Lithium Carbonate

LITHIUM CARBONATE- lithium carbonate tablet
LITHIUM CARBONATE- lithium carbonate capsule, gelatin coated
LITHIUM- lithium citrate solution
Hikma Pharmaceuticals USA Inc.


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) ].


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 [see Clinical Studies (14)]
Maintenance treatment in patients 7 years and older [see Clinical Studies (14)]


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 Recommended Dosage

See Table 1 for dosage recommendations for acute and maintenance treatment of bipolar I disorder in adult and pediatric patients (7 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 Dosing for Bipolar I Disorder

Patient Group


Starting Dose

Dose Titration

Acute Goal

Maintenance Goal

Serum Level

Usual Dose

Serum Level

Usual Dose

Adult and Pediatric Patients over30 kg

Tablets or capsules

300 mg three times daily

300 mgevery 3 days

0.8 to 1.2mEq/L

600 mg two to three times daily

0.8 to 1.0 mEq/L

300 to 600 mgtwo to three times daily


8 mEq (5 mL)three times daily

8 mEq (5 mL)every 3 days

16 mEq (10mL)two to three times daily

8 to 16 mEq(5 to 10 mL)two to three times daily

Pediatric Patients 20 to 30 kg

Tablets or capsules

300 mgtwice daily

300 mg weekly

600 to 1500 mg in divided doses daily

600 to 1200 mg in divided doses daily


8 mEq (5 mL)twice daily

8 mEq (5 mL) weekly

16 to 40 mEq(10 to 25 mL) in divided doses daily

16 to 32 mEq(10 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)

2.3 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-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 [See Boxed Warning, Warnings and Precautions (5.1), Drug Interactions (7.1)].

Patients abnormally sensitive to lithium may exhibit toxic signs at serum concentrations that are within what is considered the therapeutic range. Geriatric patients often respond to reduced dosage, and may exhibit signs of toxicity at serum concentrations ordinarily tolerated by other patients [see Specific Populations (8.5)].

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