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.
Background
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
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 | Recruiting | 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 |
|---|---|---|---|---|---|
| Lithium Carbonate Tablets | 国药准字H31021756 | 化学药品 | 片剂 | 4/9/2020 | |
| Lithium Carbonate Tablets | 国药准字H51022980 | 化学药品 | 片剂 | 3/15/2021 | |
| Lithium Carbonate Tablets | 国药准字H32023154 | 化学药品 | 片剂 | 5/11/2020 | |
| Lithium Carbonate Tablets | 国药准字H11021410 | 化学药品 | 片剂 | 11/27/2020 | |
| Lithium Carbonate Tablets | 国药准字H37022538 | 化学药品 | 片剂 | 4/17/2020 | |
| Lithium Carbonate Tablets | 国药准字H32023287 | 化学药品 | 片剂 | 6/22/2020 | |
| Lithium Carbonate Tablets | 国药准字H11021443 | 化学药品 | 片剂 | 12/11/2020 | |
| Lithium Carbonate Tablets | 国药准字H44022320 | 化学药品 | 片剂 | 9/29/2020 | |
| Lithium Carbonate Tablets | 国药准字H23020224 | 化学药品 | 片剂 | 5/24/2020 | |
| Lithium Carbonate Tablets | 国药准字H36020271 | 化学药品 | 片剂 | 2/2/2021 |
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 |