Lithium Carbonate (Page 3 of 3)

Acute Mania

Optimal patient response to lithium can usually be established and maintained with 1800 mg per day in divided doses. Such doses will normally produce the desired 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 900 mg to 1200 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 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.

HOW SUPPLIED

Product: 68151-0245

NDC: 68151-0245-2 1 TABLET, EXTENDED RELEASE in a PACKAGE

Lithium Carbonate 450 mg ER

Label ImageLabel Image
LITHIUM CARBONATE
lithium carbonate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-0245(NDC:0054-0020)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LITHIUM CARBONATE (LITHIUM CATION) LITHIUM CARBONATE 450 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
SODIUM ALGINATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (speckled, off-white to yellow) Score 2 pieces
Shape ROUND (biconvex) Size 11mm
Flavor Imprint Code 54;346
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-0245-2 1 TABLET, EXTENDED RELEASE in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076691 01/05/2004
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-0245)

Revised: 07/2017 Carilion Materials Management

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