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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(LITH ee um)
Generic Available (U.S.)
Yes
Index Terms
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Use: Labeled Indications
Management of bipolar disorders; treatment of mania in individuals with bipolar disorder (maintenance treatment prevents or diminishes intensity of subsequent episodes)
Use: Unlabeled
Potential augmenting agent for antidepressants; aggression, post-traumatic stress disorder, conduct disorder in children
Pregnancy Risk Factor
D
Pregnancy Considerations
Cardiac malformations in the infant, including Ebstein's anomaly, are associated with use of lithium during the first trimester of pregnancy. Nontoxic effects to the newborn include shallow respiration, hypotonia, lethargy, cyanosis, diabetes insipidus, thyroid depression, and nontoxic goiter when lithium is used near term. Efforts should be made to avoid lithium use during the first trimester; if an alternative therapy is not appropriate, the lowest possible dose of lithium should be used throughout the pregnancy. Fetal echocardiography and ultrasound to screen for anomalies should be conducted between 16-20 weeks of gestation. Lithium levels should be monitored in the mother and may need to be adjusted following delivery.
Lactation
Enters breast milk/contraindicated
Contraindications
Hypersensitivity to lithium or any component of the formulation; avoid use in patients with severe cardiovascular or renal disease, or with severe debilitation, dehydration, or sodium depletion; pregnancy
Warnings/Precautions
Boxed warnings:
• Monitoring: See “Other warnings/precautions” below.
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
• Renal effects: Chronic therapy results in diminished renal concentrating ability (nephrogenic DI); this is usually reversible when lithium is discontinued. Changes in renal function should be monitored, and re-evaluation of treatment may be necessary. Morphologic changes with glomerular and interstitial fibrosis and nephron atrophy have been reported in patients on chronic lithium therapy; morphologic changes have also been reported in manic-depressive patients never exposed to lithium. The relationship between morphologic changes and renal function, and the association with lithium therapy, have not been established.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with mild-moderate cardiovascular disease.
• Dehydration: Use with caution in patients with significant fluid loss (protracted sweating, diarrhea, or prolonged fever); temporary reduction or cessation of therapy may be warranted.
• Depression/suicidal ideation: Use with caution in patients at risk of suicide (suicidal thoughts or behavior).
• Renal impairment: Use with caution in patients with mild-moderate renal impairment.
• Thyroid disease: Use with caution in patients with thyroid disease.
Concurrent drug therapy issues:
• Medications altering sodium excretion: Use caution in patients receiving medications which alter sodium excretion (eg, diuretics, ACE inhibitors, NSAIDs).
• Neuroleptic medications: Use with caution in patients receiving neuroleptic medications - a syndrome resembling NMS has been associated with concurrent therapy.
• Neuromuscular-blocking agents: Administered neuromuscular-blocking agents with caution; the response may be prolonged.
Special populations:
• Elderly: Use with caution in the elderly; may be extremely sensitive to the effects of lithium, see Dosage and Reference Range.
Other warnings/precautions:
• Acute manic phase: Higher serum concentrations may be required and tolerated during an acute manic phase; however, the tolerance decreases when symptoms subside.
• Monitoring: [U.S. Boxed Warning]: Lithium toxicity is closely related to serum concentrations and can occur at therapeutic doses; serum lithium determinations are required to monitor therapy. Normal fluid and salt intake must be maintained during therapy.
Adverse Reactions
Frequency not defined.
Cardiovascular: Bradycardia, cardiac arrhythmia, edema, flattened or inverted T waves (reversible), hypotension, sinus node dysfunction, syncope
Central nervous system: Blackout spells, coma, confusion, dizziness, dystonia, fatigue, headache, lethargy, pseudotumor cerebri, psychomotor retardation, restlessness, sedation, seizure, slowed intellectual functioning, slurred speech, stupor, tics, vertigo
Dermatologic: Dry or thinning of hair, folliculitis, alopecia, exacerbation of psoriasis, rash
Endocrine & metabolic: Euthyroid goiter and/or hypothyroidism, hyperthyroidism, hyperglycemia, diabetes insipidus
Gastrointestinal: Polydipsia, anorexia, nausea, vomiting, diarrhea, xerostomia, metallic taste, weight gain, salivary gland swelling, excessive salivation
Genitourinary: Incontinence, polyuria, glycosuria, oliguria, albuminuria
Hematologic: Leukocytosis
Neuromuscular & skeletal: Tremor, muscle hyperirritability, ataxia, choreoathetoid movements, hyperactive deep tendon reflexes, myasthenia gravis (rare)
Ocular: Nystagmus, blurred vision, transient scotoma
Miscellaneous: Coldness and painful discoloration of fingers and toes
Postmarketing and/or case reports: Drug-induced Brugada syndrome
Metabolism/Transport Effects
None known.
