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Risperdal
risperidone
Black Box Warnings .
Dementia-Related Psychosis
not approved for dementia-related psychosis; incr. mortality risk in elderly patients on antipsychotic tx for dementia-related psychosis; most deaths due to cardiovascular or infectious events
Adult Dosing .
Dosage forms: TAB: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg; SOLUTION: 1 mg per mL
schizophrenia
- [2-8 mg/day PO divided qd-bid]
- Start: 2 mg/day PO divided qd-bid, then incr. by 1-2 mg/day no more frequently than q24h; Max: 8 mg/day; Info: doses >6 mg/day rarely more effective, may incr. ADR risk; start 0.5 mg PO bid, titrate slowly in elderly patients; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
bipolar I disorder, acute manic/mixed
- [1-6 mg/day PO divided qd-bid]
- Start: 2-3 mg PO qd, then may adjust dose by 1 mg/day no more frequently than q24h; Max: 6 mg/day; Info: for monotherapy or valproate or lithium adjunct; start 0.5 mg PO bid, titrate slowly in elderly patients; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
Tourette syndrome (off-label)
- [0.25-3 mg/day PO divided qd-bid]
- Start: 0.25-0.5 mg PO qd, then may incr. by up to 0.5 mg/day q4-5 days; Max: 6 mg/day; Info: periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
renal dosing
- [Tourette syndrome]
- renal impairment: not defined
- HD/PD: not defined
- [all other indications]
- CrCl <30: start 0.5 mg bid, may incr. by up to 0.5 mg bid until 1.5 mg bid, then may incr. dose no more frequently than qwk
- HD/PD: not defined
hepatic dosing
- [Tourette syndrome]
- hepatic impairment: not defined
- [all other indications]
- Child-Pugh Class C: start 0.5 mg bid, may incr. by up to 0.5 mg bid until 1.5 mg bid, then may incr. dose no more frequently than qwk
Peds Dosing .
- Dosage forms: TAB: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg; SOLUTION: 1 mg per mL
schizophrenia
- [13-17 yo]
- Dose: 1-6 mg/day PO divided qd-bid; Start: 0.5 mg PO qd, then incr. by 0.5-1 mg/day no more frequently than q24h; Max: 6 mg/day; Info: doses >3 mg/day rarely more effective, may incr. ADR risk; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
bipolar I disorder, acute manic/mixed
- [10-17 yo]
- Dose: 0.5-6 mg/day PO divided qd-bid; Start: 0.5 mg PO qd, then incr. by 0.5-1 mg/day no more frequently than q24h; Max: 6 mg/day; Info: doses >2.5 mg/day rarely more effective, may incr. ADR risk; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
irritability, autistic disorder-associated
- [5-17 yo, 15-20 kg]
- Dose: 0.5-3 mg/day PO divided qd-bid; Start: 0.25 mg PO qd for at least 4 days, then incr. to 0.5 mg/day, then may adjust dose by 0.25 mg/day no more frequently than q2wk; Max: 3 mg/day; Info: periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
- [5-17 yo, >20 kg]
- Dose: 0.5-3 mg/day PO divided qd-bid; Start: 0.5 mg/day PO divided qd-bid for at least 4 days, then incr. to 1 mg/day, then may adjust dose by 0.5 mg/day no more frequently than q2wk; Max: 3 mg/day; Info: periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
Tourette syndrome (off-label)
- [6 yo and older]
- Dose: 0.25-3 mg/day PO divided qd-bid; Start: 0.25-0.5 mg PO qd, then may incr. by up to 0.5 mg/day q4-5 days; Max: 6 mg/day; Info: periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
renal dosing
- [adjust dose amount]
- renal impairment: decr. usual dose, amount not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
- hepatic impairment: consider adult hepatic dosing for guidance
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to paliperidone
- caution: hypersensitivity to tartrazine (some generic tab forms)
- caution: CNS depressant use, concurrent
- caution: alcohol use, concurrent
- caution: elderly patients
- caution: psychosis, dementia-associated
- caution: dementia with Lewy bodies
- caution: Parkinson disease
- caution: seizure history
- caution: seizure risk
- caution: cerebrovascular disease
- caution: cardiovascular disease
- caution: hypotension risk
- caution: hypovolemia
- caution: dehydration
- caution: environmental temperature, high
- caution: aspiration pneumonia risk
- caution: PKU (phenylalanine-containing form)
- caution: diabetes mellitus
- caution: diabetes mellitus risk
- caution: leukopenia history, drug-induced
- caution: neutropenia history, drug-induced
- caution: leukopenia
- caution: neutropenia
- caution: renal impairment
- caution: hepatic impairment
Drug Interactions .
