Lithium Carbonate

LITHIUM CARBONATE- lithium carbonate capsule, gelatin coated
REMEDYREPACK INC.

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.

Table . Lithium Dosing for Bipolar I Disorder

Patient Group	Formulation	Starting Dose	Dose Titration	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	300 mg every 3 days	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	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 mg twice daily	300 mg weekly		600 to 1500 mg in divided doses daily		600 to 1200 mg in divided doses daily
	Liquid	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)