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Lithium Carbonate
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Mood Stabilizer [EPC] | EPC | All 41 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 079139-001 | LITHIUM CARBONATE | CAPSULE | LITHIUM CARBONATE | Prescription | AB | ||
| 079139-002 | LITHIUM CARBONATE | CAPSULE | LITHIUM CARBONATE | Prescription | AB | ||
| 079139-003 | LITHIUM CARBONATE | CAPSULE | LITHIUM CARBONATE | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 12 | Labeling | Approved | May 8, 2023 | Standard |
| Supplement | 9 | Labeling | Approved | September 11, 2020 | Standard |
| Supplement | 8 | Labeling | Approved | September 11, 2020 | Standard |
| Supplement | 6 | Labeling | Approved | May 3, 2018 | Standard |
| Supplement | 2 | Labeling | Approved | March 3, 2015 | — |
| Supplement | 5 | Manufacturing (CMC) | Approved | July 25, 2012 | — |
| Supplement | 4 | Labeling | Approved | March 6, 2012 | — |
| Supplement | 3 | Manufacturing (CMC) | Approved | September 7, 2010 | — |
| Original application | 1 | Approved | February 3, 2009 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260603). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingBOXED WARNING 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 ( 2.6 ), 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 ( 2.6 , 5.1 ).
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Lithium Carbonate Capsule USP is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium Carbonate Capsule USP is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.
Dosage and Administration
openFDA Drug Labeling2 DOSAGE & ADMINISTRATION • Recommended starting dosage ( 2.2 ): o Capsules: 300 mg, three times daily • Obtain serum lithium concentration assay after 4 days, drawn 12 hours after the last oral dose and regularly until patient is stabilized. • Manic Episode: Titrate to serum lithium concentrations 0.8 to 1.2 mEq/L, which may be achieved with ( 2.3 ): o Capsules: 600 mg, two to three times daily • Maintenance Treatment for Bipolar I Disorder: Titrate to serum lithium concentrations 0.8 to 1 mEq/L, which may be achieved with ( 2.4 ): o Capsules: 300 mg to 600 mg, two to three times daily • Pre-treatment screening: Evaluate renal function, vital signs, electrolytes, thyroid function, concurrent medications, and pregnancy status ( 2.1 ) • Adjust daily dosage based on serum lithium concentration and clinical response ( 2.6 ) • Mild to moderate renal impairment (CLcr 30 to 89 mL/min): Start with low dose, titrate slowly with frequent monitoring ( 2.8 ) • Severe renal impairment (CLcr < 30 mL/min): Avoid use of lithium ( 2.8 ) 2.1 Pre-treatment Screening Before initiating treatment with lithium, renal function, vital signs, serum electrolytes, and thyroid function should be evaluated. Concurrent medications should be assessed, and if the patient is a woman of childbearing potential, pregnancy status and potential should be considered. 2.2 Starting Dosage Consider medical conditions and drug interactions that would affect lithium dosage and administration [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )]. In the absence of medical conditions and concomitant medications that would suggest starting at a lower dose, the recommended starting dose in adults is: • Capsules: 300 mg three times daily Obtain serum lithium concentration assay after 4 days, drawn 12 hours after the last oral dose. Adjust daily dosage based on serum lithium concentration and clinical response. Fine hand tremor, polyuria and mild thirst may occur during initial therapy for the acute manic phase, and may persist throughout treatment. Transient and mild nausea and general discomfort may also appear during the first few days of lithium administration. These adverse reactions may subside with continued treatment, concomitant administration with food, temporary reduction or cessation of dosage. 2.3 Dosage for Acute Treatment of Manic Episodes in Bipolar I Disorder Titrate to serum lithium concentrations between 0.8 and 1.2 mEq/L, which may be achieved in adults with: • Capsules: 600 mg, two to three times daily Obtain serum lithium concentrations regularly until the serum concentration and clinical condition of the patient has stabilized [see Dosage and Administration ( 2.6 )] . Adjust daily dosage based on serum lithium concentration and clinical response. 2.4 Dosage for Maintenance Treatment of Bipolar I Disorder Titrate to serum lithium concentrations between 0.8 and 1 mEq/L, which may be achieved in adults with: • Capsules: 300 mg to 600 mg, two to three times daily Monitor the patient's clinical state and serum lithium concentrations regularly [see Dosage and Administration ( 2.6 )] . Adjust daily dosage based on serum lithium concentration and clinical response. 2.5 Dosage Recommendations in Pediatric Patients 12 to 17 Years of Age Dosage recommendations for lithium in patients 12 years and older are similar to that of adults [see Use in Specific Populations ( 8.4 )] . 2.6 Serum Lithium Monitoring Blood samples for serum lithium determination should be drawn immediately prior to the next dose when lithium concentrations are relatively stable (i.e., 12 hours after the previous dose). Total reliance must not be placed on serum concentrations alone. Accurate patient evaluation requires both clinical and laboratory analysis. In addition to regular monitoring of serum lithium concentrations for patients on maintenance treatment, serum lithium concentrations should be monitored after any change in dosage, concurrent medication (e.g., diuretics, non-ste …
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Each 150 mg capsule for oral administration contains: lithium carbonate, USP 150 mg and is a white/white size '4' hard gelatin capsules, imprinted with '97' on body and 'H' on cap, containing white to off-white powder. Each 300 mg capsule for oral administration contains: lithium carbonate, USP 300 mg and is a pink/pink size '1' hard gelatin capsules, imprinted with '98' on body and 'H' on cap, containing white to off-white powder. Each 600 mg capsule for oral administration contains: lithium carbonate, USP 600 mg and is a pink/white size '0EL' hard gelatin capsules, imprinted with ' 141' on body and 'H' on cap, containing white to off-white powder. • Capsules: 150 mg, 300 mg, 600 mg of lithium carbonate ( 3 )
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the risk of lithium toxicity is very high in such patients. If the psychiatric indication is life-threatening, and if such a patient fails to respond to other measures, lithium treatment may be undertaken with extreme caution, including daily serum lithium determinations and adjustment to the usually low doses ordinarily tolerated by these individuals. In such instances, hospitalization is a necessity.