Overview
risperidone
atypical antipsychotic
- CYP2D6 substrate
- CYP3A4 substrate
- CNS depression
- decreases central histamine effects
- dopamine antagonist
- extrapyramidal effects
- hyperglycemic effects
- hyperprolactinemic effects
- hyperthermia
- hypotensive effects
- lowers seizure threshold
Avoid/Use Alternative
- aldesleukin
- amifampridine
- apomorphine
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- asenapine
- benztropine
- bromocriptine
- butalbital
- cabergoline
- ceritinib
- clonidine
- codeine
- doxylamine
- ethanol (alcoholic beverage)
- ethanol injection
- haloperidol
- hydrocodone
- iloperidone
- isocarboxazid
- kava
- kratom
- lofexidine
- lumateperone
- lurasidone
- metaxalone
- metoclopramide
- midazolam
- milsaperidone
- olanzapine
- oxybate
- phenelzine
- pitolisant
- promethazine
- rasagiline
- ropeginterferon alfa-2b
- safinamide
- scopolamine
- selegiline
- selegiline transdermal
- thalidomide
- tradipitant
- tranylcypromine
- trimethobenzamide
- triptorelin
- ziprasidone
- zuranolone
Monitor/Modify Tx
- acarbose
- acebutolol
- alfentanil
- alfuzosin
- aliskiren
- alogliptin
- alprazolam
- alprostadil intracavernous
- amantadine
- amifostine
- amiloride
- amitriptyline
- amlodipine
- amoxapine
- apalutamide
- apraclonidine ophthalmic
- aprocitentan
- articaine
- atenolol
- avanafil
- azilsartan medoxomil
- baclofen intrathecal
- benazepril
- berberine
- betaxolol
- betaxolol ophthalmic
- bethanechol
- bexagliflozin
- bisoprolol
- bortezomib
- brexpiprazole
- brimonidine ophthalmic
- brimonidine topical
- bumetanide
- bupivacaine
- bupivacaine liposomal
- buprenorphine
- bupropion
- butorphanol
- canagliflozin
- candesartan cilexetil
- cannabis
- captopril
- carbamazepine
- cariprazine
- carteolol ophthalmic
- carvedilol
- chlordiazepoxide
- chloroprocaine
- chlorothiazide
- chlorpromazine
- chlorthalidone
- cilostazol
- clevidipine
- clobazam
- clofarabine
- clomipramine
- clonazepam
- clorazepate
- clozapine
- cobicistat
- coenzyme Q-10
- colesevelam
- dacomitinib
- dapagliflozin
- daridorexant
- darunavir
- denileukin diftitox
- desflurane
- desipramine
- dexmedetomidine
- dexmedetomidine injection
- diazepam
- dihydrocodeine
- diltiazem
- dinutuximab
- dipyridamole
- doxazosin
- doxepin
- dronabinol
- droperidol
- dulaglutide
- duloxetine
- empagliflozin
- enalapril
- enalaprilat
- encorafenib
- entacapone
- entrectinib
- enzalutamide
- eplerenone
- epoprostenol
- ertugliflozin
- esketamine
- esmolol
- estazolam
- eszopiclone
- ethacrynic acid
- ethanol (in some formulations)
- etomidate
- etripamil nasal
- exenatide
- felodipine
- fenoldopam
- fentanyl
- ferumoxytol
- flaxseed
- flibanserin
- fluoxetine
- fluphenazine
- flurazepam
- fosinopril
- foslevodopa
- fosphenytoin
- furosemide
- gabapentin
- gabapentin enacarbil
- garlic
- gilteritinib
- glimepiride
- glipizide
- glyburide
- guanfacine
- hydralazine
- hydrochlorothiazide
- hydromorphone
- hydroxyzine
- ifosfamide
- iloprost
- imipramine
- indapamide
- insulin
- iohexol
- iopamidol
- irbesartan
- iron sucrose
- isoflurane
- isosorbide dinitrate
- isosorbide mononitrate
- isradipine
- ivosidenib
- ketamine
- labetalol
- landiolol
- lemborexant
- levobunolol ophthalmic
- levodopa
- levorphanol
- lidocaine
- linagliptin
- liraglutide
- lisinopril
- lithium
- lixisenatide
- lorazepam
- losartan
- loxapine
- lubiprostone
- lumacaftor/ivacaftor
- magnesium sulfate
- maraviroc
- mavorixafor
- meperidine
- mepivacaine
- metformin
- methadone
- methohexital
- methyldopa
- methylene blue injection
- metolazone
- metoprolol
- miglitol
- milrinone
- minoxidil
- mirtazapine
- mitotane
- moexipril
- molindone
- morphine
- nadolol
- nalbuphine
- nateglinide
- nattokinase
- naxitamab
- nebivolol
- nelarabine
- niacin (vitamin B3)
- nicardipine
- nifedipine
- nimodipine
- nisoldipine
- nitric oxide
- nitrite
- nitroglycerin
- nitroprusside
- nortriptyline
- obinutuzumab
- oliceridine
- olmesartan medoxomil
- opicapone
- opium
