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Aplenzin
bupropion hydrobromide
Black Box Warnings .
Suicidality
incr. suicidality risk in children, adolescents, and young adults w/ major depressive or other psychiatric disorders; weigh risk vs. benefit; in short-term studies of antidepressants vs. placebo, suicidality risk not incr. in pts >24 yo, and risk decr. in pts 65 yo and older; depression and certain other psychiatric disorders themselves assoc. w/ incr. suicide risk; observe all pts for clinical worsening, suicidality, or unusual behavior changes; advise families and caregivers of need for close observation and communication w/ prescriber; not approved for peds use
Adult Dosing .
Dosage forms: ER TAB: 174 mg, 348 mg, 522 mg
Special Note
- [strength clarification]
- Info: bupropion HBr 174, 348, 522 mg = bupropion HCl 150, 300, 450 mg
major depressive disorder
- [348 mg PO qam]
- Start: 174 mg PO qam, may incr. to 348 mg PO qam after 4 days; Max: 522 mg/day; Info: decr. dose to 174 mg/day x2wk to D/C; do not cut/crush/chew tab
seasonal affective disorder
- [348 mg PO qam x4-6mo/year]
- Start: 174 mg PO qam, may incr. to 348 mg PO qam after 7 days; Max: 348 mg/day; Info: begin tx in Sep-Nov, continue until early spring; decr. dose to 174 mg/day x2wk to D/C; do not cut/crush/chew tab
renal dosing
- [see below]
- renal impairment: consider decr. usual dose and/or frequency; Info: ER form cannot be cut, consider IR form for dose adjustments
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: consider decr. usual dose and/or frequency; moderate-severe impairment: max 174 mg q48h
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- MAO inhibitor use w/in 14 days
- seizure disorder
- bulimia
- anorexia nervosa
- abrupt alcohol D/C
- abrupt benzodiazepine D/C
- abrupt barbiturate D/C
- abrupt antiepileptic D/C
- avoid: alcohol use
- caution: drug abuse hx
- caution: seizure risk
- caution: head injury
- caution: intracranial lesion
- caution: CNS infection
- caution: arteriovenous malformation
- caution: bipolar disorder
- caution: bipolar disorder risk
- caution: pts <25 yo
- caution: elderly pts
- caution: renal impairment
- caution: hepatic impairment
- caution: diabetes mellitus
- caution: glaucoma, angle-closure
- caution: HTN
Drug Interactions .
Overview
bupropion
norepinephrine-dopamine reuptake inhibitor; aminoketone antidepressant
- CYP2B6 substrate
- CYP2D6 inhibitor, strong
- hypertensive effects
- interferes w/ radiolabeled norepinephrine analog effect
- lowers seizure threshold
- serotonergic effects
- caution advised w/ concomitant drugs if smoking cessation use; dose adjustments may be necessary; smoking cessation may alter pharmacokinetics or pharmacodynamics of certain drugs
- add MAO inhibitor to Interaction Check if recent (14 days) use
Contraindicated
- acetazolamide
- brivaracetam
- bupropion
- cannabidiol
- carbamazepine
- cenobamate
- clobazam
- clonazepam
- clorazepate
- diazepam
- eliglustat
- eslicarbazepine acetate
- ethosuximide
- felbamate
- fenfluramine
- fosphenytoin
- gabapentin
- ganaxolone
- isocarboxazid
- lacosamide
- lamotrigine
- levetiracetam
- linezolid
- lorazepam
- methsuximide
- methylene blue injection
- midazolam
- oxcarbazepine
- perampanel
- phenelzine
- phenobarbital
- phenytoin
- pimozide
- pregabalin
- primidone
- rufinamide
- selegiline transdermal
- stiripentol
- thioridazine
- tiagabine
- topiramate
- tranylcypromine
- valproic acid
- vigabatrin
- zonisamide
Avoid/Use Alternative
- 5-HTP
- albuterol
- aldesleukin
- alfentanil
- amifampridine
- amphetamine
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- buprenorphine
- butorphanol
- citalopram
- clomipramine
- codeine
- cyclobenzaprine
- desipramine
- desvenlafaxine
- dextroamphetamine
- dihydrocodeine
- doxorubicin
- duloxetine
- efavirenz
- epinephrine inhaled
- escitalopram
- ethanol
- fentanyl
- fluoxetine
- fluvoxamine
- furosemide
- gepirone
- ginkgo
- granisetron
- hydrocodone
- hydromorphone
- iobenguane I 131
- iohexol
- levomilnacipran
- levorphanol
- lisdexamfetamine
- lithium
- lopinavir/ritonavir
- lorlatinib
- meperidine
- metaxalone
- methadone
- methamphetamine
- metoclopramide
- midodrine
- milnacipran
- mirtazapine
- morphine
