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Risperdal Consta Generic Name & Formulations
Legal Class
Rx
General Description
Risperidone 12.5mg, 25mg, 37.5mg, 50mg; per vial; pwd for long-acting IM inj after reconstitution.
Pharmacological Class
Atypical antipsychotic.
How Supplied
Single-use vial—1 (pack w. diluent, supplies)
Manufacturer
Risperdal Consta Indications
Indications
Monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder.
Risperdal Consta Dosage and Administration
Adult
Risperidone-naive: rule out risperidone hypersensitivity before using injection. Give by deep deltoid or 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 full labeling): may use lower initial dose of 12.5mg.
Children
<18yrs: not established.
Risperdal Consta Contraindications
Contraindications
Hypersensitivity to paliperidone.
Risperdal Consta Boxed Warnings
Boxed Warning
Increased mortality in elderly patients with dementia-related psychosis.
Risperdal Consta Warnings/Precautions
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. 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 breast cancer or seizures. Patients at risk for aspiration pneumonia. Exposure to extreme temperatures. Suicidal tendencies. Parkinson's disease. Dementia with Lewy bodies. Renal or hepatic impairment: titrate cautiously. 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 Consta Pharmacokinetics
See Literature
Risperdal Consta Interactions
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 potentiated by cimetidine, ranitidine. May be affected by fluoxetine, paroxetine, others that affect CYP isoenzymes. Monitor valproate. Monitor for extrapyramidal symptoms when concomitant methylphenidate.
Risperdal Consta Adverse Reactions
Adverse Reactions
Headache, parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight gain, pain in extremity, dry mouth, tremor, agitation, depression, anxiety; orthostatic hypotension, tardive dyskinesia, NMS, hyperprolactinemia, priapism, leukopenia/neutropenia, agranulocytosis.
Risperdal Consta Clinical Trials
See Literature
Risperdal Consta Note
Not Applicable
Risperdal Consta Patient Counseling
See Literature
Risperdal Consta Generic Name & Formulations
Legal Class
Rx
General Description
Risperidone 12.5mg, 25mg, 37.5mg, 50mg; per vial; pwd for long-acting IM inj after reconstitution.
Pharmacological Class
Atypical antipsychotic.
How Supplied
Single-use vial—1 (pack w. diluent, supplies)
Manufacturer
Risperdal Consta Indications
Indications
Schizophrenia.
Risperdal Consta Dosage and Administration
Adult
Risperidone-naive: rule out risperidone hypersensitivity before using injection. Give by deep deltoid or 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 full labeling): may use lower initial dose of 12.5mg.
Children
<18yrs: not established.
Risperdal Consta Contraindications
Contraindications
Hypersensitivity to paliperidone.
Risperdal Consta Boxed Warnings
Boxed Warning
Increased mortality in elderly patients with dementia-related psychosis.
Risperdal Consta Warnings/Precautions
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. 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 breast cancer or seizures. Patients at risk for aspiration pneumonia. Exposure to extreme temperatures. Suicidal tendencies. Parkinson's disease. Dementia with Lewy bodies. Renal or hepatic impairment: titrate cautiously. 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 Consta Pharmacokinetics
See Literature
Risperdal Consta Interactions
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 potentiated by cimetidine, ranitidine. May be affected by fluoxetine, paroxetine, others that affect CYP isoenzymes. Monitor valproate. Monitor for extrapyramidal symptoms when concomitant methylphenidate.
Risperdal Consta Adverse Reactions
Adverse Reactions
Headache, parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight gain, pain in extremity, dry mouth, tremor, agitation, depression, anxiety; orthostatic hypotension, tardive dyskinesia, NMS, hyperprolactinemia, priapism, leukopenia/neutropenia, agranulocytosis.
Risperdal Consta Clinical Trials
See Literature
Risperdal Consta Note
Not Applicable
Risperdal Consta Patient Counseling
See Literature
