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atomoxetine
generic
Black Box Warnings .
Suicidality
incr. risk of suicidality in children/adolescents w/ ADHD, esp. during 1st months of tx; weigh risk vs. benefit; co-morbidities occurring w/ ADHD may be assoc. w/ incr. risk of suicidal ideation or behavior; observe closely for clinical worsening, suicidality, or unusual behavior changes; not approved for major depression; avg risk 0.4% w/ atomoxetine vs. none w/ placebo in pooled analyses of short-term use, no suicides in these trials
Adult Dosing .
Dosage forms: CAP: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg
ADHD
- [80 mg/day PO divided qd-bid]
- Start: 40 mg PO qam for at least 3 days; Max: 100 mg/day; Info: may incr. to 100 mg/day after 2-4wk; in CYP2D6 poor metabolizers, start 40 mg PO qam x4wk; do not open cap; periodically reassess need for tx
cataplexy (off-label)
- [40-100 mg/day PO divided qd-bid]
- Start: 20 mg PO qam for at least 3 days; Max: 100 mg/day; Info: may incr. to 100 mg/day after 2-4wk; in CYP2D6 poor metabolizers, start 20 mg PO qam x4wk; do not open cap
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [adjust dose amount]
- Child-Pugh Class B: decr. usual start and target dose by 50%; Child-Pugh Class C: decr. usual start and target dose by 75%
Peds Dosing .
- Dosage forms: CAP: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg
ADHD
- [6 yo and older, <70 kg]
- Dose: 1.2 mg/kg/day PO divided qd-bid; Start: 0.5 mg/kg/dose PO qam for at least 3 days; Max: 1.4 mg/kg/day; Info: in CYP2D6 poor metabolizers, start 0.5 mg/kg/dose PO qam x4wk; do not open cap; periodically reassess need for tx
- [6 yo and older, >70 kg]
- Dose: 80 mg/day PO divided qd-bid; Start: 40 mg PO qam for at least 3 days; Max: 100 mg/day; Info: may incr. to 100 mg/day after 2-4wk; in CYP2D6 poor metabolizers, start 40 mg PO qam x4wk; do not open cap; periodically reassess need for tx
cataplexy (off-label)
- [5 yo and older]
- Dose: 10-25 mg PO qd; Start: 10 mg PO qam for at least 3 days; Max: 100 mg/day; Info: may incr. to 100 mg/day after 2-4wk; in CYP2D6 poor metabolizers, start 10 mg PO qam x4wk; do not open cap
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [adjust dose amount]
- Child-Pugh Class B: decr. usual start and target dose by 50%; Child-Pugh Class C: decr. usual start and target dose by 75%
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- MAO inhibitor use w/in 14 days
- glaucoma, angle-closure
- pheochromocytoma
- pheochromocytoma hx
- cardiac abnormality, structural
- cardiomyopathy
- arrhythmia, severe
- cardiovascular dz, severe
- cerebrovascular dz, severe
- caution: peds pts
- caution: adolescent pts
- caution: poor CYP2D6 metabolizers
- caution: hepatic impairment
- caution: cardiovascular dz
- caution: cardiovascular dz hx
- caution: tachycardia
- caution: HTN
- caution: hypotension
- caution: cerebrovascular dz
- caution: depression
- caution: bipolar disorder
- caution: bipolar disorder risk
- caution: suicide risk
Drug Interactions .
Overview
atomoxetine
selective norepinephrine reuptake inhibitor
- CYP2D6 substrate
- hypertensive effects
- interferes w/ radiolabeled norepinephrine analog effect
- tachycardia
- add MAO inhibitor to Interaction Check if recent (14 days) use
Contraindicated
- isocarboxazid
- linezolid
- phenelzine
- procarbazine
- rasagiline
- safinamide
- selegiline
- selegiline transdermal
- tranylcypromine
- yohimbe
Avoid/Use Alternative
- albuterol
- dronabinol
- epinephrine inhaled
- furosemide
- iobenguane I 131
- midodrine
- viloxazine
Monitor/Modify Tx
- abiraterone acetate
- acebutolol
- albuterol inhaled
- aliskiren
- almotriptan
- amiloride
- amitriptyline
- amlodipine
- amoxapine
- amphetamine
- angiotensin II
- arformoterol inhaled
- armodafinil
- asciminib
- atenolol
- atropine
- atropine ophthalmic
- axitinib
- azilsartan medoxomil
- benazepril
- benzphetamine
- benztropine
- betamethasone
- betaxolol
- bevacizumab
- bismuth subsalicylate
- bisoprolol
- brigatinib
- budesonide
- bumetanide
- bupropion
- cabozantinib
- caffeine
- caffeine citrate
- candesartan cilexetil
- cannabis
- captopril
- carfilzomib
- carvedilol
- celecoxib
- chlorothiazide
- chlorthalidone
- clevidipine
- clomipramine
- clonidine
- cocaine
- copanlisib
- corticotropin
- cortisone
- cyclosporine
- dacomitinib
- danazol
- daprodustat
- darbepoetin alfa
- deflazacort
- desipramine
- desmopressin
- desvenlafaxine
- dexamethasone
- dexmethylphenidate
- dextroamphetamine
- diclofenac
- diclofenac topical
- dicyclomine
- diethylpropion
- diflunisal
- dihydroergotamine
- diltiazem
- dobutamine
- dopamine
- doxapram
- doxazosin
- doxepin
- droxidopa
- eletriptan
- enalapril
- enalaprilat
- enzalutamide
- ephedra
- ephedrine injection
- ephedrine oral
- epinephrine
- eplerenone
- epoetin alfa
- erenumab
- ergotamine
- esketamine
- esmolol
