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Molecule

Lithium citrate

Mood Stabilizer
Available on request
Presentations
1
Brands
0
Manufacturers
0
Available from stock
0

Lithium citrate is a mood stabilizer indicated as monotherapy for the treatment of bipolar I disorder. It is available as oral solution. MedsAcross supplies Lithium citrate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Mood Stabilizer
US FDA first approval
23 December 1980
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Oral solution
Identifiers
UNII 3655633623CAS 919-16-4DrugBank DB14507Q2351742

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Treatment of acute manic and mixed episodes in patients 7 years and older Maintenance treatment in patients 7 years and older Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Treatment of acute manic and mixed episodes in patients 7 years and older. Maintenance treatment in patients 7 years and older

Source: US FDA prescribing information

Dosing overview

Recommended starting dosage for adults and pediatric patients over 30 kg: Oral Solution: 8mEq lithium (5 mL) three times daily Recommended starting dosage for pediatric patients 20 to 30 kg: Oral Solution: 8mEq (5mL), twice daily Obtain serum lithium concentration assay after 3 days, drawn 12 hours after the last oral dose and regularly until patient is stabilized. Acute Manic or Mixed Episodes (patients 7 years and older): Titrate to serum lithium concentrations 0.8 to 1.2 mEq/L. Maintenance Treatment for Bipolar I Disorder (patients 7 years and older): Titrate to serum lithium concentrations 0.8 to 1 mEq/L. Pre-treatment Screening: Evaluate renal function, vital signs, electrolytes, thyroid function, concurrent medications, and pregnancy status.

Source: US FDA prescribing information

Contraindications

Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium citrate products. Known hypersensitivity to any inactive ingredient in the drug product.

Source: US FDA prescribing information

Warnings and precautions

Boxed 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. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy. Lithium-Induced Polyuria: May develop during initiation of treatment. Increases risk of lithium toxicity. Educate patient to avoid dehydration. Monitor for lithium toxicity and metabolic acidosis. Discontinue lithium or treat with amiloride as a therapeutic agent. Hyponatremia: Symptoms are more severe with faster-onset hyponatremia. Dehydration from protracted sweating, diarrhea, or elevated temperatures from infection increases risk of hyponatremia and lithium toxicity.

Source: US FDA prescribing information

Side effects

The following adverse reactions are described in greater detail in other sections: Acute Lithium Toxicity Lithium-Induced Polyuria Hyponatremia Lithium-Induced Chronic Kidney Disease Encephalopathic Syndrome Serotonin Syndrome Hypothyroidism or Hyperthyroidism Hypercalcemia and Hyperparathyroidism Unmasking of Brugada Syndrome Pseudotumor Cerebri Common Adverse Reactions: Adult Patients: fine hand tremor, polyuria, mild thirst, nausea, general discomfort during initial treatment. Pediatric Patients (7-17 years): nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/dermatitis, ataxia/gait disturbance, decreased appetite, and blurry vision

Source: US FDA prescribing information

Interactions

Diuretics, NSAID, renin-angiotensin system antagonists, or metronidazole may increase lithium serum concentrations. Recommend frequent monitoring of serum lithium concentration and adjust dosage when necessary. Serotonergic Agents: Increased risk of serotonin syndrome when co-administered with lithium. Antipsychotics: There have been reports of neurologic adverse reactions in patients treated with lithium and an antipsychotic, ranging from extrapyramidal symptoms to neuroleptic malignant syndrome.

Source: US FDA prescribing information

Storage

Store and Dispense Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Lithium citrate, sorted by availability.

MedicineManufacturerRegisterAvailability
Lithium citrate 8 mEq/5 mL oral solutionOralGeneric name—US FDAAvailable on request

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 23 December 1980Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Lithium citrate available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Lithium citrate and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Lithium citrate approved by the US FDA?

Yes. The US FDA first approved Lithium citrate on 23 December 1980, according to Drugs@FDA.

Does Lithium citrate need cold chain shipping?

No listed presentation of Lithium citrate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. Lithium prescribing information (Advagen Pharma). U.S. National Library of Medicine, DailyMed. Retrieved 11 September 2026

Request Lithium citrate for export supply

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