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Bromocriptine mesylate is an ergot derivative indicated for the treatment of: Hyperprolactinemia-associated dysfunction including amenorrhea with or without galactorrhea, infertility, or hypogonadism in adults ( 1.1 ) Prolactin-secreting adenomas in adults and pediatric patients 11 years of age and older ( 1.2 ). Acromegaly in adults ( 1.3 ). Signs and symptoms of idiopathic Parkinson's disease or postencephalitic parkinsonism in adults ( 1.4 ). Limitations of Use Avoid use of bromocriptine mesylate capsule for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions ( 1.1 , 5.4 ) 1.1 Hyperprolactinemia-Associated Dysfunction Bromocriptine mesylate capsules are indicated for the treatment of hyperprolactinemia-associated dysfunction including amenorrhea with or without galactorrhea, infertility or hypogonadism in adults. Limitations of Use Avoid use of bromocriptine mesylate for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions ( 5.4 )]. 1.2 Prolactin-Secreting Adenomas Bromocriptine mesylate capsules are indicated for the treatment of prolactin-secreting adenomas in adults and pediatric patients 11 years of age and older. 1.3 Acromegaly Bromocriptine mesylate capsules are indicated for the treatment of acromegaly in adults. 1.4 Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism Bromocriptine mesylate capsules …

Bromocriptine mesylate capsules are contraindicated in patients with: History of cardiac valvular disorders or a history of pericardial fibrosis [see Warnings and Precautions ( 5.1 )]. History of pleural, pulmonary, or retroperitoneal fibrotic disorders [see Warnings and Precautions ( 5.2 )]. Uncontrolled hypertension [see Warnings and Precautions ( 5.3 )]. Hypersensitivity to bromocriptine or to any of the excipients of bromocriptine mesylate capsules or sensitivity to other ergot alkaloids. Bromocriptine mesylate capsules is contraindicated in patients with: History of cardiac valvular disorders or a history of pericardial fibrosis ( 4 , 5.1 ). History of pleural, pulmonary, or retroperitoneal fibrotic disorders ( 4 , 5.2 ) Uncontrolled hypertension ( 4 , 5.3 ) Hypersensitivity to bromocriptine or to any of the excipients of bromocriptine mesylate capsules or sensitivity to other ergot alkaloids ( 4 ).

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 …

8.1 Pregnancy Risk Summary Pregnancy in Patients with Hyperprolactinemia-Associated Dysfunction and Prolactin-Secreting Adenomas: In patients being treated with bromocriptine mesylate capsules for hyperprolactinemia, bromocriptine mesylate should generally be withdrawn when pregnancy is diagnosed. If bromocriptine mesylate is continued or reinstituted in select patients to manage a prolactin-secreting macroadenoma and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing bromocriptine mesylate capsules should be weighed against the possible risk of its use during a hypertensive disorder of pregnancy. Pregnancy in Patients with Acromegaly : In patients being …