Secuado Film
Generic name:asenapine
Dosage form: film, extended release
Drug class:Atypical antipsychotics
Medically reviewed by Drugs.com. Last updated on Jan 1, 2022.
On This Page
- Boxed Warning
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Drug Abuse and Dependence
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SECUADO is not approved for the treatment of patients with dementia-related psychosis [ see Warnings and Precautions (5.1)].
Indications and Usage for Secuado Film
SECUADO is indicated for the treatment of adults with schizophrenia [ see Clinical Studies (14)].
Secuado Film Dosage and Administration
Schizophrenia
Initiate SECUADO at a dosage of 3.8 mg/24 hours. In a short-term, placebo-controlled trial, there was no suggestion of added benefit at a dosage of 7.6 mg/24 hours, on average, but there was an increase in certain adverse reactions. The dosage may be increased to 5.7 mg/24 hours or 7.6 mg/24 hours, as needed, after one week. The safety of doses above 7.6 mg/24 hours has not been evaluated in clinical studies [ see Clinical Studies (14)].
Based on the average exposure (AUC) of asenapine, SECUADO 3.8 mg/24 hours corresponds to 5 mg twice daily of sublingual asenapine and SECUADO 7.6 mg/24 hours corresponds to 10 mg twice daily of sublingual asenapine [ see Clinical Pharmacology (12.3)].
Important Application Instructions
- See the FDA-approved patient labeling ( Instructions for Use<...
