Monograph Details
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Central Nervous System
> Psychosis
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RISPERDAL CONSTA |
| 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 12.5mg, 25mg, 37.5mg, 50mg; per vial; pwd for long-acting IM inj after reconstitution. |
| Also |
• RISPERDAL M-TABS
• RISPERDAL ORAL SOLUTION
• RISPERDAL TABLETS
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| Indications |
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Schizophrenia. |
| Children |
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<18yrs: not recommended. |
| Adults |
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Risperidone-naive: rule out risperidone hypersensitivity before using injection. Give by deep gluteal IM inj; alternate sides. Give with oral risperidone (or other antipsychotic) for 3 weeks, then stop oral form. ≥18yrs: 25mg IM every 2 weeks; may adjust dose every 4 weeks. Max 50mg every 2 weeks. Renal or hepatic impairment: if total daily dose of at least 2mg of oral risperidone tolerated, may give 12.5mg or 25mg IM every 2 weeks. History of poor tolerability to psychotropic drugs or drug interactions that increase risperidone plasma levels (see literature): may use lower initial dose of 12.5mg. |
| 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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