Generic Name: atomoxetine hydrochloride
Brand: Strattera
Pregnancy Category C
Drug class
Selective norepinephrine reuptake inhibitor
Therapeutic actions
Selectively blocks the reuptake of norepinephrine at the neuronal synapse. The mechanism by which this action has a therapeutic effect in attention deficit hyperactivity disorder (ADHD) is not understood.
Indication
• Treatment of ADHD as part of a total treatment program
Contraindications and cautions
• Contraindicated with hypersensitivity to atomoxetine or constituents of Strattera; use of MAOIs within the past 14 days; narrow-angle glaucoma
• Use cautiously with hypertension, tachycardia, CV or cerebrovascular disease, pregnancy, lactation
Pharmacokinetics
|
Route |
Onset |
Peak |
|
Oral |
Rapid |
1–2 hr |
Metabolism: Hepatic; T1/2: 5 hr
Distribution: May cross placenta; may enter breast milk
Excretion: Urine and feces
Available forms
Capsules—10, 18, 25, 40, 60 mg
Dosages
ADULTS AND CHILDREN > 70 KG
40 mg/day PO, increase after a minimum of 3 days to a target total daily dose of 80 mg PO given as a single dose in the morning or two evenly divided doses, in the morning and late afternoon or early evening; after 2–4 wk, total dosage may be increase to a maximum of 100 mg/day if needed.
PEDIATRIC PATIENTS < 70 KG
Initially, 0.5 mg/kg/day PO, increase after a minimum of 3 days to a target total daily dose of approximately 1.2 mg/kg/day PO as a single daily dose in the morning; may be given in two evenly divided doses in the morning and late afternoon or early evening. Do not exceed 1.4 mg/kg or 100 mg/day, whichever is less.
PATIENTS WITH HEPATIC IMPAIRMENT
For moderate hepatic impairment, reduce dose to 50% of the normal dose; for severe hepatic impairment, reduce dose to 25% of the normal dose.
Adverse effects
• CNS: Aggression, irritability, crying, somnolence, dizziness, headache, mood swings, insomnia
• CV: Palpitations
• Dermatologic: Dermatitis, increased sweating
• GI: Dry mouth, nausea, dyspepsia, flatulence, decreased appetite, constipation, upper abdominal pain, vomiting
• GU: Urinary hesitation, urinary retention, dysmenorrhea, erectile problems
• Respiratory: Cough, rhinorrhea, sinusitis
• Other: Fever, rigors, sinusitis, weight loss, myalgia
Interactions
Drug-drug
• Possible increased serum levels if combined with potent CYP2D6 inhibitors—paroxetine, fluoxetine, quinidine; monitor and adjust dosage of atomoxetine to 0.5 mg/kg/day with a target dose of 1.2 mg/kg/day for children < 70 kg or 40 mg/day with a target dose of 80 mg/day for children > 70 kg or adults
• Risk of neuroleptic malignant syndrome if combined with MAOIs; do not combine with an MAOI and do not give atomoxetine within 14 days of using an MAOI
