What should I Know Regarding Pregnancy, Nursing and Administering Aptensio XR to Children or the Elderly?
If you are PREGNANT
- FDB Only When Necessary: INSUF HUMAN DATA; CNS STIMULANTS CROSS PLACENTAL BARRIER
If you are NURSING
- Precaution: INSUFFICIENT DATA AVAILABLE, LIMITED DATA SUGGEST MINIMAL EXCRETION
If you are an adult over 60
- management or monitoring precaution: Neuro/Psych-May exacerbate pre-existing insomnia. Cardiovascular-May exacerbate pre-existing or underlying cardiac abnormality, peripheral vasculopathy. Gastrointestinal-Anorexia may cause significant weight loss.
Giving Aptensio XR to a child under 12
- management or monitoring precaution: Risk of serious adverse event with underlying cardiac structural abnormality or other cardiac condition. Monitor appetite, growth, behavioral changes including suicidal ideation. Rare risk of priapism.
- Severe Precaution: Elevated plasma exposure and high rates of adverse reactions including weight loss seen in patients < 6 years with this formulation. Use not recommended by manufacturer. Serious adverse events possible with underlying cardiac structural abnormality or other cardiac condition. Other risks: growth suppression, behavioral changes, suicidal ideation, new or breakthrough seizure.
- Severe Precaution: Risk of serious adverse event with underlying cardiac structural abnormality or other cardiac condition. Other risks; growth suppression, behavioral changes, suicidal ideation, new or breakthrough seizure. Not recommended age < 4 years (AAP). Safety and efficacy not established age < 6 years per manufacturer.
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.