Zukaria 5

• Schizophrenia in adults
• Acute treatment of manic or mixed episodes in bipolar I disorder (adults and pediatric patients 10-17 years)
• Maintenance treatment of bipolar I disorder in adults
• Adjunctive treatment to lithium or valproate in adults

Adults - Schizophrenia: 5 mg sublingually twice daily. May be increased to 10 mg twice daily after one week.

Adults - Bipolar Mania (Monotherapy): 5-10 mg sublingually twice daily.

Adults - Bipolar Mania (Adjunctive): 5 mg sublingually twice daily; may increase to 10 mg twice daily.

Pediatric (10-17 years) - Bipolar Mania: 2.5 mg sublingually twice daily (initial). May increase to 5 mg after 3 days and to 10 mg after 3 more days.

Hepatic Impairment: Moderate impairment: reduce dose by 50%; severe impairment (Child-Pugh C): not recommended.

Renal Impairment: No dose adjustment needed for mild to moderate impairment.

Common Adverse Reactions (≥5% and at least twice placebo):

• Akathisia
• Somnolence
• Oral hypoesthesia/dysgeusia
• Dizziness
• Extrapyramidal symptoms (EPS)
• Nausea
• Increased appetite
• Fatigue
• Weight gain

Serious Adverse Reactions: Neuroleptic malignant syndrome (NMS), tardive dyskinesia, metabolic changes (hyperglycemia, dyslipidemia), orthostatic hypotension, leukopenia, neutropenia, agranulocytosis, seizures.

Serious Precautions:

• Elderly patients with dementia-related psychosis have an increased risk of death; asenapine is not approved for this population.
• If neuroleptic malignant syndrome (NMS) is suspected, discontinue immediately.
• If tardive dyskinesia occurs, discontinue if clinically appropriate.
• Monitor for metabolic changes - regular blood glucose and lipid testing.
• Orthostatic hypotension - caution in patients with cardiovascular or cerebrovascular disease.
• QT prolongation risk - avoid use with drugs that prolong QT interval.
• Caution in patients with a history of seizures.
• Caution when operating machinery - may cause somnolence and cognitive impairment.