Clinical Pharmacology Details


PALIPERIDONE


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Indications & Dose:

Maintenance in schizophrenia in patients previously responsive to paliperidone or risperidone



Adult: 150 mg for 1 dose on day 1, then 100 mg for 1 dose on day 8, to be injected into the deltoid muscle, dose subsequently adjusted at monthly intervals according to response; maintenance 75 mg once a month, alternatively maintenance 25– 150 mg once a month, following the second dose, monthly maintenance doses can be administered into either the deltoid or gluteal muscle, for missed doses see product literature


Schizophrenia


Psychotic or manic symptoms of schizoaffective disorder



Adult: 6 mg once daily, dose to be taken in the morning, then adjusted in steps of 3 mg if required, dose to be adjusted over at least 5 days; usual dose 3–12 mg daily 

Contraindications:

Known hypersensitivity to paliperidone, risperidone, or to any excipients in Paliperidone . 

Side Effects:

Cautions:

Precautions:

Interaction:


IPALIPERIDONE 

Warnings:

• Cerebrovascular Adverse Reactions: An increased incidence of cerebrovascular adverse reactions (e.g. stroke, transient ischemic attack, including fatalities) has been seen in elderly patients with dementiarelated psychoses treated with atypical antipsychotics.


• Neuroleptic Malignant Syndrome: Manage with immediate discontinuation of drug and close monitoring.


• QT Prolongation: Increase in QT interval, avoid use with drugs that also increase QT interval and in patients with risk factors for prolonged QT interval.


• Tardive Dyskinesia: Discontinue drug if clinically appropriate 


• Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk.


These metabolic changes include hyperglycemia, dyslipidemia, and weight gain. Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes  Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.   Weight Gain: Significant weight gain has been reported. Monitor weight gain. 


 • Hyperprolactinemia: Prolactin elevations occur and persist during chronic administration. (5.7)


• Gastrointestinal Narrowing: Obstructive symptoms may result in patients with gastrointestinal disease.


• Orthostatic Hypotension and Syncope: Use with caution in patients with known cardiovascular or cerebrovascular disease and patients predisposed to hypotension.


• Leukopenia, Neutropenia, and Agranulocytosis: has been reported with antipsychotics, including Paliperidone Patients with a history Suicide: Closely supervise high-risk patients

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Commo


• Adults with schizophrenia: extrapyramidal symptoms, tachycardia, and akathisia.


• Adolescents with schizophrenia: somnolence, akathisia, tremor, dystonia, cogwheel rigidity, anxiety, weight increased, and tachycardia.


• Adults with schizoaffective disorder: extrapyramidal symptoms, somnolence, dyspepsia, constipation, weight increased, and nasopharyngitis.

Patient And Carer Advice: