CV: arrhythmias, orthostatic hypotension, syncope, tachycardia.
Derm: itching/skin rash, ↑ pigmentation, dry skin, photosensitivity, seborrhea, STEVENS-JOHNSON SYNDROME, sweating, TOXIC EPIDERMAL NECROLYSIS.
EENT: pharyngitis, rhinitis, visual disturbances.
Endo: galactorrhea, hyperglycemia.
F and E: polydipsia.
GI: constipation, diarrhea, dry mouth, nausea, ↑ salivation, abdominal pain, anorexia, dyspepsia, dysphagia, vomiting.
GU: ↓ libido, dysmenorrhea/menorrhagia, ↓ fertility (females), amenorrhea, difficulty urinating, gynecomastia, impotence, polyuria, priapism.
Hemat: AGRANULOCYTOSIS, leukopenia, neutropenia.
Metab: weight gain, dyslipidemia, weight loss.
MS: arthralgia, back pain.
Neuro: ↑ dreams, ↑ sleep duration, aggressive behavior, dizziness, extrapyramidal reactions, headache, insomnia, sedation, fatigue, impaired temperature regulation, nervousness, NEUROLEPTIC MALIGNANT SYNDROME, SEIZURES, tardive dyskinesia.
Resp: cough, dyspnea.
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).
Schizophrenia
- PO (Adults): 1 mg twice daily, ↑ by 1–2 mg/day no more frequently than every 24 hr to 4–8 mg daily.
- PO (Children 13–17 yr): 0.5 mg once daily, ↑ by 0.5–1.0 mg no more frequently than every 24 hr to 3 mg daily. May administer half the daily dose twice daily if drowsiness persists.
- IM (Adults): 25 mg every 2 wk; some patients may benefit from a higher dose of 37.5 or 50 mg every 2 wk.
- IM (Geriatric Patients): 25 mg every 2 wk.
- SC (Adults): Currently taking (switching from) 2 mg/day of oral risperidone: Uzedy: 50 mg once monthly or 100 mg every 2 mo; Currently taking (switching from) 3 mg/day of oral risperidone: Perseris: 90 mg once monthly; Uzedy: 75 mg once monthly or 150 mg every 2 mo; Currently taking (switching from) 4 mg/day of oral risperidone: Perseris: 120 mg once monthly; Uzedy: 100 mg once monthly or 200 mg every 2 mo; Currently taking (switching from) 5 mg/day of oral risperidone: Uzedy: 125 mg once monthly or 250 mg every 2 mo; Concurrent use of strong CYP2D6 inhibitor (e.g., fluoxetine or paroxetine): Perseris: Initiate 90 mg once monthly 2–4 wk before starting strong CYP2D6 inhibitor therapy; Uzedy: When initiation of strong CYP2D6 inhibitor is expected, place patients on a lower dose of risperidone prior to the planned start of the strong CYP2D6 inhibitor. When a strong CYP2D6 inhibitor is initiated in patients already receiving the lowest risperidone dose (50 mg once monthly or 100 mg every 2 mo), continue treatment with these doses unless clinical judgment requires interruption of treatment.Concurrent use of strong CYP3A4 inducer: Perseris: If receiving 90 mg once monthly regimen, ↑ dose to 120 mg once monthly (and consider using additional oral risperidone); if receiving 120 mg once monthly regimen, consider using additional oral risperidone; Uzedy: Upon initiation of therapy with a strong CYP3A4 inducer, closely monitor patients during the first 4–8 wk since the dose of Uzedy may need to be adjusted. A dose ↑ of Uzedy or additional oral risperidone may be considered.
Hepatic Impairment
- PO (Adults): Severe renal impairment (CCr <30 mL/min) or severe hepatic impairment: Start with 0.5 mg twice daily; ↑ by 0.5 mg twice daily, up to 1.5 mg twice daily; then ↑ at weekly intervals if necessary.
Hepatic Impairment
- IM (Adults): Start with 0.5 mg PO twice daily for 1st wk, then ↑ to 1 mg PO twice daily or 2 mg PO once daily during 2nd wk. If 2 mg/day PO dose is well tolerated, can initiate 12.5 mg or 25 mg IM every 2 wk.
