Focalin XR Warnings and Precautions

Some Focalin XR Warnings and Precautions

Some Focalin XR warnings and precautions to be aware of include:
 
  • Stimulants (including Focalin XR) are often abused. Taking high doses of Focalin XR for long periods of time can lead to dependence on Focalin XR (see Focalin XR Abuse). Because Focalin XR is so commonly abused, there are special rules for prescribing Focalin XR (see Focalin XR: A Controlled Substance for more information).
     
  • In people with psychotic disorders (including schizophrenia or schizoaffective disorder), Focalin XR can worsen psychotic symptoms such as thought disorders and behavior problems. Also, Focalin XR may worsen bipolar symptoms, especially manic symptoms.
     
  • Sudden death has been reported in children and adolescents with heart problems who took normal doses of Focalin XR. If your child has heart problems, talk with your healthcare provider about whether Focalin XR is appropriate for your situation. Also, let your healthcare provider know if your child develops any chest tightness, chest pain, shortness of breath, or fainting during treatment with Focalin XR.
     
  • Sudden death, strokes, and heart attacks have also been reported in adults taking normal doses of medications similar to Focalin XR. These events seem to occur more often in adults with heart problems. If you have heart problems, talk with your healthcare provider about whether Focalin XR is appropriate for your situation. Also, let your healthcare provider know if you develop any chest tightness, chest pain, shortness of breath, or fainting while taking Focalin XR.
     
  • Focalin XR can cause an increase in blood pressure and heart rate. In most cases, the increase is small and does not cause problems. However, there is an increased risk for people who already have high blood pressure, congestive heart failure, certain irregular heart rhythms (arrhythmias), or a recent history of a heart attack.
     
  • Focalin XR can cause a temporary slowing of growth in children. This slowing of growth is usually small (less that an inch and less than two pounds), and children usually catch up to within normal limits in time.
     
  • Focalin XR may cause an increase in aggressive behavior in people with ADHD. Let your healthcare provider know if you experience any increase in aggressive behavior while taking Focalin XR.
 
  • There have been reports of priapism in people taking ADHD medications, including this one. This side effect is an abnormally long-lasting, painful erection and can cause serious, permanent damage to the penis. It can occur in males of any age. Young boys might not recognize this side effect, and males of any age might be hesitant to seek parental or medical attention, due to embarrassment. Prompt treatment is necessary to avoid damage.
 
Be especially on the lookout for this side effect whenever the dosage is increased or during a drug "holiday" or any other time when the drug is stopped.
 
  • Stimulants used to treat ADHD have been associated with problems in blood vessels in the fingers and toes, sometimes causing problems such as Raynaud's disease. Alert your healthcare provider to any signs of this problem, such as cold or numb toes or fingers.
 
  • Focalin XR can increase the risk of seizures, especially in people who have had seizures before. Talk with your healthcare provider before taking Focalin XR if you have a history of seizures.
     
  • Focalin XR can cause blurred vision and other vision problems.
     
  • Focalin XR can interact with certain other medications (see Focalin XR Drug Interactions).
     
  • Focalin XR is considered a pregnancy Category C medication. This means that Focalin XR may not be safe to use during pregnancy. Talk with your healthcare provider before using Focalin XR during pregnancy (see Focalin XR and Pregnancy for more information).
     
  • It is not known if Focalin XR passes through breast milk. Therefore, if you are breastfeeding or plan to breastfeed, be sure to talk with your healthcare provider about this.
     
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