Select therapeutic use:

Mood disorders:

Indications for RISPERDAL ORAL SOLUTION:

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 (5–17yrs old).

Adult Dosage:

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-evaluate periodically; withdraw gradually. Oral soln: do not give with cola, tea. M-Tabs: dissolve on tongue; swallow with or without liquid.

Children Dosage:

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-evaluate periodically.

RISPERDAL ORAL SOLUTION Contraindications:

Hypersensitivity to paliperidone.

Boxed Warning:

Increased mortality in elderly patients with dementia-related psychosis.

RISPERDAL ORAL SOLUTION Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Discontinue immediately if neuroleptic malignant syndrome (NMS) is suspected occurs. Consider discontinuation if tardive dyskinesia occurs. Cardio- or cerebrovascular disease; risks may be increased due to metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain); monitor. Conditions that predispose to hypotension (eg, dehydration, hypovolemia). Diabetes risk factors (obtain baseline and periodic fasting blood sugar). Perform fall risk assessments when initiating and recurrently on long-term therapy (esp. in elderly). History of significant low WBC/ANC or drug-induced leukopenia/neutropenia; obtain CBCs frequently during 1st few months of treatment; consider discontinuation if significant decline in WBC. Monitor for signs/symptoms of infection in those with neutropenia; discontinue if severe (ANC <1000mm3) and follow WBC until recovery. History of seizures. Patients at risk for 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. Reevaluate periodically. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: monitor infants.

RISPERDAL ORAL SOLUTION Classification:

Atypical antipsychotic.

RISPERDAL ORAL SOLUTION 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. Monitor for extrapyramidal symptoms when concomitant methylphenidate.

Adverse Reactions:

Parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, 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

Psychosis:

Indications for RISPERDAL ORAL SOLUTION:

Schizophrenia.

Adult Dosage:

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 Dosage:

<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.

RISPERDAL ORAL SOLUTION Contraindications:

Hypersensitivity to paliperidone.

Boxed Warning:

Increased mortality in elderly patients with dementia-related psychosis.

RISPERDAL ORAL SOLUTION Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Discontinue immediately if neuroleptic malignant syndrome (NMS) is suspected occurs. Consider discontinuation if tardive dyskinesia occurs. Cardio- or cerebrovascular disease; risks may be increased due to metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain); monitor. Conditions that predispose to hypotension (eg, dehydration, hypovolemia). Diabetes risk factors (obtain baseline and periodic fasting blood sugar). Perform fall risk assessments when initiating and recurrently on long-term therapy (esp. in elderly). History of significant low WBC/ANC or drug-induced leukopenia/neutropenia; obtain CBCs frequently during 1st few months of treatment; consider discontinuation if significant decline in WBC. Monitor for signs/symptoms of infection in those with neutropenia; discontinue if severe (ANC <1000mm3) and follow WBC until recovery. History of seizures. Patients at risk for 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. Reevaluate periodically. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: monitor infants.

RISPERDAL ORAL SOLUTION Classification:

Atypical antipsychotic.

RISPERDAL ORAL SOLUTION 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. Monitor for extrapyramidal symptoms when concomitant methylphenidate.

Adverse Reactions:

Parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, 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