Hepatic Impairment
- SC (Adults): Perseris: Titrate patients up to at least 3 mg/day of oral risperidone before initiating Perseris. If patient tolerates this dose of oral risperidone, consider SUBQ dose of 90 mg once monthly. Uzedy: Titrate patients up to at least 2 mg/day of oral risperidone before initiating Uzedy. If patient tolerates this dose of oral risperidone, consider SUBQ dose of 50 mg once monthly.
Acute Manic or Mixed Episodes Associated With Bipolar I Disorder
- PO (Adults): 2–3 mg/day as a single daily dose, dose may be ↑ at 24-hr intervals by 1 mg (range 1–5 mg/day).
- PO (Children 13–17 yr): 0.5 mg once daily, ↑ by 0.5–1 mg no more frequently than every 24 hr to 2.5 mg daily. May administer half the daily dose twice daily if drowsiness persists.
- PO (Geriatric Patients): Start with 0.5 mg twice daily; ↑ by 0.5 mg twice daily, up to 1.5 mg twice daily; then ↑ at weekly intervals if necessary. May also be given as a single daily dose after initial titration.
Hepatic Impairment
- PO (Adults): Severe renal impairment (CCr <30 mL/min) or severe hepatic impairment: Start with 0.5 mg twice daily; ↑ by 0.5 mg twice daily, up to 1.5 mg twice daily; then ↑ at weekly intervals if necessary.
Maintenance Treatment of Bipolar I Disorder
- IM (Adults): 25 mg every 2 wk; some patients may benefit from a higher dose of 37.5 or 50 mg every 2 wk.
- IM (Geriatric Patients): 25 mg every 2 wk.
Hepatic Impairment
- IM (Adults): Start with 0.5 mg PO twice daily for 1st wk, then ↑ to 1 mg PO twice daily or 2 mg PO once daily during 2nd wk. If 2 mg/day PO dose is well tolerated, can initiate 12.5 mg or 25 mg IM every 2 wk.
Irritability Associated With Autistic Disorder
- PO (Children 5–16 yr weighing <20 kg): 0.25 mg/day initially. After at least 4 days of therapy, may ↑ to 0.5 mg/day. Dose ↑ in increments of 0.25 mg/day may be considered at 2 wk or longer intervals. May be given as a single or divided dose.
- PO (Children 5–16 yr weighing >20 kg): 0.5 mg/day initially. After at least 4 days of therapy, may ↑ to 1 mg/day. Dose ↑ in increments of 0.5 mg/day may be considered at 2 wk or longer intervals. May be given as a single or divided dose.
Hepatic Impairment
- PO (Adults): Severe renal impairment (CCr <30 mL/min) or severe hepatic impairment: Start with 0.5 mg twice daily; ↑ by 0.5 mg twice daily, up to 1.5 mg twice daily; then ↑ at weekly intervals if necessary.
Perseris, RisperDAL, RisperDAL Consta, RisperDAL M-TAB, Rykindo, Uzedy
Therapeutic Classification: antipsychotics
Pharmacologic Classification: benzisoxazoles
Absorption: 70% after administration of tablets, solution, or orally disintegrating tablets. Following IM administration, small initial release of drug, followed by 3-wk lag; the rest of release starts at 3 wk and lasts 4–6 wk. Following SUBQ administration, initial release of drug occurs at 4–6 hr, with the rest of release occurring at 10–14 days after administration.
Distribution: Unknown.
Metabolism/Excretion: Primarily metabolized by the liver by the CYP2D6 isoenzyme to 9-hydroxyrisperidone (has similar pharmacological properties as risperidone). Risperidone and its active metabolite are renally eliminated.
Half-life: Extensive metabolizers: 3 hr for risperidone, 21 hr for 9-hydroxyrisperidone. Poor metabolizers: 20 hr for risperidone and 30 hr for 9-hydroxyrisperidone; SUBQ: 9–11 days.
