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Lithium Citrate (LITHIUM CITRATE)
Lithium Citrate works by inhibiting glycogen synthase kinase-3, a key enzyme involved in the regulation of various cellular processes.
At a glance
| Generic name | LITHIUM CITRATE |
|---|---|
| Sponsor | Hikma |
| Drug class | lithium |
| Target | Glycogen synthase kinase-3 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1980 |
Mechanism of action
The mechanism of action of lithium as mood stabilizing agent is unknown.
Approved indications
- Bipolar affective disorder, current episode manic
- Bipolar disorder
- Bipolar disorder in remission
Boxed warnings
- WARNING: LITHIUM TOXICITY Lithium toxicity is closely related to serum lithium concentrations, and can occur at doses close to therapeutic concentrations. Facilities for prompt and accurate serum lithium determinations should be available before initiating treatment [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ] WARNING: LITHIUM TOXICITY See full prescribing information for complete boxed warning. Lithium toxicity is closely related to serum lithium concentrations, and can occur at doses close to therapeutic concentrations. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy ( 2.3 , 5.1 ).
Common side effects
- nausea/vomiting
- polyuria
- increased TSH
- thirst/polydipsia
- decreased appetite
- dizziness
- tremor
- rash/dermatitis
- ataxia/gait disturbance
- blurry vision
- fatigue
Drug interactions
- lisinopril
- losartan
- meclofenamic acid
- mefenamic acid
- meloxicam
- methylclothiazide
- metolazone
- nabumetone
- naproxen
- oxaprozin
- perindopril
- phenylbutazone
Key clinical trials
- Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania. (PHASE2,PHASE3)
- Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder
- Pharmacokinetic Study of the Use of Nefopam 30 mg Tablets in Patients Suffering From Acute Pain in Rheumatology (PHASE4)
- In Vitro Immunomodulation in Membranous Nephropathy Relapses (NA)
- Lithium Versus Lamotrigine in Bipolar Disorder, Type II (PHASE4)
- Validation of Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor (NA)
- Celtra Quatro Crown Study (NA)
- Prostate Stereotactic Radiation and Radio-induced Lymphocyte Apoptosis for Predicting Late Toxicities in Prostate Cancer (PROSTERA) (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lithium Citrate CI brief — competitive landscape report
- Lithium Citrate updates RSS · CI watch RSS
- Hikma portfolio CI