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Drug Catalog - Product Detail

LITHIUM CARBONATE ER TAB 450MG 100CT

NDC Mfr Size Str Form
64980-0278-01 RISING PHARMACEUTICALS 100 450MG NA
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PACKAGE FILES

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Generic Name
LITHIUM CARBONATE
Substance Name
LITHIUM CARBONATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA205663
Description
DESCRIPTION Lithium Carbonate Extended-Release Tablets contains lithium carbonate, a white, light 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. Lithium Carbonate Extended-Release Tablets: Each white to off white round tablets scored on one side and engraved with P;450 on the other side, contains lithium carbonate, 450 mg. Inactive ingredients consist of sodium alginate, sodium starch glycolate, povidone, ferric oxide yellow, and magnesium stearate. Lithium Carbonate Extended-Release Tablets 450 mg are designed to release a portion of the dose initially and the remainder gradually; the release pattern of the controlled release tablets reduces the variability in lithium blood levels seen with immediate release dosage forms. Meets USP Dissolution Test 2.
How Supplied
HOW SUPPLIED Lithium Carbonate Extended-Release Tablets 450 mg are supplied as white to off white round tablets scored on one side and engraved with P; 450 on the other side. NDC 64980-278-01: Bottle of 100 Tablets Storage Condition: Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 1-800-521-5340 Revised: Feb.2020
Indications & Usage
INDICATIONS AND USAGE Lithium Carbonate Extended-Release Tablets 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, Lithium Carbonate Extended-Release Tablets may produce a normalization of symptomatology within 1 to 3 weeks.
Dosage and Administration
DOSAGE AND ADMINISTRATION Doses of controlled-release tablets are usually given b.i.d. (approximately 12-hour intervals). When initiating therapy with controlled-release lithium, dosage must be individualized according to serum levels and clinical response. When switching a patient from immediate-release capsules to Lithium Carbonate Extended-Release Tablets, give the same total daily dose when possible. Most patients on maintenance therapy are stabilized on 900 mg daily, e.g., Lithium Carbonate Extended-Release Tablets 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 Lithium Carbonate Extended-Release Tablets 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 Lithium Carbonate Extended-Release Tablets should be given in the morning and 900 mg of Lithium Carbonate Extended-Release Tablets in the evening. If desired, the total daily dose of 1,350 mg can be given in 3 equal 450-mg doses of Lithium Carbonate Extended-Release Tablets. 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 Lithium Carbonate Extended-Release Tablets in increments of 450 mg, immediate-release capsules should be used. Acute Mania: Optimal patient response to Lithium Carbonate Extended-Release Tablets 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. 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 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. • Lithium Carbonate Extended-Release Tablets must be swallowed whole and never chewed or crushed.