Label Changes for:

Megace ES (megestrol acetate) Oral Suspension, 625 mg/5 ml 

May 2013

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

 

May 2013

8 USE IN SPECIFIC POPULATIONS

8.6 Use in Women
  • Megace ES is a progesterone derivative, which may induce vaginal bleeding in women

NOTE: changes to OVERDOSAGE, Section 10

  • In postmarketing experience, limited reports of overdose have been received. Signs and symptoms reported in the context of overdose included diarrhea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain. There is no specific antidote for overdose with Megace® ES oral suspension. In case of overdose, appropriate supportive measures should be taken.

 

April 2012

 

PRECAUTIONS

Use In Women (previously named “Use in HIV-Infected Women” and relocated to PRECAUTIONS)

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