Monograph Details
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Central Nervous System
> Mood disorders
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RISPERDAL M-TABS |
| Manufacturer |
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Janssen Pharmaceutica Products, LP |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Benzisoxazole. |
| Generic Name |
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Risperidone 0.5mg, 1mg, 2mg, 3mg, 4mg; orally-disintegrating tabs; contains phenylalanine. |
| Also |
• RISPERDAL ORAL SOLUTION
• RISPERDAL TABLETS
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| Indications |
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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). |
| Children |
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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. |
| Adults |
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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. |
| Precautions |
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Diabetes risk factors (obtain baseline fasting blood sugar). Monitor for hyperglycemia. Cardio- or cerebrovascular disease. Renal or hepatic dysfunction. Orthostatic hypotension. Diseases that affect metabolic or hemodynamic responses. History of breast cancer or seizures. Dysphagia. Reevaluate periodically. Exclude neuroleptic malignant syndrome if fever occurs. May have antiemetic effect. Exposure to temperature extremes. Suicidal patients. Elderly; consider monitoring renal function and for orthostatic effects. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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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 affected by fluoxetine, paroxetine, others that affect CYP isoenzymes. Monitor valproate. |
| Adverse Reactions |
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Anxiety, somnolence, extrapyramidal symptoms, dizziness, constipation, GI upset, dry mouth, rhinitis, rash, tachycardia, insomnia, increased dreams, longer sleep, visual or micturition disturbances, increased salivation, weight gain, hyperglycemia, menorrhagia, myalgia, decreased libido; erectile, ejaculatory, and/or orgastic dysfunction; may cause tardive dyskinesia, neuroleptic malignant syndrome; elderly with dementia: cerebrovascular events (eg, stroke, TIA), increased mortality; cognitive and/or motor impairment, orthostatic hypotension, hyperprolactinemia (esp. in children), priapism; also children: upper respiratory tract infection, increased appetite, fatigue. |
| How Supplied |
Tabs 0.25mg, 0.5mg, 1mg, 2mg, 3mg—60, 500
4mg—60
Oral soln—30mL (w. pipette)
M-Tabs—28 |
| Additional Resources |
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• Related Prescribing Note |
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