Safety

Lithobid (lithium carbonate) Extended-Release tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

May 2016

Summary View

WARNINGS

Lithium Toxicity (addition of paragraph)
  • The risk of lithium toxicity is increased in patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and for patients receiving prescribed medications that may affect kidney function, such as angiotensin converting enzyme inhibitors (ACE inhibitors), angiotensin receptor blockers (ARBs), diuretics (loops and thiazides) and NSAIDs. For these patients, consider starting with lower doses and titrating slowly while frequently monitoring serum lithium concentrations and signs of lithium toxicity.
Renal Effects (addition of paragraph)
  • Post marketing cases consistent with nephrotic syndrome have been reported with the use of lithium. Biopsy findings in patients with nephrotic syndrome include minimal change disease and focal segmental glomerulosclerosis. Discontinuation of lithium in patients with nephrotic syndrome has resulted in remission of nephrotic syndrome.

PRECAUTIONS (addition of paragraph)

  • Diuretic-, ACE-, and ARB-induced sodium loss may increase serum lithium concentrations. Start with lower doses of lithium or reduce dosage, while frequently monitoring serum lithium concentrations and signs of lithium toxicity. See WARNINGS for additional caution information.

 

October 2011

Summary View

WARNINGS

  • the unmasking of Brugada Syndrome [added]

ADVERSE REACTIONS

  • the unmasking of Brugada Syndrome [added]

PATIENT COUNSELING INFORMATION

  • the unmasking of Brugada Syndrome [added]

 

Page Last Updated: 06/10/2016
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