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Brisdelle
paroxetine
Black Box Warnings .
Suicidality
incr. suicidality risk in children, adolescents, and young adults w/ major depressive or other psychiatric disorders on SSRI tx; observe all pts for clinical worsening, suicidality, or unusual behavior changes; advise families and caregivers of need for close observation and communication w/ prescriber
Adult Dosing .
Dosage forms: CAP: 7.5 mg
vasomotor sx, mod-severe menopausal
- [7.5 mg PO qhs]
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [no adjustment]
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
- pregnancy
- caution: elderly pts
- caution: debilitated pts
- caution: alcohol use, concurrent
- caution: volume depletion
- caution: hyponatremia
- caution: seizure disorder
- caution: bleeding risk
- caution: depression
- caution: suicide risk
- caution: bipolar disorder risk
- caution: osteoporosis risk
- caution: glaucoma, angle-closure
Drug Interactions .
Overview
paroxetine
SSRI
- CYP2D6 substrate
- CYP3A4 substrate
- CYP2D6 inhibitor, strong
- P-gp inhibitor, weak
- antiplatelet effects
- CNS depression
- hyponatremia
- lowers seizure threshold
- serotonergic effects
- add MAO inhibitor to Interaction Check if recent (14 days) use
Contraindicated
- colchicine
- eliglustat
- isocarboxazid
- linezolid
- methylene blue injection
- phenelzine
- pimozide
- pitolisant
- selegiline transdermal
- thioridazine
- tranylcypromine
Avoid/Use Alternative
- 5-HTP
- aldesleukin
- alfentanil
- almotriptan
- amifampridine
- amitriptyline
- amoxapine
- amphetamine
- apixaban
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- bromocriptine
- buprenorphine
- bupropion
- buspirone
- butorphanol
- carbamazepine
- citalopram
- clomipramine
- cocaine
- codeine
- cyclobenzaprine
- dabigatran
- desipramine
- desvenlafaxine
- dexmethylphenidate
- dextroamphetamine
- dextromethorphan
- dihydrocodeine
- dihydroergotamine
- doxepin
- doxepin topical
- doxorubicin
- doxylamine
- duloxetine
- edoxaban
- eletriptan
- enoxaparin
- ergotamine
- escitalopram
- ethanol
- fenfluramine
- fentanyl
- fluoxetine
- fluvoxamine
- fondaparinux
- frovatriptan
- futibatinib
- gepirone
- granisetron
- hydrocodone
- hydromorphone
- imipramine
- iohexol
- isoniazid
- kava
- kratom
- lasmiditan
- levomilnacipran
- levorphanol
- lisdexamfetamine
- lithium
- meperidine
- metaxalone
- methadone
- methamphetamine
- methylene blue oral
- methylergonovine
- methylphenidate
- metoclopramide
- midazolam
- milnacipran
- mirtazapine
- morphine
- nalbuphine
- naratriptan
- nefazodone
- neratinib
- nortriptyline
- oliceridine
- ondansetron
- opium
- oxybate
- oxycodone
- oxymorphone
- ozanimod
- palonosetron
- paroxetine
- pentazocine
- phentermine
- pirfenidone
- pralsetinib
- procarbazine
- promethazine
- propafenone
- protriptyline
- rasagiline
- relugolix
- remifentanil
- repotrectinib
- rivaroxaban
- rizatriptan
- ropeginterferon alfa-2b
- SAMe
- selegiline
- sertraline
- sirolimus albumin-bound
- St. John's wort
- sufentanil
- sumatriptan
- tamoxifen
- tamsulosin
- tapentadol
- thalidomide
- topotecan
- tramadol
- trazodone
- trimethobenzamide
- trimipramine
- venetoclax
- venlafaxine
- vilazodone
- vortioxetine
- yohimbe
- ziprasidone
- zolmitriptan
- zuranolone
Monitor/Modify Tx
- abrocitinib
- acalabrutinib
- ado-trastuzumab emtansine
- afatinib
- alprazolam
- alteplase
- amiloride
- aminophylline
- anacaulase
- anagrelide
- antithrombin
