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Lithium carbonate

Generic Name
Lithium carbonate
Brand Names
Carbolith, Lithane, Lithmax, Lithobid
Drug Type
Small Molecule
Chemical Formula
CLi2O3
CAS Number
554-13-2
Unique Ingredient Identifier
2BMD2GNA4V

Overview

Lithium has been used to treat manic episodes since the 19th century. Though it is widely used, its mechanism of action is still unknown. Lithium carbonate has a narrow therapeutic range and so careful monitoring is required to avoid adverse effects.

Indication

Lithium carbonate is indicated as a monotherapy for the treatment of acute manic and mixed episodes associated with bipolar 1 disorder in patients ≥7 years of age. It is also indicated as a maintenance treatment for bipolar 1 disorder in patients ≥7 years of age.

Associated Conditions

  • Bipolar 1 Disorder
  • Mixed manic depressive episode
  • Acute Manic episode

Research Report

Published: Aug 12, 2025

Comprehensive Monograph on Lithium Carbonate (DB14509): A Foundational Agent in Modern Psychopharmacology

I. Introduction: An Enduring Legacy in Psychiatry

Overview

Lithium carbonate, a simple inorganic salt, occupies a unique and revered position in the history of medicine. Far more than a mere chemical compound, it represents a paradigm shift in the biological treatment of mental illness. For over half a century, it has been regarded as the "gold standard" for the management of bipolar disorder, a designation it retains despite the emergence of newer, more profitable, and often more aggressively marketed therapeutic agents.[1] The story of lithium is one of profound paradox: its remarkable and specific efficacy in stabilizing mood is juxtaposed with a narrow therapeutic window, a demanding monitoring protocol, and a significant potential for toxicity. This fundamental tension between benefit and risk defines the clinical experience with lithium and underscores the necessity of expert knowledge for its safe and effective use. Its discovery ushered in the era of modern psychopharmacology, and its continued study reveals new potential, ensuring its enduring relevance.[3]

Historical Trajectory

The therapeutic use of lithium predates modern medicine by millennia. Ancient Roman physicians, without understanding the underlying chemistry, would direct patients with "nervous and temperamental" dispositions to bathe in specific mineral springs across Europe, which are now known to possess the continent's highest natural concentrations of lithium salts.[3]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/12/06
Phase 1
Completed
2024/05/22
N/A
Recruiting
Peking University
2023/12/28
Phase 4
Recruiting
Mental Health Services in the Capital Region, Denmark
2023/04/18
Phase 1
Recruiting
First Affiliated Hospital of Chongqing Medical University
2022/06/02
Phase 2
Completed
2022/02/03
Phase 3
Completed
2021/11/18
Phase 3
Suspended
Negovsky Reanimatology Research Institute
2020/11/10
Phase 3
Active, not recruiting
2020/01/10
Phase 4
Completed
All India Institute of Medical Sciences, Bhubaneswar
2017/06/28
Early Phase 1
UNKNOWN

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Physicians Total Care, Inc.
54868-1335
ORAL
300 mg in 1 1
4/5/2011
PD-Rx Pharmaceuticals, Inc.
72789-171
ORAL
300 mg in 1 1
11/27/2023
REMEDYREPACK INC.
70518-2312
ORAL
600 mg in 1 1
2/28/2024
Mylan Institutional Inc.
51079-180
ORAL
300 mg in 1 1
12/16/2021
Hikma Pharmaceuticals USA Inc.
0054-0021
ORAL
300 mg in 1 1
10/19/2018
Proficient Rx LP
71205-238
ORAL
300 mg in 1 1
3/1/2019
PD-Rx Pharmaceuticals, Inc.
72789-171
ORAL
300 mg in 1 1
8/23/2023
Hikma Pharmaceuticals USA Inc.
0054-8527
ORAL
300 mg in 1 1
11/22/2022
A-S Medication Solutions
50090-3917
ORAL
300 mg in 1 1
11/24/2022
REMEDYREPACK INC.
70518-1434
ORAL
150 mg in 1 1
2/27/2024

EMA Drug Approvals

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

HSA Drug Approvals

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
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
EURO LITHIUM
euro-pharm international canada inc
02304538
Capsule - Oral
300 MG
2/26/2008
DOM-LITHIUM CARBONATE
dominion pharmacal
02231397
Capsule - Oral
150 MG / CAP
N/A
PMS-LITHIUM CARBONATE - CAP 150MG
02216132
Capsule - Oral
150 MG
12/31/1996
CARBOLITH
bausch health, canada inc.
00461733
Capsule - Oral
150 MG
12/31/1979
PAL-LITHIUM CARBONATE
paladin pharma inc.
02237442
Capsule - Oral
300 MG / CAP
3/3/1998
PMS-LITHIUM CARBONATE - CAP 600MG
02216159
Capsule - Oral
600 MG
12/31/1996
LITHIZINE CAP 300MG
labs maney paul labs, division of 471449 (ont) ltee/ltd.
00328790
Capsule - Oral
300 MG / CAP
12/31/1975
EURO LITHIUM
euro-pharm international canada inc
02304511
Capsule - Oral
150 MG
2/26/2008
DOM-LITHIUM CARBONATE
dominion pharmacal
02231398
Capsule - Oral
300 MG / CAP
N/A
LITHMAX
aa pharma inc
02266695
Tablet (Extended-Release) - Oral
300 MG
4/6/2005

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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