Label Changes for:
Premarin (conjugated estrogens tablets, USP)
October 2011
Changes have been made to the CONTRAINDICATIONS, WARNINGS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2011
CONTRAINDICATIONS
- ... angioedema
- ... known thrombophilic disorders
WARNINGS
- ... 7. angioedema
- ... 8. hereditary angioedema
PPI
How should I take.....
- added info about ...."tablet in stool"
also: selected sections changed to reflect recommended estrogen-class labeling
