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Lithium Carbonate (LITHIUM CARBONATE)
Lithium Carbonate is a small molecule drug that targets glycogen synthase kinase-3, a key enzyme involved in various cellular processes. It was originally developed and is currently owned by Hikma, a pharmaceutical company. Lithium Carbonate was first approved by the FDA in 1970 for the treatment of bipolar affective disorder, and its indications have since expanded to include other conditions such as dysmenorrhea and osteoarthritis. The drug is now off-patent, with 15 generic manufacturers available. Key safety considerations include monitoring for potential side effects such as thyroid dysfunction and renal impairment.
At a glance
| Generic name | LITHIUM CARBONATE |
|---|---|
| Sponsor | Hikma |
| Drug class | lithium carbonate |
| Target | Glycogen synthase kinase-3 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1970 |
Approved indications
- Bipolar affective disorder, current episode manic
- Bipolar disorder
- Bipolar disorder in remission
- Dysmenorrhea
- Fever
- Headache disorder
- Juvenile rheumatoid arthritis
- Osteoarthritis
- Pain
- Rheumatoid arthritis
Boxed warnings
- WARNING Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy [see DOSAGE AND ADMINISTRATION ].
Common side effects
- Nausea
- Diarrhea
- Vomiting
- Drowsiness
- Muscular weakness
- Lack of coordination
- Ataxia
- Giddiness
- Tinnitus
- Blurred vision
- Fine hand tremor
- Polyuria
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 Carbonate CI brief — competitive landscape report
- Lithium Carbonate updates RSS · CI watch RSS