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Risperdal Consta
risperidone
Black Box Warnings .
Dementia-Related Psychosis
not approved for dementia-related psychosis; incr. mortality risk in elderly pts on antipsychotic tx for dementia-related psychosis; most deaths due to cardiovascular or infectious events
Adult Dosing .
Dosage forms: INJ: 12.5 mg per 2 mL, 25 mg per 2 mL, 37.5 mg per 2 mL, 50 mg per 2 mL
schizophrenia
- [25-50 mg IM q2wk]
- Dose: 25-50 mg IM q2wk; Start: 25 mg IM q2wk after establishing tolerability w/ PO risperidone, may incr. dose no more frequently than q4wk; Max: 50 mg IM q2wk; Info: overlap w/ PO risperidone or other PO antipsychotic x3wk; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
bipolar I disorder, maintenance tx
- [25-50 mg IM q2wk]
- Dose: 25-50 mg IM q2wk; Start: 25 mg IM q2wk after establishing tolerability w/ PO risperidone, may incr. dose no more frequently than q4wk; Max: 50 mg IM q2wk; Info: for monotherapy or valproate or lithium adjunct; overlap w/ PO risperidone or other PO antipsychotic x3wk; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
renal dosing
- [see below]
- renal impairment: use PO form to titrate; start 0.5 mg PO bid x1wk, then may incr. to 2 mg/day PO divided qd-bid x1wk, if tolerating then may add 12.5-25 mg IM q2wk; Info: D/C PO form 3wk after 1st IM dose
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: use PO form to titrate; start 0.5 mg PO bid x1wk, then may incr. to 2 mg/day PO divided qd-bid x1wk, if tolerating then may add 12.5-25 mg IM q2wk; Info: D/C PO form 3wk after 1st IM dose
Peds Dosing .
- Dosage forms: INJ: 12.5 mg per 2 mL, 25 mg per 2 mL, 37.5 mg per 2 mL, 50 mg per 2 mL
schizophrenia, maintenance tx (off-label)
- [13 yo and older]
- Dose: 25-37.5 mg IM q2wk; Start: after establishing tolerability w/ PO risperidone, may incr. dose by 12.5 mg no more frequently than q4wk; Max: 50 mg IM q2wk; Info: overlap w/ PO risperidone x3wk; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
bipolar I disorder, maintenance tx (off-label)
- [12 yo and older]
- Dose: 25-37.5 mg IM q2wk; Start: 25 mg IM q2wk after establishing tolerability w/ PO risperidone, may incr. dose no more frequently than q4wk; Max: 50 mg IM q2wk; Info: overlap w/ PO risperidone x3wk; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- 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 pts
- caution: psychosis, dementia-associated
- caution: dementia w/ Lewy bodies
- caution: Parkinson dz
- caution: seizure hx
- caution: seizure risk
- caution: cerebrovascular dz
- caution: cardiovascular dz
- 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 hx, drug-induced
- caution: neutropenia hx, 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
- benztropine
- bromocriptine
- butalbital
- cabergoline
- ceritinib
- clonidine
- codeine
- doxylamine
- ethanol
- hydrocodone
- iloperidone
- isocarboxazid
- kava
- kratom
- lofexidine
- lurasidone
- metaxalone
- metoclopramide
- midazolam
- oxybate
- phenelzine
- pitolisant
- promethazine
- rasagiline
- ropeginterferon alfa-2b
- safinamide
- selegiline
- selegiline transdermal
- thalidomide
- tranylcypromine
- trimethobenzamide
- triptorelin
- ziprasidone
- zuranolone
Monitor/Modify Tx
- acarbose
- acebutolol
- alfentanil
- alfuzosin
- aliskiren
- alogliptin
- alprazolam
- amantadine
- amifostine
- amiloride
- amitriptyline
- amlodipine
- amoxapine
- apalutamide
- apraclonidine ophthalmic
- aprocitentan
- articaine
- asenapine
- 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
- exenatide
- felodipine
- fenoldopam
- fentanyl
- ferumoxytol
- flaxseed
- flibanserin
- fluoxetine
- fluphenazine
- flurazepam
- fosinopril
- foslevodopa
- fosphenytoin
- furosemide
- gabapentin
- gabapentin enacarbil
- garlic
- gilteritinib
- glimepiride
- glipizide
- glyburide
- guanfacine
- haloperidol
- hydralazine
- hydrochlorothiazide
- hydromorphone
- hydroxyzine
- ifosfamide
- iloprost
- iloprost inhaled
- 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
- lumateperone
- 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
- olanzapine
- 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
- 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
- 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
- lasmiditan
- 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
- scopolamine
- 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 sx, severe
- tardive dyskinesia
- dystonia
- neuroleptic malignant syndrome
- hyperglycemia
- diabetes mellitus
- pancreatitis
- SIADH
- seizures
- priapism
- stroke
- TIA
- venous thromboembolism
- ileus
- dysphagia, severe
- hypersensitivity rxn
- angioedema
- anaphylaxis
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- leukopenia
- neutropenia
- agranulocytosis
- thrombocytopenia
- hypothermia
- hyperthermia
- injection site rxn, severe (IM use)
- tumorigenicity (animal studies)
- osteodystrophy (animal studies w/ IM form)
Common Reactions
- somnolence
- hyperprolactinemia
- appetite incr.
- weight gain
- extrapyramidal sx
- insomnia
- fatigue
- headache
- injection site rxn (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 w/ diff frequently during initial tx if pre-existing or hx 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, esp. in 3rd trimester; risk of teratogenicity not expected based on limited human data, though risk of neonatal extrapyramidal and withdrawal sx based on human data w/ antipsychotics
Pregnancy Registry
encourage pts 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, incl. sedation and resp. depression, based on limited human data and drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: liver extensively; CYP450: 2D6 (primary), 3A4 substrate; Info: active metabolite (paliperidone)
Excretion: 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
Mechanism of Action
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.
intramuscular powder for injection, extended release:
- 12.5 mg (1 dose pack, 1 vial): $281.00
- 25 mg (2 dose pack, 1 vial): $1,097.00
- 37.5 mg (1 dose pack, 1 vial): $825.00
- 50 mg (1 dose pack, 1 vial): $1,097.00
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