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Uses

Bipolar Disorder

Management of bipolar disorder, particularly acute manic or mixed episodes in patients with bipolar 1 or bipolar 2 disorder.

A first-line agent in the initial treatment of depressive, manic, or mixed episodes in patients with bipolar disorder.

Combination therapy with an atypical antipsychotic, another mood stabilizing agent, and/or antidepressant may be required to adequately treat rapid cycling and more severe depressive, manic, or mixed episodes.

Maintenance therapy has been shown to prevent or diminish the intensity of subsequent manic episodes in patients with bipolar disorder with a history of mania.

Major Depression

Should be used only in patients who fail to respond to other antidepressants.†

Schizoaffective and Schizophrenic Disorders

Limited effectiveness when used alone; should be used only after antipsychotic agents have failed.†

May be added to existing antipsychotic therapy, but efficacy of such combined therapy has varied in different clinical studies. Careful monitoring (e.g., serum lithium concentrations, adverse effects, possible adverse drug interactions) recommended.†

Disorders of Impulse Control

Has reduced temper outbursts, impulsive antisocial behavior, and the number of assaultive acts in a small number of adults with disorders of impulse control†.†

Psychiatric Disorders in Children

Treatment of children with apparent mixed bipolar disorder symptomatology†, hyperactivity with psychotic or neurotic components†, or aggressive behavior† or aggressive outbursts† associated with attention-deficit hyperactivity disorder (ADHD); should be used only after more conservative therapies have failed.†

Neutropenia and Anemia

Treatment of neutropenia† or anemia† secondary to antineoplastic drugs.†

Routine use not recommended for congenital, idiopathic, or cyclic neutropenias†; Felty’s syndrome†; or aplastic anemia†.†

Hyperthyroidism

Treatment of hyperthyroidism†; other treatments (e.g., radioactive iodine, surgery, propylthiouracil, methimazole) currently are preferred.†

SIADH

No longer considered one of the therapies of choice; generally has been replaced with other more effective and/or less toxic therapies (e.g., demeclocycline).†

Dosage and Administration

General

• Careful monitoring of serum lithium concentrations and clinical status of the patient is mandatory and patients should be carefully instructed in the safe use of the drug.
• Carefully review the precautions and contraindications associated with lithium use before initiating therapy.
• Monitor serum lithium concentrations twice weekly during initiation of the acute phase of therapy and until serum concentration and clinical condition have stabilized; patient’s ability to tolerate high serum lithium concentrations usually decreases as initial manic symptoms begin to subside.
• After the patient has been stabilized, monitor serum concentrations at least every 2 months in most patients.
• Onset of acute antimanic effect of lithium usually occurs within 5–7 days; full therapeutic effect often requires 10–21 days.
• The manufacturers suggest that steady-state serum lithium concentrations be determined immediately before the next dose (i.e., 8–12 hours after the previous lithium dose). Total reliance must not be placed on serum lithium concentrations alone; accurate patient evaluation requires both careful clinical and laboratory evaluation.
• Serum lithium concentrations of 1–1.2 mEq/L usually are required during acute affective episodes. Serum concentration should not exceed 1.5 mEq/L during the acute treatment phase.
• If manifestations of lithium toxicity occur (see Lithium Toxicity under Cautions), temporarily discontinue for 24–48 hours, then resume at a lower dosage.

Administration

Oral Administration

Administer orally, preferably with meals in divided doses.

Administer conventional tablets, capsules, or oral solution 3 or 4 times daily; twice daily administration may be associated with adverse GI or nervous system effects. Administer extended-release tablets 2 or 3 times daily.

Extended-release preparations should be swallowed intact and should not be chewed, crushed, or halved.

Lithium citrate oral solutions may be useful in patients unable to swallow capsules or tablets; 5 mL of a commercially available solution contains about 8 mEq of lithium and is approximately equivalent to 300 mg of lithium carbonate.

Dosage

Available as lithium carbonate and lithium citrate; dosages expressed in terms of the salts.

Pediatric Patients

Bipolar Disorder

Acute Episodes

Oral

Children ≤11 years of age: Usual dosages not established; lithium carbonate dosages of 15–20 mg/kg (about 0.4–0.5 mEq/kg) daily or equivalent lithium citrate dosages have been given in 2 or 3 divided doses. (Do not exceed usual adult dosages.)†

Children ≥12 years of age: Dosages usually are the same as those of adults.†

Maintenance Dosages

Oral

Usual maintenance dosages have not been established; dosage should be adjusted according to serum lithium concentrations, patient tolerance, and clinical response.†

Adults

Bipolar Disorder

Acute Episodes

Oral

Initially, 1.8 g daily as conventional lithium carbonate capsules or tablets, given in 3 or 4 divided doses, or 30 mL (about 48 mEq of lithium) of lithium citrate oral solution daily, given in 3 divided doses.

Alternatively, 900 mg twice daily (morning and evening) or 600 mg 3 times daily as extended-release lithium carbonate tablets.

Maintenance Dosages

Oral

900 mg to 1.2 g daily as conventional lithium carbonate capsules or tablets, given in 3 or 4 divided doses, or 15–20 mL (about 24–32 mEq of lithium) of lithium citrate oral solution daily, given in 3 or 4 divided doses. This dosage generally provides serum lithium concentrations of 0.6–1.2 mEq/L.

Alternatively, 900 mg to 1.2 g daily as extended-release lithium carbonate tablets, given in 2 or 3 divided doses.

Prescribing Limits

Pediatric Patients

Bipolar Disorder

Oral

When calculating dosage based on weight, do not exceed usual adult dosage.

Adults

Bipolar Disorder

Oral

Maintenance dosage usually should not exceed 2.4 g of lithium carbonate (65 mEq) daily.

Special Populations

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy. Lower initial dosages (e.g., ≤900 mg of lithium carbonate daily) and more gradual dosage titration recommended.

May have decreased renal function; monitor renal function and adjust dosage accordingly.

Dosages that produce serum lithium concentrations at the lower end of therapeutic range may be sufficient for maintenance. (See Geriatric Use under Cautions.)

Pregnant Women

Dosages generally need to be increased during pregnancy but should be reduced 1 week before parturition or when labor begins. (See Fetal/Neonatal Morbidity and Mortality and also see Pregnancy under Cautions.)