"By Megan Brooks
Medscape Medical News
The US Food and Drug Administration (FDA) will require makers of prescription testosterone products to clarify the approved uses of these medications on the product label and add information"...
In clinical trials, inadvertent overdosage with AGGRASTAT occurred in doses up to 2 times the recommended dose for initial infusion doses. Inadvertent overdosage occurred in doses up to 9.8 times the 0.15 mcg/kg/min maintenance infusion rate.
The most frequently reported manifestation of overdosage was bleeding, primarily minor mucocutaneous bleeding events and minor bleeding at the sites of cardiac catheterization [see WARNINGS AND PRECAUTIONS].
Overdosage of AGGRASTAT should be treated by assessment of the patient's clinical condition and cessation or adjustment of the drug infusion as appropriate.
AGGRASTAT can be removed by hemodialysis.
AGGRASTAT is contraindicated in patients with:
- Severe hypersensitivity reaction to AGGRASTAT (i.e., anaphylactic reactions) [see ADVERSE REACTIONS].
- A history of thrombocytopenia following prior exposure to AGGRASTAT [see ADVERSE REACTIONS].
- Active internal bleeding or a history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month [see ADVERSE REACTIONS].
Last reviewed on RxList: 11/6/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Aggrastat Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.