Indications

Paliperidone extended release tablet is indicated for- Schizophrenia, including acute treatment and recurrence prevention Treatment of schizoaffective disorder as monotherapy and in combination with antidepressants or mood stabilizers

Composition

Pharmacology

Paliperidone is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. Paliperidone is the major active metabolite of Risperidone. It is a centrally active dopamine Type 2 (D2) antagonist and with predominant serotonin Type 2 (5-HT2A) antagonist activity. It is also active as an antagonist at α1 and α2 adrenergic receptors and H1 histaminergic receptors, which may explain some of the other effects of the drug. It has no affinity for cholinergic muscarinic or β1-and β2-adrenergic receptors.

Dosage & Administration

Schizophrenia : Adults : Initial dose is 6 mg/day. Recommended dose is 3-12 mg/day, Maximum dose is 12 mg/day Adolescents (Weight <51kg) : Initial dose is 3 mg/day, Recommended dose is 3-6 mg/day, Maximum dose is 6 mg/day Adolescents (Weight ≥51kg) : Initial dose is 3 mg/day, Recommended dose is 3-12 mg/day, Maximum dose is 12 mg/day Schizoaffective disorder : adults Initial dose is 6 mg/day. Recommended dose is 3-12 mg/day, Maximum dose is 12 mg/day.

Contraindications

Side Effects

The most common adverse reactions of Paliperidone are tachycardia, akathisia, somnolence, tremor, dystonia, cogwheel rigidity, anxiety, weight increased, dyspepsia, constipation, nasopharyngitis etc.

Pregnancy & Lactation

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.

Precautions & Warnings

Caution should be exercised when Paliperidone is prescribed in patients with known Cardiovascular diseases, QT prolongation, Neuroleptic malignant syndrome, Tardive dyskinesia, Hyperglycemia, Dyslipidemia, Obesity, Hyperprolactinemia, Leukopenia, Neutropenia, Agranulocytosis, Seizures, Potential for Cognitive & Motor impairment etc.

Therapeutic Class

Atypical neuroleptic drugs

Storage Conditions

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