Asenapine
Class: Atypical Antipsychotics
VA Class: CN709
Chemical Name: (3aRS,12bRS)-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1)
Molecular Formula: C17H16ClNO•C4H4O4
CAS Number: 85650-56-2
Brands: Saphris
Warning
- Increased Mortality in Geriatric Patients with Dementia-related Psychosis
Geriatric patients with dementia-related psychosis treated with antipsychotic agents are at an increased risk of death.
Asenapine is not approved for the treatment of patients with dementia-related psychosis. (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)
Introduction
Dibenzo-oxepino pyrrole derivative; atypical or second-generation antipsychotic agent.
Uses for Asenapine
Schizophrenia
Acute and maintenance treatment of schizophrenia in adults.
American Psychiatric Association (APA) considers most atypical antipsychotic agents first-line drugs for management of the acute phase of schizophrenia (including first psychotic episodes).
Patients who do not respond to or tolerate one drug may be successfully treated with an agent from a different class or with a different adverse effect profile.
Bipolar Disorder
Acute treatment as monotherapy or adjunctive therapy with lithium or valproate of manic or mixed episodes associated with bipolar I disorder (with or without psychotic features).
Maintenance treatment as monotherapy of bipolar I disorder.
Asenapine Dosage and Administration
Administration
Sublingual Administration
Administer tablets sublingually twice daily.
Do not remove sublingual tablet from blister pack until just prior to administration. With dry hands, pull blister pack out of case and peel back colored tab to expose the tablet; do not push tablet through blister pack. Gently remove tablet and place under the tongue, then allow to dissolve completely (usually takes about 10 seconds).
Do not eat or drink for 10 minutes following administration. Do not split, crush, chew, or swallow the sublingual tablets. (See Food and Water under Pharmacokinetics.)
Dosage
Available as asenapine maleate; dosage expressed in terms of asenapine.
Pediatric Patients
Bipolar Disorder
Manic and Mixed Episodes: Monotherapy
SublingualChildren and adolescents 10–17 years of age: Initially, 2.5 mg twice daily. Recommended target dosage is 2.5–10 mg twice daily. Based on individual patient response and tolerability, may increase to 5 mg twice daily after 3 days and then to 10 mg twice daily after 3 additional days. Carefully titrate dosage to reduce risk of dystonia. (See Pediatric Use under Cautions.) Safety of dosages >10 mg twice daily not evaluated.
Adults
Schizophrenia
Sublingual
For acute treatment, recommended initial and target dosage is 5 mg twice
