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Check Drug InteractionsAsenapine Prescribing Information
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Asenapine is not approved for the treatment of patients with dementia-related psychosis
[see Warnings and Precautions (5.1, 5.2)].
Asenapine is indicated for:
• Bipolar I disorder
[see Clinical Studies (14.2)]
• Acute monotherapy of manic or mixed episodes, in pediatric patients 10 to 17 years of age
• Adjunctive treatment to lithium or valproate in adults
| | Starting Dose | Recommended Dose | Maximum Dose |
Bipolar mania – pediatric patients (10 to 17 years): monotherapy (2.3) | 2.5 mg sublingually twice daily | 2.5 to 10 mg sublingually twice daily | 10 mg sublingually twice daily |
| Bipolar mania – adults: as an adjunct to lithium or valproate (2.3) | 5 mg sublingually twice daily | 5 to 10 mg sublingually twice daily | 10 mg sublingually twice daily |
• Do not swallow tablet. Asenapine sublingual tablets should be placed under the tongue and left to dissolve completely. The tablet will dissolve in saliva within seconds. Eating and drinking should be avoided for 10 minutes after administration. (2.1, 17)
2.5 mg:
White to off white, round tablets debossed with ‘L’ on one side and ‘70’ on the other side.5 mg:
White to off white, round tablets debossed with “464” on one side and plain on other side.10 mg:
White to off white round tablets debossed with “465” on one side and plain on other side.- Pregnancy:May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. (8.1)
- Pediatric Use:Safety and efficacy in the treatment of bipolar I disorder in patients less than 10 years of age have not been evaluated. (8.4)
Asenapine is contraindicated in patients with:
- Severe hepatic impairment (Child-Pugh C) [see Specific Populations (8.7), Clinical Pharmacology (12.3)].
- A history of hypersensitivity reactions to asenapine. Reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see Warnings and Precautions (5.6), Adverse Reactions (6)].
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available