"The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
Major depressive disorder (MDD), commonly referred to as depression, is a mental disorder characterized by mo"...
ESKALITH (lithium carbonate) is indicated in the treatment of manic episodes of manic-depressive illness. Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania.
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, ESKALITH (lithium carbonate) may produce a normalization of symptomatology within 1 to 3 weeks.
DOSAGE AND ADMINISTRATION
Immediate-release capsules are usually given t.i.d. or q.i.d. Doses of controlled-release tablets are usually given b.i.d. (approximately 12-hour intervals). When initiating therapy with immediate-release or controlled-release lithium, dosage must be individualized according to serum levels and clinical response.
When switching a patient from immediate-release capsules to ESKALITH (lithium carbonate) CR Controlled-Release Tablets, give the same total daily dose when possible. Most patients on maintenance therapy are stabilized on 900 mg daily, e.g., ESKALITH (lithium carbonate) CR 450 mg b.i.d. When the previous dosage of immediate-release lithium is not a multiple of 450 mg, e.g., 1,500 mg, initiate ESKALITH (lithium carbonate) CR at the multiple of 450 mg nearest to, but below, the original daily dose, i.e., 1,350 mg. When the 2 doses are unequal, give the larger dose in the evening. In the above example, with a total daily dose of 1,350 mg, generally 450 mg of ESKALITH (lithium carbonate) CR should be given in the morning and 900 mg of ESKALITH (lithium carbonate) CR in the evening. If desired, the total daily dose of 1,350 mg can be given in 3 equal 450-mg doses of ESKALITH (lithium carbonate) CR. These patients should be monitored at 1- to 2-week intervals, and dosage adjusted if necessary, until stable and satisfactory serum levels and clinical state are achieved.
When patients require closer titration than that available with doses of ESKALITH (lithium carbonate) CR in increments of 450 mg, immediate-release capsules should be used.
Acute Mania: Optimal patient response to ESKALITH (lithium carbonate) can usually be established and maintained with 1,800 mg per day in divided doses. Such doses will normally produce the desired 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 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 900 mg to 1,200 mg per day in divided doses will maintain this level. Serum lithium levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months.
Patients unusually sensitive to lithium may exhibit toxic signs at serum levels below 1.0 mEq/L.
N.B.: Blood samples for serum lithium determinations should be drawn immediately prior to the next dose when lithium concentrations are relatively stable (i.e., 8 to 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.
Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by younger patients.
ESKALITH (lithium carbonate) Capsules 300 mg are gray and yellow capsules imprinted with "ESKALITH (lithium carbonate) " and "SB" on one side of each half of the capsule, in bottles of 100 (NDC 0007-4007-20).
ESKALITH (lithium carbonate) CR Tablets 450 mg are round, yellow, biconvex, controlled-release tablets, debossed with "SKF" and "J10" on one side and scored on the other side, in bottles of 100 (NDC 0007-4010-20).
STORAGE CONDITIONS: Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Manufactured by: Cardinal Health., Winchester, KY 40391 for GlaxoSmithKline.,
Research Triangle Park, NC 27709. September 2003
FDA rev date: 03/11/2004
Last reviewed on RxList: 8/20/2007
This monograph has been modified to include the generic and brand name in many instances.
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