Potassium citrate/potassium hydrogen carbonate
Pharmaceutical drug
From Wikipedia, the free encyclopedia
Potassium citrate/potassium hydrogen carbonate, sold under the brand name Sibnayal, is a fixed-dose combination medication intended for the treatment of distal renal tubular acidosis.[1] It contains potassium citrate and potassium hydrogen carbonate.[1]
| Combination of | |
|---|---|
| Potassium citrate | Mineral supplement |
| Potassium hydrogen carbonate | Mineral supplement |
| Clinical data | |
| Trade names | Sibnayal |
| Other names | ADV7103, potassium citrate/potassium hydrogencarbonate, potassium citrate/potassium bicarbonate |
| Routes of administration | By mouth |
| ATC code | |
| Legal status | |
| Legal status | |
Potassium citrate/potassium hydrogen carbonate was approved for medical use in the European Union in April 2021.[1]
Medical uses
Potassium citrate/potassium hydrogen carbonate is indicated for the treatment of distal renal tubular acidosis (dRTA) in people aged one year and older.[1]
Society and culture
Legal status
In 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 hydrogen carbonate was approved for medical use in the European Union in April 2021.[1]
Potassium citrate/potassium hydrogen carbonate is recommended for approval in the United Kingdom.[3]
Research
Potassium citrate/potassium hydrogen carbonate is undergoing phase III trials in preparation for evaluation by the US Food and Drug Administration (FDA).[4]
