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Basic Drug Info
Drug Name:Dostinex
Manufacturer:Pharmacia and Upjohn Company
Other Info:Rx onlyLAB-0030-8.0December 2007



Clinical Trials:


Indications and Usage
DOSTINEX Tablets are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.
Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Pituitary Adenoma -- Abnormal growth of cells in the pituitary gland that can either secrete hormone or not. The diagnosis can be based on imaging studies and/or radioimmunoassays. Due to their location in the sella turcica, expansion of the tumor mass can impinge on the optic chiasm or involve the temporal lobe, third ventricle and posterior fossa. A frequently associated physical finding is bitemporal hemianopsia which may progress to further visual loss.

Contraindications

DOSTINEX Tablets are contraindicated in patients with Uncontrolled hypertension or known hypersensitivity to ergot derivatives.History of pulmonary, pericardial, cardiac valvular, or retroperitoneal fibrotic disorders.

(See PRECAUTIONS, Fibrosis)
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Retroperitoneal Disorder --

Fibrosis -- Any pathological condition where fibrous connective tissue invades any organ, usually as a consequence of inflammation or other injury.

Warnings

Post marketing cases of cardiac valvulopathy have been reported in patients receiving DOSTINEX.

These cases have generally occurred during long-term administration of high doses of DOSTINEX (>2mg/day) used for the treatment of Parkinson's disease.

Rare cases have been reported associated with short-term treatment (<6 months) or in patients receiving lower doses for the treatment of hyperprolactinemia.Physicians should use the lowest effective dose of DOSTINEX for the treatment of hyperprolactinemia and should periodically reassess the need for continuing therapy with DOSTINEX.

In addition, patients receiving long term treatment with DOSTINEX should undergo periodic reassessment of their cardiac status, and echocardiography should be considered.

Any patient who develops signs or symptoms of cardiac disease, including dyspnea, edema, congestive heart failure, or a new cardiac murmur, while being treated with DOSTINEX should be evaluated for possible valvulopathy.DOSTINEX should be used with caution in patients who have hemodynamically significant valvular disease or have been exposed to other medications associated with valvulopathy.

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