RISPERDAL CONSTA Rx

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RISPERDAL CONSTA

Mood disorders
Psychosis
Only 4 drugs may be compared at once

Generic Name and Formulations:

Risperidone 12.5mg, 25mg, 37.5mg, 50mg; per vial; pwd for long-acting IM inj after reconstitution.

Select therapeutic use:

Indications for RISPERDAL CONSTA:

Monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder.

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.

Contraindications:

Hypersensitivity to paliperidone.

Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Discontinue if neuroleptic malignant syndrome (NMS) occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease; increased risk with metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain); monitor. Diabetes risk factors (obtain baseline and periodic fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia: monitor CBCs during 1st few months of therapy; discontinue if WBCs decline. Orthostatic hypotension. History of breast cancer or seizures. Risk of aspiration pneumonia. May have antiemetic effect. Exposure to extreme temperatures. Perform fall risk assessments when initiating and recurrently on long-term therapy. Suicidal tendencies. Parkinson's disease. Dementia with Lewy bodies. Diseases that affect metabolic or hemodynamic responses. Renal or hepatic dysfunction. Reevaluate periodically. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended (do not breastfeed until at least 12 weeks after last injection).

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.

Pharmacological Class:

Atypical antipsychotic.

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, thrombotic thrombocytopenic purpura (rare).

How Supplied:

Single-use vial—1 (pack w. diluent, supplies)

RISPERDAL CONSTA 1 vial of 50mg dose packs (Qty:1)

appx. price $891.00

Indications for RISPERDAL CONSTA:

Schizophrenia.

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.

Contraindications:

Hypersensitivity to paliperidone.

Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Discontinue if neuroleptic malignant syndrome (NMS) occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease; increased risk with metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain); monitor. Diabetes risk factors (obtain baseline and periodic fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia: monitor CBCs during 1st few months of therapy; discontinue if WBCs decline. Orthostatic hypotension. History of breast cancer or seizures. Risk of aspiration pneumonia. May have antiemetic effect. Exposure to extreme temperatures. Perform fall risk assessments when initiating and recurrently on long-term therapy. Suicidal tendencies. Parkinson's disease. Dementia with Lewy bodies. Diseases that affect metabolic or hemodynamic responses. Renal or hepatic dysfunction. Reevaluate periodically. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended (do not breastfeed until at least 12 weeks after last injection).

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.

Pharmacological Class:

Atypical antipsychotic.

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, thrombotic thrombocytopenic purpura (rare).

How Supplied:

Single-use vial—1 (pack w. diluent, supplies)

RISPERDAL CONSTA 1 vial of 50mg dose packs (Qty:1)

appx. price $891.00