- apalutamide
- argatroban
- aripiprazole
- asenapine
- asparaginase
- aspirin
- atomoxetine
- atorvastatin
- avapritinib
- axitinib
- bevacizumab
- binimetinib
- bivalirudin
- brexanolone
- brexpiprazole
- bromelain
- bromfenac ophthalmic
- bumetanide
- butalbital
- cabazitaxel
- cabozantinib
- calaspargase
- cangrelor
- caplacizumab
- carfilzomib
- carvedilol
- celecoxib
- chlorothiazide
- chlorpheniramine
- chlorpromazine
- chlorthalidone
- cilostazol
- cimetidine
- cisplatin
- clonazepam
- clopidogrel
- clozapine
- collagenase clostridium histolyticum
- cyclophosphamide
- cyclosporine
- dacomitinib
- dalteparin
- danshen
- daprodustat
- daridorexant
- dasatinib
- deferasirox
- defibrotide
- desflurane
- desmopressin
- deutetrabenazine
- dexmedetomidine
- dexmedetomidine injection
- diazepam
- diclofenac
- diclofenac ophthalmic
- diclofenac topical
- diflunisal
- digoxin
- dimethyl fumarate
- dinutuximab
- diosmin
- dipyridamole
- diroximel fumarate
- droperidol
- encorafenib
- enfortumab vedotin
- enzalutamide
- epoprostenol
- eptifibatide
- erlotinib
- esketamine
- eslicarbazepine acetate
- eszopiclone
- ethacrynic acid
- etodolac
- evening primrose oil
- everolimus
- fenoprofen
- fenugreek
- flecainide
- fluphenazine
- flurbiprofen
- flurbiprofen ophthalmic
- fosamprenavir
- fosphenytoin
- fruquintinib
- furosemide
- gabapentin
- gabapentin enacarbil
- galantamine
- garlic
- gefitinib
- gemtuzumab ozogamicin
- ginkgo
- haloperidol
- heparin
- hydrochlorothiazide
- hydrocortisone
- hydroxyzine
- ibrutinib
- ibuprofen
- ibuprofen lysine
- icosapent ethyl
- ifosfamide
- iloperidone
- iloprost inhaled
- imatinib
- indapamide
- indomethacin
- inotersen
- iopamidol
- ivosidenib
- ketamine
- ketoprofen
- ketorolac
- ketorolac ophthalmic
- krill oil
- lemborexant
- lenvatinib
- lifileucel
- lofexidine
- lorazepam
- lumacaftor/ivacaftor
- magnesium citrate
- magnesium salicylate
- mannitol
- meclofenamate
- mefenamic acid
- meloxicam
- methotrexate
- methyl salicylate topical
- metolazone
- metoprolol
- mexiletine
- mitotane
- monomethyl fumarate
- nabumetone
- naproxen
- nattokinase
- nebivolol
- nelarabine
- nepafenac ophthalmic
- niacin (vitamin B3)
- nilotinib
- nintedanib
- nusinersen
- olanzapine
- omega-3-acid
- opicapone
- oxaprozin
- oxcarbazepine
- oxybutynin
- oxytocin
- pacritinib
- pazopanib
- pegaspargase
- penicillin G
- pentobarbital
- pentosan polysulfate sodium
- pentoxifylline
- perphenazine
- phenobarbital
- phenytoin
- piperacillin
- piroxicam
- pirtobrutinib
- plasminogen, human
- polyethylene glycol
- polyethylene glycol/electrolytes
- ponatinib
- porfimer
- prasugrel
- pregabalin
- primidone
- procainamide
- propofol
- propranolol
- quazepam
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- ramucirumab
- ranibizumab
- regorafenib
- remimazolam
- reteplase
- rifabutin
- rifampin
- risperidone
- ritonavir
- romidepsin
- safinamide
- salsalate
- saw palmetto
- selinexor
- selpercatinib
- selumetinib
- sevoflurane
- sirolimus
- sorafenib
- sotatercept
- spironolactone
- sulfate bowel prep
- sulindac
- sunitinib
- suvorexant
- tacrolimus
- talazoparib
- tenecteplase
- tenofovir disoproxil
- terbinafine
- tetrabenazine
- theophylline
- thiothixene
- ticagrelor
- timolol
- timolol ophthalmic
- tipranavir
- tirofiban
- tisotumab vedotin
- tivozanib
- tolmetin
- torsemide
- trametinib
- treprostinil
- triamterene
- ubrogepant
- upadacitinib
- valbenazine
- valproic acid
- vandetanib
