Basic Information
STRATTERA 10 mg HARD CAPSULE
CAPSULE
Regulatory Information
SIN13072P
April 4, 2005
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 4, 2025
Company Information
Active Ingredients
Strength: 10 mg
Detailed Information
Contraindications
**CONTRAINDICATIONS** Strattera is contraindicated in patients with: - Known hypersensitivity to atomoxetine or any excipients in Strattera - Symptomatic cardiovascular disease – moderate to severe hypertension, atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation, or ventricular flutter, advanced arteriosclerosis ( see _Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Severe cardiac or vascular disorders whose condition would be expected to deteriorate if they experienced increases in blood pressure or in heart rate that could be clinically important (for example, 15 to 20 mmHg in blood pressure or 20 beats per minute in heart rate) (see _Precautions - Cardiovascular Effects_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Uncontrolled hyperthyroidism - Phaeochromocytoma or a history of phaeochromocytoma (see _Precautions - Cardiovascular Effects_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Monoamine Oxidase Inhibitors (MAOI) – Strattera should not be taken with MAOI or within 2 weeks after discontinuing MAOI. Treatment with MAOI should not be initiated within 2 weeks after discontinuing Strattera. With other drugs that affect brain monoamine concentrations, there have been reports of serious, sometimes fatal, reactions when taken in combination with MAOI. These reactions include hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs and mental status changes that include extreme agitation progressing to delirium and coma, some cases presented with features resembling neuroleptic malignant syndrome. Such reactions may occur when these drugs are given concurrently or in close proximity. - Narrow Angle Glaucoma – In clinical studies, the use of Strattera was associated with an increased risk of mydriasis and therefore its use is not recommended in patients with narrow angle glaucoma.
Indication Information
**INDICATIONS** Strattera is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as defined by DSM-IV criteria or the guidelines in ICD-10 in children 6 years of age and older, adolescents and adults.