiasmal herniation. Bromocriptine mesylate-patients with rapidly progressive visual field loss should be evaluated by a neurosurgeon to help decide on the most appropriate therapy (5.7) Exacerbation of Psychosis in Patients with Severe Psychotic Disorders: Use of bromocriptine mesylate in patients with severe psychotic disorders in not recommended (5.8) 5.1 Cardiac Valvulopathy and Pericardial Fibrosis Before initiating bromocriptine mesylate, perform a cardiovascular evaluation, including with an echocardiogram, to evaluate for valvular disease. Bromocriptine mesylate is contraindicated in the presence of valvular disease or pericardial fibrosis . Bromocriptine mesylate is not recommended in patients treated with other drugs associated with valvulopathy. Following bromocriptine mesylate treatment initiation, monitor for the development of valvulopathy with a cardiac echocardiogram at intervals of 6 to 12 months or as clinically indicated with new onset edema, cardiac murmur, dyspnea, or heart failure. During bromocriptine mesylate treatment, monitor for chest pain and signs and symptoms of heart failure and if heart failure occurs, valvular fibrosis and pericarditis should be excluded. Consider clinical and diagnostic monitoring such as erythrocyte sedimentation rate, serum creatinine measurements, chest-x-ray, and other investigations and cardiac imaging at baseline and as necessary while patients are treated with during bromocriptine mesylate treatment. Discontinue bromocriptine mesylate if the patient has a new diagnosis of valvular regurgitation, valvular restriction, valve leaflet thickening, or pericarditis. Cases of cardiac valvulopathy have occurred in bromocriptine mesylate-treated patients. Pericardial effusions, as well as constrictive pericarditis, have been reported in bromocriptine mesylate-treated patients, particularly those on long-term and high-dosage treatment. 5.2 Pleural, Pulmonary, and Retroperitoneal Fibrosis Bromocriptine mesylate is contraindicated in patients with a history of pleural, pulmonary, or retroperitoneal fibrosis. During Bromocriptine mesylate treatment monitor for signs and symptoms of progressive fibrosis, including: Pleuro-pulmonary disease (e.g., dyspnea, shortness of breath, persistent cough, chest pain). Renal impairment or ureteral/abdominal vascular obstruction (e.g., pain in the loin/flank, lower limb edema, abdominal masses or tenderness that may indicate retroperitoneal fibrosis). Consider clinical and diagnostic monitoring for pleural, pulmonary, and retroperitoneal fibrosis such as with erythrocyte sedimentation rate, serum creatinine measurements, chest-x-ray, and other investigations at baseline and as necessary during bromocriptine mesylate treatment. If pleural, pericardial, retroperitoneal, or pulmonary fibrosis occur, discontinue bromocriptine mesylate. Pleural and Pulmonary Fibrosis Patients with unexplained pleuropulmonary disorders should be examined thoroughly and discontinuation of bromocriptine mesylate therapy should be considered. Pleural effusions, pleural fibrosis, and pulmonary fibrosis have been reported in bromocriptine mesylate-treated patients, particularly those on long-term and high-dosage treatment. In those instances in which bromocriptine mesylate treatment was stopped, the changes slowly reverted towards normal. Retroperitoneal Fibrosis To ensure recognition of retroperitoneal fibrosis at an early reversible stage recommend that patients on long-term and high-dosage treatment should be monitored for its manifestations (e.g., back pain, lower limb edema, impaired kidney function). Bromocriptine mesylate should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected. Retroperitoneal fibrosis has been reported in a few bromocriptine mesylate-treated patients, particularly those on long-term and high-dosage treatment. Retroperitoneal fibrosis has been reported in a few patients with Parkinson’s disease who received long-term bromocriptine mesylate therapy (2 to 10 years) in dosages that ranged from 30 mg daily to 140 mg daily (9.3, 1.4, and 1.4 times the maximum recommended bromocriptine mesylate dosage for the hyperprolactionemia-associate dysfunction, acromegaly, and idiopathic Parkinson’s disease or postencephalitic parkinsonism indications, respectively [see Dosage and Administration (2.6)]). 5.3 Hypotension/Orthostatic Hypotension Hypotension/Orthostatic Hypotension Check blood pressure at baseline and during treatment with bromocriptine mesylate and monitor for hypotension. Instruct patients to report dizziness or lightheadedness with changes in position to their healthcare provider. Particular care should be exercised in bromocriptine mesylate-treated patients when driving a vehicle or operating hazardous machinery. Hypotensive reactions may occur during bromocriptine mesylate treatment, especially during the first days of treatment. Orthostatic Hypotension in Patients with Parkinson’s Disease Patients with Parkinson’s disease being treated with dopaminergic agonists, including…