Lithium 8 meq/5mL Solution, 473 mL — NDC 71656-072-16 (Billing 71656-0072-16)
This is a package of 473 mL of Lithium 8 meq/5mL Solution from Saptalis Pharmaceuticals, LLC, marketed since Mar 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 004006
- GCN: 15741
- GPI-14 (Medi-Span): 59500010002010
- HICL (First Databank): 001670
- AHFS class code: 28:28.00.00
- RxCUI (RxNorm): 756059
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Lithium is used to treat and prevent episodes of mania (frenzied, abnormally excited mood) in people with bipolar disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Lithium is in a class of medications called antimanic agents. It works by decreasing abnormal activity in the brain.
Read the full MedlinePlus article ↗- Lithium treats manic episodes of bipolar disorder and helps prevent future episodes with long-term use. Some labels cover bipolar I disorder in people 7 and older. It can take 1 to...
- Take it by mouth exactly as your prescriber directs. You will need regular blood tests to check your level, usually drawn about 12 hours after your last dose. Drink plenty of fluid...
- Early on, fine hand tremor, more urination, mild thirst and nausea are common. Call us if you notice worsening tremor, weakness, unsteadiness, slurred speech, confusion or persiste...
- Dehydration from sweating, diarrhea, vomiting or fever can raise your lithium level and lead to toxicity. Call your doctor if this happens, as your dose may need to be reduced or p...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Lithium Carbonate (prescription drug) — tap one for details:
Lithium Carbonate (prescription drug) may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.5296 | $250.50 / 473 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.2861 | $135.33 / 473 ml |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 71656-0072-16 You're viewing this Main listing | 473 mL in 1 BOTTLE | 2024-04-05 | — | Active |
| 71656-0072-50 71656-072-50 | 5 TRAY in 1 CASE / 10 CUP in 1 TRAY / 5 mL in 1 CUP | 2024-03-28 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Lithium 8 meq/5mL Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lithium 8 meq/5mL 00121-1027-16 | PAI | 500 ml | $0.453 | AA | Availability likely | — |
| Lithium 8 meq/5mL 72888-0172-46 | Advagen | 500 ml | $0.453 | AA | Availability likely | — |
| Lithium 8 meq/5mL 00121-4027-94 | PAI | 10 cups | — | AA | FDA listed | — |
| Lithium 8 meq/5mL 68094-0077-62 | Precision | 10 cups | — | AA | FDA listed | — |
| Lithium 8 meq/5mL 70518-4227-00 | REMEDYREPACK | 10 cups | — | AA | FDA listed | — |
| Lithium 8 meq/5mLthis 71656-0072-16 | Saptalis | 473 ml | — | AA | FDA listed | — |
| Lithium 8 meq/5mL 17856-1172-01 | Atlantic | 30 syringes | — | AA | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
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8 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed 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 ( 2.3 ), 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 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Lithium oral solution 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 [see Clinical Studies ( 14 )]. Maintenance treatment in patients 7 years and older [see Clinical Studies ( 14 )]. 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 ( 1 ).
Maintenance treatment in patients 7 years and older ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended starting dosage for adults and pediatric patients over 30 kg ( 2.2 ): Oral Solution: 8 mEq lithium (5 mL) three times daily. Recommended starting dosage for pediatric patients 20 kg to 30 kg ( 2.2 ): Oral Solution: 8 mEq (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 mEq/L to 1.2 mEq/L ( 2.2 ). Maintenance Treatment for Bipolar I Disorder (patients 7 years and older): Titrate to serum lithium concentrations 0.8 mEq/L to 1 mEq/L ( 2.2 ). Pre-treatment Screening: Evaluate renal function, vital signs, electrolytes, thyroid function, concurrent medications, and pregnancy status ( 2.1 ).
Mild to Moderate Renal Impairment (CLer 30 mL/min to 89 mL/min): Start with dosages less than those for patients with normal renal function, titrate slowly with frequent monitoring ( 2.5 ). Severe Renal Impairment (CLer< 30mL/min): Avoid use of lithium ( 2.5 ).
2.1Pre-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.
2.2Recommended Dosage See Table 1 for dosage recommendations for acute and maintenance treatment of bipolar I disorder in adult and pediatric patients (7 years to 17 years). Obtain serum lithium concentration assay after 3 days, drawn 12 hours after the last oral dose and regularly until patient is stabilized. Fine hand tremor, polyuria, and thirst may occur during initial therapy for the acute manic phase and may persist throughout treatment.
