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
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]
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
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
CAMCOLIT-400 TABLET 400 mg | SIN01305P | TABLET, FILM COATED | 400 mg | 5/19/1988 |
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. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
QUILONUM SR lithium carbonate 450mg tablet blister pack | 53377 | Medicine | A | 9/18/1995 | |
EAGLE TRESOS-B tablet - film coated bottle | 15457 | Medicine | A | 9/27/1991 | |
LITHICARB SR 400 Lithium carbonate 400mg tablet blister pack. | 53258 | Medicine | A | 8/14/1995 | |
LITHICARB lithium carbonate 250mg tablet bottle | 49625 | Medicine | A | 7/21/1994 | |
LITHICARB SR 400 Lithium carbonate 400mg tablet bottle | 53260 | Medicine | A | 8/14/1995 |
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. |
Help Us Improve
Your feedback helps us provide better drug information and insights.