Modesto XR6 mg

Modesto XR 6 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

Modesto XR 6 mg is an atypical antipsychotic developed by Janssen Pharmaceutica. Chemically, Modesto XR 6 mg is primary active metabolite of the older antipsychotic risperidone (Modesto XR 6 mg is 9-hydroxyrisperidone). While its specific mechanism of action is unknown, it is believed Modesto XR 6 mg and risperidone act via similar, if not the same, pathways.Modesto XR 6 mg is the major active metabolite of risperidone. The mechanism of action of Modesto XR 6 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.

Modesto XR 6 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.

Modesto XR 6 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 Modesto XR 6 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 Modesto XR 6 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 Modesto XR 6 mg. Co-administration of divalproex sodium increased Cmax and AUC of Modesto XR 6 mg by approximately 50%. Adjust dose of Modesto XR 6 mg if necessary based on clinical assessment.

Modesto XR 6 mg is contraindicated in patients with a known hypersensitivity to either Modesto XR 6 mg or risperidone, or to any of the excipients in the Modesto XR 6 mg formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with Modesto XR 6 mg. Modesto XR 6 mg is a metabolite of risperidone.

The most common adverse reactions of Modesto XR 6 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 Modesto XR 6 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 Modesto XR 6 mg, when taken near the end of pregnancy, will lead to similar neonatal signs and symptoms.Nursing Mothers: Modesto XR 6 mg is excreted in human breast milk. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to Modesto XR 6 mg.

Caution should be exercised when Modesto XR 6 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 Modesto XR 6 mg is limited; there is no specific antidote to Modesto XR 6 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. Modesto XR 6 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

Modesto XR 6 mg is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. Modesto XR 6 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. Modesto XR 6 mg should be used during pregnancy only if the potential benefits justifies the potential risk to the fetus. Modesto XR 6 mg is excreted in human breast milk. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to Modesto XR 6 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.