Potassium citrate/potassium hydrogen carbonate

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Potassium citrate/potassium hydrogen carbonate
Combination of
Potassium citrate Mineral supplement
Potassium hydrogencarbonate Mineral supplement
Clinical data
Trade names Sibnayal
Other namesADV7103
License data
ATC code
Legal status
Legal status

Potassium citrate/potassium hydrogencarbonate is a fixed-dose combination medication intended for the treatment of distal renal tubular acidosis. [1] It contains potassium citrate and potassium hydrogencarbonate. [1]

Contents

Potassium citrate/potassium hydrogencarbonate was approved for medical use in the European Union in April 2021. [1]

Medical uses

Potassium citrate/potassium hydrogencarbonate is indicated for the treatment of distal renal tubular acidosis (dRTA) in people aged one year and older. [1]

History

On 10 December 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Sibnayal. [1] The applicant for this medicinal product is Advicenne S.A. [1] Potassium citrate/potassium hydrogencarbonate was approved for medical use in the European Union in April 2021. [1]

Potassium citrate/potassium hydrogencarbonate is recommended for approval in the United Kingdom. [3]

Research

Potassium citrate/potassium hydrogencarbonate is undergoing Phase III trials in preparation for evaluation by the U.S. Food and Drug Administration (FDA). [4]

Related Research Articles

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Renal tubular acidosis (RTA) is a medical condition that involves an accumulation of acid in the body due to a failure of the kidneys to appropriately acidify the urine. In renal physiology, when blood is filtered by the kidney, the filtrate passes through the tubules of the nephron, allowing for exchange of salts, acid equivalents, and other solutes before it drains into the bladder as urine. The metabolic acidosis that results from RTA may be caused either by insufficient secretion of hydrogen ions into the latter portions of the nephron or by failure to reabsorb sufficient bicarbonate ions from the filtrate in the early portion of the nephron. Although a metabolic acidosis also occurs in those with chronic kidney disease, the term RTA is reserved for individuals with poor urinary acidification in otherwise well-functioning kidneys. Several different types of RTA exist, which all have different syndromes and different causes. RTA is usually an incidental finding based on routine blood draws that show abnormal results. Clinically, patients may present with vague symptoms such as dehydration, mental status changes, or delayed growth in adolescents.

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References

  1. 1 2 3 4 5 6 7 8 "Sibnayal EPAR". European Medicines Agency (EMA). 9 December 2020. Retrieved 22 May 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  2. "Sibnayal Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  3. "Potassium bicarbonate + potassium citrate". SPS - Specialist Pharmacy Service. 19 February 2021. Retrieved 22 May 2021.
  4. "Advicenne receives positive feedback from the US FDA on pathway to approval and amended Phase III study protocol for its treatment of distal renal tubular acidosis (dRTA)" (Press release). Advicenne. 17 May 2021. Retrieved 22 May 2021 via GlobeNewswire.