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Cabergoline Tablets, USP contain Cabergoline USP a dopamine receptor agonist. The chemical name for Cabergoline USP is 1-[(6-allylergolin-8?-yl)-carbonyl]-1-[3-(dimethylamino)propyl]-3-ethylurea. Its molecular formula is C 26 H 37 N 5 O 2 , and its molecular weight is 451. The structural formula is as follows: Cabergoline USP is a white powder soluble in ethyl alcohol, chloroform, and N, N-dimethylformamide (DMF); slightly soluble in 0. Cabergoline Tablets, USP for oral administration, contains 0. Inactive ingredients consist of microcrystalline cellulose, croscarmellose sodium, citric acid, and magnesium stearate. Cabergoline – Clinical Pharmacology. Mechanism of Action: The secretion of prolactin by the anterior pituitary is mainly under hypothalmic inhibitory control, likely exerted through release of dopamine by tuberoinfundibular neurons. Cabergoline is a long-acting dopamine receptor agonist with a high affinity for D 2 receptors. Results of in vitro studies demonstrate that Cabergoline exerts a direct inhibitory effect on the secretion of prolactin by rat pituitary lactotrophs. Cabergoline decreased serum prolactin levels in reserpinized rats. Receptor-binding studies indicate that Cabergoline has low affinity for dopamine D 1 , ? 1 – and ? 2 -adrenergic, and 5-HT 1 – and 5-HT 2 -serotonin receptors. Clinical Studies: The prolactin-lowering efficacy of Cabergoline was demonstrated in hyperprolactinemic women in two randomized, double-blind, comparative studies, one with placebo and the other with bromocriptine. In the placebo-controlled study (placebo n=20; Cabergoline n=168), Cabergoline produced a dose-related decrease in serum prolactin levels with prolactin normalized after 4 weeks of treatment in 29%, 76%, 74% and 95% of the patients receiving 0. In the 8-week, double-blind period of the comparative trial with bromocriptine (Cabergoline n=223; bromocriptine n=236 in the intent-to-treat analysis), prolactin was normalized in 77% of the patients treated with Cabergoline at 0. Restoration of menses occurred in 77% of the women treated with Cabergoline, compared with 70% of those treated with bromocriptine. Among patients with galactorrhea, this symptom disappeared in 73% of those treated with Cabergoline compared with 56% of those treated with bromocriptine, what is the best legal steroid for muscle gain. Absorption: Following single oral doses of 0. A repeat-dose study in 12 healthy volunteers suggests that steady-state levels following a once-weekly dosing schedule are expected to be twofold to threefold higher than after a single dose. The absolute bioavailability of Cabergoline is unknown. A significant fraction of the administered dose undergoes a first-pass effect. The elimination half-life of Cabergoline estimated from urinary data of 12 healthy subjects ranged between 63 to 69 hours. The prolonged prolactin-lowering effect of Cabergoline may be related to its slow elimination and long half-life. Distribution: In animals, based on total radioactivity, Cabergoline (and/or its metabolites) has shown extensive tissue distribution. Radioactivity in the pituitary exceeded that in plasma by >100-fold and was eliminated with a half-life of approximately 60 hours.
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