Palimax ER3 mg

Palimax ER 3 mg 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

Atypical neuroleptic drugs

Palimax ER 3 mg is an atypical antipsychotic developed by Janssen Pharmaceutica. Chemically, Palimax ER 3 mg is primary active metabolite of the older antipsychotic risperidone (Palimax ER 3 mg is 9-hydroxyrisperidone). While its specific mechanism of action is unknown, it is believed Palimax ER 3 mg and risperidone act via similar, if not the same, pathways.Palimax ER 3 mg is the major active metabolite of risperidone. The mechanism of action of Palimax ER 3 mg, 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.

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.

Palimax ER 3 mg extended release tablet can be taken with or without food. It must be swallowed whole with the aid of liquids. Tablets should not be chewed, divided or crushed.

Palimax ER 3 mg should be used with caution in combination with other centrally acting drugs and alcohol. It may antagonize the effect of Levodopa and other dopamine agonists. Because of its potential for inducing orthostatic hypotension, an additive effect may be observed when Palimax ER 3 mg is administered with other therapeutic agents that have this potential. Strong CYP3A4/P-glycoprotein (P-gp) inducers: It may be necessary to increase the dose of Palimax ER 3 mg when a strong inducer of both CYP3A4 and P-gp (e.g., carbamazepine) is co-administered. Conversely, on discontinuation of the strong inducer, it may be necessary to decrease the dose of Palimax ER 3 mg. Co-administration of divalproex sodium increased Cmax and AUC of Palimax ER 3 mg by approximately 50%. Adjust dose of Palimax ER 3 mg if necessary based on clinical assessment.

Palimax ER 3 mg is contraindicated in patients with a known hypersensitivity to either Palimax ER 3 mg or risperidone, or to any of the excipients in the Palimax ER 3 mg formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with Palimax ER 3 mg. Palimax ER 3 mg is a metabolite of risperidone.

The most common adverse reactions of Palimax ER 3 mg are tachycardia, akathisia, somnolence, tremor, dystonia, cogwheel rigidity, anxiety, weight increased, dyspepsia, constipation, nasopharyngitis etc.

Pregnancy Category C. There are no adequate and well controlled studies of Palimax ER 3 mg 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 Palimax ER 3 mg, when taken near the end of pregnancy, will lead to similar neonatal signs and symptoms.Nursing Mothers: Palimax ER 3 mg is excreted in human breast milk. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to Palimax ER 3 mg.

Caution should be exercised when Palimax ER 3 mg 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.

Overdose of Palimax ER 3 mg is limited; there is no specific antidote to Palimax ER 3 mg. 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.

Renal Impairment: Dosing must be individualized according to the patient's renal function statusHepatic Impairment: No dosage adjustment is required in patients with mild to moderate hepatic impairment. Palimax ER 3 mg has not been studied in patients with severe hepatic impairment.Elderly: No dosage adjustment is recommended based on age alone. However, dose adjustment may be required because of age-related decreases in creatinine clearance

Atypical neuroleptic drugs

Palimax ER 3 mg is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. Palimax ER 3 mg 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.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Palimax ER 3 mg should be used during pregnancy only if the potential benefits justifies the potential risk to the fetus. Palimax ER 3 mg is excreted in human breast milk. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to Palimax ER 3 mg.

Pediatric use: Safety and effectiveness in the treatment of schizophrenia not established in patients less than 12 years of age. Safety and effectiveness in the treatment of schizoaffective disorder not established in patients less than 18 years of age.