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Cabergoline, an ergot derivative, is a potent dopamine receptor agonist on D₂ receptors. Rat studies show cabergoline has a direct inhibitory effect on pituitary lactotroph cells.
Agalates Tablets USP contain Agalates, USP, a dopamine receptor agonist. The chemical name for Agalates, 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
Agalates, 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 Agalates Tablet USP, for oral administration, contains 0.5 mg of Agalates, 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. Agalates is a long-acting dopamine receptor agonist with a high affinity for D2 receptors. Results of in vitro studies demonstrate that Agalates exerts a direct inhibitory effect on the secretion of prolactin by rat pituitary lactotrophs. Agalates decreased serum prolactin levels in reserpinized rats. Receptor-binding studies indicate that Agalates has low affinity for dopamine D1, α1- and α2-adrenergic, and 5-HT1- and 5-HT2-serotonin receptors.
The prolactin-lowering efficacy of Agalates 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, Agalates 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 0.125, 0.5, 0.75, and 1 mg twice weekly respectively.
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 Agalates at 0.5 mg twice weekly compared with 59% of those treated with bromocriptine at 2.5 mg twice daily. Restoration of menses occurred in 77% of the women treated with Agalates, compared with 70% of those treated with bromocriptine. Among patients with galactorrhea, this symptom disappeared in 73% of those treated with Agalates compared with 56% of those treated with bromocriptine.
DOSAGE AND ADMINISTRATION
The recommended dosage of Agalates 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 Agalates 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, Agalates may be discontinued, with periodic monitoring of the serum prolactin level to determine whether or when treatment with Agalates should be reinstituted. The durability of efficacy beyond 24 months of therapy with Agalates has not been established.
Agalates Tablets USP, 0.5 mg are available as white, oval-shaped, scored tablets, debossed “Ivax hourglass logo”, “0.5” with a score on one side and “5420” on the other side containing 0.5 mg Agalates, packaged in unit-of-use bottles of 8 tablets.
Store at 20° to 25°C (68° to 77°F).
Dispense in original container.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured In Czech Republic By:
TEVA CZECH INDUSTRIES s.r.o.
Opava-Komarov, Czech Republic
TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454
Rev. D 4/2015
Agalates Tablets USP 0.5 mg 8s Carton, Part 1 of 2
Agalates Tablets USP 0.5 mg 8s Carton Text
Each tablet contains:
Agalates, USP 0.5 mg
Dispense in original container
8 TABLETS UNIT-OF-USE
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