- oxazepam
- oxybutynin
- oxycodone
- oxymorphone
- paliperidone
- palopegteriparatide
- paroxetine
- pentamidine
- pentazocine
- pentobarbital
- perindopril
- perphenazine
- phenobarbital
- phenoxybenzamine
- phentolamine
- phenytoin
- pindolol
- pioglitazone
- pramipexole
- pramlintide
- prazosin
- pregabalin
- primidone
- procarbazine
- prochlorperazine
- propafenone
- propofol
- propranolol
- protriptyline
- quazepam
- quetiapine
- quinapril
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- ramipril
- remifentanil
- remimazolam
- repaglinide
- rifabutin
- rifampin
- riociguat
- ritonavir
- ropinirole
- ropivacaine
- rosiglitazone
- rotigotine transdermal
- sacubitril
- saxagliptin
- semaglutide
- sevoflurane
- sildenafil
- silodosin
- sitagliptin
- sodium ferric gluconate complex
- sotagliflozin
- sotalol
- sparsentan
- spironolactone
- St. John's wort
- sufentanil
- suvorexant
- tadalafil
- tagraxofusp
- tamsulosin
- tapentadol
- taurine
- telmisartan
- temazepam
- terazosin
- terbinafine
- thioridazine
- thiothixene
- timolol
- timolol ophthalmic
- tirzepatide
- tizanidine
- tolcapone
- torsemide
- tramadol
- trandolapril
- trazodone
- treprostinil
- triamterene
- triazolam
- trifluoperazine
- trimipramine
- valsartan
- vardenafil
- verapamil
- vosoritide
- yohimbe
- zaleplon
- ziconotide
- zolpidem
Caution Advised
- 5-HTP
- acetazolamide
- aclidinium inhaled
- adagrasib
- allopurinol
- almotriptan
- atazanavir
- atropine
- baclofen
- belladonna alkaloids
- bosentan
- botulinum toxin
- brivaracetam
- brompheniramine
- buspirone
- busulfan
- cannabidiol
- carbinoxamine
- carisoprodol
- cenobamate
- cetirizine
- chamomile, German
- chasteberry
- chlophedianol
- chlorambucil
- chloramphenicol
- chlorcyclizine
- chloroquine
- chlorpheniramine
- chlorzoxazone
- citalopram
- clarithromycin
- clemastine
- clidinium
- cyclobenzaprine
- cyproheptadine
- dabrafenib
- dantrolene
- darifenacin
- desvenlafaxine
- deutetrabenazine
- dexbrompheniramine
- dexchlorpheniramine
- dexmethylphenidate
- dichlorphenamide
- dicyclomine
- difelikefalin
- difenoxin
- dimenhydrinate
- diphenhydramine
- diphenoxylate
- disopyramide
- domperidone
- doxepin topical
- efavirenz
- eletriptan
- elinzanetant
- escitalopram
- eslicarbazepine acetate
- ethosuximide
- etravirine
- felbamate
- fenfluramine
- fesoterodine
- fexinidazole
- flavoxate
- fluvoxamine
- frovatriptan
- galantamine
- ganaxolone
- glofitamab
- glycopyrrolate
- glycopyrrolate inhaled
- glycopyrronium topical
- goserelin
- histrelin
- homatropine
- hydroxychloroquine
- hyoscyamine
- idelalisib
- ipratropium inhaled
- itraconazole
- ketoconazole
- lacosamide
- lamotrigine
- leuprolide
- levetiracetam
- levocetirizine
- levoketoconazole
- levomilnacipran
- linvoseltamab
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- magnesium citrate
- mavacamten
- meclizine
- melatonin
- meprobamate
- methocarbamol
- methscopolamine
- methsuximide
- methylphenidate
- metyrapone
- metyrosine
- mifepristone
- milnacipran
- mitapivat
- modafinil
- mosunetuzumab
- mycophenolate mofetil
- nafcillin
- naltrexone
- naratriptan
- nefazodone
- nelfinavir
- orphenadrine
- oxcarbazepine
- pacritinib
- passion flower
- perampanel
- pexidartinib
- pheniramine
- pimozide
- polyethylene glycol
- polyethylene glycol/electrolytes
- posaconazole
- pyrilamine
- ramelteon
- repotrectinib
- revefenacin inhaled
- ribociclib
- rifapentine
- rivastigmine
- rizatriptan
- rufinamide
- selinexor
- sertraline
- sodium picosulfate
- sofpironium topical
- solifenacin
- solriamfetol
- sotorasib
- stiripentol
- sulfate bowel prep
- sumatriptan
- tasimelteon
- tetrabenazine
- thiotepa
- tiagabine
- tiotropium inhaled
- tipranavir
- tolterodine
- topiramate
- treosulfan
- trihexyphenidyl
- triprolidine
- trospium
- tucatinib
- umeclidinium inhaled
- valbenazine
- valerian
- valproic acid
- venlafaxine
- vigabatrin
- vilazodone
- viloxazine
- voriconazole
- zolmitriptan
- zonisamide
Adverse Reactions .
