Lactic acid

Overview

A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed) Sodium lactate is the sodium salt of lactic acid, and has a mild saline taste. It is produced by fermentation of a sugar source, such as corn or beets, and then, by neutralizing the resulting lactic acid to create a compound having the formula NaC3H5O3. Lactic acid was one of active ingredients in Phexxi, a non-hormonal contraceptive agent that was approved by the FDA on May 2020.

Indication

For use as an alkalinizing agent.

Associated Conditions

Corns
Dehydration
Fluid Loss
Hyperkeratosis
Lichenification
Shock, Hypovolemic
Vasoplegic Shock
Verruca (Warts)
Mild Metabolic acidosis
Mild, moderate Metabolic Acidosis
Moderate Metabolic acidosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
ELI in TBI 24 Hour	2024/11/22	NCT06701760	Phase 2	Not yet recruiting	University of California, Los Angeles
Study SOLACE SEPSIS	2024/10/09	NCT06634069	Phase 2	Recruiting	University Hospital Pilsen
Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata	2024/03/25	NCT06327581	Not Applicable	Recruiting	Zagazig University
Feasibility of Conducting a Clinical Trial Assessing Efficacy of Lactate as Adjunctive Therapy in Patients With Major Depressive Disorder	2023/12/13	NCT06168175	Phase 2	Not yet recruiting	Centre Hospitalier Universitaire Vaudois
STA363 in the Treatment of Lumbar Disc Herniation	2023/09/01	NCT06022263	Phase 1	Recruiting	Stayble Therapeutics
Hypertonic Lactate After Cardiac Arrest	2021/08/13	NCT05004610	Phase 2	Recruiting	Erasme University Hospital
Sodium Lactate and Brain Relaxation (LSD)	2020/07/28	NCT04488874	Phase 3	Completed	Centre Hospitalier Universitaire de Besancon
The Effect Lactate Administration on Cerebral Blood Flow During Hypoglycemia	2018/11/05	NCT03730909	Not Applicable	UNKNOWN	Radboud University Medical Center
The Effect of Intravenous Lactate on Brain Lactate Concentrations During Hypoglycemia	2017/09/19	NCT03286816	Not Applicable	Completed	Radboud University Medical Center
A Single Ascending Dose Study of Safety and Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain	2017/02/16	NCT03055845	Phase 1	Completed	Stayble Therapeutics

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Lactated Ringers	Baxter Healthcare Corporation	0338-0117	INTRAVENOUS	310 mg in 100 mL	10/9/2019
Potassium Chloride in Lactated Ringers and Dextrose	ICU Medical Inc.	0990-7111	INTRAVENOUS	3.1 g in 1000 mL	6/24/2021
DELFLEX	Fresenius Medical Care North America	49230-212	INTRAPERITONEAL	448 mg in 100 mL	10/19/2023
Ionosol MB and Dextrose	ICU Medical Inc.	0990-7372	INTRAVENOUS	260 mg in 100 mL	3/8/2021
Lactated Ringers	Baxter Healthcare Corporation	0338-0137	IRRIGATION	3.1 g in 1000 mL	9/29/2015
LACTATED RINGERS	HF Acquisition Co LLC, DBA HealthFirst	51662-1300	INTRAVENOUS	310 mg in 100 mL	2/20/2020
Lacellate Solution - 250	IT3 Medical LLC	70529-025	INTRAVENOUS	310 mg in 100 mL	6/6/2018
DIANEAL Low Calcium with Dextrose	Baxter Healthcare Corporation	0941-0433	INTRAPERITONEAL	448 mg in 100 mL	11/21/2019
Delflex	Fresenius Medical Care de Mexico, S.A. de C.V.	46163-209	INTRAPERITONEAL	448 mg in 100 mL	3/24/2025
DIANEAL LOW CALCIUM WITH DEXTROSE	Vantive US Healthcare LLC	0941-0715	INTRAPERITONEAL	448 mg in 100 mL	5/7/2025

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
COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP	B BRAUN MEDICAL INDUSTRIES SDN BHD, B. Braun Melsungen AG, B. Braun Medical SA	SIN06429P	INJECTION	0.312 g/100 ml	7/8/1991
DUOFILM COLLODION	Delpharm Bladel B.V.	SIN04047P	TINCTURE	15 %	3/28/1990
SATO UONOME SOLUTION	SATO PHARMACEUTICAL CO LTD	SIN04987P	SOLUTION	8.85% w/v	6/25/1990
PHYSIONEAL 40 DEXTROSE SOLUTION 1.5% w/v/15.0 mg/ml	BAXTER HEALTHCARE SA, BAXTER HEALTHCARE SA, SINGAPORE BRANCH	SIN12435P	SOLUTION, STERILE	2.63 g/l	10/7/2003
PHYSIONEAL 40 DEXTROSE SOLUTION 4.25% w/v/ 42.5 mg/ml	BAXTER HEALTHCARE SA, BAXTER HEALTHCARE SA, SINGAPORE BRANCH	SIN12437P	SOLUTION, STERILE	2.63 g/l	10/7/2003
EUROPERSOL WITH DEXTROSE 1.5% PERITONEAL DIALYSIS SOLUTION	EURO-MED LABORATORIES PHIL INC	SIN10281P	SOLUTION, STERILE	392 mg/100 ml	10/14/1998
COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP	PT OTSUKA INDONESIA, THAI OTSUKA PHARMACEUTICAL CO LTD	SIN06281P	INJECTION	0.24 ml/100 ml	6/11/1991
LACTATED RINGER'S INJECTION USP	Baxter Healthcare Corporation, North Cove Plant, BAXTER HEALTHCARE PHILIPPINES INC	SIN05592P	INJECTION	310 mg/100 ml	3/27/1991
BAXTER-LACTATED RINGER’S INJECTION USP	Baxter Healthcare Philippines, Inc	SIN16604P	INFUSION, SOLUTION	310mg per 100mL	9/14/2022
DIANEAL LOW CALCIUM (2.5 mEq/l) PERITONEAL DIALYSIS SOLUTION WITH 1.5% DEXTROSE	BAXTER HEALTHCARE SA, SINGAPORE BRANCH, BAXTER HEALTHCARE CORPORATION	SIN06627P	SOLUTION, STERILE	448 mg/100 ml	10/14/1991

