Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Do not co-administer aliskiren with Capoten in patients with diabetes.
- Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema
*The following was added:
- Dual blockade…RAS… Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors … other agents that block the RAS
- Do not co-administer Aliskiren with Capoten in patients with diabetes…
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…
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
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….
Information for Patients
- Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to Capoten during pregnancy…
- 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…
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.