MedPath

Lithium Carbonate

Lithium Carbonate Extended-release Tablets, USP 300 mg

Approved
Approval ID

039f188c-413a-6e64-e063-6294a90a2972

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 23, 2023

Manufacturers
FDA

PD-Rx Pharmaceuticals, Inc.

DUNS: 156893695

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lithium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72789-171
Application NumberANDA076832
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lithium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2023
FDA Product Classification

INGREDIENTS (13)

CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LITHIUM CARBONATEActive
Quantity: 300 mg in 1 1
Code: 2BMD2GNA4V
Classification: ACTIB
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT

Drug Labeling Information

BOXED WARNING SECTION

LOINC: 34066-1Updated: 10/17/2022

WARNING

Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy**[see DOSAGE AND ADMINISTRATION].**


DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/17/2022

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.

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 10/17/2022

OVERDOSAGE

The toxic concentrations for lithium (≥1.5 mEq/L) are close to the therapeutic concentrations. 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 [see WARNINGS: Lithium Toxicity].

Treatment

No specific antidote for lithium poisoning is known. Treatment is supportive. 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 functioning. 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. However, patient recovery may be slow.

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

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