- Active ingredient
- asenapine
- Strength
- 2.5 mg
- Form
- tablet
- Manufacturer
- hikma pharma
- Route
- oral.solid
Uses
Asenapine is an atypical antipsychotic indicated for Bipolar I disorder. It is used as acute monotherapy for manic or mixed episodes in pediatric patients aged 10–17 years, and as adjunctive therapy to lithium or valproate in adults.
Do not use if
Contraindicated in patients with severe hepatic impairment (Child-Pugh C) and in those with a history of hypersensitivity to asenapine, including anaphylaxis, angioedema, and severe skin reactions.
Side effects
Common side effects include somnolence, dizziness, extrapyramidal symptoms, weight gain, and metabolic changes including hyperglycaemia and dyslipidaemia. Oral hypoaesthesia may occur with the sublingual formulation.
Warnings
Elderly patients with dementia-related psychosis treated with antipsychotics face increased mortality risk. Asenapine is not approved for this indication. Monitor for neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes during treatment.
How it works
Asenapine is an atypical antipsychotic with high binding affinity for serotonin (5-HT1A, 5-HT2A, 5-HT2C, 5-HT6, 5-HT7), dopamine (D2, D3, D4), histamine H1, and adrenergic alpha-1 and alpha-2 receptors. Its precise mechanism in bipolar disorder is not fully established.
Storage
Store at controlled room temperature, away from moisture and light. Sublingual tablets should be kept in the original blister packaging until use.