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS 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 (5.2) . 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. Educate patients on maintaining a normal diet with salt and staying hydrated. Monitor for and treat hyponatremia and lithium toxicity, which may necessitate a temporary reduction or cessation of lithium and infusion of serum sodium (5.3) . Lithium-Induced Chronic Kidney Disease: Associated with structural changes in patients on chronic lithium therapy. Monitor kidney function during treatment with lithium (5.4) . Encephalopathic Syndrome: Increased risk in patients treated with lithium and an antipsychotic. Monitor routinely for changes to cognitive function (5.5) . Hypothyroidism and Hyperthyroidism: Monitor thyroid function regularly (5.7) . Hypercalcemia and Hyperparathyroidism: Associated with long-term lithium use. Monitor serum calcium (5.8) . 5.1 Lithium Toxicity The toxic concentrations for lithium (≥1.5 mEq/L) are close to the therapeutic range (0.8 to 1.2mEq/L). Some patients abnormally sensitive to lithium may exhibit toxic signs at serum concentrations that are considered within the therapeutic range [see Boxed Warning , Dosage and Administration (2.3) ]. Lithium may take up to 24 hours to distribute into brain tissue, so occurrence of acute toxicity symptoms may be delayed. Neurological signs of lithium toxicity range from mild neurological adverse reactions such as fine tremor, lightheadedness, lack of coordination, and weakness; to moderate manifestations like giddiness, apathy, drowsiness, hyperreflexia, muscle twitching, ataxia, blurred vision, tinnitus, and slurred speech; and severe manifestations such as clonus, confusion, seizure, coma, and death. In rare cases, neurological sequelae may persist despite discontinuing lithium treatment and may be associated with cerebellar atrophy. Cardiac manifestations involve electrocardiographic changes, such as prolonged QT interval, ST and T-wave changes and myocarditis. Renal manifestations include urine concentrating defect, nephrogenic diabetes insipidus, and renal failure. Respiratory manifestations include dyspnea, aspiration pneumonia, and respiratory failure. Gastrointestinal manifestations include nausea, vomiting, diarrhea, and bloating. No specific antidote for lithium poisoning is known [see Overdosage (10) ]. The risk of lithium toxicity is increased by: Recent onset of concurrent febrile illness Concomitant administration of drugs which increase lithium serum concentrations by pharmacokinetic interactions or drugs affecting kidney function [see Drug Interactions (7) ]. Acute ingestion Impaired renal function Volume depletion or dehydration Significant cardiovascular disease Changes in electrolyte concentrations (especially sodium and potassium) Monitor for signs and symptoms of lithium toxicity. If symptoms occur, decrease dosage or discontinue lithium treatment. 5.2 Lithium-Induced Polyuria Chronic lithium treatment may be associated with diminution of renal concentrating ability, occasionally presenting as nephrogenic diabetes insipidus, with polyuria and polydipsia. The concentrating defect and natriuretic effect characteristic of this condition may develop within weeks of lithium initiation. Lithium can also cause renal tubular acidosis, resulting in hyperchloremic metabolic acidosis. Such patients should be carefully managed to avoid dehydration with resulting lithium retention and toxicity. This condition is usually reversible when lithium is discontinued, although for patients treated with long-term lithium, nephrogenic diabetes insipidus may be o …
Warnings
openFDA Drug LabelingWARNINGS Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels (see DOSAGE AND ADMINISTRATION ). Unmasking of Brugada Syndrome There have been postmarketing reports of a possible association between treatment with lithium and the unmasking of Brugada Syndrome. Brugada Syndrome is a disorder characterized by abnormal electrocardiographic (ECG) findings and a risk of sudden death. Lithium should generally be avoided in patients with Brugada Syndrome or those suspected of having Brugada Syndrome. Consultation with a cardiologist is recommended if: (1) treatment with lithium is under consideration for patients suspected of having Brugada Syndrome or patients who have risk factors for Brugada Syndrome, e.g., unexplained syncope, a family history of Brugada Syndrome, or a family history of sudden unexplained death before the age of 45 years, (2) patients who develop unexplained syncope or palpitations after starting lithium therapy. Pregnancy Lithium may cause fetal harm when administered to a pregnant woman. There have been reports of lithium having adverse effects on nidations in rats, embryo viability in mice, and metabolism in-vitro of rat testis and human spermatozoa have been attributed to lithium, as have teratogenicity in submammalian species and cleft palates in mice. Studies in rats, rabbits and monkeys have shown no evidence of lithium-induced teratology. Data from lithium birth registries suggest an increase in cardiac and other anomalies, especially Ebstein’s anomaly. If the patient becomes pregnant while taking lithium, she should be apprised of the potential risk to the fetus. If possible, lithium should be withdrawn for at least the first trimester unless it is determined that this would seriously endanger the mother. Lithium-Induced Renal Effects Chronic lithium therapy may be associated with diminution of renal concentrating ability, occasionally presenting as nephrogenic diabetes insipidus, with polyuria and polydipsia. Such patients should be carefully managed to avoid