Generic Name and Formulations:
Paliperidone (as palmitate) 39mg, 78mg, 117mg, 156mg, 234mg; ext-rel susp for IM inj.
Janssen Pharmaceuticals, Inc.
Treatment of schizophrenia. Treatment of schizoaffective disorder as monotherapy or as an adjunct to mood stabilizers or antidepressants.
Establish tolerability with oral paliperidone or oral risperidone prior to initiating. Give by deep deltoid IM inj, initially 234mg on Day 1, then 156mg one week later. Maintenance: Give by deep deltoid or gluteal IM inj once monthly. Schizophrenia: 117mg; may increase or decrease in the range of 39–234mg. Schizoaffective: usual range of 78–234mg. Both max: 234mg/month. Renal impairment: CrCl ≥50–<80mL/min: initially 156mg on Day 1, then 117mg one week later, then 78mg monthly; CrCl<50mL/min: not recommended. Missed doses or switching from other antipsychotics: see full labeling.
<18yrs: not established.
Elderly (not for dementia-related psychosis): increased risk of death. Avoid in congenital long QT syndrome, cardiac arrhythmias. Discontinue if neuroleptic malignant syndrome (NMS) occurs; consider discontinuing if tardive dyskinesia occurs. Diabetes risk factors (obtain baseline fasting blood sugar). Cardio- or cerebrovascular disease; risks may be increased due to metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain); monitor. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Monitor for signs/symptoms of infection; discontinue if severe neutropenia (ANC <1000mm3) occurs. Predisposition to hypotension; monitor. Perform fall risk assessments when initiating and recurrently on long-term therapy. Parkinson's disease. Dementia with Lewy bodies. History of seizures. Patients at risk for aspiration pneumonia. Renal impairment. Severe hepatic impairment. Exposure to extreme temperatures. Suicidal patients. Reevaluate periodically. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: not recommended.
Avoid drugs that prolong QT interval (eg, Class 1A and Class III antiarrhythmics, chlorpromazine, thioridazine, gatifloxacin, moxifloxacin). Avoid concomitant strong CYP3A4 and/or P-gp inducers (eg, carbamazepine, rifampin, St. John's Wort); if coadmin necessary, consider oral paliperidone ext-rel tabs. Caution with other CNS drugs, alcohol, drugs that may cause orthostatic hypotension (monitor). May antagonize levodopa, other dopamine agonists. Additive effects with concomitant risperidone or oral paliperidone for long-term use; caution.
Inj site reactions, somnolence/sedation, dizziness, akathisia, extrapyramidal disorder; may cause NMS, tardive dyskinesia, QT prolongation, metabolic changes, orthostatic hypotension, syncope, hyperprolactinemia, priapism.
Kit—1 (prefilled syringe + needles)
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