Sodium acetate

Overview

Sodium Acetate is chemically designated CH3COONa, a hygroscopic powder very soluble in water. Sodium acetate could be used as additives in food, industry, concrete manufacture, heating pads and in buffer solutions. Medically, sodium acetate is important component as an electrolyte replenisher when given intravenously. It is mainly indicated to correct sodium levels in hyponatremic patients. It can be used also in metabolic acidosis and for urine alkalinization.

Indication

Injection, USP 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Sodium acetate and other bicarbonate precursors are alkalinising agents, and can be used to correct metabolic acidosis, or for alkalinisation of the urine.

Associated Conditions

Hyponatremia
Hypovolaemia
Mild, moderate Metabolic Acidosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Study of DTX301 AAV-Mediated Gene Transfer for Ornithine Transcarbamylase (OTC) Deficiency	2022/04/25	NCT05345171	Phase 3	Active, not recruiting	Ultragenyx Pharmaceutical Inc

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
SODIUM ACETATE	Woodward Pharma Services LLC	69784-232	INTRAVENOUS	328 mg in 1 mL	11/1/2023
CLINIMIX E	Baxter Healthcare Company	0338-1147	INTRAVENOUS	340 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-1147	INTRAVENOUS	340 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Company	0338-1142	INTRAVENOUS	217 mg in 100 mL	9/21/2020
CLINIMIX E	Baxter Healthcare Corporation	0338-1142	INTRAVENOUS	217 mg in 100 mL	9/21/2020
Isolyte P in Dextrose	B. Braun Medical Inc.	0264-7730	INTRAVENOUS	0.32 g in 100 mL	10/17/2022
Multiple Electrolytes pH 7.4	Fresenius Kabi USA, LLC	65219-389	INTRAVENOUS	368 mg in 100 mL	6/18/2021
CLINIMIX E	Baxter Healthcare Company	0338-7032	INTRAVENOUS	340 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Corporation	0338-7032	INTRAVENOUS	340 mg in 100 mL	4/13/2021
CLINIMIX E	Baxter Healthcare Company	0338-1145	INTRAVENOUS	297 mg in 100 mL	9/21/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
GELASPAN SOLUTION FOR INFUSION	B. Braun Medical SA (equivalent to B. Braun Medical AG)	SIN15336P	INFUSION, SOLUTION	3.27g/1000ml	10/4/2017
AMINOPLASMAL B.BRAUN 10% E SOLUTION FOR INFUSION	B. Braun Melsungen AG	SIN15411P	INFUSION, SOLUTION	2.858g/1000ml	1/23/2018
SmofKabiven Peripheral Emulsion for Infusion	Fresenius Kabi AB	SIN14287P	INJECTION, EMULSION	5.62g /1000ml	1/8/2013
OLICLINOMEL N7-1000 E EMULSION FOR INFUSION	BAXTER SA, Ajinomoto North America Incorporated (Intermediate)	SIN12539P	EMULSION	2.45 g/l	5/6/2004
PLASMA-LYTE A INJECTION	Baxter Healthcare Corporation	SIN06523P	INJECTION	368 mg/100 ml	8/19/1991
NUTRIFLEX® OMEGA SPECIAL EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15469P	INJECTION, EMULSION	0.250g/1000ml	4/23/2018
PERIOLIMEL N4E Emulsion for Infusion	Ajinomoto Health & Nutrition North America Inc. (Intermediate), Baxter S.A	SIN16888P	EMULSION	1.16g/L	10/20/2023
NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN16734P	INJECTION, EMULSION	0.250g/1000ml	3/7/2023
OLIMEL N9E Emulsion for Infusion	Ajinomoto Health & Nutrition North America Inc. (Intermediate), Baxter S.A	SIN16890P	EMULSION	1.50g/L	10/20/2023
OLICLINOMEL N4-550 E EMULSION FOR INFUSION	BAXTER SA, Ajinomoto North America Incorporated (Intermediate)	SIN12542P	EMULSION	0.98 g/l	5/6/2004

