MedPath
FDA Approval

Lithium Carbonate

November 27, 2023

HUMAN PRESCRIPTION DRUG LABEL

Lithium carbonate(300 mg in 1 1)

Registrants (1)

PD-Rx Pharmaceuticals, Inc.

156893695

Manufacturing Establishments (1)

PD-Rx Pharmaceuticals, Inc.

PD-Rx Pharmaceuticals, Inc.

PD-Rx Pharmaceuticals, Inc.

156893695

Products (1)

Lithium Carbonate

72789-171

ANDA076832

ANDA (C73584)

ORAL

November 27, 2023

CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Code: 2BMD2GNA4VClass: ACTIBQuantity: 300 mg in 1 1

Drug Labeling Information

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION

Acute Mania

Optimal patient response can usually be established with 1800 mg/day in the following dosages:

ACUTE MANIA

Morning

Afternoon

Nighttime

Lithium Carbonate Extended-Release Tablets 1

3 tabs

(900 mg)

3 tabs

(900 mg)

1. Can also be administered on 600 mg TID recommended dosing interval.

Such doses will normally produce an effective serum lithium concentration ranging between 1 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:

LONG-TERM CONTROL

Morning

Afternoon

Nighttime

Lithium Carbonate Extended-Release Tablets 1

2 tabs

(600 mg)

2 tabs

(600 mg)

1. Can be administered on TID recommended dosing interval up to 1200 mg/day.

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 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.

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