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, or temporary reduction or cessation of dosage. Table 1.
Lithium Oral Solution Dosing for Bipolar I Disorder Patient Group Formulation Starting Dose Dose Titration Acute Goal Maintenance Goal Serum Level Usual Dose Serum Level Usual Dose Adult and Pediatric Patients over 30 kg Liquid 8 mEq (5 mL) three times daily 8 mEq (5 mL) every 3 days 0.8 mEq/L to 1.2 mEq/L 16 mEq (10 mL) two to three times daily 0.8 mEq/L to 1 mEq/L 8 mEq to 16 mEq (5 mL to 10 mL) two to three times daily Pediatric Patients 20 kg to 30 kg Liquid 8 mEq (5 mL) twice daily 8 mEq (5 mL) weekly 16 mEq to 40 mEq (10 mL to 25 mL) in divided doses daily 16 mEq to 32 mEq (10 mL to 20 mL) in divided doses daily Each 5 mL of lithium oral solution contains 8 mEq of lithium ion (Li + ) which is equivalent to the amount of lithium in 300 mg of lithium carbonate.
See Table 2 for lithium carbonate and lithium oral solution dose conversion. Table 2. Lithium Carbonate and Lithium Oral Solution Dose Conversion Lithium Carbonate Tablets or Capsules Lithium Oral Solution 150 mg 4 mEq (2.5 mL) 300 mg 8 mEq (5 mL) 600 mg 16 mEq (10 mL)
2.3Serum 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-steroidal anti-inflammatory drugs, renin-angiotensin system antagonists, or metronidazole), marked increase or decrease in routinely performed strenuous physical activity (such as an exercise program) and in the event of a concomitant disease [… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Each 5 mL of clear, slightly yellow lithium oral solution, USP contains 8 mEq lithium ion (Li + ) (equivalent to the amount of lithium in 300 mg of lithium carbonate, USP). Oral Solution: 8 mEq of lithium (Li + ) per 5mL ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium citrate products [see Adverse Reactions ( 6 )]. Known hypersensitivity to any inactive ingredient in the drug product ( 4 ).
⚠️ Warnings and Cautions ▾
5 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 ).
5.1Lithium Toxicity The toxic concentrations for lithium (≥ 1.5 mEq/L) are close to the therapeutic range (0.8 mEq/L to 1.2 mEq/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.
5.2Lithium-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 diabete… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 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 years 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 Saptalis Pharmaceuticals, LLC. at 1-833-727-8254 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
6.1Clinical 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 years 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 years to 17 years (N = 81).
In this study, lithium was administered at daily doses ranging from 300 to 3,600 (mean dose 1,483 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. Adverse 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, s… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 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 ).
7.1Drugs 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 )].
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 )] .
Renin-Angiotensin System Antagonists Clinical Impact: Concomitant use increases 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 )] .
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 )].
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 )].
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 )] .
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 )] . 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.
Atypical and Typical Antipsychotic Drugs Clinical Impact: Reports of neurotoxic reactions in patients treated with both lithium and an antipsychotic, ranging from extrapyramidal symptoms to neuroleptic malignant syndrome, as well as reports of an encephalopathic syndrome in few patients treated with concomitant therapy [see Warnings and Precautions ( 5.5 )]. Intervention: Monitor for neurologic adverse reactions. Sodium-Glucose Cotransporter 2 (SGLT2) inhibitor Clinical Impact: Concomitant use of lithium with an SG… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 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 ).
8.1Pregnancy 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 weeks and 20 weeks gestation in a woman with first trimester lithium exposure because of the potential increased risk of cardiac malformations.
8.2Lactation Risk Summary: Limited published data reports the presence of lithium carbonate in human milk with breast milk levels measured at 0.12 mEq 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 fun… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy 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 weeks and 20 weeks gestation in a woman with first trimester lithium exposure because of the potential increased risk of cardiac malformations.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of lithium for monotherapy treatment of acute manic or mixed episodes of bipolar I disorder and maintenance monotherapy of bipolar I disorder in pediatric patients ages 7 years to 17 years of age have been established in an acute-phase clinical trial of 8 weeks in duration followed by a 28-week randomized withdrawal phase [see Dosage and Administration ( 2.1 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14 )] . The safety and effectiveness of lithium has not been established in pediatric patients less than 7 years of age with bipolar I disorder.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of lithium carbonate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other treatment.
Lithium is known to be substantially excreted by the kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
10 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 1-800-222-1222 or www.poison.org.