dehydration with resulting lithium retention and toxicity. This condition is usually reversible when lithium is discontinued. Morphologic changes with glomerular and interstitial fibrosis and nephron-atrophy have been reported in patients on chronic lithium therapy. Morphologic changes have also been seen in bipolar patients never exposed to lithium. The relationship between renal functional and morphologic changes and their association with lithium therapy has not been established. When kidney function is assessed, for baseline data prior to starting lithium therapy or thereafter, routine urinalysis and other tests may be used to evaluate tubular function (e.g., urine specific gravity or osmolality following a period of water deprivation, or 24-hour urine volume) and glomerular function (e.g., serum creatinine or creatinine clearance). During lithium therapy, progressive or sudden changes in renal function, even within the normal range, indicate the need for reevaluation of treatment.
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: • Acute Lithium Toxicity [see Warnings and Precautions ( 5.1 )] • Lithium-Induced Polyuria [see Warnings and Precautions ( 5.2 )] • Hyponatremia [see Warnings and Precautions ( 5.3 )] • Lithium-Induced Chronic Kidney Disease [see Warnings and Precautions ( 5.4 )] • Encephalopathic Syndrome [see Warnings and Precautions ( 5.5 )] • Serotonin Syndrome [see Warnings and Precautions ( 5.6 )] • Hypothyroidism or Hyperthyroidism [see Warnings and Precautions ( 5.7 )] • Hypercalcemia and Hyperparathyroidism [see Warnings and Precautions ( 5.8 )] • Unmasking of Brugada Syndrome [see Warnings and Precautions ( 5.9 ) ] • Pseudotumor Cerebri [see Warnings and Precautions ( 5.10 )] Common Adverse Reactions: • Adult Patients: fine hand tremor, polyuria, mild thirst, nausea, general discomfort during initial treatment ( 6 ) • Pediatric Patients (7 to 17 years): nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/dermatitis, ataxia/gait disturbance, decreased appetite, and blurry vision ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1(888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Pediatric Patients (7 to 17 years): Bipolar I Disorder : The following findings are based on an 8-week, placebo-controlled study for acute manic or mixed episodes of bipolar I disorder in pediatric patients 7 to 17 years (N= 81). In this study, lithium was administered at daily doses ranging from 300 to 3600 (mean dose 1483 mg ± 584) with serum levels ranging from 0 to 2 (mean level 0.98 mEq/L ± 0.47). Common Adverse Reactions (incidence ≥ 5% and at least twice the rate of placebo) : nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/dermatitis, ataxia/gait disturbance, decreased appetite, and blurry vision. A dverse Reactions Occurring at an Incidence of 2% or More in Lithium-Treated Pediatric Patients : Adverse reactions associated with the use of lithium (incidence of 2% or greater, rounded to the nearest percent, and lithium incidence greater than placebo) that occurred during acute therapy (up to 8-weeks in pediatric patients with bipolar disorder) are shown in Table 3. Table 3: Adverse Reactions Reported in 2% or More of Pediatric Patients on Lithium and That Occurred at Greater Incidence Than in the Placebo Group in the 8-Week Acute Bipolar Trial System Organ Class/ Preferred Term Placebo N=28 % Lithium N=53 % Gastrointestinal Disorders Nausea/vomiting 29 57 General Disorders Fatigue 4 26 Genitourinary Disorders Polyuria (Including Enuresis) 14 38 Investigations Increased TSH 0 25 Metabolism and nutrition disorders Thirst/polydipsia 11 28 Decreased appetite 4 9 Nervous system disorders Ataxia/gait disturbance 0 13 Blurry vision 0 9 Disorientation 0 6 Dizziness 7 23 Tremor 7 32 Skin and subcutaneous tissue disorders Rash/dermatitis 0 13 Adult Patients: The following adverse reactions have been identified following use of lithium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Central Nervous System : tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), hypertonicity, ataxia, choreoathetotic movements, hyperactive deep tendon reflexes, extrapyramidal symptoms including acute dystonia, cogwheel rigidity, blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, downbeat nystagmus, incontinence of urine or feces, so …
Drug Interactions
openFDA Drug Labeling7 DRUG 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. ( 2.3 , 7.1 ) • Serotonergic Agents: Increased risk of serotonin syndrome when co-administered with lithium. ( 5.6 , 7.1 ) • 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. ( 5.5 , 7.1 ) 7.1 Drugs Having Clinically Important Interactions with Lithium Table 4: Clinically Important Drug Interactions with Lithium Diuretics Clinical Impact: Diuretic-induced sodium loss may reduce lithium clearance and increase serum lithium concentrations . Intervention: More frequent monitoring of serum electrolyte and lithium concentrations. Reduce lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.3 ), Warning and Precautions ( 5.3 )]. Examples: hydrochlorothiazide, chlorothiazide, furosemide Non-Steroidal Anti-inflammatory Drugs (NSAID) Clinical Impact: NSAID decrease renal blood flow, resulting in decreased renal clearance and increased serum lithium concentrations. Intervention: More frequent serum lithium concentration monitoring. Reduce lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.3 )]. Examples: indomethacin, ibuprofen, naproxen Renin-Angiotensin System Antagonists Clinical Impact: Concomitant use increase steady-state serum lithium concentrations. Intervention: More frequent monitoring of serum lithium concentration. Reduce lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.3 )]. Examples: lisinopril, enalapril, captopril, valsartan Serotonergic Drugs Clinical Impact: Concomitant use can precipitate serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during lithium initiation. If serotonin syndrome occurs, consider discontinuation of lithium and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.6 )] . Examples: selective serotonin reuptake inhibitors (SSRI), serotonin and norepinephrine reuptake inhibitors (SNRI), monoamine oxidase inhibitors (MAOI) Nitroimidazole Antibiotics Clinical Impact: Concomitant use may increase serum lithium concentrations due to reduced renal clearance. Intervention: More frequent monitoring of serum lithium concentration. Reduce lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.3 )]. Examples: metronidazole Acetazolamide, Urea, Xanthine Preparations, Alkalinizing Agents Clinical Impact: Concomitant use can lower serum lithium concentrations by increasing urinary lithium excretion. Intervention: More frequent serum lithium concentration monitoring. Increase lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.3 )]. Examples: acetazolamide, theophylline, sodium bicarbonate Methyldopa, Phenytoin and Carbamazepine Clinical Impact: Concomitant use may increase risk of adverse reactions of these drugs. Intervention: Monitor patients closely for adverse reactions of methyldopa, phenytoin, and carbamazepine. Iodide Preparations Clinical Impact: Concomitant use may produce hypothyroidism. Intervention: Monitor patients for signs or symptoms of hypothyroidism [see Warnings and Precautions ( 5.7 )]. Examples: potassium iodide Calcium Channel Blocking Agents (CCB) Clinical Impact: Concomitant use may increase the risk of neurologic adverse reactions in the form of ataxia, tremors, nausea, vomiting, diarrhea and/or tinnitus. Intervention: Monitor for neurologic adverse reactions. Examples: diltiazem, nifedipine, verapamil Atypical and Typical Antipsychotic Drugs Clinical Impact: Re …
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS • Pregnancy: May cause fetal and/or neonatal harm ( 8.1 ) • Renal Impairment: Use caution during dose selection, starting with dosages less than those for patients with normal renal function while carefully monitoring for side effects ( 2.5 , 6 ) 8.1 Pregnancy Risk Summary: Lithium may cause harm when administered to a pregnant woman. Early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for Ebstein’s anomaly, with first trimester use of lithium. Subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-associated risk. There are concerns for maternal and/or neonatal lithium toxicity during late pregnancy and the postpartum period [see Clinical Considerations]. Published animal developmental and toxicity studies in mice and rats report an increased incidence of fetal mortality, decreased fetal weight, increased fetal skeletal abnormalities, and cleft palate (mouse fetuses only) with oral doses of lithium that produced serum concentrations similar to the human therapeutic range. Other published animal studies report adverse effects on embryonic implantation in rats after lithium administration. Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population(s) is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations: Dose Adjustments During Pregnancy and the Postpartum Period: If the decision is made to continue lithium treatment during pregnancy, serum lithium concentrations should be monitored and the dosage adjusted during pregnancy. Two to three days prior to delivery, lithium dosage should be decreased or discontinued to reduce the risk of maternal and/or neonatal toxicity. Lithium may be restarted in the post-partum period at preconception doses in medically stable patients as long as serum lithium levels are closely monitored [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.1 )]. Fetal/Neonatal Adverse Reactions: Lithium toxicity may occur in neonates who were exposed to lithium in late pregnancy. A floppy baby syndrome including neurological, cardiac, and hepatic abnormalities that are similar to those seen with lithium toxicity in adults have been observed. Symptoms include hypotonia, respiratory distress syndrome, cyanosis, lethargy, feeding difficulties, depressed neonatal reflexes, neonatal depression, apnea, and bradycardia. Monitor neonates and provide supportive care until lithium is excreted and toxic signs disappear, which may take up to 14 days. Consider fetal echocardiography between 16 and 20 weeks gestation in a woman with first trimester lithium exposure because of the potential increased risk of cardiac malformations. 8.2 Lactation Risk Summary: Limited published data reports the presence of lithium carbonate in human milk with breast milk levels measured at 0.12 to 0.7 mEq or 40 to 45% of maternal plasma levels. Infants exposed to lithium during breastfeeding may have plasma levels that are 30 to 40% of maternal plasma levels. Signs and symptoms of lithium toxicity such as hypertonia, hypothermia, cyanosis, and ECG changes have been reported in some breastfed neonates and infants. Increased prolactin levels have been measured in lactating women, but the effects on milk production are not known. Breastfeeding is not recommended with maternal lithium use; however, if a woman chooses to breastfeed, the infant should be closely monitored for signs of lithium toxicity. Discontinue breastfeeding if a breastfed infant develops lithium toxicity. Clinical Considerations: Consider regular monitoring of lithium levels and thyroid function in a b …
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action The mechanism of action of lithium as a mood stabilizing agent is unknown.
