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Dostinex Tablets USP contain Dostinex, USP, a dopamine receptor agonist. The chemical name for Dostinex, USP is 1-[(6-Allylergolin-8β-yl)-carbonyl]-1-[3-(dimethylamino)propyl]-3-ethylurea and has the following structural formula:
- C26H37N5O2 M.W. 451.6
Dostinex, USP is a white powder soluble in ethyl alcohol, chloroform, and N, N-dimethylformamide (DMF); slightly soluble in 0.1N hydrochloric acid; very slightly soluble in n-hexane; and insoluble in water.
Each Dostinex Tablet USP, for oral administration, contains 0.5 mg of Dostinex, USP and has the following inactive ingredients: anhydrous lactose and leucine.
Mechanism of Action
The secretion of prolactin by the anterior pituitary is mainly under hypothalamic inhibitory control, likely exerted through release of dopamine by tuberoinfundibular neurons. Dostinex is a long-acting dopamine receptor agonist with a high affinity for D2 receptors. Results of in vitro studies demonstrate that Dostinex exerts a direct inhibitory effect on the secretion of prolactin by rat pituitary lactotrophs. Dostinex decreased serum prolactin levels in reserpinized rats. Receptor-binding studies indicate that Dostinex has low affinity for dopamine D1, α1- and α2-adrenergic, and 5-HT1- and 5-HT2-serotonin receptors.
DOSAGE AND ADMINISTRATION
The recommended dosage of Dostinex tablets for initiation of therapy is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patient’s serum prolactin level. Before initiating treatment, cardiovascular evaluation should be performed and echocardiography should be considered to assess for valvular disease.
Dosage increases should not occur more rapidly than every 4 weeks, so that the physician can assess the patient’s response to each dosage level. If the patient does not respond adequately, and no additional benefit is observed with higher doses, the lowest dose that achieved maximal response should be used and other therapeutic approaches considered. Patients receiving long-term treatment with Dostinex should undergo periodic assessment of their cardiac status and echocardiography should be considered.
After a normal serum prolactin level has been maintained for 6 months, Dostinex may be discontinued, with periodic monitoring of the serum prolactin level to determine whether or when treatment with Dostinex should be reinstituted. The durability of efficacy beyond 24 months of therapy with Dostinex has not been established.
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