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

 

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