- nalbuphine
- nortriptyline
- oliceridine
- ondansetron
- opium
- oxycodone
- oxymorphone
- paroxetine
- pentazocine
- pirfenidone
- procarbazine
- propafenone
- remifentanil
- rifampin
- SAMe
- sertraline
- sufentanil
- tamsulosin
- tapentadol
- tramadol
- trimipramine
- venlafaxine
- vilazodone
- vortioxetine
Monitor/Modify Tx
- abiraterone acetate
- acebutolol
- acyclovir
- albuterol inhaled
- aliskiren
- almotriptan
- amantadine
- amiloride
- aminophylline
- amitriptyline
- amlodipine
- amoxapine
- amoxicillin
- ampicillin
- angiotensin II
- apalutamide
- arformoterol inhaled
- aripiprazole
- armodafinil
- asciminib
- asenapine
- atenolol
- atomoxetine
- atropine ophthalmic
- axicabtagene ciloleucel
- axitinib
- azilsartan medoxomil
- baclofen
- baclofen intrathecal
- benazepril
- benzphetamine
- betamethasone
- betaxolol
- bevacizumab
- bismuth subsalicylate
- bisoprolol
- brexpiprazole
- brexucabtagene autoleucel
- brigatinib
- bromocriptine
- budesonide
- bumetanide
- buspirone
- busulfan
- cabozantinib
- caffeine
- caffeine citrate
- candesartan cilexetil
- cannabis
- captopril
- carfilzomib
- cariprazine
- carvedilol
- cefazolin
- cefepime
- cefiderocol
- ceftaroline fosamil
- ceftazidime
- celecoxib
- chlorambucil
- chloroquine
- chlorothiazide
- chlorpheniramine
- chlorpromazine
- chlorthalidone
- ciltacabtagene autoleucel
- ciprofloxacin
- cisatracurium
- clevidipine
- clonidine
- clopidogrel
- clozapine
- cobicistat
- cocaine
- copanlisib
- corticotropin
- cortisone
- cyclosporine
- dalfampridine
- danazol
- daprodustat
- darbepoetin alfa
- darolutamide
- deflazacort
- delafloxacin
- desmopressin
- deutetrabenazine
- dexamethasone
- dexmethylphenidate
- dextromethorphan
- diclofenac
- diclofenac topical
- dicloxacillin
- diethylpropion
- diflunisal
- digoxin
- dihydroergotamine
- diltiazem
- dobutamine
- donepezil
- dopamine
- doxapram
- doxazosin
- doxepin
- doxepin topical
- dronabinol
- droxidopa
- eletriptan
- elivaldogene autotemcel
- enalapril
- enalaprilat
- enzalutamide
- ephedra
- ephedrine injection
- ephedrine oral
- epinephrine
- eplerenone
- epoetin alfa
- erenumab
- ergotamine
- ertapenem
- esketamine
- esmolol
- estetrol (contraceptive)
- estradiol (contraceptive)
- ethacrynic acid
- ethinyl estradiol (contraceptive)
- etodolac
- etrasimod
- felodipine
- fenoldopam
- fenoprofen
- fingolimod
- flecainide
- fludrocortisone
- fluphenazine
- flurbiprofen
- formoterol inhaled
- foscarnet
- fosinopril
- fostamatinib
- frovatriptan
- fruquintinib
- galantamine
- ganciclovir
- goserelin
- guanfacine
- haloperidol
- histrelin
- hoodia
- hydralazine
- hydrochlorothiazide
- hydrocortisone
- hydroxychloroquine
- ibrutinib
- ibuprofen
- idecabtagene vicleucel
- iloperidone
- imipenem
- imipramine
- indapamide
- indomethacin
- iopamidol
- irbesartan
- isoniazid
- isradipine
- ketamine
- ketoprofen
- ketorolac
- labetalol
- lanreotide
- lasmiditan
- leflunomide
- lenvatinib
- leuprolide
- levalbuterol inhaled
- levocarnitine
- levofloxacin
- levoketoconazole
- levonordefrin
- levothyroxine
- licorice
- lidocaine
- lidocaine topical
- lindane topical
- liothyronine
- lisinopril
- lisocabtagene maraleucel
- lofexidine
- losartan
- loxapine
- lumacaftor/ivacaftor
- lumateperone
- lurasidone
- luspatercept
- magnesium citrate
- magnesium salicylate
- meclofenamate
- mefenamic acid
- mefloquine
- meloxicam
- meropenem
- methocarbamol
- methotrexate
- methoxy polyethylene glycol-epoetin beta
- methyldopa
- methylene blue oral
- methylergonovine
- methylphenidate
- methylprednisolone
- metolazone
- metoprolol
- metronidazole
- mexiletine
- mifepristone
- minoxidil
- mirabegron
- modafinil
- moexipril
- molindone
- moxifloxacin
- nabumetone
- nadolol
- nafarelin
- nafcillin
- naproxen
- naratriptan
- naxitamab
- nebivolol
- nefazodone
- nelarabine
- nicardipine
- nicotine
- nifedipine
- nilotinib
- nimodipine
- niraparib
- nisoldipine
- norepinephrine
- ofloxacin
- olanzapine
- olmesartan medoxomil
- olodaterol inhaled
- osilodrostat
- oxacillin
- oxaprozin
- oxymetazoline nasal
- oxytocin
- ozanimod
- paliperidone
- palonosetron
- pazopanib
- penicillin G
- penicillin V
- perindopril
- perphenazine
- pexidartinib
- phendimetrazine
- phenoxybenzamine