Description
openFDA Drug LabelingDESCRIPTION Each capsule for oral administration contains 150 mg, 300 mg or 600 mg of Lithium Carbonate USP. Inactive Ingredients The capsules contain talc. The hard gelatin shell consists of gelatin, titanium dioxide, sodium lauryl sulphate and FD & C Red 40. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide E172 dye, potassium hydroxide. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. The empirical formula for Lithium Citrate is C 6 H 5 Li 3 O 7 ; molecular weight 209.92. Lithium acts as an antimanic. Lithium Carbonate is a white, light, alkaline powder with molecular formula Li 2 CO 3 and molecular weight 73.89.
Overdosage
openFDA Drug Labeling10 OVERDOSAGE The toxic concentrations for lithium (≥ 1.5 mEq/L) are close to the therapeutic concentrations [see Warnings and Precautions ( 5.1 )]. At lithium concentrations greater than 3 mEq/L, patients may progress to seizures, coma, and irreversible brain damage. Treatment For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1800-222-1222 or www.poison.org . No specific antidote for lithium poisoning is known. Early symptoms of lithium toxicity can usually be treated by reduction or cessation of dosage of the drug and resumption of the treatment at a lower dose after 24 to 48 hours. In severe cases of lithium poisoning, the first and foremost goal of treatment consists of elimination of this ion from the patient. Administration of gastric lavage should be performed, but use of activated charcoal is not recommended as it does not significantly absorb lithium ions. Hemodialysis is the treatment of choice as it is an effective and rapid means of removing lithium in patients with severe toxicity. As an alternative option, urea, mannitol and aminophylline can induce a significant increase in lithium excretion. Appropriate supportive care for the patient should be undertaken. In particular, patients with impaired consciousness should have their oral airway protected and it is critical to correct any volume depletion or electrolyte imbalance. Specifically, patients should be monitored to prevent hypernatremia while receiving normal saline and careful regulation of kidney function is of utmost importance. Serum lithium concentrations should be closely monitored as there may be a rebound in serum lithium concentrations as a result of delayed diffusion from the body tissues. Likewise, during the late recovery phase, lithium should be re-administered with caution taking into account the possible release of significant lithium stores in body tissues.
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING Lithium Carbonate Capsules, USP Lithium Carbonate Capsules USP, 150 mg are white/white size '4' hard gelatin capsules, imprinted with '97' on body and 'H' on cap, containing white to off-white powder. They are supplied in Bottles of 30 Capsules (NDC 31722-544-30) Bottles of 100 Capsules (NDC 31722-544-01) Bottles of 500 Capsules (NDC 31722-544-05) Bottles of 1000 Capsules (NDC 31722-544-10) Lithium Carbonate Capsules USP, 300 mg are pink/pink size '1' hard gelatin capsules, imprinted with '98' on body and 'H' on cap, containing white to off-white powder. They are supplied in Bottles of 30 Capsules (NDC 31722-545-30) Bottles of 100 Capsules (NDC 31722-545-01) Bottles of 500 Capsules (NDC 31722-545-05) Bottles of 1000 Capsules (NDC 31722-545-10) Bottles of 5000 Capsules (NDC 31752- 545-50) Blister Pack of 3x10' s (NDC 31722-545-03) Lithium Carbonate Capsules USP, 600 mg are pink/white size '0EL' hard gelatin capsules, imprinted with '141' on body and 'H' on cap, containing white to off-white powder. They are supplied in Bottles of 30 Capsules (NDC 31722-546-30) Bottles of 100 Capsules (NDC 31722-546-01) Bottles of 500 Capsules (NDC 31722-546-05) Bottles of 1000 Capsules (NDC 31722-546-10) Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, child-resistant container as defined in the USP/NF. PROTECT FROM MOISTURE.
