Invega

Invega

paliperidone

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Paliperidone
Indications/Uses
Treatment of schizophrenia. Treatment of schizoaffective disorder as monotherapy or adjunct to mood stabilizers &/or antidepressants.
Dosage/Direction for Use
Schizophrenia Adult 6 mg once daily. Dose increases >6 mg/day only after clinical reassessment w/ increments of 3 mg/day at >5 days interval. Recommended range: 3-12 mg once daily. Max: 12 mg/day. Adolescent 12-17 yr 3 mg once daily. Dose increases only after clinical reassessment w/ increments of 3 mg/day at >5 days interval. Schizoaffective disorder Adult 6 mg once daily. Dose increases only after clinical reassessment w/ increments of 3 mg/day at >4 days interval. Recommended range: 3-12 mg once daily. Max: 12 mg/day. Mild renal impairment (CrCl ≥50 to <80 mL/min) 3 mg once daily. Max: 6 mg once daily. Moderate to severe renal impairment (CrCl ≥10 to <50 mL/min) 1.5 mg once daily. Max: 3 mg once daily after clinical reassessment.
Administration
May be taken with or without food: Take consistently either always w/ or always w/o food. Swallow whole, do not divide/chew/crush.
Contraindications
Hypersensitivity to paliperidone & risperidone.
Special Precautions
Increased mortality w/ dementia-related psychosis. Cerebrovascular adverse events, including stroke, in elderly patients w/ dementia-related psychosis. Discontinue if neuroleptic malignant syndrome or tardive dyskinesia occurs. QTc prolongation, patients w/ congenital QT syndrome & history of cardiac arrhythmias. Monitor for symptoms of hyperglycemia, DM & wt gain. Hyperprolactinemia. Potential for GI obstruction, cognitive & motor impairment. Monitor orthostatic vital signs in patients vulnerable to hypotension. Leukopenia, neutropenia & agranulocytosis. History of seizures, risk for venous thromboembolism, at risk of aspiration pneumonia & Parkinson's disease or dementia w/ Lewy bodies. Close supervision of patients w/ high risk of suicide. Priapism. Thrombotic thrombocytopenic purpura (TTP). Intraoperative floppy iris syndrome. Conditions that contribute to core body temp elevation or dehydration. May impair ability to drive or operate machinery. Pregnancy & lactation. Elderly & childn.
Adverse Reactions
Cerebrovascular adverse events including stroke. Neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia, hyperglycemia & DM. Hyperprolactinemia, orthostatic hypotension & syncope. Leukopenia, neutropenia & agranulocytosis. Seizures, dysphagia, suicide attempt, priapism, TTP. Disruption of body temp regulation. Antiemetic effect. Adult EPS, tachycardia, akathisia, somnolence, dyspepsia, constipation, increased wt & nasopharyngitis. Adolescents EPS, somnolence, akathisia, headache, increased wt & tachycardia.
Drug Interactions
Centrally-acting drugs & alcohol. May antagonize effect of levodopa & other dopamine agonists. Additive effect w/ drugs w/ hypotensive effects. Decreased Cmax & AUC w/ carbamazepine. Increased exposure to metabolizers w/ paroxetine. Increased Cmax & AUC w/ divalproex.
MIMS Class
ATC Classification
N05AX13 - paliperidone ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Invega ER tab 9 mg
Packing/Price
28's
Form
Invega ER tab 3 mg
Packing/Price
28's
Form
Invega ER tab 6 mg
Packing/Price
28's
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