No specific antidote for lithium poisoning is known. Mild symptoms of lithium toxicity can usually be treated by reduction in dose or cessation of the drug. In severe cases of lithium poisoning, the goal of treatment is 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. Patients with impaired consciousness should have their airway protected and it is critical to correct any volume depletion or electrolyte imbalance. 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of lithium as a mood stabilizing agent is unknown.
12.3Pharmacokinetics Absorption: After oral administration, lithium is reported to be completely absorbed in the upper gastrointestinal tract. Peak serum concentrations (T max ) occur 0.25 hour to 3 hours after oral administration of immediate release preparations and 2 hours to 6 hours after sustained-release preparations. Distribution: The distribution space of lithium approximates that of total body water, and the plasma protein binding is negligible.
After equilibrium, the apparent volume of distribution is
0.7L/kg to 1 L/kg. Metabolism: Lithium is not metabolized. Excretion: Lithium is primarily excreted in urine, proportionally to its serum concentration.
Lithium is filtered by the glomerulus, and 80% is reabsorbed by passive diffusion in the proximal tubule. The elimination half-life of lithium is approximately 18 hours to 36 hours. Lithium excretion in feces is insignificant.
Specific Populations: Pediatric Use: A pharmacokinetic study of lithium was performed in 39 subjects with bipolar I disorder. Both apparent clearance and apparent volume of distribution increase as body weight increases. A lower dose in patients < 30 kg is necessary to achieve lithium exposures in pediatric patients similar to those observed in adults treated at recommended doses of lithium [see Dosage and Administration ( 2.2 )].
The estimated plasma clearance was
0.59 L/h,
0.79 L/h and
1.17L/h for pediatric patients weighing 20 kg, 30 kg and 50 kg, respectively.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of lithium as a mood stabilizing agent is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Lithium oral solution, USP, is supplied as a clear, slightly yellow liquid with citrus aroma packed in 16 oz white HDPE modern round bottle with CRC or 7 mL blue unit-dose cup with peelable HDPE lidding. Bottle of 473 mL (16 oz) NDC 71656-072-16 5 mL (8 mEq) fill, case of 5 trays x 10s NDC 71656-072-50 Storage 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) [See USP Controlled Room Temperature]. Dispense in a tight, child-resistant container as defined in the USP/NF.
📋 Description ▾
11 DESCRIPTION Each 5 mL of solution for oral administration contains lithium ion (Li + ), 8 mEq (equivalent to amount of lithium in 300 mg of lithium carbonate, USP), and the following other inactive ingredients: citric acid, glycerin, orange flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, and sucralose. Lithium oral solution, USP is a palatable oral dosage form of lithium ion. It is prepared in solution from lithium carbonate, USP and citric acid in a ratio approximately di-lithium citrate.
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 209.93. Lithium acts as an antimanic.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read FDA-approved patient labeling (Medication Guide). Dosage and Administration: Advise patients that lithium is a mood stabilizer, and should only be taken as directed. Emphasize the importance of compliance with the prescribed treatment and to not adjust the dose of lithium without first consulting their healthcare provider.
Inform patients that they will need to have regular blood draws to determine if their dose of lithium is appropriate. Instruct patients not to double the dose if a dose is missed, due to the complexity of individualized dosing and potential for lithium toxicity [see Dosage and Administration ( 2 ), Warnings and Precautions ( 5.1 )]. Lithium Toxicity: Inform patients on adverse reactions related to lithium toxicity that require medical attention.
Advise patients to discontinue lithium treatment and contact their healthcare provider if clinical signs of lithium toxicity such as diarrhea, vomiting, tremor, lack of muscle coordination, drowsiness, abnormal heart rhythm or muscular weakness occur [see Warnings and Precautions ( 5.1 )]. Lithium-Induced Polyuria: Counsel patients on the adverse reactions related to lithium-induced polyuria, when to seek medical attention, and the importance of maintaining normal diet with salt and staying hydrated [see Warnings and Precautions ( 5.2 )].
Hyponatremia: Counsel patients on the adverse reactions of hyponatremia, when to seek medical attention, the importance of maintaining a normal diet including adequate salt intake and staying hydrated [see Warnings and Precautions ( 5.3 )]. Salt supplements and additional fluids may be required if excessive losses occur. Serotonin Syndrome: Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of lithium with other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, tramadol, tryptophan, buspirone, St.