Serious Reactions
- hypotension, orthostatic
- syncope
- extrapyramidal symptoms, severe
- tardive dyskinesia
- dystonia
- neuroleptic malignant syndrome
- hyperglycemia
- diabetes mellitus
- pancreatitis
- SIADH
- seizures
- priapism
- stroke
- TIA
- venous thromboembolism
- ileus
- dysphagia, severe
- hypersensitivity reaction
- angioedema
- anaphylaxis
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- leukopenia
- neutropenia
- agranulocytosis
- thrombocytopenia
- hypothermia
- hyperthermia
- injection site reaction, severe (IM use)
- tumorigenicity (animal studies)
- osteodystrophy (animal studies with IM form)
Common Reactions
- somnolence
- hyperprolactinemia
- appetite incr.
- weight gain
- extrapyramidal symptoms
- insomnia
- fatigue
- headache
- injection site reaction (SC or IM use)
- vomiting
- nasopharyngitis
- constipation
- anxiety
- abdominal pain
- nausea
- fever
- dizziness
- urinary incontinence
- hyperglycemia
- sialorrhea
- rhinorrhea
- nasal congestion
- xerostomia
- pharyngolaryngeal pain
- dyspepsia
- dyslipidemia
- rhinitis
- diarrhea
- URI
- rash
- extremity pain
- blurred vision
- back pain
- musculoskeletal pain
- tachycardia
- impaired body temperature regulation
Safety/Monitoring .
Monitoring Parameters
Cr at baseline; fasting lipid panel at baseline, then periodically; weight; fasting glucose at baseline if diabetes risk factors, then periodically; CBC with diff frequently during initial tx if pre-existing or history of leukopenia/neutropenia; consider orthostatic vital signs if hypotension risk
Look/Sound-Alike Drug Names
RisperDAL confused with: bisoprolol; estradiol; lisinopril; Pediapred; Requip; reserpine; Restoril; Rocaltrol; rOPINIRole
risperiDONE confused with: busPIRone; repaglinide; Requip; reserpine; risedronate; RisperDAL; rOPINIRole; rosiglitazone
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy, especially in 3rd trimester; risk of teratogenicity not expected based on limited human data, though risk of neonatal extrapyramidal and withdrawal symptoms based on human data with antipsychotics
Pregnancy Registry
encourage patients to enroll in National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; low risk of infant harm, including sedation and respiratory depression, based on limited human data and drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for risperidone: liver extensively; CYP450: 2D6 (primary), 3A4 substrate; Info: active metabolite (paliperidone)
Excretion: for risperidone: urine 70%, feces 14%; Half-life: 20h (PO form), 3-6 days (IM form), 9-22 days (SC form)
Subclass: Antipsychotics, 2nd generation ; Bipolar Disorder ; Tic Disorders/Tourette Syndrome
Mechanism of Action
for risperidone: exact mechanism of action unknown; antagonizes dopamine D2, serotonin 5-HT2, and other receptors
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Janssen Pharmaceuticals, Inc.
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
oral tablet:
- 0.5 mg (60 ea): $292.00
- 1 mg (30 ea): $158.00
- 2 mg (30 ea): $260.00
- 3 mg (30 ea): $304.00
- 4 mg (10 ea): $139.00
oral solution:
- 1 mg/mL (2 dropper, 30 mL): $345.00
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