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: LITHIUM CARBONATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 62332-013-30 | 62332-013 | Alembic Pharmaceuticals Inc. | 30 CAPSULE in 1 BOTTLE (62332-013-30) | December 27, 2016 |
| 62332-013-31 | 62332-013 | Alembic Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE (62332-013-31) | December 27, 2016 |
| 62332-013-71 | 62332-013 | Alembic Pharmaceuticals Inc. | 500 CAPSULE in 1 BOTTLE (62332-013-71) | December 27, 2016 |
| 62332-013-91 | 62332-013 | Alembic Pharmaceuticals Inc. | 1000 CAPSULE in 1 BOTTLE (62332-013-91) | December 27, 2016 |
| 62332-014-30 | 62332-014 | Alembic Pharmaceuticals Inc. | 30 CAPSULE in 1 BOTTLE (62332-014-30) | December 27, 2016 |
| 62332-014-31 | 62332-014 | Alembic Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE (62332-014-31) | December 27, 2016 |
| 62332-014-71 | 62332-014 | Alembic Pharmaceuticals Inc. | 500 CAPSULE in 1 BOTTLE (62332-014-71) | December 27, 2016 |
| 62332-014-91 | 62332-014 | Alembic Pharmaceuticals Inc. | 1000 CAPSULE in 1 BOTTLE (62332-014-91) | December 27, 2016 |
| 62332-015-30 | 62332-015 | Alembic Pharmaceuticals Inc. | 30 CAPSULE in 1 BOTTLE (62332-015-30) | December 27, 2016 |
| 62332-015-31 | 62332-015 | Alembic Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE (62332-015-31) | December 27, 2016 |
| 62332-015-71 | 62332-015 | Alembic Pharmaceuticals Inc. | 500 CAPSULE in 1 BOTTLE (62332-015-71) | December 27, 2016 |
| 46708-303-30 | 46708-303 | Alembic Pharmaceuticals Limited | 30 CAPSULE in 1 BOTTLE (46708-303-30) | December 27, 2016 |
| 46708-303-31 | 46708-303 | Alembic Pharmaceuticals Limited | 100 CAPSULE in 1 BOTTLE (46708-303-31) | December 27, 2016 |
| 46708-303-71 | 46708-303 | Alembic Pharmaceuticals Limited | 500 CAPSULE in 1 BOTTLE (46708-303-71) | December 27, 2016 |
| 46708-303-91 | 46708-303 | Alembic Pharmaceuticals Limited | 1000 CAPSULE in 1 BOTTLE (46708-303-91) | December 27, 2016 |
| 46708-304-30 | 46708-304 | Alembic Pharmaceuticals Limited | 30 CAPSULE in 1 BOTTLE (46708-304-30) | December 27, 2016 |
| 46708-304-31 | 46708-304 | Alembic Pharmaceuticals Limited | 100 CAPSULE in 1 BOTTLE (46708-304-31) | December 27, 2016 |
| 46708-304-71 | 46708-304 | Alembic Pharmaceuticals Limited | 500 CAPSULE in 1 BOTTLE (46708-304-71) | December 27, 2016 |
| 46708-304-91 | 46708-304 | Alembic Pharmaceuticals Limited | 1000 CAPSULE in 1 BOTTLE (46708-304-91) | December 27, 2016 |
| 46708-305-30 | 46708-305 | Alembic Pharmaceuticals Limited | 30 CAPSULE in 1 BOTTLE (46708-305-30) | December 27, 2016 |
| 46708-305-31 | 46708-305 | Alembic Pharmaceuticals Limited | 100 CAPSULE in 1 BOTTLE (46708-305-31) | December 27, 2016 |
| 46708-305-71 | 46708-305 | Alembic Pharmaceuticals Limited | 500 CAPSULE in 1 BOTTLE (46708-305-71) | December 27, 2016 |
| 60687-806-01 | 60687-806 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-806-01) / 1 CAPSULE in 1 BLISTER PACK (60687-806-11) | June 16, 2024 |
| 60687-964-21 | 60687-964 | American Health Packaging | 30 BLISTER PACK in 1 CARTON (60687-964-21) / 1 CAPSULE in 1 BLISTER PACK (60687-964-11) | June 14, 2026 |
| 71610-557-70 | 71610-557 | Aphena Pharma Solutions - Tennessee, LLC | 120 CAPSULE in 1 BOTTLE (71610-557-70) | May 20, 2021 |
| 83209-220-06 | 83209-220 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 6 CAPSULE in 1 BLISTER PACK (83209-220-06) | August 21, 2024 |
| 83209-220-15 | 83209-220 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 15 CAPSULE in 1 BLISTER PACK (83209-220-15) | August 21, 2024 |
| 83209-220-20 | 83209-220 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 20 CAPSULE in 1 BLISTER PACK (83209-220-20) | August 21, 2024 |
| 83209-220-30 | 83209-220 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 30 CAPSULE in 1 BLISTER PACK (83209-220-30) | August 21, 2024 |
