Apo-Atomoxetine Special Precautions

BEFORE using APO-ATOMOXETINE, the patient should talk to the doctor or pharmacist if he/she: has structural heart abnormalities; has inborn, acquired or family history of long QT interval; has mental problems, including psychosis, mania, bipolar illness, or depression; has had seizures (convulsions, epilepsy) or abnormal EEGs (electroencephalograms); has or had any disorder of the blood vessels in the brain (e.g. aneurysm, stroke, vasculitis); has a family history of sudden death or death related to heart problems; does strenuous exercise; takes other drugs for ADHD; has or had liver problems [lower dose may be needed]; has mild high blood pressure [atomoxetine can increase blood pressure]; has problems with the heart or an irregular heartbeat [atomoxetine can increase heart rate (pulse)]; has low blood pressure [atomoxetine can cause dizziness or fainting in people with low blood pressure]; is nursing, pregnant, or thinking of becoming pregnant.
Other Important Safety Information: Severe liver damage: Call the doctor right away if the following signs of liver problems are present: dark urine, yellow skin or eyes, right upper belly pain, itching, unexplained flu-like symptoms.
Sudden death has been reported in association with stimulant drugs for ADHD treatment in children with structural heart abnormalities. Although atomoxetine is not a stimulant drug, it generally should not be used in children, adolescents or adults with known structural heart abnormalities.
New or Worsened Emotional or Behavioural Problems: Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen, consult the doctor immediately. Close observation by a doctor is necessary in this situation.
During treatment with these types of medication, it is important that the patient and the doctor have good ongoing communication about how the patient is feeling.
The patient should not drive a car or operate hazardous machinery until he/she knows how APO-ATOMOXETINE affects him/her.
This medicine was prescribed for the patient's use only. The patient should not let anyone else take his/her APO-ATOMOXETINE capsules.
More Information: Atomoxetine is contraindicated in patients with symptomatic cardiovascular disease, moderate to severe hypertension or severe cardiovascular disorders whose condition would be expected to deteriorate if they experienced increases in blood pressure or in heart rate that could be clinically important.
Atomoxetine should be used with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease because it can increase blood pressure and heart rate.
Atomoxetine should be used with caution in patients with congenital or acquired long QT or a family history of QT prolongation.
Patients should be screened for pre-existing or underlying cardiovascular or cerebrovascular conditions before initiation of treatment with atomoxetine and monitored during the course of treatment.
Heart rate and blood pressure should be measured at baseline, following atomoxetine dose increases, and periodically while on therapy.
Priapism: Rare post-marketing cases of priapism, defined as painful and non-painful penile erection lasting more than 4 hours, have been reported for paediatric and adult patients treated with atomoxetine.
The erections resolved in cases in which follow-up information was available, some following discontinuation of atomoxetine. Prompt medical attention is required in the event of suspected priapism.
Potential association with the occurrence of behavioural and emotional changes, including self-harm: There have been very rare reports of suicidal ideation, suicidal attempts, suicidal depression and completed suicides in children, adolescents and adults.
ADHD and its related co-morbidities may be associated with increased risk of suicidal ideation and/or behaviour. Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages. This includes monitoring for agitation-type of emotional and behavioural changes, and clinical worsening.