Drug Interactions
ACE Inhibitors: May increase the serum concentration of Lithium. Management: Lithium dosage reductions will likely be needed following the addition of an ACE inhibitor. Monitor patient response to lithium closely following addition or discontinuation of concurrent ACE inhibitor treatment. Risk D: Consider therapy modification
Amphetamines: Lithium may diminish the stimulatory effect of Amphetamines. Risk C: Monitor therapy
Angiotensin II Receptor Blockers: May increase the serum concentration of Lithium. Management: Lithium dosage reductions will likely be needed following the addition of an angiotensin II receptor antagonist. Risk D: Consider therapy modification
Antipsychotics: Lithium formulations may enhance the neurotoxic effect of Antipsychotics. Lithium formulations may decrease the serum concentration of Antipsychotics. Specifically noted with chlorpromazine. Risk C: Monitor therapy
Antipsychotics: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy
Calcitonin: May decrease the serum concentration of Lithium. Risk C: Monitor therapy
Calcium Channel Blockers (Nondihydropyridine): May enhance the neurotoxic effect of Lithium. Calcium Channel Blockers (Nondihydropyridine) may increase the serum concentration of Lithium. Decreased or unaltered lithium concentrations have also been reported with this combination. Exceptions: Bepridil [Off Market]. Risk C: Monitor therapy
Calcium Polystyrene Sulfonate: May decrease the serum concentration of Lithium. Risk C: Monitor therapy
CarBAMazepine: May enhance the adverse/toxic effect of Lithium. Risk C: Monitor therapy
Carbonic Anhydrase Inhibitors: May decrease the serum concentration of Lithium. Exceptions: Brinzolamide; Dorzolamide. Risk C: Monitor therapy
Desmopressin: Lithium may diminish the therapeutic effect of Desmopressin. Desmopressin may increase the serum concentration of Lithium. Risk C: Monitor therapy
Fosphenytoin: May enhance the adverse/toxic effect of Lithium. Risk C: Monitor therapy
Loop Diuretics: May decrease the serum concentration of Lithium. Loop Diuretics may increase the serum concentration of Lithium. Risk C: Monitor therapy
MAO Inhibitors: May enhance the adverse/toxic effect of Lithium. Exceptions: Moclobemide. Risk C: Monitor therapy
Methyldopa: May enhance the adverse/toxic effect of Lithium. This may occur without notable changes in serum lithium concentrations. Risk C: Monitor therapy
Metoclopramide: Serotonin Modulators may enhance the adverse/toxic effect of Metoclopramide. This may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Risk C: Monitor therapy
Neuromuscular-Blocking Agents: Lithium may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May increase the serum concentration of Lithium. Exceptions: Sulindac. Risk D: Consider therapy modification
Phenytoin: May enhance the adverse/toxic effect of Lithium. Risk C: Monitor therapy
Potassium Iodide: May enhance the hypothyroid effect of Lithium. Risk C: Monitor therapy
Selective Serotonin Reuptake Inhibitors: May enhance the adverse/toxic effect of Lithium. Risk C: Monitor therapy
Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Risk D: Consider therapy modification
Sodium Bicarbonate: May increase the excretion of Lithium. Risk C: Monitor therapy
Sodium Chloride: May increase the excretion of Lithium. Risk C: Monitor therapy
Sodium Polystyrene Sulfonate: May decrease the serum concentration of Lithium. Risk C: Monitor therapy
Theophylline Derivatives: May decrease the serum concentration of Lithium. Exceptions: Dyphylline. Risk C: Monitor therapy
Thiazide Diuretics: May decrease the excretion of Lithium. Risk D: Consider therapy modification
Topiramate: May increase the serum concentration of Lithium. Risk C: Monitor therapy
Tricyclic Antidepressants: Lithium may enhance the neurotoxic effect of Tricyclic Antidepressants. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Food: Limit caffeine.
