Label Changes for:
Capoten (captopril) Tablets
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May and December 2011
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.