The capsule shells also contain one or more of the following: FD&C Blue No. Drug treatment may not be indicated for all patients with this syndrome. Your doctor should check you or your child carefully for heart problems before starting Atomoxetine.Your doctor should check your blood pressure or your child’s blood pressure and heart rate regularly during treatment with Atomoxetine.Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor medicine.
Atomoxetine is a noradrenaline reuptake inhibitor used for treating children, adolescents and adults with attention deficit hyperactivity disorder (ADHD). Atomoxetine (US brand name Strattera®) is a selective norepinephrine reuptake inhibitor. Such monitoring should include daily observation by families and caregivers.Atomoxetine should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted.Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart ProblemsAssessing Cardiovascular Status in Patients being Treated with AtomoxetineFigure 1: Mean Weight and Height Percentiles Over Time for Patients with Three Years of Atomoxetine TreatmentReasons for discontinuation of treatment due to adverse reactions in child and adolescent clinical trialsCommonly observed adverse reactions in acute child and adolescent, placebo-controlled trialsTable 2: Common Treatment-Emergent Adverse Reactions Associated with the Use of Atomoxetine in Acute (up to 18 weeks) Child and Adolescent TrialsGeneral Disorders and Administration Site ConditionsTable 3: Common Treatment-Emergent Adverse Reactions Associated with the Use of Atomoxetine in Acute (up to 18 weeks) Child and Adolescent TrialsPercentage of Patients Reporting Reaction from BID TrialsPercentage of Patients Reporting Reaction from QD TrialsReasons for discontinuation of treatment due to adverse reactions in acute adult placebo-controlled trialsCommonly observed adverse reactions in acute adult placebo-controlled trialsTable 4: Common Treatment-Emergent Adverse Reactions Associated with the Use of Atomoxetine in Acute (up to 25 weeks) Adult TrialsGeneral Disorders and Administration Site ConditionsGeneral disorders and administration site conditionsTics in patients with ADHD and comorbid Tourette’s DisorderAnxiety in patients with ADHD and comorbid Anxiety DisordersWhat is the most important information I should know about Atomoxetine capsules?The following have been reported with use of Atomoxetine:Suicidal thoughts and actions in children and teenagers:Children and teenagers sometimes think about suicide, and many report trying to kill themselves.
No fatal overdoses of STRATTERA alone have been reported. The chemical structure is: Atomoxetine HCl is a white to practically white solid, which has a solubility of 27.8 mg/mL in water.
It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. This study shows that STRATTERA is effective when administered once daily in the morning.In 2 identical, 9-week, acute, randomized, double-blind, placebo-controlled studies of children aged 7 to 13 (Study 3, N=147; Study 4, N=144), STRATTERA and methylphenidate were compared with placebo. There was 1 suicide attempt among these approximately 2200 patients, occurring in a patient treated with Atomoxetine.
Thus, patients being treated with Atomoxetine should be observed for the emergence of such symptoms.Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients who are experiencing emergent suicidality or symptoms that might be precursors to emerging suicidality, especially if these symptoms are severe or abrupt in onset, or were not part of the patient’s presenting symptoms.Postmarketing reports indicate that Atomoxetine can cause severe liver injury. Some cases presented with features resembling neuroleptic malignant syndrome.
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