- Approval Id
- 3054ae20de50c92a
- Drug Name
- STRATTERA 25 mg HARD CAPSULE
- Product Name
- STRATTERA 25 mg HARD CAPSULE
- Approval Number
- SIN13073P
- Approval Date
- 2005-04-04
- Registrant
- DKSH SINGAPORE PTE. LTD.
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- CAPSULE
- Dosage
- **DOSAGE AND ADMINISTRATION**
**Initial Treatment**
**Dosing of Children and Adolescents up to 70 kg body weight**: Strattera should be initiated at a total daily dose of approximately 0.5 mg/kg and increased after a minimum of 3 days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. After 2 to 4 additional weeks, the total daily dose may be increased to a maximum of 1.4 mg/kg in patients who have not achieved an optimal response (see _Pharmacology, Clinical Trials_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
The maximum recommended total daily dose in children and adolescents is 1.4 mg/kg or 100mg, whichever is less.
**Dosing of Children and Adolescents over 70kg body weight and Adults**: Strattera should be initiated at a total daily dose of 40mg and increased after a minimum of 3 days to a target total daily dose of approximately 80mg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. After 2 to 4 additional weeks, the dose may be increased to a maximum of 100mg in patients who have not achieved an optimal response (see _Pharmacology, Clinical Trials_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). There are no data supporting increased effectiveness at higher doses.
The maximum recommended total daily dose in children and adolescents over 70kg and adults is 100mg.
**Interrupted Treatment**
If therapy is interrupted for more than 1 week, treatment should be started at the recommended starting dose – refer to Initial Treatment.
**Maintenance/Extended Treatment**
There is no evidence available from controlled trials to indicate how long the patient with ADHD should be treated with Strattera. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use Strattera for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
**General Dosing Information**
Strattera may be taken with or without food.
The safety of single doses over 120mg and total daily doses above 150mg have not been systematically evaluated.
For those ADHD patients who have end stage renal disease, cautious titration of Strattera to the desired clinical response is recommended (see _Pharmacology – Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Atomoxetine may exacerbate hypertension in patients with end stage renal disease.
Strattera may be discontinued without tapering the dose.
**Hepatic Impairment Dosage Adjustment**
Atomoxetine clearance may be reduced in patients with hepatic impairment. For those ADHD patients who have hepatic impairment, dosage adjustment is recommended as follows: For patients with moderate hepatic impairment (Child-Pugh Class B), initial and target doses should be reduced to 50% of the normal dose. For patients with severe hepatic impairment (Child-Pugh Class C), initial dose and target doses should be reduced to 25% of the normal dose.
**Dosing adjustment for use with a strong CYP2D6 inhibitor**
In children and adolescents up to 70kg body weight administered strong CYP2D6 inhibitors, e.g. paroxetine, fluoxetine and quinidine, Strattera should be initiated at 0.5 mg/kg/day and only increased to the usual target dose of 1.2 mg/kg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.
In children and adolescents over 70kg body weight and adults administered strong CYP2D6 inhibitors, e.g. paroxetine, fluoxetine and quinidine, Strattera should be initiated at 40 mg/day and only increased to the usual target dose of 80 mg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.
- Route Of Administration
- ORAL
- Indication Info
- **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.
- 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.
- Pharma Manufacturer Name
- DKSH SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/dksh-singapore-pte-ltd