- phentermine
- phentolamine
- phenylephrine
- phenylephrine injection
- phenylephrine nasal
- phenylephrine ophthalmic
- phenylephrine rectal
- pindolol
- piperacillin
- piroxicam
- pitolisant
- polyethylene glycol
- polyethylene glycol/electrolytes
- ponatinib
- ponesimod
- pralsetinib
- prazosin
- prednisolone
- prednisone
- procainamide
- prochlorperazine
- promethazine
- propofol
- propranolol
- protriptyline
- pseudoephedrine
- pyridostigmine
- pyrimethamine
- quetiapine
- quinapril
- quinine
- ramipril
- ramucirumab
- rasagiline
- regadenoson
- regorafenib
- ripretinib
- risperidone
- rivastigmine
- rizatriptan
- ropinirole
- rotigotine transdermal
- safinamide
- salmeterol inhaled
- salsalate
- scopolamine
- selegiline
- selpercatinib
- sevoflurane
- siponimod
- sodium phenylbutyrate/taurursodiol
- sodium phosphate (bowel prep)
- sodium picosulfate
- solriamfetol
- sorafenib
- spironolactone
- St. John's wort
- sulfate bowel prep
- sulindac
- sumatriptan
- sunitinib
- tacrolimus
- tagraxofusp
- teclistamab
- telmisartan
- terazosin
- terbutaline
- teriflunomide
- testosterone
- tetrabenazine
- thalidomide
- theophylline
- thiotepa
- thiothixene
- thyroid
- timolol
- timolol ophthalmic
- tisagenlecleucel
- tivozanib
- tolmetin
- torsemide
- trametinib
- trandolapril
- tranexamic acid
- trazodone
- triamcinolone
- triamterene
- trifluoperazine
- triptorelin
- valacyclovir
- valbenazine
- valganciclovir
- valsartan
- vamorolone
- vandetanib
- varenicline
- vasopressin
- verapamil
- vilanterol inhaled
- viloxazine
- voclosporin
- voriconazole
- warfarin
- yohimbe
- ziprasidone
- ziv-aflibercept
- zolmitriptan
Caution Advised
- butalbital
- dexchlorpheniramine
- fexinidazole
- gefitinib
- isavuconazonium
- lemborexant
- levodopa
- midostaurin
- mitapivat
- nevirapine
- pentobarbital
- ritonavir
- sparsentan
- tamoxifen
- telotristat ethyl
Adverse Reactions .
Serious Reactions
- suicidality
- neuropsychiatric disorders
- depression exacerbation
- mania
- homicidal ideation
- seizures
- HTN, severe
- MI
- arrhythmia
- glaucoma, angle-closure
- hypersensitivity rxn
- anaphylaxis
- anaphylactoid rxn
- Stevens-Johnson syndrome
- erythema multiforme
- acute generalized exanthematous pustulosis
- hepatotoxicity
- hyponatremia
Common Reactions
- xerostomia
- headache
- agitation
- nausea
- dizziness
- constipation
- tremor
- diaphoresis
- abnormal dreams
- insomnia
- tinnitus
- pharyngitis
- tachycardia
- anorexia
- weight loss
- infection
- abdominal pain
- diarrhea
- anxiety
- flatulence
- rash
- palpitations
- arthralgia
- myalgia
- chest pain
- blurred vision
- urinary frequency
Safety/Monitoring .
Monitoring Parameters
Cr at baseline, then in elderly pts cont. periodically; BP at baseline, then periodically; sx suicidality, clinical worsening, and/or unusual behavior changes, especially during initial tx or after dose changes
Look/Sound-Alike Drug Names
buPROPion confused with: busPIRone
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; risk of congenital heart defects inconclusive, though no known risk of other teratogenicity based on human data
Pregnancy Registry
encourage pts to enroll in National Pregnancy Registry for Antidepressants at 1-844-405-6185; additional info at www.womensmentalhealth.org/research/pregnancyregistry/antidepressants
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; inadequate human data available, though possible risk of infant seizures; no human data available to assess effects on milk production
Pharmacology .
Metabolism: liver; CYP450: 2B6 substrate; Info: active metabolites
Excretion: urine 87% (0.5% unchanged), feces 10%; Half-life: 14-21h (parent drug), 20-51h (active metabolites)
Subclass: Norepinephrine-Dopamine Reuptake Inhibitors (NDRIs)
Mechanism of Action
exact mechanism of action in smoking cessation or depression unknown; inhibits neuronal uptake of norepinephrine and dopamine (aminoketone)
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Bausch Health Companies Inc.
DEA/FDA: Rx
Approximate Retail Price
from http://www.goodrx.com/aplenzin
oral tablet, extended release:
- 174 mg (30 ea): $1,648.00
- 348 mg (30 ea): $2,169.00
- 522 mg (30 ea): $4,925.00
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