| 83209-220-60 | 83209-220 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 60 CAPSULE in 1 BLISTER PACK (83209-220-60) | August 21, 2024 |
| 71335-0120-1 | 71335-0120 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-0120-1) | December 16, 2021 |
| 71335-0120-2 | 71335-0120 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE (71335-0120-2) | December 16, 2021 |
| 71335-0120-3 | 71335-0120 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-0120-3) | December 16, 2021 |
| 71335-0120-4 | 71335-0120 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-0120-4) | December 16, 2021 |
| 71335-0120-5 | 71335-0120 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE (71335-0120-5) | December 16, 2021 |
| 71335-1006-1 | 71335-1006 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-1006-1) | May 17, 2019 |
| 71335-1006-2 | 71335-1006 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE (71335-1006-2) | May 17, 2019 |
| 71335-1006-3 | 71335-1006 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-1006-3) | October 18, 2019 |
| 71335-1006-4 | 71335-1006 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-1006-4) | October 4, 2019 |
| 71335-1006-5 | 71335-1006 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE (71335-1006-5) | May 17, 2019 |
| 31722-544-01 | 31722-544 | Camber Pharmaceuticals, Inc. | 100 CAPSULE in 1 BOTTLE (31722-544-01) | December 15, 2009 |
| 31722-544-05 | 31722-544 | Camber Pharmaceuticals, Inc. | 500 CAPSULE in 1 BOTTLE (31722-544-05) | December 15, 2009 |
| 31722-544-10 | 31722-544 | Camber Pharmaceuticals, Inc. | 1000 CAPSULE in 1 BOTTLE (31722-544-10) | December 15, 2009 |
| 31722-544-30 | 31722-544 | Camber Pharmaceuticals, Inc. | 30 CAPSULE in 1 BOTTLE (31722-544-30) | December 15, 2009 |
| 31722-545-01 | 31722-545 | Camber Pharmaceuticals, Inc. | 100 CAPSULE in 1 BOTTLE (31722-545-01) | December 15, 2009 |
| 31722-545-03 | 31722-545 | Camber Pharmaceuticals, Inc. | 30 CAPSULE in 1 BLISTER PACK (31722-545-03) | December 15, 2009 |
| 31722-545-05 | 31722-545 | Camber Pharmaceuticals, Inc. | 500 CAPSULE in 1 BOTTLE (31722-545-05) | December 15, 2009 |
| 31722-545-10 | 31722-545 | Camber Pharmaceuticals, Inc. | 1000 CAPSULE in 1 BOTTLE (31722-545-10) | December 15, 2009 |
| 31722-545-30 | 31722-545 | Camber Pharmaceuticals, Inc. | 30 CAPSULE in 1 BOTTLE (31722-545-30) | December 15, 2009 |
| 31722-545-50 | 31722-545 | Camber Pharmaceuticals, Inc. | 5000 CAPSULE in 1 BOTTLE (31722-545-50) | December 15, 2009 |
| 31722-546-01 | 31722-546 | Camber Pharmaceuticals, Inc. | 100 CAPSULE in 1 BOTTLE (31722-546-01) | December 15, 2009 |
| 31722-546-05 | 31722-546 | Camber Pharmaceuticals, Inc. | 500 CAPSULE in 1 BOTTLE (31722-546-05) | December 15, 2009 |
| 31722-546-10 | 31722-546 | Camber Pharmaceuticals, Inc. | 1000 CAPSULE in 1 BOTTLE (31722-546-10) | December 15, 2009 |
| 31722-546-30 | 31722-546 | Camber Pharmaceuticals, Inc. | 30 CAPSULE in 1 BOTTLE (31722-546-30) | December 15, 2009 |
| 67046-0547-3 | 67046-0547 | Coupler LLC | 30 CAPSULE in 1 BLISTER PACK (67046-0547-3) | May 4, 2026 |
| 67046-1690-3 | 67046-1690 | Coupler LLC | 30 CAPSULE in 1 BLISTER PACK (67046-1690-3) | August 3, 2026 |
| 68462-220-01 | 68462-220 | Glenmark Pharmaceuticals Inc., USA | 100 CAPSULE in 1 BOTTLE (68462-220-01) | February 3, 2009 |
| 68462-220-11 | 68462-220 | Glenmark Pharmaceuticals Inc., USA | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (68462-220-11) / 10 CAPSULE in 1 BLISTER PACK | February 3, 2009 |
| 68462-221-01 | 68462-221 | Glenmark Pharmaceuticals Inc., USA | 100 CAPSULE in 1 BOTTLE (68462-221-01) | February 3, 2009 |
| 68462-221-10 | 68462-221 | Glenmark Pharmaceuticals Inc., USA | 1000 CAPSULE in 1 BOTTLE (68462-221-10) | February 3, 2009 |
| 68462-221-11 | 68462-221 | Glenmark Pharmaceuticals Inc., USA | 10 BLISTER PACK in 1 CARTON (68462-221-11) / 10 CAPSULE in 1 BLISTER PACK | February 3, 2009 |
