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
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 |
|---|---|---|---|---|---|
| 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 |
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