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U.S. Department of Health and Human Services

Safety

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Capoten (captopril) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May and December 2011 and August 2012

 

August 2012

Summary View

 

CONTRAINDICATIONS

  • Do not co-administer Aliskiren with Capoten in patients with diabetes…
 

PRECAUTIONS

Drug Interactions

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…
  

December 2011 

Summary View

 

BOXED WARNING

WARNING: FETAL TOXICITY (revised)

  • When pregnancy is detected, discontinue Capoten as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity

 

WARNINGS (revised)

Fetal Toxicity

Pregnancy Category D

  • Use of drugs that act on the rennin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death….

 

PRECAUTIONS (revised)

Information for Patients
  • Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to Capoten during pregnancy…
Pediatric Use
  • Neonates with a history of in utero exposure to Capoten: If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion…

 

May 2011

Summary View

PRECAUTIONS

Drug Interactions
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors with ACE inhibitors, including captopril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving captopril and NSAID therapy. The antihypertensive effect of ACE inhibitors, including captopril may be attenuated by NSAIDs.

 

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