Uses of Palimax ER 3: - Schizophrenia - Mania Schizophrenia, Schizoaffective Disorder Hypersensitivity to paliperidone or risperidone.

Atypical neuroleptic drugs

Paliperidone is an atypical antipsychotic developed by Janssen Pharmaceutica. Chemically, paliperidone is primary active metabolite of the older antipsychotic risperidone (paliperidone is 9-hydroxyrisperidone). While its specific mechanism of action is unknown, it is believed paliperidone and risperidone act via similar, if not the same, pathways.Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone, as with other drugs having efficacy in schizophrenia, is unknown, but it has been proposed that the drug's therapeutic activity in schizophrenia is mediated through a combination of central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptor antagonism.

How to use Paliperidone: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Paliperidone may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food Adult Dose: Oral Schizophrenia Adult: Initially, 6 mg once daily in the morning. May be titrated upward or downward in increments of 3 mg/day at intervals >5 days; not to exceed 12 mg/day Schizoaffective Disorder Indicated for schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers or antidepressants 6 mg PO qDay in am (range 3-12 mg); titration may not be necessary; if exceeding 6 mg/day, increases of 3 mg/day recommended at intervals of 4 days of more; not to exceed 12 mg/day Child Dose: Schizophrenia <12 years: Safety and efficacy not established >12 years (<51 kg): 3 mg/day PO initially; may be increased if necessary in increments of 3 mg/day at intervals ?5 days; not to exceed 6 mg/day >12 years (>51 kg): 3 mg/day PO initially; may be increased if necessary in increments of 3 mg/day at intervals ?5 days; not to exceed 12 mg/day Schizoaffective Disorder <18 years: Safety and efficacy not established Renal Dose: Renal impairment CrCl 50-79 mL/min: 3 mg/day initially; not to exceed 6 mg/day CrCl 10-49 mL/min: 1.5 mg/day initially; not to exceed 3 mg/day CrCl <10 mL/min: Not recommended

Increased risk of QT prolongation w/ class IA (e.g. quinidine, disopyramide) and class III (e.g. amiodarone, sotalol) antiarrhythmics. Additive effects w/ drugs that cause orthostatic hypotension (e.g. other antipsychotics, tricyclics). May antagonise actions of levodopa and other dopaminergics. Additive effect w/ drugs known to lower seizure threshold (e.g. phenothiazines or butyrophenones, clozapine, tricyclics or SSRIs, tramadol, mefloquine). May reduce plasma levels w/ carbamazepine. Enhanced central effects w/ other CNS depressants. May increase plasma levels w/ valproate. May affect the absorption w/ metoclopramide.

Hypersensitivity to paliperidone or risperidone.

Common - Abnormal involuntary movements - Dizziness - Nystagmus (involuntary eye movement) - Sleepiness - Tremor >10% Akathisia,Somnolence,Insomnia,Parkinsonism,Tachycardia,Hyperprolactinemia,Others similar to placebo (eg, headache) <10% (selected) Cough,Dystonia,Extrapyramidal symptoms (EPS),Orthostatic hypotension,QT prolongation,Sialorrhea,Priapism,Weight gain,Constipation,Indigestion,Amenorrhea,Galactorrhea,Nausea,Dyspepsia,Salivation,Xerostomia,Myalgia,Extremity pain,Nasopharyngitis

Pregnancy Category C. There are no adequate and well controlled studies of Paliperidone in pregnant women.Use of first generation antipsychotic drugs during the last trimester of pregnancy has been associated with extrapyramidal symptoms in the neonate. These symptoms are usually self- limited. It is not known whether paliperidone, when taken near the end of pregnancy, will lead to similar neonatal signs and symptoms.Nursing Mothers: Paliperidone is excreted in human breast milk. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to paliperidone.

Precaution: Patient w/ known CV disease or family history of QT prolongation, history of seizures or other conditions that potentially lower the seizure threshold, predisposition to GI obstruction, possible prolactin-dependent tumours, Parkinson's disease. Cataract surgery. Elderly w/ dementia-related psychosis and risk factors for stroke. Renal impairment. Pregnancy and lactation. Patient Counselling This drug may cause somnolence and impairment of judgment, thinking or motor skills, if affected, avoid driving, operating machinery or performing hazardous tasks. Monitoring Parameters Monitor mental status changes, vital signs, wt, BP, electrolyte, renal and hepatic function. Closely monitor for worsening glucose control in patients w/ pre-existing DM. Lactation: Drug excreted in breast milk; do not nurse

Overdose of Paliperidone is limited; there is no specific antidote to Paliperidone. If overdose occurs general supportive and symptomatic measures should be employed.

Store in a cool and dry place, away from light. Keep out of reach of children.

Atypical neuroleptic drugs

Major metabolite of risperidone; improves negative symptoms of psychoses and reduces incidence of EPS Has high affinity for serotonin type 2 (5-HT2) receptors; binds to dopamine D2 receptors with 20 times lower affinity than that for 5-HT2 receptors; antagonizes alpha1-adrenergic, alpha2-adrenergic, and histaminergic receptors; has moderate affinity for serotonin type 1 (5-HT1C, 5-HT1D, 5-HT1A) receptors; has weak affinity for dopamine D1 receptors; has no affinity for muscarinic, beta1-adrenergic, and beta2-adrenergic receptors

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Paliperidone should be used during pregnancy only if the potential benefits justifies the potential risk to the fetus. Paliperidone is excreted in human breast milk. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to Paliperidone.