Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2010 Publisher: RenaCare NephroMed GmbH, Werrastr. 1 a, 35625 Hüttenberg, Germany Phone: +49 (0) 64 03 9 21 60 Fax: +49 (0) 64 03 9 21 63 E-mail: mail@renacare.com
Pharmacotherapeutic group: Drug for treatment of hyperphosphatemia
ATC-Code: A12AA12
Calcium is an endogenous ion of the body essential for the maintenance of a number of physiologic processes. It participates as an integral factor in the maintenance of the functional integrity of the nervous system, in the contractile mechanisms of muscle tissue, in the clotting of blood, and in the formation of the major structural material of the skeleton.
A dynamic equilibrium occurs between blood calcium and skeletal calcium, homeostasis being mainly regulated by the parathyroid hormone, by calcitonin and by vitamin D.
Variations in the concentration of ionised calcium are responsible for the symptoms of hyper/hypocalcaemia. Soluble calcium salts are commonly used in the treatment of calcium deficiency.
The pharmacokinetics of calcium and its salts are well known. Bioavailability of calcium acetate depends on the dissolution rate which is normally completed after 15 minutes. After 15 minutes the calcium acetate is released. The serum concentration of phosphate may decrease after interaction with calcium resulting in the formation of the less soluble calcium phosphate salts.
Preclinical studies with calcium acetate are very limited and reveal no special additional risks to those already mentioned in other sections of the SPC. Preclinical effects were observed only at doses considered in excess of the maximum human dose.
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