Mechanism of Action
Alters cation transport across cell membrane in nerve and muscle cells and influences reuptake of serotonin and/or norepinephrine; second messenger systems involving the phosphatidylinositol cycle are inhibited; postsynaptic D2 receptor supersensitivity is inhibited
Pharmacodynamics/Kinetics
Absorption: Rapid and complete
Distribution: Vd: Initial: 0.3-0.4 L/kg; Vdss: 0.7-1 L/kg; crosses placenta; enters breast milk at 35% to 50% the concentrations in serum; distribution is complete in 6-10 hours
CSF, liver concentrations: 1/3 to 1/2 of serum concentration
Erythrocyte concentration: ~1/2 of serum concentration
Heart, lung, kidney, muscle concentrations: Equivalent to serum concentration
Saliva concentration: 2-3 times serum concentration
Thyroid, bone, brain tissue concentrations: Increase 50% over serum concentrations
Protein binding: Not protein bound
Metabolism: Not metabolized
Bioavailability: Not affected by food; Capsule, immediate release tablet: 95% to 100%; Extended release tablet: 60% to 90%; Syrup: 100%
Half-life elimination: 18-24 hours; can increase to more than 36 hours in elderly or with renal impairment
Time to peak, serum: Immediate release: ~0.5-2 hours; extended release: 4-12 hours; syrup: 15-60 minutes
Excretion: Urine (90% to 98% as unchanged drug); sweat (4% to 5%); feces (1%)
Clearance: 80% of filtered lithium is reabsorbed in the proximal convoluted tubules; therefore, clearance approximates 20% of GFR or 20-40 mL/minute
Dosage
Oral: Monitor serum concentrations and clinical response (efficacy and toxicity) to determine proper dose
Children 6-12 years:
Bipolar disorder (unlabeled use): 15-60 mg/kg/day in 3-4 divided doses; dose not to exceed usual adult dosage
Conduct disorder (unlabeled use): 15-30 mg/kg/day in 3-4 divided doses; dose not to exceed usual adult dosage
Adults: Bipolar disorder: 900-2400 mg/day in 3-4 divided doses or 900-1800 mg/day (extended release) in 2 divided doses
Elderly: Bipolar disorder: Initial dose: 300 mg once or twice daily; increase weekly in increments of 300 mg/day, monitoring levels; rarely need >900-1200 mg/day
Dosing adjustment in renal impairment:
Clcr 10-50 mL/minute: Administer 50% to 75% of normal dose
Clcr <10 mL/minute: Administer 25% to 50% of normal dose
Hemodialysis: Dialyzable (50% to 100%); 4-7 times more efficient than peritoneal dialysis
Administration: Oral
Administer with meals to decrease GI upset. Extended release tablets must be swallowed whole; do not crush or chew.
Monitoring Parameters
Serum lithium every 4-5 days during initial therapy; draw lithium serum concentrations 8-12 hours postdose; renal, thyroid, and cardiovascular function; fluid status; serum electrolytes; CBC with differential, urinalysis; monitor for signs of toxicity; beta-hCG pregnancy test for all females not known to be sterile
Reference Range
Levels should be obtained twice weekly until both patient's clinical status and levels are stable then levels may be obtained every 1-3 months
Timing of serum samples: Draw trough just before next dose (8-12 hours after previous dose)
Therapeutic levels:
Acute mania: 0.6-1.2 mEq/L (SI: 0.6-1.2 mmol/L)
Protection against future episodes in most patients with bipolar disorder: 0.8-1 mEq/L (SI: 0.8-1.0 mmol/L); a higher rate of relapse is described in subjects who are maintained at <0.4 mEq/L (SI: 0.4 mmol/L)
Elderly patients can usually be maintained at lower end of therapeutic range (0.6-0.8 mEq/L)
Toxic concentration: >1.5 mEq/L (SI: >1.5 mmol/L)
Adverse effect levels:
GI complaints/tremor: 1.5-2 mEq/L
Confusion/somnolence: 2-2.5 mEq/L
Seizures/death: >2.5 mEq/L
Dietary Considerations
May be taken with meals to avoid GI upset; maintain adequate fluid intake.
