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atomoxetine (Rx)Brand and Other Names:Strattera

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 10mg
  • 18mg
  • 25mg
  • 40mg
  • 60mg
  • 80mg
  • 100mg
more...

Attention-Deficit/Hyperactivity Disorder

40 mg PO once daily initially; increased after ≥3 days to 80 mg PO once daily or divided q12hr; may be increased to ≤100 mg if optimal response is not achieved

Dosing considerations

  • When drug is coadministered with strong CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) or used in patients known to be poor CYP2D6 metabolizers, decrease dosage; initiate with 40 mg/day, but do not exceed 80 mg/day

Dosing Modifications

Renal impairment: Dosage adjustment not necessary

Mild hepatic impairment (Child-Pugh class A): Dosage adjustment not necessary

Moderate hepatic impairment (Child-Pugh class B): Decrease initial and target dosage by 50%

Severe hepatic impairment (Child-Pugh class C): Decrease initial and target dosage by 75%

Dosage Forms & Strengths

capsule

  • 10mg
  • 18mg
  • 25mg
  • 40mg
  • 60mg
  • 80mg
  • 100mg
more...

Attention-Deficit/Hyperactivity Disorder

>6 years and ≤70 kg: 0.5 mg/kg PO once daily; increased after ≥3 days to target dosage of ~1.2 mg/kg PO once daily or divided q12hr; total daily dose not to exceed 1.4 mg/kg or 100 mg, whichever is less; no benefit observed with higher doses 

>70 kg: 40 mg PO once daily initially; increased after ≥3 days to 80 mg PO once daily or divided q12hr; if necessary, may be increased after 2-4 additional weeks to 100 mg PO once daily

Dosing considerations

  • When drug is coadministered with strong CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) or used in patients known to be poor CYP2D6 metabolizers, decrease dosage
  • ≤70 kg: 0.5 mg/kg/day initially; increased to usual target dosage of 1.2 mg/kg/day only if symptoms fail to improve after 4 weeks and initial dosage is well tolerated
  • >70 kg: 40 mg/day initially; not to exceed 80 mg/day

Administration

Must be swallowed whole with aid of liquids; must not be chewed, divided, or crushed

Administer once daily in morning, with or without food

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Interactions

Interaction Checker

atomoxetine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Xerostomia (dry mouth) (21%)

            Headache (2-19%)

            Abdominal pain (7-18%)

            Decreased appetite (11-16%)

            Insomnia (2-15%)

            Cough (11%)

            Somnolence (11%)

            Vomiting (3-11%)

            1-10%

            Nausea (10%)

            Increases in blood pressure (BP; ≥15-20 mm Hg) and heart rate (HR; ≥20 beats/min) (5-10%)

            Erectile dysfunction (9%)

            Hot flashes (8%)

            Dizziness (5-8%)

            Urinary hesitation or retention (7%)

            Decreased weight (4-7%)

            Depression (4-7%)

            Irritability (<6%)

            Dyspepsia (4%)

            Ejaculation disorder (3%)

            Sinus headache (3%)

            Constipation (2%)

            Dermatitis (2%)

            Menstrual disorder (2%)

            Mood swings (1-2%)

            Postmarketing Reports

            Paresthesia

            Cardiovascular: QT prolongation, syncope

            Peripheral vascular: Raynaud phenomenon

            General: Lethargy

            Neurologic: Hypesthesia, paresthesia in children and adolescents, sensory disturbances, tics

            Psychiatric: Depression and depressed mood, anxiety

            Seizures: Cases include patients with preexisting seizure disorders and those with identified risk factors for seizures, as well as patients with neither history of nor identified risk factors for seizures; exact relation between atomoxetine and seizures is difficult to evaluate because of uncertainty about background risk of seizures in patients with attention-deficit/hyperactivity disorder (ADHD)

            Skin: Hyperhidrosis

            Urogenital: Male pelvic pain, urinary hesitation or retention in children and adolescents

            Musculoskeletal: Rhabdomyolysis

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            Warnings

            Black Box Warnings

            Atomoxetine use has been associated with increased risk of suicidal ideation in short-term studies in children or adolescents with ADHD; this risk must be balanced against clinical need in patients with ADHD

            Monitor patients closely for suicidal thinking and behavior, clinical worsening, or unusual behavioral changes; families and caregivers should be advised of need for close observation and communication with prescribing healthcare provider

            Average risk of suicidal ideation in patients receiving atomoxetine has been shown to be ~0.4% (5/1357 patients)

            Contraindications

            Hypersensitivity

            Narrow-angle glaucoma

            Administration concomitantly with or within 14 days of monoamine oxidase inhibitor (MAOI) therapy; risk of potentially fatal reaction, including hyperthermia, myoclonus, altered mental status, and neuroleptic malignant syndrome (NMS)-like symptoms

            Pheochromocytoma: Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with current or previous pheochromocytoma

            Severe cardiovascular disorders where condition would deteriorate because BP increases by 15-20 mm Hg or HR increases by 20 beats/min; risk is greater in poor CYP2D6 metabolizers

            Cautions

            If drug is given concomitantly with CYP2D6 inhibitor, wait 4 weeks after initiation before adjusting dosage

            Liver injury reported within 120 days of initiation of atomoxetine; patients may present with elevated liver enzymes (>20 × ULN) and jaundice with significantly elevated bilirubin levels (>2 × ULN), followed by recovery upon discontinuance of atomoxetine

            Orthostatic hypotension and syncope reported

            Risk of suicidal thoughts in children and adolescents

            Small risk of allergic reaction

            Use caution in hypertension, tachycardia (see Contraindications)

            Sudden deaths, stroke, and myocardial infarction reported in patients with structural cardiac abnormalities or other serious heart problems taking stimulants at usual doses; patients should have a careful history and physical exam to assess for presence of cardiovascular disease; consider not using atomoxetine in adults with clinically significant cardiac abnormalities

            Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation

            Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients

            Aggressive behavior or hostility is often observed in children and adolescents with ADHD; monitor for the appearance of or worsening of aggressive behavior or hostility

            Monitor growth of children ages 7 to 10 years during treatment with stimulants; may need to interrupt therapy in patients not growing or gaining weight as expected

            Urinary hesitancy or sexual dysfunction may occur

            Rare instances of priapism reported, sometimes necessitating surgical intervention; typically not reported during initiation but often occurring subsequent to dosage increase; immediate medical attention should be sought for abnormally sustained or frequent and painful erections

            Drug can be discontinued without being tapered

            Hypesthesia, paresthesia in children and adolescents, sensory disturbances

            Rare reports of allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash

            Use with caution in patietns with bipolar disorder, history of hypertension, hepatic impairment, existing anxiety disorder, history of urinary retention, or tics related to Tourette disorder

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Unknown whether drug is excreted in milk; use with caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Selective inhibition of presynaptic norepinephrine reuptake

            Absorption

            Bioavailability: 63-94%

            Onset: 2-4 wk

            Peak plasma time: 1-2 hr

            Distribution

            Vd: 0.85 L/kg (IV)

            Protein bound: 98%

            Vd: 0.85 L/kg

            Metabolism

            Metabolized in liver by CYP2D6

            Metabolites: 4-Hydroxyatomoxetine (equipotent), N-desmethylatomoxetine (less potent)

            Elimination

            Half-life: 5.2 hr

            Total body clearance: 0.35 L/hr/kg

            Excretion: Urine (80%), feces (17%)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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