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Cabergoline does not cause enzyme induction and/or inhibition in the rat. Hydrolysis of the acylurea or urea moiety abolishes the prolactin-lowering effect of Cabergoline, and major metabolites identified thus far do not contribute to the therapeutic effect. Excretion: After oral dosing of radioactive Cabergoline to five healthy volunteers, approximately 22% and 60% of the dose was excreted within 20 days in the urine and feces, respectively. Less than 4% of the dose was excreted unchanged in the urine. Nonrenal and renal clearances for Cabergoline are about 3. Urinary excretion in hyperprolactinemic patients was similar. Renal Insufficiency: The pharmacokinetics of Cabergoline were not altered in 12 patients with moderate-to severe renal insufficiency as assessed by creatinine clearance. Hepatic Insufficiency: In 12 patients with mild-to-moderate hepatic dysfunction (Child-Pugh score ?10), no effect on mean Cabergoline C max or area under the plasma concentration curve (AUC) was observed. However, patients with severe insufficiency (Child-Pugh score >10) show a substantial increase in the mean Cabergoline C max and AUC, and thus necessitate caution. Elderly: Effect of age on the pharmacokinetics of Cabergoline has not been studied. In 12 healthy adult volunteers, food did not alter Cabergoline kinetics. Dose response with inhibition of plasma prolactin, onset of maximal effect, and duration of effect has been documented following single Cabergoline doses to healthy volunteers (0. In volunteers, prolactin inhibition was evident at doses >0, buy ghrp-2 5 mg peptides . Higher doses produce prolactin suppression in a greater proportion of subjects and with an earlier onset and longer duration of action. In 12 healthy volunteers, 0. In hyperprolactinemic patients (n=51), the maximal prolactin decrease after a 0. The time to maximal effect was shorter for bromocriptine than Cabergoline (6 hours vs. In 72 healthy volunteers, single or multiple doses (up to 2 mg) of Cabergoline resulted in selective inhibition of prolactin with no apparent effect on other anterior pituitary hormones (GH, FSH, LH, ACTH, and TSH) or cortisol. Indications and Usage for Cabergoline. Cabergoline Tablets, USP are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas. Cabergoline Tablets, USP are contraindicated in patients with: Uncontrolled hypertension or known hypersensitivity to ergot derivatives. History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve, determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis. Pregnancy: Dopamine agonists in general should not be used in patients with pregnancy-induced hypertension, for example, preeclampsia eclampsia, and post partum hypertension, unless the potential benefit is judged to outweigh the possible risk. Cardiac Valvulopathy: All patients should undergo a cardiovascular evaluation, including echocardiogram to assess the potential presence of valvular disease. If valvular disease is detected, the patient should not be treated with Cabergoline (See Contraindications ).
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