| 68462-222-01 | 68462-222 | Glenmark Pharmaceuticals Inc., USA | 100 CAPSULE in 1 BOTTLE (68462-222-01) | February 3, 2009 |
| 68462-222-11 | 68462-222 | Glenmark Pharmaceuticals Inc., USA | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (68462-222-11) / 10 CAPSULE in 1 BLISTER PACK | February 3, 2009 |
| 0615-8480-39 | 0615-8480 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 CAPSULE in 1 BLISTER PACK (0615-8480-39) | August 21, 2023 |
| 63187-304-30 | 63187-304 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (63187-304-30) | May 2, 2016 |
| 63187-304-60 | 63187-304 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (63187-304-60) | May 2, 2016 |
| 63187-304-90 | 63187-304 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (63187-304-90) | May 2, 2016 |
| 70518-0668-0 | 70518-0668 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-0668-0) | August 10, 2017 |
| 70518-0668-1 | 70518-0668 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-0668-1) | December 19, 2023 |
| 70518-2312-0 | 70518-2312 | REMEDYREPACK INC. | 100 POUCH in 1 BOX (70518-2312-0) / 1 CAPSULE in 1 POUCH (70518-2312-1) | September 13, 2019 |
| 70518-2312-2 | 70518-2312 | REMEDYREPACK INC. | 70 POUCH in 1 BOX, UNIT-DOSE (70518-2312-2) / 1 CAPSULE in 1 POUCH (70518-2312-1) | May 11, 2026 |
| 70518-2312-3 | 70518-2312 | REMEDYREPACK INC. | 50 POUCH in 1 BOX (70518-2312-3) / 1 CAPSULE in 1 POUCH (70518-2312-1) | July 21, 2026 |
| 70518-3565-0 | 70518-3565 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-3565-0) | October 31, 2022 |
| 70518-3565-1 | 70518-3565 | REMEDYREPACK INC. | 100 POUCH in 1 BOX (70518-3565-1) / 1 CAPSULE in 1 POUCH (70518-3565-2) | September 28, 2023 |
| 70518-4627-0 | 70518-4627 | REMEDYREPACK INC. | 50 POUCH in 1 BOX (70518-4627-0) / 1 CAPSULE in 1 POUCH (70518-4627-1) | April 24, 2026 |
| 62332-013 | 62332-013 | Alembic Pharmaceuticals Inc. | — | December 27, 2016 |
| 62332-014 | 62332-014 | Alembic Pharmaceuticals Inc. | — | December 27, 2016 |
| 62332-015 | 62332-015 | Alembic Pharmaceuticals Inc. | — | December 27, 2016 |
| 46708-303 | 46708-303 | Alembic Pharmaceuticals Limited | — | December 27, 2016 |
| 46708-304 | 46708-304 | Alembic Pharmaceuticals Limited | — | December 27, 2016 |
| 46708-305 | 46708-305 | Alembic Pharmaceuticals Limited | — | December 27, 2016 |
| 60687-806 | 60687-806 | American Health Packaging | — | June 16, 2024 |
| 60687-964 | 60687-964 | American Health Packaging | — | June 14, 2026 |
| 71610-557 | 71610-557 | Aphena Pharma Solutions - Tennessee, LLC | — | December 15, 2009 |
| 83209-220 | 83209-220 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | — | August 21, 2024 |
| 71335-0120 | 71335-0120 | Bryant Ranch Prepack | — | December 15, 2009 |
| 71335-1006 | 71335-1006 | Bryant Ranch Prepack | — | February 3, 2009 |
| 31722-544 | 31722-544 | Camber Pharmaceuticals, Inc. | — | December 15, 2009 |
| 31722-545 | 31722-545 | Camber Pharmaceuticals, Inc. | — | December 15, 2009 |
| 31722-546 | 31722-546 | Camber Pharmaceuticals, Inc. | — | December 15, 2009 |
| 67046-0547 | 67046-0547 | Coupler LLC | — | May 4, 2026 |
| 67046-1690 | 67046-1690 | Coupler LLC | — | August 3, 2026 |
| 68462-220 | 68462-220 | Glenmark Pharmaceuticals Inc., USA | — | February 3, 2009 |
| 68462-221 | 68462-221 | Glenmark Pharmaceuticals Inc., USA | — | February 3, 2009 |
| 68462-222 | 68462-222 | Glenmark Pharmaceuticals Inc., USA | — | February 3, 2009 |
| 0615-8480 | 0615-8480 | NCS HealthCare of KY, LLC dba Vangard Labs | — | February 3, 2009 |
| 63187-304 | 63187-304 | Proficient Rx LP | — | December 15, 2009 |
| 70518-0668 | 70518-0668 | REMEDYREPACK INC. | — | August 10, 2017 |
| 70518-2312 | 70518-2312 | REMEDYREPACK INC. | — | September 13, 2019 |
| 70518-3565 | 70518-3565 | REMEDYREPACK INC. | — | October 31, 2022 |
| 70518-4627 | 70518-4627 | REMEDYREPACK INC. | — | April 24, 2026 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.