COLOPREP Tablet Ref.[50583] Active ingredients: Sodium phosphate

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Laboratoires Mayoly Spindler, 6 avenue de leurope BP 51, 78401 CHATOU Cedex, France

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: OSMOTICALLY ACTING LAXATIVE
ATC code: A06AD

This medicine is a saline laxative that acts by an osmotic process by increasing fluid retentionin the lumen of the small intestine. The fluid accumulation in ileum produces distention and thus facilitates peristalsis and bowel evacuation.

5.2. Pharmacokinetic properties

Approximately 60-65% of ingested dietary phosphate is absorbed from the gastro-intestinal tract via an active energy-dependent process.

Phosphate distributes into plasma and extracellular fluid, cell membranes and intracellular fluids. More than 90% of plasma phosphate is filtered and 80% of the filtered phosphate is actively reabsorbed in the steady state. The ionised, inorganic form of phosphate in the circulating plasma is excreted almost entirely by the kidneys. This medicine is not expected to be metabolised in the liver.

Clinical studies with a higher dose of a previous formulation of this medicine have demonstrated that maximum peak plasma concentrations of serum inorganic phosphorous are achieved at approximately three hours after the administration of the first 30 g dose of this medicine, where serum inorganic phosphorous levels are increased by a mean of 1.21 ± 0.53 mmol/L. Following a second 30 g dose of this medicine a maximum peak plasma concentration of serum inorganic phosphorous is obtained at approximately four hours and the serum inorganic phosphorous levels are increased by a mean of 1.42 ± 0.60 mmol/L. The dosing instructions for this medicine recommend a first dose of 30 g and a second dose of 18 g.

5.3. Preclinical safety data

Limited non-clinical data reveal no special hazard for humans.

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