- estetrol (contraceptive)
- estradiol (contraceptive)
- ethacrynic acid
- ethinyl estradiol (contraceptive)
- etodolac
- etrasimod
- felodipine
- fenfluramine
- fenoldopam
- fenoprofen
- fingolimod
- fludrocortisone
- fluoxetine
- flurbiprofen
- formoterol inhaled
- fosinopril
- fostamatinib
- frovatriptan
- fruquintinib
- glycopyrrolate
- guanfacine
- hoodia
- hydralazine
- hydrochlorothiazide
- hydrocortisone
- hyoscyamine
- ibrutinib
- ibuprofen
- imipramine
- indapamide
- indomethacin
- irbesartan
- isoproterenol
- isradipine
- ketamine
- ketoprofen
- ketorolac
- labetalol
- lanreotide
- leflunomide
- lenvatinib
- levalbuterol inhaled
- levomilnacipran
- levonordefrin
- levothyroxine
- licorice
- lifileucel
- liothyronine
- lisdexamfetamine
- lisinopril
- lorlatinib
- losartan
- lumacaftor/ivacaftor
- luspatercept
- magnesium salicylate
- mavorixafor
- meclofenamate
- mefenamic acid
- meloxicam
- methamphetamine
- methoxy polyethylene glycol-epoetin beta
- methscopolamine
- methyldopa
- methylergonovine
- methylprednisolone
- metoclopramide
- metolazone
- metoprolol
- milnacipran
- minoxidil
- mirabegron
- modafinil
- moexipril
- nabumetone
- nadolol
- naproxen
- naratriptan
- naxitamab
- nebivolol
- nicardipine
- nifedipine
- nilotinib
- nimodipine
- niraparib
- nisoldipine
- norepinephrine
- nortriptyline
- olmesartan medoxomil
- olodaterol inhaled
- orphenadrine
- osilodrostat
- oxaprozin
- oxymetazoline nasal
- oxytocin
- ozanimod
- paroxetine
- pazopanib
- perindopril
- pexidartinib
- phendimetrazine
- phenoxybenzamine
- phentermine
- phentolamine
- phenylephrine
- phenylephrine injection
- phenylephrine nasal
- phenylephrine ophthalmic
- phenylephrine rectal
- pindolol
- piroxicam
- ponatinib
- ponesimod
- pralsetinib
- prazosin
- prednisolone
- prednisone
- propranolol
- protriptyline
- pseudoephedrine
- quetiapine
- quinapril
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- ramipril
- ramucirumab
- regorafenib
- ripretinib
- rizatriptan
- ropinirole
- rotigotine transdermal
- salmeterol inhaled
- salsalate
- selpercatinib
- siponimod
- solriamfetol
- sorafenib
- spironolactone
- sulindac
- sumatriptan
- sunitinib
- tacrolimus
- tagraxofusp
- telmisartan
- terazosin
- terbinafine
- terbutaline
- teriflunomide
- testosterone
- thyroid
- timolol
- tivozanib
- tolmetin
- torsemide
- trametinib
- trandolapril
- triamcinolone
- triamterene
- trimipramine
- valsartan
- vamorolone
- vandetanib
- vasopressin
- venlafaxine
- verapamil
- vilanterol inhaled
- voclosporin
- ziv-aflibercept
- zolmitriptan
Adverse Reactions .
Serious Reactions
- psychosis
- mania
- aggressive behavior
- suicidal ideation
- depression
- hypotension, orthostatic
- syncope
- HTN
- tachycardia
- QT prolongation
- MI
- stroke
- sudden death
- seizures
- hepatotoxicity
- priapism
- Raynaud phenomenon
- hypersensitivity rxn
- angioedema
- anaphylaxis
- rhabdomyolysis
Common Reactions
- xerostomia
- headache
- abdominal pain
- anorexia
- nausea
- vomiting
- insomnia
- somnolence
- erectile dysfxn
- hot flashes
- fatigue
- urinary hesitancy
- urinary retention
- irritability
- dysmenorrhea
- dizziness
- constipation
- dyspepsia
- libido decr.
- diaphoresis
- weight loss
- palpitations
- sleep disorders
- ejaculatory dysfxn
- dysuria
- paresthesia
- rigors
- BP incr.
- HR incr.
- rash
- mood swings
- tremor
Safety/Monitoring .
Monitoring Parameters
cardiac eval. at baseline; BP, HR at baseline, after dose incr, then periodically; height, weight in peds at baseline, then periodically; sx suicidality, clinical worsening, and/or unusual behavior changes in peds, especially during initial tx or after dose changes
Look/Sound-Alike Drug Names
atomoxetine confused with: atorvastatin
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy, esp. in poor CYP2D6 metabolizers; risk of teratogenicity not expected based on limited human data; no known risk of fetal harm based on animal data at 7x and 17x MRHD
Pregnancy Registry
enroll pts or encourage pts to enroll in National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or https://womensmentalhealth.org/adhd-medications
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: liver; CYP450: 2C19, 2D6 substrate; Info: minor active metabolites
Excretion: urine primarily, feces; Half-life: 5.2h, 21.6h (poor metabolizers at CYP2D6)
Subclass: Attention Deficit Hyperactivity Disorder (ADHD) ; Narcolepsy/Somnolence
Mechanism of Action
exact mechanism of action unknown; selectively inhibits norepinephrine reuptake
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: generic
DEA/FDA: Rx
Approximate Retail Price
from http://www.goodrx.com/atomoxetine
oral capsule:
- 10 mg (30 ea): $57.00
- 18 mg (30 ea): $55.00
- 25 mg (30 ea): $57.00
- 40 mg (30 ea): $58.00
- 60 mg (30 ea): $59.00
- 80 mg (30 ea): $60.00
- 100 mg (30 ea): $60.00
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