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U.S. Department of Health and Human Services

Safety

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Aldactazide (spironolactone/HCTZ) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2013

Summary View

 

CONTRAINDICATIONS

  • hypercalcemia
  • Addison’s disease or other conditions associated with hyperkalemia
 

WARNINGS

Concomitant administration of Aldactazide with the following drugs or potassium sources may lead to severe hyperkalemia:
  • other potassium-sparing diuretics
  • ACE inhibitors
  • angiotensin II receptor 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 receptor 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 spironolactone concurrently with cholestyramine.
  • Thiazides are excreted in human milk in small amounts. Thiazides when given at high doses can cause intense diuresis which can in turn inhibit milk production. The use of Aldactazide during breast feeding is not recommended. If Aldactazide is used during breast feeding, doses should be kept as low as possible.
 

ADVERSE REACTIONS

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