Efficient Medicine Powder Cabergoline (Dostinex) Used for Hyperprolactinemia
Efficient Medicine powder Cabergoline(Dostinex) used for hyperprolactinemia
Alias: Cabaser, Dostinex; Dostine, 6-Allyl-N-[3-(dimethylamino)propyl]-N-(ethylcarbamoyl)ergoline-8-carboxamide
Molecular Formula: C26H37N5O2
Molecular Weight: 451.6
Melting Point: 102-104° C
White powder. Soluble in ethyl alcohol, chloroform, and N, Ndimethylformamide (DMF); Slightly soluble in 0.1N hydrochloric acid; Very slightly soluble in n-hexane; And insoluble in water.
Pharmaceutical intermediates. This medication is used to treat high levels of prolactin hormone in your body. High levels of prolactin in women can cause symptoms such as unwanted breast milk and missed periods and can cause difficulty becoming pregnant. High levels of prolactin in men can cause symptoms such as enlarged breasts and decreased sexual ability/desire. Cabergoline is an ergot medication and works by blocking the release of prolactin from the pituitary gland.
2. adjunctive therapy of prolactin-producing pituitary gland tumors (prolactinomas);
3. monotherapy of Parkinson's disease in the early phase;
4. combination therapy, together with levodopa and a decarboxylase inhibitor such as carbidopa, in progressive-phase Parkinson's disease;
5. in some countries also: ablactation and dysfunctions associated with hyperprolactinemia (amenorrhea, oligomenorrhea, anovulation, nonpuerperal mastitis and galactorrhea);
6. treatment of uterine fibroids.
7. adjunctive therapy of acromegaly, cabergoline has low efficacy in suppressing levels and is highly efficient in suppressing hyperprolactinemia that is present in 20-30% of acromegaly cases;
8.and prolactin are similar structurally and have similar effects in many target tissues, therefore targeting prolactin may help symptoms when hormone secretion can not be sufficiently controlled by other methods;
9. Cushing's disease - cabergoline may be used to lower ACTH levels and cause regression of ACTH producing pituitary adenomas;
10. other pituitary adenomas - cabergoline has demonstrated certain efficacy in controlling or reducing other kinds of pituitary adenomas, as well as silent or non-functional adenomas.
How to use cabergoline:
Use cabergoline as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take cabergoline by mouth with or without food.
It may be helpful to mark on a calendar which days you are supposed to take cabergoline.
If you miss a dose of cabergoline, contact your doctor right away.
Ask your health care provider any questions you may have about how to use cabergoline.
Parkinson's disease: Monotherapy: Initial dose should be 0.5 mg daily. The usual maintenance dose is 2 to 4 mg daily. Combination therapy: Usually 2 to 6 mg daily.
Tumors of the pituitary gland and other hyperprolactinemic conditions: Initially 0.5 mg per week, slowly titrated to 4.5 mg per week, if necessary.
Ablactation: According to specific treatment scheme.
CERTIFCATE OF ANALYSIS
|Analysis Date||2015. 06. 01||MFG Date||2015. 05. 07|
|Description||White or almost white crystarlline powder||Conforn|
|Identify||1. IR complies|
2. X-Ray complies
3. HPLC complies
|Water||No more than 0.5%||0.2%|
|Reiated substances||1.Allylamide (USP,rel,D) no more than 0.10%|
2. Allyl DHLA(USP,rel,D) no more than 0.15%;
3.Cabergoline oxide no more than 0.10% ;
4.Other impurities individually no more than 0.10% ;
5.Total no more than 0.50% ;
Less than 0.02%
Less than 0.02%
Less than 0.02%
|Opdical rotation||-83.0-- -77.0||-78|
|Residual Solvents||1.Dichloromethane no more than 100ppm;|
2.Acetone no more than200ppm;
3.Tert-butylmethylether no more than 200ppm;
4.Xylene no more than 1500ppm;
5.HEptane no more than 1000ppm;
|Residue on ignition||NO more than0.10 %||0.02%|
|Heavy metals||NO more than 20ppm||2ppm|
|Partcle size||90%af particles no mone than 80μm||Conform|
|Conclusion||Conforn with EP6.0/ USP38|
Packaging & Delivery Process:
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