Generic Name and Formulations:
Risperidone 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg.

Company:
Janssen Pharmaceuticals, Inc.

Indications for RISPERDAL TABLETS:
Monotherapy in adults and children/adolescents (10–17yrs old) for short-term treatment of acute manic or mixed episodes associated with bipolar I disorder, or in combination with lithium or valproate in adults. Irritability associated with autistic disorder in children/adolescents (5–16yrs old).

Adult:
Initially 2–3mg once daily; may adjust at intervals of at least 24hrs by 1mg/day. Usual range: 1–6mg/day; max 6mg/day. Elderly, debilitated, hypotensive, severe renal or hepatic impairment: 0.5mg twice daily; adjust in increments of up to 0.5mg twice daily; titrate at intervals of at least 1 week if exceeding 1.5mg twice daily; may switch to once-daily dosing after titration. For all: re-eva luate periodically; withdraw gradually. Oral soln: do not give with cola, tea. M-Tabs: dissolve on tongue; swallow with or without liquid.

Children:
Bipolar mania: <10yrs: not established. ≥10yrs: Initially 0.5mg once daily (AM or PM); may adjust at intervals of at least 24hrs by 0.5mg–1mg/day to target doses of 1–2.5mg/day. Usual range: 1–6mg/day; max 6mg/day. If somnolence occurs: give ½ daily dose twice daily. Irritability w. autism: <5yrs: not recommended. ≥5yrs: Give as a single daily dose or ½ total daily dose twice daily. <20kg: initially 0.25mg/day; may increase to 0.5mg/day after ≥4 days. Maintain dose for ≥14 days; if no response, may increase at ≥2 week intervals in increments of 0.25mg/day. ≥20kg: initially 0.5mg/day; may increase to 1mg/day after ≥4 days. Maintain dose for ≥14 days; if no response, may increase at ≥2 week intervals in increments of 0.5mg/day. Usual range: 0.5–3mg/day. If somnolence occurs, give once daily dose at bedtime, or ½ daily dose twice daily, or reduce dose. <15kg: use cautiously. For all: re-eva luate periodically.

Warnings/Precautions:
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Discontinue if neuroleptic malignant syndrome (NMS) occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease; increased risk with metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain); monitor. Diabetes risk factors (obtain baseline and periodic fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia: monitor CBCs during 1st few months of therapy; discontinue if WBCs decline. Orthostatic hypotension. History of seizures. Risk of aspiration pneumonia. Exposure to extreme temperatures. Parkinson's disease. Dementia with Lewy bodies. Renal or hepatic dysfunction. Phenylketonuria (M-Tabs). Write ℞ for smallest practical amount. Reeva luate periodically. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
Caution with alcohol, or other CNS drugs. May potentiate antihypertensives. May antagonize levodopa, dopamine agonists. Clearance may be decreased by clozapine; may be increased by carbamazepine, other enzyme inducers (eg, phenytoin, rifampin, phenobarbital); adjust risperidone dose. May be affected by fluoxetine or paroxetine (max risperidone dose: 8mg/day), or others that affect CYP isoenzymes. Monitor valproate.

See Also:
RISPERDAL M-TABS

RISPERDAL ORAL SOLUTION

Pharmacological Class:
Atypical antipsychotic (benzisoxazole deriv.).

Adverse Reactions:
Parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, abdominal pain, dyspepsia, diarrhea, increased saliva, constipation, dry mouth, increased appetite or weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, pharyngolaryngeal pain; orthostatic hypotension, tardive dyskinesia, NMS, hyperprolactinemia, priapism, leukopenia/neutropenia, agranulocytosis.

How Supplied:
Tabs 0.25mg, 0.5mg, 1mg, 2mg, 3mg—60, 500; 4mg—60; Oral soln—30mL (w. pipette); M-Tabs—28
Indications for RISPERDAL TABLETS:
Schizophrenia.

Adult:
Give once daily or in 2 divided doses. Initially 2mg/day; may adjust at intervals of at least 24hrs by 1–2mg/day to target dose of 4–8mg/day. Usual range: 4–16mg/day; max 16mg/day. Elderly, debilitated, hypotensive, severe renal or hepatic impairment: 0.5mg twice daily; adjust in increments of up to 0.5mg twice daily; titrate at intervals of at least 1 week if exceeding 1.5mg twice daily; may switch to once-daily dosing after titration. For all: reassess periodically; withdraw gradually. Oral soln: do not give with cola, tea. M-Tabs: dissolve on tongue; swallow with or without liquid.

Children:
<13yrs: not established. ≥13yrs: initially 0.5mg once daily (AM or PM); may adjust at intervals of at least 24hrs by 0.5mg–1mg/day to target dose of 3mg/day. Usual range: 1–6mg/day; max 6mg/day. If somnolence occurs: give ½ daily dose twice daily.

Warnings/Precautions:
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Discontinue if neuroleptic malignant syndrome (NMS) occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease; increased risk with metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain); monitor. Diabetes risk factors (obtain baseline and periodic fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia: monitor CBCs during 1st few months of therapy; discontinue if WBCs decline. Orthostatic hypotension. History of seizures. Risk of aspiration pneumonia. Exposure to extreme temperatures. Parkinson's disease. Dementia with Lewy bodies. Renal or hepatic dysfunction. Phenylketonuria (M-Tabs). Write ℞ for smallest practical amount. Reeva luate periodically. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
Caution with alcohol, or other CNS drugs. May potentiate antihypertensives. May antagonize levodopa, dopamine agonists. Clearance may be decreased by clozapine; may be increased by carbamazepine, other enzyme inducers (eg, phenytoin, rifampin, phenobarbital); adjust risperidone dose. May be affected by fluoxetine or paroxetine (max risperidone dose: 8mg/day), or others that affect CYP isoenzymes. Monitor valproate.

See Also:
RISPERDAL M-TABS

RISPERDAL ORAL SOLUTION

Pharmacological Class:
Atypical antipsychotic (benzisoxazole deriv.).

Adverse Reactions:
Parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, abdominal pain, dyspepsia, diarrhea, increased saliva, constipation, dry mouth, increased appetite or weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, pharyngolaryngeal pain; orthostatic hypotension, tardive dyskinesia, NMS, hyperprolactinemia, priapism, leukopenia/neutropenia, agranulocytosis.

How Supplied:
Tabs 0.25mg, 0.5mg, 1mg, 2mg, 3mg—60, 500; 4mg—60; Oral soln—30mL (w. pipette); M-Tabs—2