calcium chloride injection, USP - ANYSYR Clinical Pharmacology

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12 CLINICAL PHARMACOLOGY

     

12.1 Mechanism of Action

Intravenous administration of calcium chloride increases serum ionized calcium concentration. Calcium chloride dissociates into ionized calcium in plasma.

12.2 Pharmacodynamics

The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Calcium Chloride Injection have not been fully characterized.

12.3 Pharmacokinetics

Absorption

Calcium Chloride Injection is 100% bioavailable following intravenous injection.

Distribution

Calcium in the body is distributed mainly in skeleton (99%) and 1% is distributed within the extracellular fluids and soft tissues. About 50% of total serum calcium is in the ionized form and represents the biologically active part; 8% to 10% serum calcium is bound to organic and inorganic acid, respectively; and approximately 40% is protein-bound (primarily to albumin).

Elimination

Metabolism

Calcium itself does not undergo direct metabolism.

Excretion

Calcium is excreted by the kidney through a combination of glomerular filtration and tubular reabsorption. A significant increase in urinary excretion of calcium was observed during and after intravenous infusion of calcium chloride.

Specific Populations

The effect of age, sex, race, ethnicity, renal or hepatic impairment on the pharmacokinetics of calcium have not been evaluated in clinical studies.

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Clinical Pharmacology

12 CLINICAL PHARMACOLOGY

     

12.1 Mechanism of Action

Intravenous administration of calcium chloride increases serum ionized calcium concentration. Calcium chloride dissociates into ionized calcium in plasma.

12.2 Pharmacodynamics

The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Calcium Chloride Injection have not been fully characterized.

12.3 Pharmacokinetics

Absorption

Calcium Chloride Injection is 100% bioavailable following intravenous injection.

Distribution

Calcium in the body is distributed mainly in skeleton (99%) and 1% is distributed within the extracellular fluids and soft tissues. About 50% of total serum calcium is in the ionized form and represents the biologically active part; 8% to 10% serum calcium is bound to organic and inorganic acid, respectively; and approximately 40% is protein-bound (primarily to albumin).

Elimination

Metabolism

Calcium itself does not undergo direct metabolism.

Excretion

Calcium is excreted by the kidney through a combination of glomerular filtration and tubular reabsorption. A significant increase in urinary excretion of calcium was observed during and after intravenous infusion of calcium chloride.

Specific Populations

The effect of age, sex, race, ethnicity, renal or hepatic impairment on the pharmacokinetics of calcium have not been evaluated in clinical studies.
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