Atomoxetine hydrochloride or Strattera is a selective norepinephrine reuptake inhibitor used for treatment of ADHD as part of a total treatment program.
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Pregnancy Category C
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.
- Treatment of ADHD as part of a total treatment program
- 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
Metabolism: Hepatic; T1/2: 5 hr
Distribution: May cross placenta; may enter breast milk
Excretion: Urine and feces
Capsules—10, 18, 25, 40, 60 mg
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.
- 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
- 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
- History: Hypersensitivity to atomoxetine or constituents of Strattera; use of MAOIs within the past 14 days; narrow-angle glaucoma, hypertension, tachycardia, CV or cerebrovascular disease, pregnancy, lactation
- Physical: Height, weight, T; skin color, lesions; orientation, affect; P, BP, auscultation; R, adventitious sounds; bowel sounds, normal output
- Ensure proper diagnosis before administering to children for behavioral syndromes: drug should not be used until other causes and concomitants of abnormal behavior (learning disability, EEG abnormalities,neurological deficits) are ruled out.
- Ensure that drug is being used as part of an overall treatment program including education and psychosocial interventions.
- Arrange to interrupt drug dosage periodically in children being treated for behavioral disorders to determine if symptoms recur at an intensity that warrants continued drug therapy.
- Monitor growth of children on long-term atomoxetine therapy.
- Administer drug before 6 PM to prevent insomnia if that is a problem.
- Monitor BP early in treatment, particularly with adult patients.
- Arrange for consult with school nurse of school-age patients receiving this drug.
- For women of childbearing age who are using this drug, suggest using contraceptives.
- Take this drug exactly as prescribed. It can be taken once a day in the morning, if adverse effects are a problem, the drug can be taken in two evenly divided doses in the morning and in the late afternoon or early evening.
- Take drug before 6 PM to avoid night-time sleep disturbance.
- Avoid the use of alcohol and OTC drugs, including nose drops, cold remedies, and herbal therapies while taking this drug; some of these products cause dangerous effects. If you feel that you need one of these preparations, consult your health care provider.
- The effects of this drug on the unborn baby are not known. Women of childbearing age are advised to use contraceptives.
- You may experience these side effects: Dizziness, insomnia, moodiness (these effects may become less pronounced after a few days; avoid driving a car or engaging in activities that require alertness if these occur; notify your health care provider if these are pronounced or bothersome); headache (analgesics may be available to help), loss of appetite, dry mouth (eat frequent small meals and suck on sugarless lozenges).
- Report palpitations, dizziness, weight loss, severe dry mouth and difficulty swallowing, pregnancy.