Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Uzedy Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose kit—1 (w. supplies)
Manufacturer
Generic Availability
NO
Mechanism of Action
The mechanism of action of risperidone, in schizophrenia, is unclear. The drug’s therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptor antagonism.
Uzedy Indications
Indications
Schizophrenia.
Uzedy Dosage and Administration
Adult
Must be administered by a healthcare professional. Give by SC inj in the abdomen or upper arm only. Risperidone-naive: establish tolerability with oral risperidone prior to starting. Initiate as once monthly (50mg, 75mg, 100mg, 125mg) or once every 2 months (100mg, 150mg, 200mg, 250mg) inj, the day after last dose of oral risperidone: see full labeling. Renal or hepatic impairment: titrate with oral risperidone up to ≥2mg/day; if dose tolerated and is psychiatrically stable, may consider 50mg monthly. Concomitant strong CYP2D6 inhibitors (eg, fluoxetine, paroxetine): give lower dose of Uzedy before starting inhibitor; continue with 50mg once monthly or 100mg once every 2 months unless treatment interruption is necessary. Concomitant strong CYP3A4 inducers (eg, rifampin, cabamazepine, phenytoin, phenobarbital): monitor closely during first 4–8 weeks; consider increasing dose or additional oral risperidone. Re-evaluate and decrease Uzedy or any oral risperidone dose when discontinuing strong CYP3A4 inducers; for those treated with Uzedy 50mg once monthly or 200mg once every 2 months, continue with these doses unless treatment interruption is necessary.
Children
Not established.
Uzedy Contraindications
Contraindications
Hypersensitivity to paliperidone.
Uzedy Boxed Warnings
Boxed Warning
Uzedy Warnings/Precautions
Warnings/Precautions
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Discontinue immediately and treat appropriately if neuroleptic malignant syndrome (NMS) is suspected; monitor. Consider discontinuing if tardive dyskinesia occurs. Monitor for metabolic changes that may increase cardio- or cerebrovascular risk (eg, hyperglycemia, dyslipidemia, weight gain). Diabetes risk factors (eg, obesity, family history); obtain baseline and periodic fasting blood glucose. Pre-existing low WBCs or history of leukopenia/neutropenia: monitor CBCs during 1st few months of therapy; discontinue if WBCs decline <1000/mm3. Known cardio- or cerebrovascular disease, other conditions (eg, dehydration, hypovolemia), elderly, renal or hepatic impairment: monitor orthostatic vital signs and consider dose reduction if hypotension occurs. Perform fall risk assessments when initiating and recurrently on long-term therapy. History of seizures or conditions that can lower the seizure threshold. Risk of aspiration pneumonia. Parkinson disease or dementia with Lewy bodies. Strenuous exercise. Exposure to extreme temperatures. Re-evaluate periodically. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: monitor infants.
Uzedy Pharmacokinetics
Absorption
-
All Uzedy doses showed 2 absorption peaks for risperidone in plasma.
-
Median time to peak plasma concentration for risperidone and 9-hydroxyrisperidone combined ranges from 8 to 14 days. Therapeutic plasma concentrations are within 6 to 24 hours.
Distribution
-
Volume of distribution: 1 to 2 L/kg.
-
~90% plasma protein bound (risperidone); 77% plasma protein bound (9-hydroxyrisperidone).
Elimination
-
Renal (70%), fecal (14%).
-
Half-life: 14–22 days.
Uzedy Interactions
Interactions
See Adults. May be potentiated by strong CYP2D6 inhibitors (eg, paroxetine, fluoxetine). May be antagonized by strong CYP3A4 inducers (eg, rifampin, cabamazepine, phenytoin, phenobarbital). May potentiate antihypertensives. May antagonize levodopa, dopamine agonists. Additive effects with centrally-acting drugs, alcohol; caution. Increased risk for extrapyramidal symptoms (EPS) with methylphenidate; monitor.
Uzedy Adverse Reactions
Adverse Reactions
Parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, pharyngolaryngeal pain, pruritus, nodule; NMS, tardive dyskinesia, hyperprolactinemia, orthostatic hypotension, leukopenia/neutropenia, agranulocytosis, potential cognitive/motor impairment, dysphagia, seizure, priapism.
Uzedy Clinical Trials
See Literature
Uzedy Note
Notes
Register patients in National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.
Uzedy Patient Counseling
See Literature
