Monograph Details
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Central Nervous System
> Psychosis
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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 CONSTA
• RISPERDAL ORAL SOLUTION
• RISPERDAL TABLETS
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| Indications |
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Schizophrenia. |
| Children |
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<13yrs: not recommended. ≥13yrs: initially 0.5mg once daily (AM or PM); may adjust at intervals of at least 24 hours by 0.5mg or 1mg per day to target dose of 3mg/day. Usual range: 1–6mg/day; max 6mg/day. If somnolence occurs: give ½ daily dose twice daily. |
| Adults |
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Give once daily or in 2 divided doses. Initially 2mg/day; may adjust at intervals of at least 24 hours 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. |
| 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 response. History of breast cancer or seizures. Dysphagia. Reevaluate periodically. Exclude neuroleptic malignant syndrome if fever occurs. 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 |
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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, 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, priapism. Inj: local reactions. |
| How 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 |
| Additional Resources |
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• Related Prescribing Note |
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