John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid) [see Warnings and Precautions ( 5.6 ) and Drug Interactions ( 7 )]. Drug Interactions: Advise patients that many drugs can interact with lithium and to inform their doctor and pharmacist if they are taking any over the counter medication, including herbal medication, or are started on a new prescription [see Drug Interactions ( 7 )]. Somnolence: Tell patients that lithium may cause somnolence particularly when initiating treatment and to be cautious about operating vehicles or hazardous machinery, until they are reasonably certain that lithium treatment does not affect them adversely [see Adverse Reactions ( 6 )].
Pregnancy: Advise pregnant women of the potential risk to a fetus and/or neonate [see Use in Specific Populations ( 8.1 )]. Lactation: Advise women that breastfeeding is not recommended during treatment with lithium [see Use in Specific Populations ( 8.2 )]. Distributed by: Saptalis Pharmaceuticals, LLC.
Hauppauge, NY 11788 MADE IN USA April 2025-R2 PPM-0050
💬 Medication Guide ▾
MEDICATION GUIDE Lithium (LITH-ee-əm) Oral Solution, USP What is the most important information I should know about lithium oral solution? Lithium oral solution can cause serious side effects, including: too much lithium in your blood (lithium toxicity) . Lithium toxicity that can cause death may happen even if the lithium level in your blood is close to the right level for you.
Your healthcare provider will need to monitor your blood levels of lithium to find the best dose for you. Take your lithium oral solution exactly as your healthcare provider tells you to take it. Stop taking lithium oral solution and call your healthcare provider right away if you have any symptoms of lithium toxicity including: ○ abnormal heartbeat ○ vomiting ○ diarrhea ○ drowsiness ○ weak muscles ○ blurred vision ○ clumsiness ○ ringing in your ears ○ muscle twitching Other symptoms may include: ○ lightheadedness ○ confusion ○ bloating ○ mood changes ○ slurred speech ○ breathing problems ○ seizure ○ coma What is lithium oral solution?
Lithium oral solution is a prescription medicines called mood-stabilizing agents used alone (monotherapy) for: the acute (short-term) treatment of people 7 years of age and older with manic and mixed episodes that happen with bipolar I disorder. maintenance treatment of bipolar I disorder in people 7 years of age and older. It is not known if lithium oral solution is safe and effective in children under 7 years of age with bipolar I disorder. Who should not take lithium oral solution?
Do not take lithium oral solution if you are allergic to lithium or any of the ingredients in lithium oral solution. See the end of this medication guide for a complete list of ingredients in lithium oral solution. What should I tell my healthcare provider before taking lithium oral solution?
Before taking lithium oral solution, tell your healthcare provider if you: have kidney problems have heart problems have breathing problems have thyroid problems are pregnant or plan to become pregnant. Lithium oral solution may harm your unborn baby. are breastfeeding or plan to breastfeed. Lithium can pass into your breastmilk and may harm your baby.
You should not breastfeed during treatment with lithium oral solution. Talk to your healthcare provider about the best way to feed your baby if you take lithium oral solution. Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements.
Using lithium oral solution with certain other medicines may affect each other causing possible side effects. Lithium oral solution may affect the way other medicines work, and other medicines may affect how lithium oral solution works. Especially tell your healthcare provider if you take: MAOIs selective serotonin reuptake inhibitors (SSRIs) serotonin norepinephrine reuptake inhibitors (SNRIs) medicines used to treat migraine headaches called triptans tricyclic antidepressants fentanyl antipsychotic medicines tramadol tryptophan buspirone St John’s Wort Your healthcare provider can tell you if it is safe to take lithium oral solution with your other medicines.
Do not start or stop any medicines while taking lithium oral solution without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.
How should I take lithium oral solution? Take your lithium oral solution exactly as prescribed by your healthcare provider. Your healthcare provider will do certain blood tests before starting and during treatment with lithium oral solution.
Your healthcare provider may change your dose if needed. Do not change your dose on your own. Do not double your dose if a dose is missed.
Talk with your healthcare provider if you miss a dose. Do not stop taking lithium oral solution suddenly without talking to your healthcare provider. Your healthcare provider may change your lithium or… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption: After oral administration, lithium is reported to be completely absorbed in the upper gastrointestinal tract. Peak serum concentrations (T max ) occur 0.25 hour to 3 hours after oral administration of immediate release preparations and 2 hours to 6 hours after sustained-release preparations. Distribution: The distribution space of lithium approximates that of total body water, and the plasma protein binding is negligible.
After equilibrium, the apparent volume of distribution is
0.7L/kg to 1 L/kg. Metabolism: Lithium is not metabolized. Excretion: Lithium is primarily excreted in urine, proportionally to its serum concentration.