Patient Education
Do not crush or chew extended release tablets or capsules. Maintain adequate hydration unless instructed to restrict fluid intake. Avoid changes in sodium content (eg, low sodium diets); reduction of sodium can increase lithium toxicity. Frequent blood tests and monitoring will be necessary. You may experience decreased appetite, altered taste sensation, drowsiness, or dizziness, especially during early therapy. Immediately report unresolved diarrhea, abrupt changes in weight, muscular tremors or lack of coordination, fever, or changes in urinary volume.
Geriatric Considerations
Some elderly patients may be extremely sensitive to the effects of lithium. Initial doses need to be adjusted for renal function in the elderly; thereafter, adjust doses based upon serum concentrations and response.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Xerostomia and changes in salivation (normal salivary flow resumes upon discontinuation), salivary gland swelling, and metallic taste. Avoid NSAIDs if analgesics are required since lithium toxicity has been reported with concomitant administration; acetaminophen products (ie, singly or with narcotics) are recommended.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Child/Adolescent Considerations
Pediatric bipolar guidelines include lithium as a treatment option for children and adolescents with bipolar disorder. Lithium single dose pharmacokinetics was studied in 39 children (10 male, 9 female) 7-17 years of age (mean: 11.8 years) with bipolar disorder as part of a clinical trial. Great variability in clearance was found across subjects with linear pharmacokinetics correlated to fat-free mass. The mean terminal half-life of lithium in the study group was 17.9 hours. Mean half-life in adults is estimated at 24 hours.
Findling RL, Landersdorfer CB, Kafantaris V, et al, "First-Dose Pharmacokinetics of Lithium Carbonate in Children and Adolescents," J Clin Psychopharmacol, 2010, 30(4):404-10.
Kowatch RA, Fristad M, Birmaher B, et al, "Treatment Guidelines for Children and Adolescents With Bipolar Disorder," J Am Acad Child Adolesc Psychiatry, 2005, 44(3):213-35.
Pavuluri MN, Birmaher B, and Naylor MW, "Pediatric Bipolar disorder: A Review of the Past 10 Years," J Am Acad Child Adolesc Psychiatry, 2005, 44(9):846-71.
Mental Health: Comment
Lithium remains the gold standard for bipolar disorder. It is most useful for the management of euphoric mania and least effective for the mixed and rapid-cycling types of bipolar disorder. Among patients treated for bipolar disorder, risk of suicide attempt and suicide death is lower during treatment with lithium than during treatment with divalproex (Goodwin, 2003). Fine hand tremor associated with lithium therapy may be treated with propranolol. Incidence of hypothyroidism secondary to lithium therapy is 7% to 8% with a 9:1 female to male ratio. Diabetes insipidus may be treated with a thiazide diuretic (hydrochlorothiazide 25-50 mg/day) or amiloride (5-10 mg twice daily). The thiazide diuretics are thought to work by decreasing intracellular volume via sodium depletion, thereby enhancing reabsorption of sodium and water proximally leading to a decrease in fluid volume to the distal convoluted tubule and collecting duct which increases sodium reabsorption and decreases water excretion. Leukocytosis (without a left shift) begins in the first week of lithium therapy, peaks at 2 weeks.
Goodwin GM and Young AH, “The British Association for Psychopharmacology Guidelines for Treatment of Bipolar Disorder: A Summary,” J Psychopharmacol, 2003, 17(4 Suppl):3-6.
Nursing: Physical Assessment/Monitoring
Monitor cardiovascular status; assess for fluid retention. Educate patient about risks of toxicity and how to minimize.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, oral, as carbonate: 150 mg, 300 mg, 600 mg
Solution, oral, as citrate: 300 mg/5 mL (5 mL, 473 mL [DSC], 500 mL) [equivalent to amount of lithium in lithium carbonate]
Tablet, oral, as carbonate: 300 mg, 600 mg
Tablet, extended release, oral, as carbonate: 300 mg, 450 mg
Lithobid®: 300 mg
Pricing: U.S. (www.drugstore.com)
Capsules (Lithium Carbonate)
150 mg (90): $18.99
300 mg (90): $25.99
Syrup (Lithium Citrate)
8 mEq/5 mL (500): $59.99
Tablet, controlled release (Lithium Carbonate)
300 mg (30): $17.99
450 mg (60): $35.99
Tablet, controlled release (Lithobid)
300 mg (90): $222.00
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International Brand Names
Lexi-Comp.com
Last full review/revision March 2012
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