Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany
Pharmacotherapeutic group: antacids with sodium bicarbonate
ATC code: A02AH
Sodium hydrogen carbonate is a salt whose essential pharmacological properties result from its physiological role as a component of the HCO3/CO2 buffer. Sodium hydrogen carbonate leads to an increase in the body’s pH level.
Sodium hydrogen carbonate in Nephrotrans 500 mg is provided in the form of gastro-resistant gelatin capsules, soft that are dissolvable in the small intestine, thereby avoiding gastric meteorism caused by the formation of carbon dioxide gas in the acidic environment of the stomach. The administered amount of bicarbonate available is similar to administration via sodium hydrogen carbonate infusions as the gastro-resistant formulation prevents gastric bicarbonate degradation. There is a rise in the plasma carbonate level and correction of the bicarbonate deficit. Hence, it is possible to treat metabolic acidosis of various aetiology, provided the blood pH level is not below 7.2. Notwithstanding this, treatment of diabetic ketoacidosis has shown that, after correction of the pH level to 7.2, further use of insulin is more effective than treatment with buffer agents.
In one study, absorption of orally administered sodium hydrogen carbonate in the form of gastro-resistant capsules versus IV administration was studied by measuring the acid-base status and renal Na+ elimination.
Based on this, absorption of sodium hydrogen carbonate from a total of 12 capsules of 0.5 g each sets in after about 2 hours, peak changes in the acid-base status are seen after approximately 5-8 hours and, in correlation to this, renal elimination of Na+ and base equivalents is greatest at this time.
Overall, the changes in current and standard bicarbonate and base excess were significantly greater after oral administration than after IV administration. Although this indicates that a significant fraction of the oral sodium hydrogen carbonate dose is absorbed, it does not however allow any quantification of this amount. However, a rough estimate of the intestinally absorbed amount is possible by comparing the renally eliminated Na+ amount after oral and intravenous administration, resulting in an absorption rate of 70%.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
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