Label Changes for:

Aldactone (spironolactone) Tablets

October 2014

Changes have been made to the WARNINGS sections of the safety label.

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

October 2014

WARNINGS

  • ... or conditions known to cause hyperkalemia added 

 

June 2013

CONTRAINDICATIONS

  • Addison’s disease or other conditions associated with hyperkalemia, and with concomitant use of eplerenone. 

WARNINGS

Concomitant administration of Aldactone with the following drugs or potassium sources may lead to severe hyperkalemia:
  • other potassium-sparing diuretics
  • ACE inhibitors
  • angiotensin II antagonists
  • aldosterone blockers
  • non-steroidal anti-inflammatory drugs (NSAIDs), e.g., indomethacin
  • heparin and low molecular weight heparin
  • other drugs known to cause hyperkalemia
  • potassium supplements
  • diet rich in potassium
  • salt substitutes containing potassium 

PRECAUTIONS

  • Somnolence and dizziness have been reported to occur in some patients. Caution is advised when driving or operating machinery until the response to initial treatment has been determined.
  • Angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin, and other drugs known to cause hyperkalemia: Concomitant administration may lead to severe hyperkalemia.
  • Cholestyramine: Hyperkalemic metabolic acidosis has been reported in patients given Aldactone concurrently with cholestyramine. 

ADVERSE REACTIONS

  • Reproductive: breast pain
  • Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia
  • Metabolism: electrolyte disturbances
  • Musculoskeletal: Leg cramps.
  • Nervous system /psychiatric: Lethargy, dizziness
  • Skin: alopecia, pruritis

 

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