Lithium Carbonate (Lithium Carbonate) - Indications and Dosage

INDICATIONS AND USAGE

Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology.

Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder.

Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur.

Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.

DOSAGE AND ADMINISTRATION

Acute Mania - Optimal patient response to Lithium Carbonate usually can be established and maintained with 600 mg t.i.d. Such doses will normally produce an effective serum lithium level ranging between 1 and 1.5 mEq/L. Dosage must be individualized according to serum levels and clinical response. Regular monitoring of the patient's clinical state and serum lithium levels is necessary. Serum levels should be determined twice per week during the acute phase, and until the serum level and clinical condition of the patient have been stabilized.

Long-Term Control - The desirable serum lithium levels are 0.6 to 1.2 mEq/L. Dosage will vary from one individual to another, but usually 300 mg of Lithium Carbonate t.i.d. or q.i.d. will maintain this level. Serum lithium levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months.

Patients abnormally sensitive to lithium may exhibit toxic signs at serum levels of 1 to 1.5 mEq/L. Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by other patients.

N.B.: Blood samples for serum lithium determination should be drawn immediately prior to the next dose when lithium concentrations are relatively stable (i.e., 8-12 hours after the previous dose). Total reliance must not be placed on serum levels alone. Accurate patient evaluation requires both clinical and laboratory analysis.

HOW SUPPLIED

Lithium Carbonate Capsules USP, 300 mg are supplied as No. 1 Grey/Yellow Opaque Hard Gelatin Capsules Printed "West-ward 3189" in Black Ink and are available in:

Boxes of UD100 NDC 63739-265-10        

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured By:
West-ward Pharmaceutical Corp.

401 Industrial Way West
Eatontown, NJ 07724

Distributed by:

McKesson Packaging Services

a business unit of McKesson Corporation

7101 Weddington Rd., Concord, NC 28027

IS-4001892-R4

July 2011