Lithium Carbonate
LITHIUM CARBONATE- lithium carbonate capsule, gelatin coated
REMEDYREPACK INC.
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) ].
1 INDICATIONS AND USAGE
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 DOSAGE AND ADMINISTRATION
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.
Patient Group | Formulation | Starting Dose |
| Acute Goal | Maintenance Goal | ||
Serum Level | Usual Dose | Serum Level | Usual Dose | ||||
Adult and Pediatric Patients over 30 kg | Tablets or capsules | 300 mg three times daily |
| 0.8 to 1.2 mEq/L | 600 mg two to three times daily | 0.8 to 1.0 mEq/L | 300 to 600 mg two to three times daily |
Liquid | 8 mEq (5 mL) three times daily |
| 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 mg twice daily |
| 600 to 1500 mg in divided doses daily | 600 to 1200 mg in divided doses daily | ||
Liquid | 8 mEq (5 mL) twice daily |
| 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) |
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