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Uses

Schizophrenia

Symptomatic management of schizophrenia.

Bipolar Disorder

Short-term management (alone or in combination with lithium or divalproex sodium) of acute manic or mixed episodes associated with bipolar I disorder.

Autistic Disorders

Management of severe behavioral problems associated with autistic disorders†; not shown to improve core symptoms of autism (e.g., language deficits, social withdrawal).

Dosage and Administration

Administration

Administer orally or IM.

Establish tolerability with oral risperidone prior to initiating IM therapy.

Oral Administration

Administer orally once or twice (in equally divided doses) daily without regard to meals.

Just prior to administration of orally disintegrating tablet, remove blister from aluminum blister pack or child-resistant pouch; with dry hands, peel open blister package, place tablet on tongue to dissolve, and swallow with or without liquids. Do not chew or divide orally disintegrating tablet.

Oral solution may be administered with compatible beverages. (See Compatibility under Stability.)

When switching from other antipsychotic agents to risperidone, abrupt discontinuance of previous agent may be acceptable for some patients, but gradual discontinuance may be appropriate for others. In all cases, minimize period of overlapping antipsychotic administration.

In patients being switched from long-acting (depot) parenteral antipsychotic therapy to oral risperidone therapy, administer first oral dose in place of next scheduled dose of the long-acting preparation.

IM Administration

Administer by deep IM injection into upper outer quadrant of the gluteal area every 2 weeks, alternating buttocks. Do not administer IV.

Administer only with needle and other components of dose pack supplied by manufacturer.

Do not combine 2 different strengths of IM risperidone in a single administration.

Reconstitution

Consult manufacturer's labeling for instructions for using components of dose pack for reconstitution.

Allow the risperidone dose pack to reach room temperature before reconstituting.

Reconstitute vial containing risperidone extended-release microspheres only with diluent in prefilled syringe supplied by manufacturer. Inject entire contents of prefilled syringe and shake vial vigorously while holding plunger rod down with thumb for ≥10 seconds to ensure a homogeneous suspension (appears uniform, thick, milky).

Upon suspension in diluent, immediate use is recommended because suspension will settle over time. If >2 minutes pass before administration, shake vigorously to resuspend. Must be used within 6 hours of reconstitution.

Dosage

If reinitiated after a drug-free period, titrate oral dosage as with initial therapy.

Adults

Schizophrenia

Oral

Initially, 1 mg twice daily, with increases in increments of 1 mg twice daily on second and third day, as tolerated, to target dosage of 6–8 mg daily (once daily or in 2 equally divided doses) recommended by manufacturer. Make subsequent dosage adjustments at intervals of ≥7 days.

Alternatively, an initial dosage of 1–2 mg daily, with increases in increments of 0.5–1 mg daily titrated over 6–7 days, as tolerated, to target dosage of 4 mg daily may be more appropriate in most otherwise healthy adult patients.

Lower initial dosages (e.g., 1 mg daily) and slower dosage titrations to an initial target dosage of 2 mg daily may be appropriate for younger patients and those being treated for their first psychotic episode. Titrate dosage up to 4 mg daily depending on clinical response and adverse neurologic effects; 1–3 mg may be optimal.

Maximal efficacy generally observed in dosage range of 4–8 mg daily; dosages >6 mg daily did not result in greater efficacy, but were associated with more adverse effects (e.g., extrapyramidal symptoms).

Efficacy maintained for up to 2 years, but optimum duration of therapy currently is not known. In responsive patients, continue as long as clinically necessary and tolerated, but at lowest possible effective dosage; periodically reassess need for continued therapy.

IM

25 mg IM every 2 weeks.

Administer oral risperidone (or another antipsychotic agent) with the first IM risperidone injection and continue oral therapy for 3 weeks thereafter to ensure adequate therapeutic plasma concentrations are maintained prior to main release of risperidone from injection site. (See Bioavailability and Plasma Concentrations under Pharmacokinetics.)

Some patients not responding to 25 mg may benefit from dosages of 37.5 or 50 mg IM every 2 weeks, although dose response for efficacy not established.

Increase dosage at intervals of 4 weeks.

If reinitiating IM risperidone after a drug-free period, administration of oral risperidone (or another antipsychotic agent) for supplementation will be needed.

Bipolar Disorder

Acute Manic or Mixed Episodes

Oral

Initially 2–3 mg once daily.

Adjust dosage, if indicated, in increments or decrements of 1 mg daily at intervals of not less than 24 hours.

Antimanic efficacy demonstrated in dosage range of 1–6 mg daily; dosages >6 mg daily not studied.

Not studied >3 weeks. If elect to use risperidone for extended periods, periodically reevaluate long-term risks and benefits for the individual patient.

Prescribing Limits

Adults

Schizophrenia

Oral

Dosages >6 mg (in 2 divided doses) generally not recommended; safety of dosages >16 mg daily not established.

IM

Maximum 50 mg every 2 weeks.

Bipolar Disorder

Acute Manic or Mixed Episodes

Oral

Safety and efficacy of dosages >6 mg not established.

Special Populations

Dosage in Hepatic Impairment

Oral: Initially, 0.5 mg twice daily in patients with severe hepatic impairment; increase dosage in increments of ≤0.5 mg twice daily. If increase in dosage beyond 1.5 mg twice daily is planned, adjust at intervals of at least 1 week; slower titration may be appropriate in some patients.

IM: Titrate oral therapy prior to initiation of IM therapy in patients with hepatic impairment; if an oral dosage of ≥2 mg daily is well tolerated, administer 25 mg IM every 2 weeks. Administer oral risperidone with the first IM risperidone injection and continue oral supplementation for 3 weeks thereafter.

Dosage in Renal Impairment

Oral: Initially, 0.5 mg twice daily in patients with severe renal impairment; increase dosage in increments of ≤0.5 mg twice daily. If increase in dosage beyond 1.5 mg twice daily is planned, adjust at intervals of at least 1 week; slower titration may be appropriate in some patients.

IM: Titrate oral therapy prior to initiation of IM therapy in patients with renal impairment; if an oral dosage of ≥2 mg daily is well tolerated, administer 25 mg IM every 2 weeks. Administer oral risperidone with first IM risperidone injection and continue oral supplementation for 3 weeks thereafter.

Geriatric, Debilitated, or Hypotensive Patients

Oral: Initially, 0.5 mg twice daily in geriatric or debilitated patients and patients either predisposed to hypotension or for whom hypotension would pose a risk; increase dosage in increments of ≤0.5 mg twice daily. If increase in dosage beyond 1.5 mg twice daily is planned, adjust at intervals of at least 1 week; slower titration may be appropriate in some patients. If a once-daily dosage regimen is considered, titrate on a twice-daily regimen for 2–3 days at the target dosage before switching to a once-daily regimen.

Alternatively, in geriatric patients, initially give 0.25 mg daily; gradually increase dosage as tolerated.

IM: 25 mg every 2 weeks in otherwise healthy geriatric patients. Administer oral risperidone with the first IM risperidone injection and continue oral supplementation for 3 weeks thereafter.