Lithium is filtered by the glomerulus, and 80% is reabsorbed by passive diffusion in the proximal tubule. The elimination half-life of lithium is approximately 18 hours to 36 hours. Lithium excretion in feces is insignificant.
Specific Populations: Pediatric Use: A pharmacokinetic study of lithium was performed in 39 subjects with bipolar I disorder. Both apparent clearance and apparent volume of distribution increase as body weight increases. A lower dose in patients < 30 kg is necessary to achieve lithium exposures in pediatric patients similar to those observed in adults treated at recommended doses of lithium [see Dosage and Administration ( 2.2 )].
The estimated plasma clearance was
0.59 L/h,
0.79 L/h and
1.17L/h for pediatric patients weighing 20 kg, 30 kg and 50 kg, respectively.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The safety and efficacy of lithium as a treatment for acute manic or mixed episodes of bipolar I disorder in pediatric patients (ages 7 years to 18 years) was demonstrated in an 8-week, randomized, placebo-controlled, parallel group study ( NCT01166425 ). In this study, 81 patients with a Young Mania Rating Scale (YMRS) score of 20 or more were randomized to receive lithium or placebo in a 2:1 ratio. Patients weighing more than 30 kg started lithium at 300 mg three times daily (900 mg/day) and could increase their dose by 300 mg every 3 days.
Patients weighing 20 kg to 30 kg started lithium at 300 mg twice daily (600 mg/day) and could increase their dose by 300 mg weekly. No patients weighing less than 20 kg were enrolled. Lithium (mean serum level 0.98 ± 0.47 mEq/L) was statistically significantly superior to placebo in decreasing acute mania or mixed states as measured by the YMRS (see Table 5).
In a 28-week randomized withdrawal analysis, 31 pediatric patients stabilized on lithium were assigned to either continue lithium or switch to placebo. The group receiving lithium demonstrated superiority to those receiving placebo in all-cause discontinuation (see Table 5). Table 5: Primary Efficacy Results Analysis Treatment Group Change From Baseline at Week 8 in YMRS Summary Score N Mean Baseline Score (SD) LS Mean Change from Baseline (SE) Difference 1 (95% CI) Acute Efficacy Lithium 53 29.5 (5.6) -12.9 (3.1) -5.5 (-10.5, -0.5) Placebo 28 30.0 (6.0) -7.3 (3.1) Analysis Treatment Group 2 All-cause Discontinuation N Number of Discontinued Subjects Hazard Ratio 3 (95% CI) Randomized Withdrawal Lithium 17 7 (41.2%) 0.28 (0.10, 0.78) Placebo 14 11 (78.6%) SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval.
1. Difference (drug minus placebo) in least-squares mean change from baseline. 2.
Patients analyzed by received treatment. 3. Lithium to placebo.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: There have been no long-term studies performed in animals to evaluate the carcinogenic potential of lithium. Mutagenesis: There have been no adequate studies conducted to evaluate the mutagenic and genotoxic potential of lithium. Impairment of Fertility: There have been no adequate studies performed in animals at current standards to evaluate the effect of lithium treatment on fertility.
However, published studies in male mice and rats administered repeated daily dosing of lithium carbonate report adverse effects on male reproductive organs, decreased spermatogenesis and decreased testosterone levels.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: There have been no long-term studies performed in animals to evaluate the carcinogenic potential of lithium. Mutagenesis: There have been no adequate studies conducted to evaluate the mutagenic and genotoxic potential of lithium. Impairment of Fertility: There have been no adequate studies performed in animals at current standards to evaluate the effect of lithium treatment on fertility.
However, published studies in male mice and rats administered repeated daily dosing of lithium carbonate report adverse effects on male reproductive organs, decreased spermatogenesis and decreased testosterone levels.
📄 Package Label / Principal Display Panel ▾
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Lot#21XXXAX Exp:MMM/YYYY 71656-072-05 Lithium Oral Solution, USP 8 mEq per 5 mL Unit-dose delivers 5 mL Orange Flavor image description
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 71656-072-16 Lithium Oral Solution, USP 8 mEq per 5 mL Orange Flavor PHARMACIST: Dispense the Medication Guide to each patient. Rx only 473 mL(16 oz) image description
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 71656-072-50 Lithium Oral Solution, USP 8 mEq per 5 mL Unit-dose delivers 5 mL Orange Flavor PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 5 Trays contain 50 Unit-dose Cups image description
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