November 28, 2015
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"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"...




There is no known treatment to reverse the antiplatelet effect of ZONTIVITY, and neither dialysis nor platelet transfusion can be expected to be beneficial if bleeding occurs after overdose. Inhibition of platelet aggregation can be expected for weeks after discontinuation of normal dosing [see CLINICAL PHARMACOLOGY]. There is no standard test available to assess the risk of bleeding in an overdose situation.


History Of Stroke, Transient Ischemic Attack (TIA), Or Intracranial Hemorrhage (ICH)

ZONTIVITY is contraindicated in patients with a history of stroke, TIA, or ICH because of an increased risk of ICH in this population [see ADVERSE REACTIONS].

Discontinue ZONTIVITY in patients who experience a stroke, TIA, or ICH [see ADVERSE REACTIONS and Clinical Studies].

Active Pathologic Bleeding

ZONTIVITY is contraindicated in patients with active pathological bleeding such as ICH or peptic ulcer [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 5/6/2015


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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.

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