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Drug Catalog - Product Detail

LITHIUM CARBONATE ER USP 300MG TB 100

NDC Mfr Size Str Form
62559-0340-01 ANI PHARMACEUTICALS 100 300MG TABLET
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Description
DESCRIPTION Lithium Carbonate Extended-Release Tablets USP contain lithium carbonate, a white odorless alkaline powder with molecular formula Li 2 CO 3 and molecular weight 73.89. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Each peach-colored, film-coated, extended-release tablet contains 300 mg of lithium carbonate. This slowly dissolving film-coated tablet is designed to give lower serum lithium peak concentrations than obtained with conventional oral lithium dosage forms. Inactive ingredients consist of calcium stearate, carnauba wax, cellulose compounds, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, povidone, propylene glycol, sodium chloride, sodium lauryl sulfate, sodium starch glycolate, sorbitol, and titanium dioxide. Product meets USP Drug Release Test 1.
How Supplied
HOW SUPPLIED Lithium Carbonate Extended-Release Tablets USP 300 mg, peach-colored imprinted “LITHOBID 300” NDC 62559-340-01 Bottle of 100
Indications & Usage
Dosage and Administration
DOSAGE AND ADMINISTRATION Acute Mania Optimal patient response can usually be established with 1800 mg/day in the following dosages: 1 Can also be administered on 600 mg TID recommended dosing interval. ACUTE MANIA Morning Afternoon Nighttime Lithium Carbonate Extended-Release Tablets 1 3 tabs (900 mg) 3 tabs (900 mg) Such doses will normally produce an effective serum lithium concentration ranging between 1.0 and 1.5 mEq/L. Dosage must be individualized according to serum concentrations and clinical response. Regular monitoring of the patient's clinical state and of serum lithium concentrations is necessary. Serum concentrations should be determined twice per week during the acute phase, and until the serum concentrations and clinical condition of the patient have been stabilized. Long-Term Control Desirable serum lithium concentrations are 0.6 to 1.2 mEq/L which can usually be achieved with 900 to 1200 mg/day. Dosage will vary from one individual to another, but generally the following dosages will maintain this concentration: 1 Can be administered on TID recommended dosing interval up to 1200 mg/day. LONG-TERM CONTROL Morning Afternoon Nighttime Lithium Carbonate Extended-Release Tablets 1 2 tabs (600 mg) 2 tabs (600 mg) Serum lithium concentrations 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 concentrations of 1.0 to 1.5 mEq/L. Geriatric patients often respond to reduced dosage, and may exhibit signs of toxicity at serum concentrations ordinarily tolerated by other patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Important Considerations 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 previous dose). Total reliance must not be placed on serum concentrations alone. Accurate patient evaluation requires both clinical and laboratory analysis. Lithium carbonate extended-release tablets must be swallowed whole and never chewed or crushed.