(October 19, 2007)
Summary of REGPARA® TABLETS
| Product name: | REGPARA® TABLETS 25 mg REGPARA® TABLETS 75 mg |
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| Generic name: | Cinacalcet hydrochloride |
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| Date of approval: | October 19, 2007 |
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| Indication: | secondary hyperparathyroidism during maintenance dialysis |
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| Dosage and administration: | In adults, the initial oral dose is 25 mg cinacalcet, given once daily. The oral dose, given once daily, is subsequently adjusted between 25 and 75 mg based on sufficient monitoring of the patient's parathyroid hormone (PTH) and serum calcium levels. However, in the event that no improvements in PTH are observed, the product is given orally with an upper limit of 100 mg per administration. Dose may be increased in 25 mg increments at intervals of at least three weeks. |
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| Characteristic: | REGPARA® TABLETS are the only treatment medicine for secondary hyperparathyroidism that acts on calcium receptors in the parathyroid gland. It is expected to prevent the development and progression of cardiovascular disorders, which account for nearly half of deaths among dialysis patients. |
