Generic Name and Formulations:
Paliperidone 1.5mg, 3mg, 6mg, 9mg; ext-rel tabs.
Janssen Pharmaceuticals, Inc.
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Indications for INVEGA:
Treatment of schizophrenia in adults and adolescents 12–17yrs of age. Treatment of schizoaffective disorder in adults, as monotherapy or as an adjunct to mood stabilizer and/or antidepressants.
Swallow whole. ≥18yrs: 6mg once daily in AM; may increase in increments of 3mg/day at intervals of >4 days (for schizoaffective disorder) or >5 days (for schizophrenia) if needed. Usual range: 3–12mg/day. Max 12mg/day. Renal impairment: CrCl ≥50–<80mL/min: initially 3mg daily, max 6mg/day; CrCl ≥10–<50mL/min: initially 1.5mg daily, max 3mg/day; CrCl <10mL/min: not recommended.
Swallow whole. Schizoaffective disorder: <18yrs: not studied. Schizophrenia: <12yrs: not established. 12–17yrs: initially 3mg once daily in AM; may increase in increments of 3mg/day at intervals of >5 days if needed. Higher doses of 6mg/day (<51kg) and 12mg/day (≥51kg) may not be beneficial.
Elderly with dementia-related psychosis (not approved use): 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. Orthostatic hypotension. 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 insufficiency. Severe hepatic impairment. Exposure to extreme temperatures. May have antiemetic effect. Suicidal patients. Write ℞ for smallest practical amount. Tabs: Pre-existing severe GI narrowing: not recommended. 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.
Avoid drugs that prolong QT interval (eg, Class 1A and Class III antiarrhythmics, chlorpromazine, thioridazine, gatifloxacin, moxifloxacin). Caution with other CNS drugs, alcohol, drugs that may cause orthostatic hypotension. May be potentiated by divalproex sodium; consider dose reduction. May be antagonized by carbamazepine; adjust dose. May antagonize levodopa, other dopamine agonists. Additive effects with concomitant risperidone; caution.
Extrapyramidal symptoms, akathisia, somnolence, tremor, dystonia, cogwheel rigidity, anxiety, weight gain, tachycardia, dyspepsia, constipation, nasopharyngitis; may cause NMS, tardive dyskinesia, QT prolongation, hyperglycemia, dyslipidemia, orthostatic hypotension, syncope, hyperprolactinemia, priapism.
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