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
OLIMEL N9E EMULSION FOR INFUSION	N/A	Baxter Healthcare Ltd	N/A	N/A	10/24/2013
PLASMA-LYTE 148 AND GLUCOSE 5% W/V SOLUTION FOR INFUSION	N/A	Baxter Healthcare Ltd	N/A	N/A	8/23/2024
NUTRIFLEX OMEGA SPECIAL EMULSION FOR INFUSION	N/A	B BRAUN MEDICAL SA	N/A	N/A	1/11/2012
VOLULYTE 6% SOLUTION FOR INFUSION	N/A	FRESENIUS KABI HONG KONG LIMITED	N/A	N/A	7/20/2009
NUTRIFLEX OMEGA PLUS EMULSION FOR INFUSION	N/A	B BRAUN MEDICAL SA	N/A	N/A	1/11/2012

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SYNTHAMIN 17 Amino acid 10% with Electrolytes and Glucose 25% 1000mL injection AHB6350	19609	Baxter Healthcare Pty Ltd	Medicine	A	9/30/1991
SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1970 mL	180546	Fresenius Kabi Australia Pty Ltd	Medicine	A	1/9/2012
OLICLINOMEL N4-550 E 1000 mL IV emulsion for infusion with electrolytes bag	136599	Baxter Healthcare Pty Ltd	Medicine	A	9/4/2007
OLICLINOMEL N4-550 E 2500 mL IV emulsion for infusion with electrolytes bag	141396	Baxter Healthcare Pty Ltd	Medicine	A	9/4/2007
OLIMEL N5-860E Emulsion for intravenous infusion	197417	Baxter Healthcare Pty Ltd	Medicine	A	8/9/2013
SMOFKABIVEN LOW OSMO amino acids 2.5%, electrolytes 0.4%, lipids 3.5% & glucose 6.8% emulsion for intravenous infusion 2500 mL biofine bag	329619	Fresenius Kabi Australia Pty Ltd	Medicine	A	8/27/2020
SMOFKABIVEN LOW OSMO amino acids 2.5%, electrolytes 0.4%, lipids 3.5% & glucose 6.8% emulsion for intravenous infusion 1400 mL biofine bag	329617	Fresenius Kabi Australia Pty Ltd	Medicine	A	8/27/2020
OLIMEL N7-960E Emulsion for intravenous infusion	197418	Baxter Healthcare Pty Ltd	Medicine	A	8/9/2013
OLICLINOMEL N5-800 E 2000 mL IV emulsion for infusion with electrolytes bag	141383	Baxter Healthcare Pty Ltd	Medicine	A	9/4/2007
PLASMA-LYTE 148 and 5% GLUCOSE 1000mL injection bag AHB2584	19438	Baxter Healthcare Pty Ltd	Medicine	A	9/30/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
4.25% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 10% DEXTROSE	baxter corporation clintec nutrition division	N/A	Solution - Intravenous	297 MG / 100 ML	12/31/1996
2.75%TRAVASOL AMINO ACID INJ.W.ELEC.W.5%DEX.	clintec nutrition company	02143240	Liquid - Intravenous	215 MG / 100 ML	12/31/1996
16.4% SODIUM ACETATE INJECTION, USP	baxter corporation	02247204	Solution - Intravenous	16.4 %	2/13/2003
4.25%TRAVASOL AMINO ACID INJ.W.ELECW.5%DEX.	clintec nutrition company	02143224	Liquid - Intravenous	297 MG / 100 ML	12/31/1996
BALANCED SALT SOLUTION	pharma stulln inc.	02023709	Solution - Irrigation	3.9 MG / ML	12/31/1994
HEMOSATE ULTRA HS4125	chief medical supplies ltd	02413922	Solution - Haemodialysis	1.11 G / L	3/30/2020
2.5% TRAVASOL AMINO ACID INJECTION WITH ELECTROLYTES IN 10% DEXTROSE CLINIMIX	baxter corporation clintec nutrition division	02013975	Solution - Intravenous	170 MG / 100 ML	12/31/1993
HEMOSATE ULTRA HS1125	chief medical supplies ltd	02413892	Solution - Haemodialysis	1.11 G / L	3/30/2020
HEMOSATE ULTRA HS2150	chief medical supplies ltd	02413957	Solution - Haemodialysis	1.11 G / L	3/4/2020
CLINIMIX E	baxter corporation	02013967	Solution - Intravenous	205 MG / 100 ML	12/31/1993

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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