RISPERDAL ORAL SOLUTION

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Generic Name for RISPERDAL ORAL SOLUTION Risperidone 1mg/mL. Legal Classification: Rx Pharmacological Class for RISPERDAL ORAL SOLUTION Benzisoxazole. Manufacturer of RISPERDAL ORAL SOLUTION Janssen Pharmaceutica Products, LP

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 1 disorder, or in combination with lithium or valproate in adults. Irritability associated with autistic disorder in children/adolescents (5–16yrs old).

Adult dose for RISPERDAL ORAL SOLUTION

Initially 2–3mg once daily; may adjust at intervals of at least 24 hours 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's dosing for RISPERDAL ORAL SOLUTION

Bipolar mania: <10yrs: not recommended. ≥10yrs: Initially 0.5mg once daily (AM or PM); may adjust at intervals of at least 24 hours by 0.5mg or 1mg/day to target dose of 2.5mg/day. Usual range: 0.5–6mg/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. 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.

Also:

Precautions for RISPERDAL ORAL SOLUTION

Diabetes risk factors (obtain baseline fasting blood sugar). Monitor for hyperglycemia. Cardio- or cerebrovascular disease. Renal or hepatic dysfunction. Orthostatic hypotension. Pre-existing low WBC count or history of leukopenia/neutropenia: monitor CBC during 1st few months of therapy; discontinue if WBCs decline. Parkinson's disease. Dementia with Lewy bodies. Diseases that affect metabolic or hemodynamic response. History of breast cancer or seizures. Dysphagia. Reevaluate periodically. Monitor for neuroleptic malignant syndrome. May have antiemetic effect. Exposure to extreme temperatures. Suicidal patients. Elderly (not for dementia-related psychosis); consider monitoring renal function and for orthostatic effects. Pregnancy (Cat.C). Nursing mothers: not recommended (do not breastfeed until at least 12 weeks after last injection).

Interactions for RISPERDAL ORAL SOLUTION

Avoid alcohol. Caution with 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 potentiated by cimetidine, ranitidine. May be affected by fluoxetine, paroxetine, others that affect CYP isoenzymes. Monitor valproate.

Adverse Reactions for RISPERDAL ORAL SOLUTION

Headache, somnolence, increased appetite, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary incontinence, increased saliva, constipation, fever, parkinsonism, dystonia, abdominal pain, anxiety, GI upset, dizziness, dry mouth, tremor, rash, akathisia; orthostatic hypotension, tardive dyskinesia, neuroleptic malignant syndrome, hyperprolactinemia, priapism, leukopenia/neutropenia, agranulocytosis, thrombotic thrombocytopenic purpura (rare).

How is RISPERDAL ORAL SOLUTION supplied?

Inj: single-use vial—1 (pack w. diluent, supplies)
Tabs 0.25mg, 0.5mg, 1mg, 2mg, 3mg—60, 500
4mg—60
Oral soln—30mL (w. pipette)
M-Tabs—28

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