atomoxetine hydrochloride
(at oh mox' ah teen)
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
Nursing considerations
Assessment
· 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
Interventions
· 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.
Adverse effects in Italic
are most common; those in Bold are
life-threatening.