ASENAPINE- asenapine maleate tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ASENAPINE MALEATE (UNII: CU9463U2E2) (ASENAPINE - UNII:JKZ19V908O)

Boleh didapati daripada:

Breckenridge Pharmaceutical, Inc.

Laluan pentadbiran:

SUBLINGUAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Asenapine sublingual tablets are indicated for: - Schizophrenia in adults [see Clinical Studies (14.1)] - Bipolar I disorder [see Clinical Studies (14.2)] Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age Adjunctive treatment to lithium or valproate in adults Maintenance monotherapy treatment in adults - Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age - Adjunctive treatment to lithium or valproate in adults - Maintenance monotherapy treatment in adults Asenapine sublingual tablets are 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)]. Pregnancy Exposure Registry There is a pregnancy

Ringkasan produk:

Asenapine sublingual tablets are supplied as: Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

ASENAPINE- ASENAPINE MALEATE TABLET
BRECKENRIDGE PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ASENAPINE SUBLINGUAL
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ASENAPINE SUBLINGUAL
TABLETS.
ASENAPINE SUBLINGUAL TABLETS
INITIAL U.S. APPROVAL: 2009
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE
AT AN INCREASED RISK OF DEATH. ASENAPINE SUBLINGUAL TABLETS ARE NOT
APPROVED FOR THE
TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1, 5.2)
RECENT MAJOR CHANGES
Indications and Usage (1)
01/2017
Dosage and Administration (2.3)
01/2017
Contraindications (4)
01/2017
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.7, 5.9, 5.10,
5.11, 5.12, 5.13, 5.14,
5.15)
01/2017
Warnings and Precautions (5.8)
02/2017
INDICATIONS AND USAGE
Asenapine sublingual tablets are an atypical antipsychotic indicated
for (1):
Schizophrenia in adults
Bipolar I disorder
Acute monotherapy treatment of manic or mixed episodes, in adults and
pediatric patients 10 to 17
years of age
Adjunctive treatment to lithium or valproate in adults
Maintenance monotherapy treatment in adults
DOSAGE AND ADMINISTRATION
STARTING DOSE
RECOMMENDED
DOSE
MAXIMUM DOSE
Schizophrenia – acute treatment in adults
(2.2)
5 mg sublingually
twice daily
5 mg sublingually
twice daily
10 mg sublingually
twice daily
Schizophrenia – maintenance treatment in
adults (2.2)
5 mg sublingually
twice daily
5-10 mg sublingually
twice daily
10 mg sublingually
twice daily
Bipolar mania-adults: acute and
maintenance monotherapy (2.3)
5-10 mg
sublingually twice
daily
5-10 mg sublingually
twice daily
10 mg sublingually
twice daily
Bipolar mania – pediatric patients (10 to 17
years): monotherapy (2.3)
2.5 mg sublingually
twice daily
2.5-10 mg
sublingually twice
daily
10 mg sublingually
twic