MedPath

Potassium bicarbonate

Generic Name
Potassium bicarbonate
Brand Names
Effer-K, Sibnayal
Drug Type
Small Molecule
Chemical Formula
CHKO3
CAS Number
298-14-6
Unique Ingredient Identifier
HM5Z15LEBN

Overview

Potassium bicarbonate is a white, crystalline, slightly alkaline and salty substance. It is produced by the passage of carbon dioxide through an aqueous potassium carbonate solution. It is used in medicine as an antacid. It is registered in the FDA under the section of suitable, safe and effective ingredients for OTC antacids. This FDA denomination classifies potassium bicarbonate as a GRAS ingredient.

Background

Potassium bicarbonate is a white, crystalline, slightly alkaline and salty substance. It is produced by the passage of carbon dioxide through an aqueous potassium carbonate solution. It is used in medicine as an antacid. It is registered in the FDA under the section of suitable, safe and effective ingredients for OTC antacids. This FDA denomination classifies potassium bicarbonate as a GRAS ingredient.

Indication

Potassium bicarbonate is used as an antacid, electrolyte replenisher and potassium supplement. It can also be used as an excipient in drug formulations. An antacid is a medication used to neutralize gastric acid in a short timeframe after ingestion and the effect is soon overcome by meal-stimulated acid secretion.

Associated Conditions

  • Arrhythmias Cardiac caused by Hypokalemia
  • Gastro-esophageal Reflux Disease (GERD)
  • Hypocitraturia
  • Hypokalemia
  • Ketoacidosis caused by Hypokalemia
  • Kidney Stones
  • Neuromuscular Disorders caused by Hypokalemia
  • Uric Acid Stones
  • Calcium oxalate calculi Renal Calculi

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code
ORAL
391 mg in 1 1
2019/12/19
51801-013
ORAL
782 mg in 1 1
2019/12/19
51801-012
ORAL
391 mg in 1 1
2019/12/19
51801-014
ORAL
25 meq in 1 1
2010/10/08
50201-2400
ORAL
782 mg in 1 1
2019/12/19
51801-011
ORAL
25 meq in 1 1
2012/04/20
0603-4170
ORAL
978 mg in 1 1
2020/06/30
0245-5326
ORAL
977.5 mg in 1 1
2019/12/23
51801-006
ORAL
977.5 mg in 1 1
2019/12/23
51801-007
ORAL
977.5 mg in 1 1
2019/12/23
51801-005

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision
EMEA/H/C/005407
France
N/A
Authorised
2021/04/30
2020/12/10
3

HSA Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.
SUSPENSION
200 MG/10ML
2020/11/17
SIN16042P
SUSPENSION
200 mg/10 ml
2004/12/24
SIN12635P

NMPA Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import

No NMPA products found

No NMPA products found for this drug

PPB Approved Products

Product Name
Registration Code
Company
Category
Sale Type
Reg. Date

No PPB products found

No PPB products found for this drug

TGA Approved Products

Product Name
ARTG ID
Sponsor
Status
Reg. Date
Ingredient
71981
Active
1999/12/01
potassium bicarbonate
77810
Active
2001/03/13
potassium bicarbonate
346341
Active
2020/10/21
potassium bicarbonate
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