Lithium Carbonate (Page 3 of 3)

OVERDOSAGE

The toxic levels for lithium (≥ 1.5 mEq/L) are close to the therapeutic levels (0.6 to 1.2 mEq/L). It is therefore important that patients and their families be cautioned to watch for early toxic symptoms and to discontinue the drug and inform the physician should they occur. Toxic symptoms are listed in detail under ADVERSE REACTIONS.

Treatment

No specific antidote for lithium poisoning is known. Early symptoms of lithium toxicity can usually be treated by reduction or cessation of dosage of the drug and resumption of the treatment at a lower dose after 24 to 48 hours. In severe cases of lithium poisoning, the first and foremost goal of treatment consists of elimination of this ion from the patient.

Treatment is essentially the same as that used in barbiturate poisoning: 1) gastric lavage, 2) correction of fluid and electrolyte imbalance, and 3) regulation of kidney function. Urea, mannitol and aminophylline all produce significant increases in lithium excretion. Hemodialysis is an effective and rapid means of removing the ion from the severely toxic patient.

Infection prophylaxis, regular chest X-rays and preservation of adequate respiration are essential.

DOSAGE AND ADMINISTRATION

Doses of extended-release tablets are usually given b.i.d. (approximately 12-hour intervals). When initiating therapy with extended-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 2 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.

HOW SUPPLIED:

Lithium Carbonate Extended-Release Tablets, USP are available containing 450 mg of lithium carbonate, USP.

The 450 mg tablets are white to off-white, round, scored tablets debossed with LC above the score and 450 below the score on one side of the tablet and M on the other side. They are available as follows:

NDC 51079-142-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from moisture.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Laboratories Limited
Hyderabad — 500 096, India

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-12618
1/20

PRINCIPAL DISPLAY PANEL – 450 mg

NDC 51079-142-20

Lithium
Carbonate
Extended-Release
Tablets, USP

450 mg

100 Tablets (10 x 10)

Each tablet contains:
Lithium carbonate, USP 450 mg

Usual Dosage: 1 or 2 tablets b.i.d. See
accompanying prescribing information for
complete directions for use.

WARNINGS: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]
Protect from moisture.

Code No.: MH/DRUGS/25/NKD/89

Manufactured for:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in India

Rx only

S-11243 R2

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Keep container tightly closed.

Lithium Carbonate Extended-Release 450 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
LITHIUM CARBONATE lithium carbonate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-142(NDC:0378-1450)
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
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
SODIUM ALGINATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code LC;450;M
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-142-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-142-01)
1 NDC:51079-142-01 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (51079-142-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202219 04/20/2012
Labeler — Mylan Institutional Inc. (039615992)
Registrant — Mylan Institutional Inc. (039615992)

Revised: 04/2020 Mylan Institutional Inc.

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