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.
Background
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 |
|---|---|---|---|---|---|
2024/11/22 | Phase 2 | Not yet recruiting | |||
2024/10/09 | Phase 2 | Recruiting | University Hospital Pilsen | ||
2024/03/25 | Not Applicable | Recruiting | |||
2023/12/13 | Phase 2 | Not yet recruiting | |||
2023/09/01 | Phase 1 | Recruiting | Stayble Therapeutics | ||
2021/08/13 | Phase 2 | Recruiting | Erasme University Hospital | ||
2020/07/28 | Phase 3 | Completed | |||
2018/11/05 | Not Applicable | UNKNOWN | |||
2017/09/19 | Not Applicable | Completed | |||
2017/02/16 | Phase 1 | Completed | Stayble Therapeutics |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Baxter Healthcare Corporation | 0338-0117 | INTRAVENOUS | 310 mg in 100 mL | 10/9/2019 | |
| ICU Medical Inc. | 0990-7111 | INTRAVENOUS | 3.1 g in 1000 mL | 6/24/2021 | |
| Fresenius Medical Care North America | 49230-212 | INTRAPERITONEAL | 448 mg in 100 mL | 10/19/2023 | |
| ICU Medical Inc. | 0990-7372 | INTRAVENOUS | 260 mg in 100 mL | 3/8/2021 | |
| Baxter Healthcare Corporation | 0338-0137 | IRRIGATION | 3.1 g in 1000 mL | 9/29/2015 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1300 | INTRAVENOUS | 310 mg in 100 mL | 2/20/2020 | |
| IT3 Medical LLC | 70529-025 | INTRAVENOUS | 310 mg in 100 mL | 6/6/2018 | |
| Baxter Healthcare Corporation | 0941-0433 | INTRAPERITONEAL | 448 mg in 100 mL | 11/21/2019 | |
| Fresenius Medical Care de Mexico, S.A. de C.V. | 46163-209 | INTRAPERITONEAL | 448 mg in 100 mL | 3/24/2025 | |
| 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 | SIN06429P | INJECTION | 0.312 g/100 ml | 7/8/1991 | |
| DUOFILM COLLODION | SIN04047P | TINCTURE | 15 % | 3/28/1990 | |
| SATO UONOME SOLUTION | SIN04987P | SOLUTION | 8.85% w/v | 6/25/1990 | |
| PHYSIONEAL 40 DEXTROSE SOLUTION 1.5% w/v/15.0 mg/ml | SIN12435P | SOLUTION, STERILE | 2.63 g/l | 10/7/2003 | |
| PHYSIONEAL 40 DEXTROSE SOLUTION 4.25% w/v/ 42.5 mg/ml | SIN12437P | SOLUTION, STERILE | 2.63 g/l | 10/7/2003 | |
| EUROPERSOL WITH DEXTROSE 1.5% PERITONEAL DIALYSIS SOLUTION | SIN10281P | SOLUTION, STERILE | 392 mg/100 ml | 10/14/1998 | |
| COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP | SIN06281P | INJECTION | 0.24 ml/100 ml | 6/11/1991 | |
| LACTATED RINGER'S INJECTION USP | SIN05592P | INJECTION | 310 mg/100 ml | 3/27/1991 | |
| BAXTER-LACTATED RINGER’S INJECTION USP | SIN16604P | INFUSION, SOLUTION | 310mg per 100mL | 9/14/2022 | |
| DIANEAL LOW CALCIUM (2.5 mEq/l) PERITONEAL DIALYSIS SOLUTION WITH 1.5% DEXTROSE | SIN06627P | SOLUTION, STERILE | 448 mg/100 ml | 10/14/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Sodium Lactate Injection | 国药准字H36020693 | 化学药品 | 注射剂 | 7/17/2022 | |
| Sodium Lactate Injection | 国药准字H41021117 | 化学药品 | 注射剂 | 3/17/2020 | |
| Sodium Lactate Injection | 国药准字H12020521 | 化学药品 | 注射剂 | 7/27/2020 | |
| Sodium Lactate Injection | 国药准字H50020150 | 化学药品 | 注射剂 | 9/25/2020 | |
| Sodium Lactate Injection | 国药准字H32022456 | 化学药品 | 注射剂 | 8/24/2020 | |
| Sodium Lactate Injection | 国药准字H32021591 | 化学药品 | 注射剂 | 8/31/2020 | |
| Sodium Lactate Injection | 国药准字H50020825 | 化学药品 | 注射剂 | 9/25/2020 | |
| Sodium Lactate Injection | 国药准字H42021929 | 化学药品 | 注射剂 | 9/28/2020 | |
| Sodium Lactate Injection | 国药准字H32021533 | 化学药品 | 注射剂(注射液) | 12/17/2020 | |
| Sodium Lactate Injection | 国药准字H62020619 | 化学药品 | 注射剂 | 7/22/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| EXTRANEAL SOLN 7.5% | N/A | N/A | N/A | 8/18/2000 | |
| PRISMASOL B0 SOLUTION FOR HAEMOFILTRATION AND HAEMODIALYSIS | N/A | N/A | N/A | 10/15/2013 | |
| LACTATED RINGER'S INJ | N/A | luen cheong hong ltd | N/A | N/A | 5/17/1979 |
| BALANCE 4.25% GLU. 1.25MMOL/L CAL. P.D. SOLUTION (JAPAN) | N/A | 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 | N/A | N/A | 10/10/2005 | |
| CAPD/DPCA 18 PERITONEAL DIALYSIS SOLUTION | N/A | N/A | N/A | 5/13/2010 | |
| DIANEAL LOW CALCIUM PERITONEAL SOLN 2.5% | N/A | N/A | N/A | 7/17/1991 | |
| DIANEAL LOW CALCIUM P.D.SOLN & 1.5%DEXT | N/A | N/A | N/A | 3/12/1990 | |
| DIANEAL PD-2 PD SOLN WITH 1.5% DEXTROSE | N/A | 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 | Medicine | A | 9/27/2013 | |
| DIANEAL PD-4 Peritoneal Dialysis Solution with 0.55% w/v Glucose Low Calcium Standard Single Bag | 52436 | Medicine | A | 6/21/1995 | |
| DIANEAL PD-4 Peritoneal Dialysis Solution | 33532 | Medicine | A | 3/5/1992 | |
| DIANEAL PD-2 Peritoneal Dialysis with 2.5% w/v Glucose Solution | 19697 | Medicine | A | 9/30/1991 | |
| PHYSIONEAL 40 Glucose 3.86% w/v Peritoneal Dialysis Solution Twin Bag | 119079 | Medicine | A | 5/31/2005 | |
| EXTRANEAL 7.5% w/v icodextrin peritoneal dialysis solution bag | 91344 | Medicine | A | 10/29/2002 | |
| DUOFILM solution bottle | 14820 | Medicine | A | 9/12/1991 | |
| COMPOUND SODIUM LACTATE (HARTMANN'S SOLUTION) 1000mL injection bag | 47410 | Medicine | A | 1/31/1994 | |
| DIANEAL PD-4 Peritoneal Dialysis Solution with 0.55% w/v Glucose Low Calcium Freeline Solo Twin | 51244 | Medicine | A | 3/17/1995 | |
| WART-OFF PAINT bottle | 18915 | Pharmacare Laboratories Pty Ltd | Medicine | A | 9/30/1991 |