- vasopressin
- vinpocetine
- vorapaxar
- warfarin
- willow bark
- zaleplon
- zanubrutinib
- ziconotide
- ziv-aflibercept
- zolpidem
Caution Advised
- acetazolamide
- allopurinol
- amantadine
- apomorphine
- apraclonidine ophthalmic
- baclofen
- baclofen intrathecal
- brimonidine ophthalmic
- brimonidine topical
- brivaracetam
- brompheniramine
- busulfan
- cannabidiol
- cannabis
- carbinoxamine
- cariprazine
- carisoprodol
- cenobamate
- cetirizine
- chamomile, German
- chlorambucil
- chlordiazepoxide
- chlorzoxazone
- clemastine
- clobazam
- clonidine
- clorazepate
- cobicistat
- cyproheptadine
- dantrolene
- darifenacin
- darolutamide
- darunavir
- dexchlorpheniramine
- dichlorphenamide
- difelikefalin
- difenoxin
- dimenhydrinate
- diphenhydramine
- diphenoxylate
- domperidone
- donepezil
- dronabinol
- efavirenz
- entacapone
- entrectinib
- estazolam
- ethanol (in some formulations)
- ethosuximide
- etomidate
- felbamate
- fesoterodine
- flibanserin
- ganaxolone
- gilteritinib
- glecaprevir
- glofitamab
- glycopyrrolate
- guanfacine
- histrelin
- hydroxychloroquine
- hyoscyamine
- isoflurane
- lacosamide
- lamotrigine
- leuprolide
- levetiracetam
- levocetirizine
- levodopa
- lindane topical
- loxapine
- lumateperone
- lurasidone
- meclizine
- melatonin
- meprobamate
- methocarbamol
- methohexital
- methsuximide
- methyldopa
- metyrapone
- metyrosine
- molindone
- mosunetuzumab
- mycophenolate mofetil
- nafarelin
- naldemedine
- naltrexone
- orphenadrine
- oxazepam
- paliperidone
- passion flower
- perampanel
- pheniramine
- pibrentasvir
- pramipexole
- prochlorperazine
- pyrilamine
- quetiapine
- ramelteon
- ropinirole
- rotigotine transdermal
- rufinamide
- scopolamine
- sodium phosphate (bowel prep)
- sodium picosulfate
- solifenacin
- stiripentol
- tasimelteon
- temazepam
- tiagabine
- tizanidine
- tolcapone
- tolterodine
- topiramate
- triazolam
- trifluoperazine
- trihexyphenidyl
- triprolidine
- triptorelin
- trospium
- valerian
- vigabatrin
- viloxazine
- zonisamide
Adverse Reactions .
Serious Reactions
- suicidality
- depression exacerbation
- mania
- serotonin syndrome
- extrapyramidal sx
- akathisia
- anaphylactoid rxn
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- drug rxn w/ eosinophilia and systemic sx
- hyponatremia
- SIADH
- seizures
- bleeding
- glaucoma, angle-closure
- fractures
Common Reactions
- headache
- fatigue
- nausea
- vomiting
- sexual dysfxn
Safety/Monitoring .
Monitoring Parameters
sx suicidality, clinical worsening, and/or unusual behavior changes, especially during initial tx
Look/Sound-Alike Drug Names
PARoxetine confused with: famotidine; Feldene; FLUoxetine; PACLitaxel; pantoprazole; piroxicam; Pravachol; pyridoxine
Pregnancy/Lactation .
Pregnancy
Clinical Summary
N/A; only indicated in menopausal female pts
Lactation
Clinical Summary
N/A; only indicated in menopausal female pts
Pharmacology .
Metabolism: liver extensively; CYP450: 2D6 substrate
Excretion: urine 64% (2% unchanged), feces 36% (<1% unchanged); Half-life: 21h
Subclass: Selective Serotonin Reuptake Inhibitors (SSRIs), Gynecologic
Mechanism of Action
exact mechanism of action for vasomotor sx unknown; selectively inhibits serotonin reuptake
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Sebela Pharmaceuticals Inc.
DEA/FDA: Rx
Approximate Retail Price
from http://www.goodrx.com/brisdelle
oral capsule:
- 7.5 mg (1 package, 30 capsules): $226.00
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