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U.S. Department of Health and Human Services

Safety

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Atacand HCT (Candesartan Cilexetil/Hydrodchlorothiazide) Tablets

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

Summary View

 

CONTRAINDICATIONS

  • Atacand HCT is contraindicated in patients who are hypersensitive to candesartan, to hydrochlorothiazide or to other sulfonamide-derived drugs.
  • Do not co-administer Aliskiren with Atacand HCT in patients with diabetes
 

WARNINGS

Hypotension
  • Atacand HCT can cause symptomatic hypotension…
  • Impaired Renal Function - Monitor renal function periodically in patients treated with Atacand HCT…
  • Potassium Abnormalities - Drugs that inhibit the renin-angiotensin system can cause hyperkalemia…
 

PRECAUTIONS

  • Metabolic Disturbances - Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides…
Systemic Lupus Erythematosus
  • Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
Drug Interactions
  • Interactions common to both Candesartan Cilexetil and Hydrochlorothiazides - Lithium − Renal clearance of lithium is reduced by thiazides and increases the risk of lithium toxicity.
  • Interactions with Candesartan Cilexetil – Dual Blockade of the Renin-Angiotensin System (RAS) - Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy…
  • Interactions with Hydrochlorothiazide - Stagger the dosage of hydrochlorothiazide and ion exchange resins such that hydrochlorothiazide is administered at least 4 hours before or 4-6 hours after the administration of resins.
  • Digitalis: Thiazide-induced hypokalemia or hypomagnesemia may predispose to digoxin toxicity.
 

ADVERSE REACTIONS

Postmarketing Experience
  • Immunologic: Angioedema
  • Respiratory System Disorders: Cough
  • Skin and Appendages Disorders – rash