Siznil Tablet

Siznil is indicated for-

• Schizophrenia
• Bipolar disorder
• Adjunctive treatment of major depressive disorder
• Irritability associated with autistic disorder
• Agitation associated with schizophrenia or bipolar mania

Aripiprazole is an atypical antipsychotic and it has been proposed that the efficacy of Aripiprazole is mediated through a combination of partial agonist activity at Dopamine D2 and Serotonin 5-HT 1A receptors and antagonist activity at Serotonin 5-HT 2A receptors. This is associated with improvement of schizophrenia, bipolar disorder, major depressive disorder, irritability associated with autistic disorder, and agitation associated with schizophrenia or bipolar disorder.

Schizophrenia: adults

• Initial Dose: 10-15 mg/day
• Recommended Dose: 10-15 mg/day
• Maximum Dose: 30 mg/day

Schizophrenia: adolescents (ages 13-17 years)

• Initial Dose: 2 mg/day
• Recommended Dose: 10 mg/day
• Maximum Dose: 30 mg/day

Bipolar mania: adults: monotherapy

• Initial Dose: 15 mg/day
• Recommended Dose: 15 mg/day
• Maximum Dose: 30 mg/day

Bipolar mania: adults: adjunct to lithium or valproate

• Initial Dose: 10-15 mg/day
• Recommended Dose: 15 mg/day
• Maximum Dose: 30 mg/day

Bipolar mania: pediatric patients (ages 10-17 years): monotherapy or as an adjunct to lithium or valproate

• Initial Dose: 2 mg/day
• Recommended Dose: 10 mg/day
• Maximum Dose: 30 mg/day

As an adjunct to antidepressants for the treatment of major depressive disorder: adults

• Initial Dose: 2-5 mg/day
• Recommended Dose: 5-10 mg/day
• Maximum Dose: 15 mg/day

Irritability associated with autistic disorder: pediatric patients (ages 6-17 years):

• Initial Dose: 2 mg/day
• Recommended Dose: 5-10 mg/day
• Maximum Dose: 15 mg/day

Oral formulations: Administer once daily without regard to meals.
IM injection: Wait at least 2 hours between doses. Maximum daily dose 30 mg.

Caution should be exercised when Siznil is taken in combination with other centrally acting drugs and alcohol. Carbamazepine could cause an increase in Siznil clearance and lower blood levels. Ketoconazole, quinidine, fluoxetine or paroxetine can inhibit Siznil elimination and cause increased blood levels.

Known hypersensitivity to Aripiprazole.

Vomiting, nausea, akathisia, extrapyramidal disorder, somnolence, sedation, dizziness, insomnia, tremor, restlessness, fatigue, blurred vision, salivary hypersecretion, constipation, pyrexia, drooling, decreased appetite.

Pregnancy category C. It should be avoided during pregnancy. It is recommended that women receiving Aripiprazole should not breast-feed.

Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse events (eg, stroke, transient ischemic attack, including fatalities).

Suicidality & antidepressants: Increased risk of suicidality in children, adolescents, young and adults with major depressive disorder.

Tardive dyskinesia: Discontinue if clinically appropriate.

Metabolic changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain.

Orthostatic hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease.

Seizures/Convulsions: Use cautiously in patients with a history of seizures.

Use caution when operating machinery.

Siznil at doses up to 1080 mg causes no fatalities. The signs and symptoms observed with Siznil overdose included nausea, vomiting, asthenia, diarrhea, and somnolence.

Atypical neuroleptic drugs

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.