ASENAPINE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

ASENAPINE (UNII: JKZ19V908O) (ASENAPINE - UNII:JKZ19V908O)

Disponible des:

Alembic Pharmaceuticals Inc.

Vía de administración:

SUBLINGUAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 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 exposure registry that monitors pregnancy outcomes in women exposed to asenapine during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk  Summary Neonates exposed to a

Resumen del producto:

Asenapine sublingual tablets are supplied as: 2.5 mg Tablets: White to off white, round tablets debossed with ‘L’ on one side and ‘70’ on the other side. Cartons of 60 - 6 blister cards of 10 tablets each       NDC 62332-544-60 Cartons of 100 - 10 blister cards of 10 tablets each   NDC 62332-544-31 5-mg Tablets:  White to off white, round tablets debossed with “464” on one side and plain on other side. Cartons of 60 - 6 blister cards of 10 tablets each       NDC 62332-198-60 Cartons of 100 - 10 blister cards of 10 tablets each  NDC 62332-198-31 10-mg Tablets: White to off white, round tablets debossed with “465” on one side and plain on other side. Cartons of 60 - 6 blister cards of 10 tablets each       NDC 62332-199-60 Cartons of 100 - 10 blister cards of 10 tablets each  NDC 62332-199-31   Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ASENAPINE - ASENAPINE TABLET
ALEMBIC PHARMACEUTICALS INC.
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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 IS NOT APPROVED FOR THE
TREATMENT OF PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS. (5.1, 5.2)
INDICATIONS AND USAGE
Asenapine is an atypical antipsychotic indicated for (1): (1)
Bipolar I disorder
o Acute monotherapy treatment of manic or mixed episodes, in pediatric
patients 10 to 17
years of age (1)
o Adjunctive treatment to lithium or valproate in adults (1)
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 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)
DOSAGE FORMS AND STRENGTHS
Sublingual tablets: 2.5 mg, 5 mg and 10 mg (3) (3)
CONTRAINDICATIONS
• Severe hepatic impairment (Child-Pugh C). (8.7, 12.3)
• Known hypersensitivity to asenapine, or to any components in the
formulation. (4, 5.6, 17)
(4)
WARNINGS AND PRECAUTIONS
_• Cerebrovascular Adverse Reactions in Elderly Patients with
Dementia-Related Psychosis: _Increased
incidence of