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
EXTRANEAL SOLN 7.5%	N/A	Vantive Healthcare Limited	N/A	N/A	8/18/2000
PRISMASOL B0 SOLUTION FOR HAEMOFILTRATION AND HAEMODIALYSIS	N/A	Vantive Healthcare Limited	N/A	N/A	10/15/2013
LACTATED RINGER'S INJ	N/A	LUEN CHEONG HONG	N/A	N/A	5/17/1979
BALANCE 4.25% GLU. 1.25MMOL/L CAL. P.D. SOLUTION (JAPAN)	N/A	FRESENIUS MEDICAL CARE HONG KONG LIMITED	N/A	N/A	7/12/2005
WIDA RL RINGER LACTATE INTRAVENOUS INFUSION	N/A	otsuka pharmaceutical (h.k.) limited	N/A	N/A	10/30/2009
PHYSIONEAL 40 DEXTROSE 1.5% P.D. SOLUTION	N/A	Vantive Healthcare Limited	N/A	N/A	10/10/2005
CAPD/DPCA 18 PERITONEAL DIALYSIS SOLUTION	N/A	FRESENIUS MEDICAL CARE HONG KONG LIMITED	N/A	N/A	5/13/2010
DIANEAL LOW CALCIUM PERITONEAL SOLN 2.5%	N/A	Vantive Healthcare Limited	N/A	N/A	7/17/1991
DIANEAL LOW CALCIUM P.D.SOLN & 1.5%DEXT	N/A	Vantive Healthcare Limited	N/A	N/A	3/12/1990
DIANEAL PD-2 PD SOLN WITH 1.5% DEXTROSE	N/A	Vantive Healthcare Limited	N/A	N/A	5/18/1984

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Physioneal 40 Glucose 3.86%w/v Peritoneal Dialysis solution Single Bag	215417	Baxter Healthcare Pty Ltd	Medicine	A	9/27/2013
DIANEAL PD-4 Peritoneal Dialysis Solution with 0.55% w/v Glucose Low Calcium Standard Single Bag	52436	Vantive Pty Ltd	Medicine	A	6/21/1995
DIANEAL PD-4 Peritoneal Dialysis Solution	33532	Vantive Pty Ltd	Medicine	A	3/5/1992
DIANEAL PD-2 Peritoneal Dialysis with 2.5% w/v Glucose Solution	19697	Vantive Pty Ltd	Medicine	A	9/30/1991
PHYSIONEAL 40 Glucose 3.86% w/v Peritoneal Dialysis Solution Twin Bag	119079	Vantive Pty Ltd	Medicine	A	5/31/2005
EXTRANEAL 7.5% w/v icodextrin peritoneal dialysis solution bag	91344	Vantive Pty Ltd	Medicine	A	10/29/2002
DUOFILM solution bottle	14820	Stada Pharmaceuticals Australia Pty Ltd	Medicine	A	9/12/1991
COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) 1000mL injection bag	47410	Fresenius Kabi Australia Pty Ltd	Medicine	A	1/31/1994
DIANEAL PD-4 Peritoneal Dialysis Solution with 0.55% w/v Glucose Low Calcium Freeline Solo Twin	51244	Vantive Pty Ltd	Medicine	A	3/17/1995
WART-OFF PAINT bottle	18915	Pharmacare Laboratories Pty Ltd	Medicine	A	9/30/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
(40 MMOLS/L) POTASSIUM CHLORIDE IN LACTATED RINGER'S INJECTION USP	baxter corporation	02246134	Solution - Intravenous	310 MG / 100 ML	12/11/2002
DIANEAL PD101 CAPD SOLUTION WITH 1.5% DEXTROSE	Vantive ULC	00799815	Solution - Haemodialysis (Intraperitoneal)	392 MG / 100 ML	12/31/1989
BALANCE 1.5% GLUCOSE, 1.25 MMOL/L CALCIUM	fresenius medical care canada inc	02261057	Solution - Haemodialysis (Intraperitoneal)	3.925 G / L	7/25/2006
INPERSOL W DEXTROSE 1.5%	ABBOTT LABORATORIES, LIMITED	00039608	Solution - Haemodialysis , Intraperitoneal	5 MG / ML	12/31/1960
TI-U-LAC LOTION	merit industries inc.	00505749	Lotion - Topical	2 %	12/31/1980
SELUTRIO 10	fresenius medical care deutchland gmbh	02246719	Solution - Intraperitoneal	4.72 G / L	10/20/2002
HEMOSOL LG4	gambro inc	02230505	Solution - Haemodialysis	4.483 G / L	2/20/1997
DIANEAL PD4 CAPD SOLUTION WITH 4.25% DEXTROSE AND 2.5MEQ/L CALCIUM	Vantive ULC	00865117	Solution - Haemodialysis (Intraperitoneal)	448 MG / 100 ML	12/31/1990
PENEDERM LOTION	penederm inc.	02119404	Lotion - Topical	5 %	12/31/1995
LACTATED RINGER'S IRRIGATION	b. braun medical inc	01974076	Liquid - Irrigation	310 MG / 100 ML	9/3/1998

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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