INDICATIONS AND USAGE
Lithium citrate 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 judgement, 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.
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DOSAGE AND ADMINISTRATION
Acute Mania
Optimal patient response to Lithium Citrate usually can be established and maintained with 600 mg t.i.d. [10 mL (2 teaspoonfuls) (16 mEq of lithium) t.i.d.]. Such doses will normally produce an effective serum lithium level ranging between 1.0 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 of 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 t.i.d. or q.i.d. [5 mL (1 teaspoonful) (8 mEq of lithium) 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 1.0 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.
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HOW SUPPLIED
Lithium Citrate Syrup, USP 8 mEq/5 mL (equivalent to the amount of lithium in 300 mg of lithium carbonate) is supplied in pint containers (fill volume 473 mL) as a clear, colorless solution, with a raspberry flavor.
RECOMMENDED STORAGE
Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].
Dispense in a tight container as defined in the USP.
Rx Only
Product No.: 8616
Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053
A50-8616-16
REV. 10-07
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