Usual Adult Dose for Mania

Acute Control: 1800 mg/day

• Regular release formulations: 600 mg orally 2 to 3 times a day
• Extended release formulations: 900 mg orally 2 times a day

Long-term Control: 900 to 1200 mg/day

• Regular release formulations: 300 to 600 mg orally 2 to 3 times a day
• Extended release formulations: 600 mg orally 2 times a day

Comments:

• Regular release formulations should be given in the morning, afternoon, and nighttime (3 times a day dosing) or in the morning and at nighttime (2 times a day dosing).
• Extended release formulations should be given in the morning and at nighttime.
• Dosing must be individualized according to serum levels and the response to treatment.
• Alternative extended release formulation doses are 600 mg 3 times a day (acute control) and 300 mg 3 to 4 times a day (long-term control).

Uses:

• Treatment of manic episodes of bipolar disorder
• Maintenance treatment for individuals with bipolar disorder

Usual Adult Dose for Bipolar Disorder

Acute Control: 1800 mg/day

• Regular release formulations: 600 mg orally 2 to 3 times a day
• Extended release formulations: 900 mg orally 2 times a day

Long-term Control: 900 to 1200 mg/day

• Regular release formulations: 300 to 600 mg orally 2 to 3 times a day
• Extended release formulations: 600 mg orally 2 times a day

Comments:

• Regular release formulations should be given in the morning, afternoon, and nighttime (3 times a day dosing) or in the morning and at nighttime (2 times a day dosing).
• Extended release formulations should be given in the morning and at nighttime.
• Dosing must be individualized according to serum levels and the response to treatment.
• Alternative extended release formulation doses are 600 mg 3 times a day (acute control) and 300 mg 3 to 4 times a day (long-term control).

Uses:

• Treatment of manic episodes of bipolar disorder
• Maintenance treatment for individuals with bipolar disorder

Usual Pediatric Dose for Mania

12 years and older:
Acute Control: 1800 mg/day

• Regular release formulations: 600 mg orally 2 to 3 times a day
• Extended release formulations: 900 mg orally 2 times a day

Long-term Control: 900 to 1200 mg/day

• Regular release formulations: 300 to 600 mg orally 2 to 3 times a day
• Extended release formulations: 600 mg orally 2 times a day

Comments:

• Regular release formulations should be given in the morning, afternoon, and nighttime (3 times a day dosing) or in the morning and at nighttime (2 times a day dosing).
• Extended release formulations should be given in the morning and at nighttime.
• Dosing must be individualized according to serum levels and the response to treatment.
• Alternative extended release formulation doses are 600 mg 3 times a day (acute control) and 300 mg 3 to 4 times a day (long-term control).
• Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of the episodes.

Uses:

• Treatment of manic episodes of bipolar disorder
• Maintenance treatment for individuals with bipolar disorder

Usual Pediatric Dose for Bipolar Disorder

12 years and older:
Acute Control: 1800 mg/day

• Regular release formulations: 600 mg orally 2 to 3 times a day
• Extended release formulations: 900 mg orally 2 times a day

Long-term Control: 900 to 1200 mg/day

• Regular release formulations: 300 to 600 mg orally 2 to 3 times a day
• Extended release formulations: 600 mg orally 2 times a day

Comments:

• Regular release formulations should be given in the morning, afternoon, and nighttime (3 times a day dosing) or in the morning and at nighttime (2 times a day dosing).
• Extended release formulations should be given in the morning and at nighttime.
• Dosing must be individualized according to serum levels and the response to treatment.
• Alternative extended release formulation doses are 600 mg 3 times a day (acute control) and 300 mg 3 to 4 times a day (long-term control).
• Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of the episodes.

Uses:

• Treatment of manic episodes of bipolar disorder
• Maintenance treatment for individuals with bipolar disorder

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 30 to 89 mL/min): Begin with lower doses and titrate slowly; closely monitor serum concentrations and signs/symptoms of lithium toxicity.
Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended.

Any progressive/sudden change in renal function (even within the normal range): Reevaluate treatment.

Liver Dose Adjustments

Data not available

Dose Adjustments

Therapeutic drug monitoring/range:

• Acute episodes: 0.8 to 1.5 mEq/L, not to exceed 2 mEq/L
• Long-term control: 0.6 to 1.2 mEq/L
• Patients who are abnormally sensitive may exhibit toxicity at concentrations of 1 to 1.5 mEq/L.

Serum levels should be drawn immediately prior to the next dose (e.g., 8 to 12 hours after the previous dose).

• Acute episodes: Levels should be determined 2 times a week, and continued until the patient is stable.
• Long-term control: Levels should be assessed regularly.
• Serum levels should be monitored after any change in dose, concomitant medication, marked increase/decrease in routine physical activity, and/or in the event of concomitant disease.

Elderly patients: Begin at the lower end of the dosing range

Patients with significant cardiovascular disease, debilitation, dehydration, and/or sodium depletion and those receiving drugs that could affect kidney function: Begin with lower doses and titrate slowly; closely monitor serum concentrations and signs/symptoms of lithium toxicity.

Precautions

US BOXED WARNINGS:
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 therapy.

NARROW THERAPEUTIC INDEX:

• This drug should be considered a narrow therapeutic index (NTI) drug as small differences in dose or blood concentrations may lead to serious therapeutic failures or adverse drug reactions.

Recommendations:

• Generic substitution should be done cautiously, if at all, as current bioequivalence standards are generally insufficient for NTI drugs.
• Additional and/or more frequent monitoring should be done to ensure receipt of an effective dose while avoiding unnecessary toxicities.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Extended/controlled/prolonged/sustained release tablet formulations should not be crushed or chewed.
• Take with food to decrease gastrointestinal side effects.
• This drug should be taken at the same time(s) each day.

Storage requirements:

• The manufacturer product information should be consulted.

General:

• Lithium toxicity is related to serum lithium levels, and may occur at doses close to therapeutic levels.
• Patients in the manic phase are better able to tolerate lithium; tolerance to lithium decreases when manic symptoms subside.
• Mania is characterized by pressure of speech, motor hyperactivity, reduced sleep requirements, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and/or hostility. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of the episodes.

Monitoring:

• Cardiac: ECG, especially in patients at risk of unmasking Brugada syndrome; cardiac function at baseline and at regular intervals thereafter
• Endocrine: Thyroid function at baseline and at regular intervals thereafter
• Metabolic: Lithium levels at baseline and at regular intervals thereafter
• Renal: Renal function tests (e.g., urinalysis, urine specific gravity, serum creatinine, creatinine clearance), especially in patients who develop polyuria and/or polydipsia

Patient advice:

• Patients should be told to seek immediate medical attention if signs/symptoms of Brugada syndrome, encephalopathic syndrome, or diabetes insipidus occur.
• Patients, family members, and/or caregivers should be instructed to discontinue therapy and immediately report any signs/symptoms of lithium toxicity, change in behavior, or suicidality.
• Inform patients that this drug may cause drowsiness and central nervous system disturbances, and they should avoid driving or operating machinery until the full effects of the drug are seen.
• Patients should be counseled on the importance of maintaining adequate salt and water intake.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Frequently asked questions

• What is a proper diet to go on with lithium?