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Asenapine

Asenapine is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: Asenapine; Generic name: ASENAPINE; Drug class: Atypical Antipsychotic [EPC].

Brand nameAsenapine
Generic nameASENAPINE
Drug classAtypical Antipsychotic [EPC]
ManufacturerAlembic Pharmaceuticals Inc.
Used for1 INDICATIONS AND USAGE 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 Asenapine is an atypical antipsychotic indicated for ( 1 ): Bipolar I disorder o Acute monotherapy treatment of manic or mixed episodes, in pediatric patients 10 to 17 years of age o Adjunctive treatment to lithium or valproate in adults
Dosage2 DOSAGE AND ADMINISTRATION 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
WarningsWARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS 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)]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementi
Active ingredient(s)ASENAPINE
RouteSUBLINGUAL
Official labelhttps://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=16e1cc9f-7699-49ea-b179-acb65e162304

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