What should I Know Regarding Pregnancy, Nursing and Administering Adzenys XR-ODT to Children or the Elderly?

If you are pregnant

  • Not Recommended:
  • If you are nursing

  • Precaution: POTENTIAL ADVERSE EFFECTS IN INFANT, MFR REC TO AVOID BREASTFEEDING
  • If you are an adult over 60

  • management or monitoring precaution: Neuro/Psych-May exacerbate pre-existing insomnia. Cardiovascular-May exacerbate pre-existing coronary insufficiency, cause or exacerbate peripheral vasculopathy. Gastrointestinal-Anorexia may cause significant weight loss.
  • Pediatric use

  • Severe Precaution: Risk of slowed growth and possible effects on development. Not recommended age < 6 years.
  • Severe Precaution: Possible cardiovascular event with underlying cardiac structural defect, cardiomyopathy or serious arrhythmia. Monitor growth, behavior and for cardiac symptoms. Rare risk of priapism. Rare reports of suicidal ideation/suicide.
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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.