Modesto XR 6 POT

Indications

Modesto XR Extended Release Tablet is indicated for:

• Schizophrenia: For the acute treatment and prevention of recurrence.
• Schizoaffective Disorder: Effective as monotherapy or in combination with antidepressants or mood stabilizers.

Use only under the guidance of a registered healthcare provider.

Pharmacology

Paliperidone, the active ingredient in Modesto XR, is a psychotropic medication belonging to the benzisoxazole class. It is the primary metabolite of Risperidone and functions as a potent dopamine D2 antagonist with strong serotonin 5-HT2A antagonist activity. Additionally, it blocks α1 and α2 adrenergic receptors and H1 histamine receptors, contributing to its therapeutic effects. Paliperidone does not interact with cholinergic muscarinic or β1/β2-adrenergic receptors.

Dosage

Schizophrenia:

• Adults: Initial dose of 6 mg/day, with a recommended range of 3-12 mg/day. Maximum dose is 12 mg/day.
• Adolescents (<51kg): Initial dose of 3 mg/day, with a recommended range of 3-6 mg/day. Maximum dose is 6 mg/day.
• Adolescents (≥51kg): Initial dose of 3 mg/day, with a recommended range of 3-12 mg/day. Maximum dose is 12 mg/day.

Schizoaffective Disorder (Adults):

• Initial dose of 6 mg/day, with a recommended range of 3-12 mg/day. Maximum dose is 12 mg/day.

Always consult a registered healthcare provider before use.

Administration

Modesto XR Extended Release Tablets can be taken with or without food. Swallow the tablet whole with liquid—do not chew, crush, or divide the tablet for optimal effectiveness.

Consult a healthcare provider for personalized guidance.

Drug Interactions

• Centrally acting drugs and alcohol should be used cautiously with Modesto XR.
• May reduce the effectiveness of Levodopa and other dopamine agonists.
• Orthostatic hypotension may be intensified when combined with other drugs that have similar effects.
• Co-administration with strong CYP3A4/P-glycoprotein inducers (e.g., carbamazepine) may require a dose increase. Upon discontinuation, the dose of Modesto XR may need to be reduced.
• Combining with divalproex sodium may increase Modesto XR‘s plasma concentration by approximately 50%, necessitating possible dose adjustments based on clinical assessment.

Side Effects

Common side effects of Modesto XR include:

• Tachycardia, akathisia, somnolence, tremors, dystonia, cogwheel rigidity, anxiety, weight gain, dyspepsia, constipation, and nasopharyngitis.

Pregnancy & Lactation

Pregnancy Category C: Adequate studies are lacking in pregnant women. Paliperidone should only be used during pregnancy if the potential benefits outweigh the risks to the fetus.

Lactation: Paliperidone is excreted in human breast milk. Weigh the benefits of breastfeeding against the potential risks to the infant.

Precautions & Warnings

Exercise caution when prescribing Modesto XR to patients with:

• Cardiovascular diseases, QT prolongation, neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia, dyslipidemia, obesity, hyperprolactinemia, leukopenia, neutropenia, agranulocytosis, seizures, and cognitive & motor impairments.

Use in Special Populations

• Pediatric Use: Safety and efficacy for treating schizophrenia have not been established for children under 12. Similarly, schizoaffective disorder has not been studied in those under 18.

Overdose Effects

In the event of an overdose, there is no specific antidote for Modesto XR. Supportive and symptomatic treatment should be employed.

Therapeutic Class

Atypical neuroleptic drugs

Storage Conditions

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